Central Nervous System / Behavioral Health

Prior Authorization for stimulants is required for all tiers for members greater than 20 years of age and for members 0-4 years of age. All prior authorization requests for members under the age of 5 years must be reviewed by an OHCA or SoonerSelect Health contracted psychiatrist.

Tier 2 Prior Authorization Approval Criteria:

• A covered diagnosis; AND 
• A previously failed trial with at least one long-acting Tier-1 stimulant that resulted in an inadequate response:
  • Trials should have been within the last 180 days; AND 
  • Trials should have been dosed up to maximum recommended dose or documented adverse effects at higher doses should be included; AND  
  • If trials are not in member’s claim history, the pharmacy profile should be submitted or detailed information regarding dates and doses should be included along with the signature from the physician.
• For Quillivant XR^®, an age restriction of 10 years and younger will apply. Members older than 10 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed.
• Kapvay^® [Clonidine Extended-Release (ER) Tablet] Approval Criteria: 
  • An FDA approved diagnosis; and
  • Previously failed trials (within the last 180 days) with a long-acting Tier-1 stimulant, Intuniv^®, and Strattera^®, unless contraindicated, that did not yield adequate results; and
  • A patient-specific, clinically significant reason why the member cannot use clonidine immediate-release tablets must be provided.

Tier 3 Prior Authorization Approval Criteria:

• A covered diagnosis; AND 
• A previously failed trial with at least one long-acting Tier-1 stimulant that resulted in an inadequate response; AND 
• A previously failed trial with at least one Tier-2 stimulant that resulted in an inadequate response:
  • Trials should have been within the last 365 days; AND 
  • Trials should have been dosed up to maximum recommended dose or documented adverse effects at higher doses should be included; AND  
  • If trials are not in member’s claim history, the pharmacy profile should be submitted or detailed information regarding dates and doses should be included along with the signature from the physician.  
• For Dyanavel^® XR oral suspension, an age restriction of 10 years and younger will apply. Members older than 10 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed. 

ADHD Medications Special Prior Authorization (PA) Approval Criteria: 

Adzenys XR-ODT™, Adzenys ER™ Suspension, Cotempla XR-ODT™, Evekeo ODT™, QuilliChew ER^®, and Xelstrym™ Approval Criteria:  

• FDA approved diagnosis; AND
• A patient-specific, clinically significant reason why member cannot use all other available formulations of stimulant medications that can be used for members who cannot swallow capsules/tablets; AND
• An age restriction of ten years and younger will apply.  Members older than ten years of age will require a patient-specific, clinically significant reason why a special formulation product is needed. 

Desoxyn®, Dexedrine®, Evekeo®, Methylphenidate ER 72mg Tablet, ProCentra® ,Relexxii®, and Zenzedi® Criteria:

• Covered diagnosis; AND 
• A patient-specific, clinically significant reason why member cannot use all other available stimulant medications.

Methylin® Chewable Tablets Criteria:

• A covered diagnosis; AND
• A patient-specific, clinically significant reason why the member cannot use methylphenidate immediate-release tablets must be provided; AND
• An age restriction of 10 years and younger will apply. Members older than 10 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed.

Mydayis™ Criteria:

• An FDA approved diagnosis; AND
• Member must be 13 years of age or older; AND
• A patient-specific, clinically significant reason why the member cannot use all other available stimulant medications. 

Qelbree™ [Viloxazine Extended-Release (ER) Capsule] Approval Criteria:

• An FDA approved diagnosis; and
• Member must be 6 of age; and
• Previously failed trials (within the last 180 days) with atomoxetine or any 2 Tier-1 or Tier-2 ADHD medications, unless contraindicated, that did not yield adequate results; and
  • Qelbree™ will not require a prior authorization and claims will pay at the point of sale if the member has paid claims for atomoxetine or 2 Tier-1 or Tier-2 ADHD medications within the past 180 days of claims history; and
• Member must not be taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the last 14 days; and
• Member must not be taking sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (e.g., alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline) concomitantly with Qelbree™; and
• Quantity limits will apply based on FDA-approved dosing.

Narcolepsy Medications Approval Criteria:

• An FDA approved diagnosis; AND  
• Use of Lumryz™ (sodium oxybate), Sunosi^® (solriamfetol), Wakix^® (pitolisant), Xyrem^® (sodium oxybate), or Xywav^® (calcium/magnesium/potassium/sodium oxybates) requires previously failed trials (within the last 180 days) with Tier-1 and Tier-2 stimulants from different chemical categories, Provigil^®, and Nuvigil^®, unless contraindicated, that did not yield adequate results; AND
  • Xyrem^® is brand preferred. Requests for generic sodium oxybate will require a patient-specific, clinically significant reason (beyond convenience) why brand name Xyrem^® cannot be used; AND
• Additionally, use of Lumryz™ (sodium oxybate) or Xywav^® (calcium/magnesium/potassium/sodium oxybates) requires a patient-specific, clinically significant reason (beyond convenience) why the member cannot use Xyrem^®; AND
  • For members requesting Xywav^® due to lower sodium content in comparison to Xyrem^®, a patient-specific, clinically significant reason why the member requires a low-sodium product must be provided; AND
• The diagnosis of obstructive sleep apnea (OSA) requires concurrent treatment for the obstructive sleep apnea; AND
• The diagnosis of shift work sleep disorder requires the member’s work schedule to be included with the prior authorization request. 

Idiopathic Hypersomnia (IH) Medications Approval Criteria:

• Diagnosis of IH meeting the following ICSD-3 (International Classification of Sleep Disorders) criteria:
  • Daily periods of irresistible need to sleep or daytime lapses into sleep for >3 months; and
  • Absence of cataplexy; and
  • Multiple sleep latency test (MSLT) results showing 1 of the following:
    • <2 sleep-onset rapid eye movement (REM) periods (SOREMPs); or
    • No SOREMPs if the REM sleep latency on the preceding polysomnogram is ≤15 minutes; and
  • At least 1 of the following:
    • MSLT showing mean sleep latency ≤8 minutes; or
    • Total 24-hour sleep time ≥660 minutes on 24-hour polysomnography monitoring (performed after the correction of chronic sleep deprivation) or by wrist actigraphy in association with a sleep log (averaged over ≥7 days with unrestricted sleep); and
  • Insufficient sleep syndrome has been ruled out; and
  • Hypersomnolence or MSLT findings are not better explained by any other sleep disorder, medical or neurologic disorder, mental disorder, medication use, or substance abuse; and
• Diagnosis must be confirmed by a sleep specialist; and
• Use of Xyrem^® (sodium oxybate) or Xywav^® (calcium/magnesium/ potassium/sodium oxybates) requires previously failed trials (within the last 180 days) with at least 4 of the following, unless contraindicated, that did not yield adequate results:
  • Tier-1 stimulant; or
  • Tier-2 stimulant; or
  • Nuvigil^®; or
  • Provigil^®; or
  • Clarithromycin; and
• Xyrem^® is brand preferred. Requests for generic sodium oxybate will require a patient-specific, clinically significant reason why brand name Xyrem^® cannot be used; and
• Xywav^® (calcium/magnesium/potassium/sodium oxybates) additionally requires a patient-specific, clinically significant reason why the member cannot use Xyrem^®; and
  • For members requesting Xywav^® due to lower sodium content in comparison to Xyrem^®, a patient-specific, clinically significant reason why the member requires a low-sodium product must be provided.

ADHD & Narcolepsy Medications Additional Criteria:

• Doses exceeding 1.5 times the FDA maximum are not covered.
• Prior Authorization is required for all tiers for members greater than 20 years of age and for members 0-4 years of age.  All prior authorization requests for members under the age of 5 years must be reviewed by an OHCA or SoonerSelect Health plan contracted psychiatrist.
• For Daytrana® patches and Methylin® oral solution, and Vyvanse^® chewable tablet an age restriction of 10 years and younger will apply. Members older than 10 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed; and
  • Daytrana^® patches and Vyvanse^® chewable tablets are brand preferred. Approval of generic methylphenidate transdermal patches or lisdexamfetamine chewable tablets will require a patient-specific, clinically significant reason why brand name Daytrana^®  or Vyvanse® cannot be used.
• Vyvanse® (Lisdexamfetamine) Approval Criteria: Binge Eating Disorder (BED)
  • An FDA approved diagnosis of moderate-to-severe binge eating disorder; AND
  • Member must be 18 years or older; AND
  • Vyvanse®  for the diagnosis of BED must be prescribed by a psychiatrist; AND    
  • Authorizations will not be granted for the purpose of weight loss without the diagnosis of BED or for the diagnosis of obesity alone.  The safety and effectiveness of Vyvanse® for the treatment of obesity have not been established; AND
  • Vyvanse^® is brand preferred. Approval of generic lisdexamfetamine will require a patient-specific, clinically significant reason why brand name Vyvanse^® cannot be used; and
  • A quantity limit of 30 capsules per 30 days will apply; AND
• Initial approvals will be for the duration of three months.  Continued authorization will require prescriber documentation of improved response/effectiveness of Vyvanse®.
    

Prior Authorization form  

Second Opinion Process for Children 0-4 Years of Age and Unusual Dosing Requests

Children less than 5 years of age will require a "second opinion" prior authorization to be reviewed by an OHCA or SoonerSelect Health Plan-contracted child psychiatrist. Current users will be allowed to remain on current medication until the petition is submitted and reviewed. The second opinion process is as follows: Clinical pharmacist reviews petition for necessary information including diagnosis and behavioral information to submit to on-call OHCA or SoonerSelect Health Plan psychiatrist. On-call psychiatrist at OHCA or Health Plan reviews submitted prior authorization request. OHCA or SoonerSelect Health Plan responds back within 24 hours. Clinical pharmacist issues appropriate response for petition based on the results.

  

ADHD TIER CHART
Tier-1*	Tier-2*	Tier-3*	Special PA
Amphetamine Short-Acting			amphetamine ER susp (Adzenys ER™)** amphetamine ER ODT (Adenyls XR-ODT®) amphetamine (Evekeo®) amphetamine ODT (Evekeo ODT™) amphetamine/ dextroamphetamine ER (Mydayis®) dextroamphetamine (Dexedrine®) dextroamphetamine soln (ProCentra®) dextroamphetamine (Xelstrym™) dextroamphetamine (Zenzedi®) methamphetamine (Desoxyn®) methylphenidate ER 72mg methylphenidate ER ODT (Cotempla XR-ODT®) methylphenidate ER (Relexxii®) methylphenidate chew tab (Methylin®) methylphenidate ER chew tab (QuilliChew ER®) viloxazine (Qelbree®)∆
Adderall® (amphetamine/ dextroamphetamine)
Amphetamine Long-Acting
amphetamine/ dextroamphetamine ER (Adderall XR®) lisdexamfetamine cap and chew tab (Vyvanse®)+ -Brand Preferred	amphetamine ER tab (Dyanavel® XR) dextroamphetamine ER (Dexedrine Spansules®)	amphetamine ER susp (Dyanavel® XR)
Methylphenidate Short-Acting
Focalin® (dexmethylphenidate)
Methylin® (methylphenidate tab and soln)
Ritalin® (methylphenidate)
Methylphenidate Long-Acting
Focalin XR® (dexmethylphenidate ER) BRAND PREFERRED	dexmethylphenidate ER (generic Focalin XR®)	Adhansia XR™ (methylphenidate ER)
Metadate CD® (methylphenidate ER)	Aptensio XR™ (methylphenidate ER)	Jornay™ PM (methylphenidate ER)
methylphenidate ER (generic Concerta®)	methylphenidate ER susp (Quillivant XR®)	serdexmethylphen-idate/dexmethylphe-nidate (Azstarys™)
methylphenidate ER (Daytrana®) – Brand Preferred	methylphenidate ER (Ritalin LA®)
methylphenidate ER (Ritalin SR®)
methylphenidate ER (Metadate ER®)
methylphenidate ER (Methylin ER®)
Non-Stimulants
Intuniv® (guanfacine ER)	clonidine ER (Kapvay®)∆
Strattera® (atomoxetine)

*Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), or Wholesale Acquisition Costs (WAC) if NADAC unavailable. Products may be moved to a higher tier based on net cost if the manufacturer chooses not to participate in supplemental rebates.

**no products available for coverage by SoonerCare currently

⁺Unique criteria applies for the diagnosis of binge eating disorder (BED).

^∆Unique criteria applies in addition to tier trial requirements.

ADHD = attention-deficit/hyperactivity disorder; cap = capsule; chew tab = chewable tablet;

ER = extended-release; ODT = orally disintegrating tablet; PA = prior authorization; soln = solution; susp = suspension; tab = tablet

SECOBARBITAL (SECONAL SODIUM™)

Seconal Sodium™ (Secobarbital Sodium Capsule) Approval Criteria:    An FDA approved indication for 1 of the following: The short-term treatment of insomnia; OR A preanesthetic; AND   A patient-specific, clinically significant reason why the member cannot use other cost-effective therapeutic alternatives must be provided; AND or the short-term treatment of insomnia, a quantity limit of 1 capsule per day not to exceed 14 capsules per 30 days will apply.    Prior Authorization form

 

ROPINIROLE (REQUIP XL®) AND PRAMIPEXOLE (MIRAPEX ER®)
PA criteria: Diagnosis of Parkinson's Disease, and Clinically significant reason why the immediate release products cannot be used.  Prior Authorization form

   

DROXIDOPA (NORTHERA™)

PA criteria: An FDA approved diagnosis of symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy; AND Member must be 18 years of age or older; AND Member must have tried and failed two of the following medications at recommended dosing within the last 90 days: Midodrine; OR Fludrocortisone; OR Pyridostigmine; OR Have a contraindication to all preferred medications. Initial approval will be for the duration of two weeks of treatment only.  Continued approval will require the prescriber to provide information regarding improved member response/effectiveness of this medication to determine whether Northera™ is continuing to provide a benefit. Continued approval will be for the duration of three months.  Each approval will require prescriber documentation of member response/effectiveness to Northera™.  Prior Authorization form

• Prior Authorization is required for the following special formulation products:   
  • donepezil (Adlarity®) transdermal system
  • donepezil (Aricept®) and 23 mg tablets
  • rivastigmine (Exelon®) solution and patch
    
  • memantine (Namenda®) solution and tablets
  • galantamine (Razadyne®) solution and extended release capsules
• Member must have a documented reason why the special formulation is clinically necessary over the regular formulation
• Application of Age Restriction for ages 0-50 with the following approval criteria.  
• FDA approved diagnosis

memantine extended-release (ER) capsules (Namenda XR®) Approval Criteria:

• An FDA approved diagnosis for the treatment of moderate-to-severe Alzheimer’s type dementia; AND
• A patient-specific, clinically significant reason why the member cannot use memantine immediate-release tablets.

memantine er/donepezil (Namzaric™ ) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe Alzheimer’s type dementia; and
• Member must have a patient-specific, clinically significant reason why the separate immediate release products which do not require a prior authorization cannot be used in place of this combination product; AND
• A quantity limit of 30 capsules per 30 days will apply.

Aduhelm® (Aducanumab-avwa) Approval Criteria:

• An FDA approved diagnosis of mild cognitive impairment or mild dementia stage of Alzheimer’s disease [stage 3 or stage 4 Alzheimer’s disease based on the Global Deterioration Scale (GDS)]. Diagnosis must be confirmed by at least 2 of the following:
  • Mini-Mental State Exam (MMSE) score between 24 and 30; OR
  • Clinical Dementia Rating Global Score (CDR-GS) equal to 0.5; OR
  • Montreal Cognitive Assessment (MoCA) score ≥19; OR
  • Quick Dementia Rating System (QDRS) score ≤5; AND
• Member must have presence of amyloid pathology confirmed by a positive amyloid positron emission tomography (PET) scan or cerebral spinal fluid (CSF) test; AND
• Aduhelm® must be prescribed by, or in consultation with, a neurologist (or an advanced care practitioner with a supervising physician who is a neurologist); AND
• Other known medical or neurological causes of dementia have been ruled out (i.e., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Parkinson’s disease dementia); AND
• Member must not have brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities that increase the risk of hemorrhage; AND
• Prescriber must verify member and/or caregiver has been counseled on the risks of amyloid related imaging abnormalities (ARIA) that may occur and testing for ApoE ԑ4 status has been completed if appropriate; AND
• Member must not be taking anticoagulant or antiplatelet agents except for aspirin 325mg per day or less, and the prescriber must attest that the increased safety risks for developing ARIA with the concomitant use have been discussed and are acceptable to the member prior to initiating Aduhelm^®; AND
• Member must not have had a stroke or transient ischemic attack (TIA) or unexplained loss of consciousness in the past year; AND
• Member must not have any contraindications to brain magnetic resonance imaging (MRI) or PET scans; AND
• Member must not have any pre-treatment localized superficial siderosis, ≥10 brain microhemorrhages, or a brain hemorrhage >1cm within 1 year of treatment initiation as safety with Aduhelm® has not been established in patients with these conditions; AND
• Member must have a recent (within 1 year) brain MRI prior to initiating treatment with Aduhelm® and prior to the 7th infusion (1st dose of 10mg/kg) and 12th infusion (6th dose of 10mg/kg); AND
• The prescriber must confirm that the member will be monitored for amyloid-related imaging abnormalities (ARIA) during the first 8 doses of treatment with Aduhelm®, particularly during titration, and also throughout treatment; AND
• If ≥10 new incident microhemorrhages or >2 focal areas of superficial siderosis [radiographic severe amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H)] are observed on MRI, prescriber must confirm that treatment will be continued with caution and only after a clinical evaluation and a follow-up MRI demonstrating radiographic stabilization (i.e., no increase in size or number of ARIA-H); AND
• Aduhelm^® must be administered by a health care professional in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Approvals will not be granted for self-administration; AND
  • Aduhelm^® must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment and stored in the refrigerator; AND
• Member’s weight must be provided and have been taken within the last 4 weeks to ensure accurate weight-based dosing; AND
• A patient-specific, clinically significant reason why the member cannot use Leqembi™ (lecanemab-irmb) must be provided; AND 
• Initial approvals will be for 6 months. Confirmation that MRI has been completed and is acceptable to the provider prior to 7th infusion is required for continuation; AND
• Subsequent approvals will be for 6 months and prescriber must document that the member has responded well to therapy compared to pretreatment baseline status as evidenced by improvement, stability, or slowing in cognitive and/or functional impairment using the same baseline test(s) performed at initiation of therapy; AND
• Approval quantities will be dependent on the member’s weight and dosing based on the Aduhelm® Prescribing Information; AND
• The maximum dose approvable is 10mg/kg per 28 days; and
• Approvals will not be granted for concurrent use with other amyloid beta-directed monoclonal antibodies. 

Leqembi™ (Lecanemab-irmb) Approval Criteria:

• An FDA approved diagnosis of mild cognitive impairment or mild dementia stage of Alzheimer’s disease [stage 3 or stage 4 Alzheimer’s disease based on the Global Deterioration Scale (GDS)]. Diagnosis must be confirmed by at least 2 of the following:
  • Mini-Mental State Exam (MMSE) score between 22 and 30; or
  • Clinical Dementia Rating Global Score (CDR-GS) equal to 0.5 or 1; or
  • Montreal Cognitive Assessment (MoCA) score ≥19; or
  • Quick Dementia Rating System (QDRS) score ≤5; and
• Member must have presence of amyloid pathology confirmed by a positive amyloid positron emission tomography (PET) scan or cerebral spinal fluid (CSF) test; and
• Leqembi™ must be prescribed by, or in consultation with, a neurologist (or an advanced care practitioner with a supervising physician who is a neurologist); and
• Other known medical or neurological causes of dementia have been ruled out (i.e., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Parkinson’s disease dementia); and
• Member must not have brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities that increase the risk of hemorrhage; and
• Prescriber must verify member and/or caregiver has been counseled on the risks of amyloid related imaging abnormalities (ARIA) that may occur and testing for ApoE ԑ4 status has been completed if appropriate; and
• Member must not be taking anticoagulant or antiplatelet agents except for aspirin or clopidogrel, and the prescriber must attest that the increased safety risks for developing intracerebral hemorrhage with the concomitant use have been discussed and are acceptable to the member prior to initiating Leqembi™; and
• Member must not have had a stroke, transient ischemic attack (TIA), or unexplained loss of consciousness in the past year; and
• Member must not have any contraindications to brain magnetic resonance imaging (MRI) or PET scans; and
• Member must not have risk factors for intracerebral hemorrhage, including the following:
  • Prior cerebral hemorrhage >1cm in greatest diameter; or
  • >4 microhemorrhages; or
  • An area of superficial siderosis; or
  • Evidence of vasogenic edema; or
  • Evidence of cerebral contusion, aneurysms, vascular malformations, or infective lesions; or
  • Evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; and
• Member must have a recent (within 1 year) brain MRI prior to initiating treatment with Leqembi™ and prior to the 5th, 7th, and 14th infusions; and
• Prescriber must confirm that the member will be monitored for ARIA during the first 14 weeks and throughout treatment with Leqembi™; and
• If ≥10 new incident microhemorrhages or >2 focal areas of superficial siderosis [radiographic severe amyloid related imaging abnormalities-hemosiderin deposition (ARIA-H)] are observed on MRI, prescriber must confirm that treatment will be continued with caution and only after a clinical evaluation confirming resolution of symptoms, if present, and a follow-up MRI demonstrating radiographic stabilization (i.e., no increase in size or number of ARIA-H) have been completed; and
• Leqembi™ must be administered by a health care professional in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Approvals will not be granted for self-administration; and
  • Leqembi™ must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment and stored in the refrigerator; and
• Member’s weight must be provided and have been taken within the last 4 weeks to ensure accurate weight-based dosing; and
• Initial approvals will be for 6 months. Confirmation that MRIs have been completed and were acceptable to the provider prior to the 5th and 7th infusions is required for continuation; and
• Subsequent approvals will be for 6 months, and prescriber must document that the member has responded well to therapy compared to pretreatment baseline status as evidenced by improvement, stability, or slowing in cognitive and/or functional impairment using the same baseline test(s) performed at initiation of therapy for each subsequent approval; and
• Approval quantities will be dependent on the member’s weight and dosing based on package labeling; and
• The maximum dose approvable is 10mg/kg per 14 days; and
• Approvals will not be granted for concurrent use with other amyloid beta-directed monoclonal antibodies.

 Prior Authorization form  

Qalsody^® (Tofersen) Approval Criteria:

• An FDA approved diagnosis of amyotrophic lateral sclerosis (ALS); and
• Member must have a confirmed pathogenic mutation in the superoxide dismutase 1 (SOD1) gene (results of genetic testing must be submitted); and
• Member must have weakness attributable to ALS; and
• Member must be 18 years of age or older; and
• Must be prescribed by a neurologist or other specialist with expertise in the treatment of ALS (or an advanced care practitioner with a supervising physician who is a neurologist or other specialist with expertise in the treatment of ALS); and
• Must be administered in a health care facility by a specialist experienced in performing lumbar punctures; and
  • Qalsody^® must be shipped to the facility where the member is scheduled to receive treatment; and
• Approvals will be for the duration of 6 months. For each subsequent approval, the prescriber must document the member is responding to the medication, as indicated by a slower progression in symptoms and/or slower decline in quality of life compared to the typical ALS disease progression.

edaravone (Radicava™) and Radicava ORS® (Edaravone Oral Suspension) Approval Criteria: 

• An FDA approved diagnosis of amyotrophic lateral sclerosis (ALS); AND
• Member must have been evaluated by a physician specializing in the treatment of ALS within the last three months; AND
• Disease duration of two years or less (for initial approval); AND  
  • A prior authorization request with patient-specific information may be submitted for consideration of edaravone for members with disease duration greater than two years, including but not limited to disease progression, specific symptoms related to the disease, activities of daily living currently affected by the disease, or prognosis; AND  
• Approvals will be for the duration of six months.  For each subsequent approval, the prescriber must document that the member is responding to the medication, as indicated by a slower progression in symptoms and/or slower decline in quality of life compared to the typical ALS disease progression.  

riluzole oral film and suspension (Exservan™ and Tiglutik®) Approval Criteria: 

• An FDA approved indication for the treatment of amyotrophic lateral sclerosis (ALS); AND
• A patient-specific, clinically significant reason why the member cannot use riluzole tablets, even when tablets are crushed, must be provided; AND
• A quantity limit of 20mL per day or 600mL per 30 days will apply for Tiglutik®; AND
• A quantity limit of 2 films per day or 60 films per 30 days will apply for Exservan™.

Rilutek^® (Riluzole Oral Tablet) Approval Criteria:

• An FDA approved diagnosis of amyotrophic lateral sclerosis (ALS); and
• Must be prescribed by a neurologist or other specialist with expertise in the treatment of ALS (or an advanced care practitioner with a supervising physician who is a neurologist or other specialist with expertise in the treatment of ALS); and
• A quantity limit of 60 tablets per 30 days will apply.

Tier 1 products available with no authorization necessary

Tier 2 Authorization Criteria:

• A documented, recent (within six months) trial of two Tier-1 medications at least four weeks in duration and titrated to recommended dosing, that did not provide an adequate response. Tier-1 selection must include at least one medication from the SSRI category; OR
• Prior stabilization on the Tier-2 medication documented within the last 100 days. A past history of success on the Tier-2 medication will also be considered with adequate documentation; OR
• A unique FDA-approved indication not covered by Tier-1 products or other products from a different therapeutic class; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
  

Tier 3 Authorization Criteria

• A documented, recent (within six months) trial with two Tier-1 medications (Tier-1 selection must include at least one medication from the SSRI category) and a Tier-2 medication at least four weeks in duration and titrated to recommended dose, that did not provide an adequate response; OR
• Prior stabilization on the Tier-3 medication documented within the last 100 days.  A past history of success on the Tier-3 medication will also be considered with adequate documentation; OR
• A unique FDA-approved indication not covered by a lowered tiered product or other products from a different therapeutic class; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
  

Special Criteria:

• Use of any Special PA product will require a patient-specific, clinically significant reason why the member cannot use other available generic Tier-1 products; OR
• A petition may be submitted for consideration whenever a unique patient-specific situation exists.
• Tier structure rules still apply.

When Irenka™ (duloxetine 40mg) is being requested for non-depression related diagnoses, the criteria below will apply:  

• An FDA approved diagnosis of diabetic peripheral neuropathy or chronic musculoskeletal pain; AND
• A patient-specific, clinically significant reason why the member cannot use two duloxetine 20mg capsules in place of Irenka™ 40mg capsules; AND    
• A quantity limit of 30 capsules per 30 days will apply. 

Marplan® (Isocarboxazid) Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use any of the Tier-3 monoamine oxidase inhibitors (MAOIs) or other cost-effective, lower tiered alternatives in place of Marplan®. Tier structure rules still apply. 

Sertraline Capsule Approval Criteria:

• An FDA approved indication of major depressive disorder (MDD) in adults or obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years of age and older; and
• Member must have initiated treatment with sertraline tablets for dose titration up to the 150mg or 200mg dose; and
• A patient-specific, clinically significant reason why the member cannot use sertraline tablets, which are available without a prior authorization, in place of the capsule formulation must be provided; and
• A quantity limit of 30 capsules per 30 days will apply.

Venlafaxine 112.5mg Extended-Release (ER) Tablet Approval Criteria:

• An FDA approved diagnosis of major depressive disorder (MDD) or generalized anxiety disorder (GAD); AND
• Member must be 18 years of age or older; AND
• Member must have received at least 75mg of venlafaxine ER capsules for at least 4 days; AND
• A patient-specific, clinically significant reason why the member cannot use venlafaxine ER capsules must be provided; AND
• A quantity limit of 30 tablets per 30 days will apply.

Desyrel® (Trazodone 300mg Tablets) Approval Criteria:  

• A patient-specific, clinically significant reason why the member cannot use other available generic Tier-1 products including two trazodone 150mg tablets or three trazodone 100mg tablets to achieve a 300mg dose. 

Fluoxetine capsules will be preferred over fluoxetine tablets.

• Fluoxetine capsules will be available without a prior authorization. The tablet formulation will require prior authorization and reasoning why the tablet formulation is required in place of the capsule formulation.  

Auvelity™ (Dextromethorphan/Bupropion) Approval Criteria:

• An FDA approved diagnosis of major depressive disorder; AND
• Member must be 18 years of age or older; AND
• Prescriber must agree that member’s blood pressure will be assessed prior to treatment initiation and monitored periodically during treatment; AND
• Prescriber must agree to screen members for history of bipolar disorder, mania, or hypomania; AND
• Member must not be taking any other medications containing bupropion or dextromethorphan; AND
• Member must not have any contraindications to therapy (i.e., seizure disorder; current or prior diagnosis of bulimia or anorexia nervosa; abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; concomitant use of a monoamine-oxidase inhibitor (MAOI) or within 14 days of discontinuing an MAOI; known hypersensitivity to bupropion, dextromethorphan, or other components of Auvelity™); AND
• Member must not have severe hepatic or renal impairment; AND
• The maximum approvable dose is 1 tablet once daily if the member has moderate renal impairment, is taking a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, quinidine), or is a known poor CYP2D6 metabolizer; AND
• Prescribers must verify that female members are not currently pregnant and will use effective contraception while receiving treatment with Auvelity™; AND
• Member must have a documented, recent (within 6 months) trial with 2 Tier-1 medications (Tier 1 selection must include bupropion as 1 of the 2 trials), 1 Tier-2 medication, and 1 Tier-3 medication at least 4 weeks in duration each and titrated to recommended dosing, that did not provide an adequate response; OR
• Prior stabilization on the requested medication documented within the last 100 days. A history of success on the requested medication will also be considered with adequate documentation; AND
• A quantity limit of 60 tablets per 30 days will apply.

Citalopram 20mg/10mL, Escitalopram 10mg/10mL, and Fluoxetine 20mg/5mL Unit Dose Cups Approval Criteria:c

• An FDA approved indication; AND
• A patient-specific, clinically significant reason why the member cannot use the bulk medication must be provided.

Citalopram Capsule Approval Criteria:

• An FDA approved indication of major depressive disorder (MDD) in adults; and
• Member must have initiated treatment with citalopram tablets for dose titration up to the 30mg dose; and
• A patient-specific, clinically significant reason why the member cannot use citalopram tablets, which are available without prior authorization, in place of the capsule formulation must be provided; and
• Citalopram capsules will not be approved for members 60 years of age or older; and
• A quantity limit of 30 capsules per 30 days will apply.

Citalopram 20mg and 40mg Age Restriction:

• Doses of citalopram above 20mg are not covered for members older than 60 years of age due to an FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 20mg/day for those older than 60 years of age because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Prolongation of the QT interval of the electrocardiogram (ECG) can lead to a risk of an abnormal heart rhythm called Torsade de Pointes, which can be fatal

duloxetine Delayed-Release Capsule (Drizalma Sprinkle™) Approval Criteria [Diabetic Peripheral Neuropathy/Chronic Musculoskeletal Pain Diagnosis]:

• An FDA approved diagnosis of diabetic peripheral neuropathy or chronic musculoskeletal pain; AND
• A patient-specific, clinically significant reason why the member cannot use generic duloxetine 20mg, 30mg, or 60mg capsules, which are available without prior authorization, in place of Drizalma Sprinkle™ must be provided; AND
• A quantity limit of 30 capsules per 30 days will apply.

Prozac weekly (Fluoxetine DR) Approval Criteria:

• Clients currently stabilized on Prozac^® Weekly should be continued; and
• New start clients must meet all of the following criteria:
  • Client must have been stabilized on 20mg daily of fluoxetine for at least 12 weeks.
  • Start date should be 7 days after the last daily dose.
  • Client must have a compelling clinical reason for use of this convenience only medication. This medication should not be approved for patients in nursing homes or assisted living centers compliance/convenience should not be an issue.
• Prior authorization can be given for a 12 week supply per petition.
• The quantity limit for Prozac^® Weekly is 3 packs of 4 tablets each (12 week supply).

Spravato^® (Esketamine Nasal Spray) Approval Criteria [Depressive Symptoms in Adults with Major Depressive Disorder (MDD) with Acute Suicidal Ideation or Behavior Diagnosis]:

• An FDA approved indication of depressive symptoms in adults with MDD with acute suicidal ideation or behavior; and 
• Member must be 18 years of age or older; AND
• Spravato® must be used in conjunction with an oral antidepressant; AND  
• Prescriber must agree that member will be monitored by a health care provider for at least 2 hours after each administration; AND
• Prescriber must agree that member’s blood pressure will be monitored prior to and after administration of Spravato® in accordance with the Spravato® prescribing information; AND
• Member must not have any contraindications to therapy [i.e., aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation; intracerebral hemorrhage; hypersensitivity to esketamine, ketamine, or any of the excipients]; AND
• Member must not have severe hepatic impairment (Child Pugh C); AND
• Prescriber must verify that female members are not currently pregnant and will use effective contraception while receiving treatment with Spravato®; AND
• Prescriber must verify member is not breastfeeding; AND
• Pharmacy and health care setting must be certified in the Spravato® Risk Evaluation and Mitigation Strategy (REMS) program; AND
• Member must be enrolled in the Spravato® REMS program; AND
• Spravato® must be administered under the direct observation of a health care provider in a REMS certified health care setting; AND
• For initial approval, the number of doses the member received while hospitalized, if applicable, and the dates of these doses must be provided to allow authorization of the appropriate quantity for the initial 4 weeks of treatment; and
• For continued authorization, prescriber must verify member demonstrated an adequate response during the initial 4 weeks of treatment, verify member is using Spravato^® in combination with an oral antidepressant, and provide patient-specific, clinically significant information to support continued use of Spravato®; and
• A quantity limit of 8 kits per 28 days will apply.

Approval Criteria for Atypical Antipsychotics as Adjunctive Treatment for Major Depression Disorder:

• An FDA approved indication of treatment-resistant depression in adult; and
• Member must be 18 year of age or older; and
• Spravato^® must be used in conjunction with an oral antidepressant; and 
• Member must have had an inadequate response to at least 2 different antidepressants from different classes at least 4 weeks in duration each and titrated to recommended dosing during the current depressive episode, unless contraindicated or clinically significant adverse effects; and
• Prescriber must agree that member will be monitored by a health care provider for at least 2 hours after each administration; and 
• Prescriber must agree that member’s blood pressure will be monitored prior to and after administration of Spravato^® in accordance with the Spravato^® Prescribing Information; and
• Member must not have any contraindications to therapy [e.g., aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation; intracerebral hemorrhage; hypersensitivity to esketamine, ketamine, or any of the excipients]; and
• Member must not have severe hepatic impairment (Child Pugh C); and
• Prescriber must verify that female members are not currently pregnant and will use effective contraception while receiving treatment with Spravato^®; and
• Prescriber must verify female member is not breastfeeding; and 
• Pharmacy and health care setting must be certified in the Spravato^® Risk Evaluation and Mitigation Strategy (REMS) program; and 
• Member must be enrolled in the Spravato^® REMS program; and 
• Spravato^® must be administered under the direct observation of a health care provider in a REMS certified health care setting; and 
• Initial approvals will be for the duration of the induction phase. For continued authorization, prescriber must verify member demonstrated an adequate response during the induction phase and verify member is using Spravato^® in combination with an oral antidepressant; and
• A quantity limit of 4 kits per 28 days will apply for maintenance dosing. 

Authorization of Rexulti® (brexipiprazole) or Symbyax® (olanzapine/fluoxetine) for a diagnosis of major depression disorder requires current use of an antidepressant, and previous trials with at least two other antidepressants from both categories (an SSRI and duloxetine) and a trial of aripiprazole tablets that did not yield adequate response. Tier structure rules still apply (the member would have needed to try the Tier-2 atypical antipsychotics indicated for adjunctive treatment of MDD before trying a Tier-3).     

 Exxua™ (Gepirone) Approval Criteria:

• An FDA approved diagnosis of major depressive disorder (MDD); and
• Member must be 18 years of age or older; and
• Member must have a documented, recent (within 6 months) trial with 2 Tier-1 medications (Tier-1 selection must include at least 1 medication from the SSRI category), 1 Tier-2 medication, and 1 Tier-3 medication at least 4 weeks in duration each and titrated to recommended dosing, that did not provide an adequate response; and
• Member must not have any contraindications to Exxua™, including:
  • Prolonged QTc interval >450msec; and
  • Congenital long QT syndrome; and
  • Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin); and
  • Severe hepatic impairment; and
  • Concomitant use of a monoamine-oxidase inhibitor (MAOI) or within 14 days of discontinuing an MAOI; and
• A quantity limit of 30 tablets per 30 days will apply.

Zurzuvae™ (Zuranolone) Approval Criteria:

• An FDA approved diagnosis of moderate to severe postpartum depression (PPD); and
• Member must be ≤12 months postpartum and the date of delivery must be provided; and
• Member must be a female 18 years of age or older; and
• Prescriber must verify the following:
  • Member has been counseled on the proper administration of Zurzuvae™ including taking with a fat-containing meal; and
  • Member has been counseled on the central nervous system (CNS) depression effects of Zurzuvae™ and the member agrees not to drive or engage in other potentially hazardous activities until at least 12 hours after administration; and
  • Member is not currently pregnant and will use effective contraception while receiving treatment and for 7 days after the last dose of Zurzuvae™; and
  • Member is not breastfeeding or has agreed to temporarily hold breastfeeding during Zurzuvae™ therapy and for 7 days after the last dose; or
  • If the member does not agree to cease breastfeeding, the following must be provided:
    • Prescriber attests that the benefits of Zurzuvae™ therapy while breastfeeding outweigh the risks to the infant due to studies showing that Zurzuvae™ is present in breastmilk; and
    • Member has been counseled on the potential risks of CNS depression effects that may occur in the infant; and
• Dosing and approval duration will be limited to the following:
  • 50mg once daily for 14 days; or
  • Form members with severe hepatic impairment, moderate to severe renal impairment, or concomitant use with CYP3A4 inhibitors:
    • 30mg once daily for 14 days; and
  • If a dose reduction to 40mg once daily is required due to CNS depression effects, the prescriber should contact the specialty pharmacy that filled the member’s initial Zurzuvae™ prescription to obtain the 20mg capsules from the manufacturer for the remainder of the members treatment course; and
• Approvals will be for 1 treatment course.        
  

 Prior Authorization form

Tier 1	Tier 2	Tier 3	Special PA
Selective Serotonin Reuptake Inhibitors (SSRIs)
citalopram tabs & sol (Celexa®) escitalopram tabs & sol (Lexapro®) fluoxetine caps & sol (Prozac®) fluvoxamine (Luvox®) paroxetine (Paxil®) sertraline tabs & sol (Zoloft®)			citalopram 30mg capsules* fluoxetine tablets* fluoxetine DR (Prozac® Weekly™)* fluvoxamine CR (Luvox CR®) paroxetine CR (Paxil CR®) Sertraline 150mg & 200mg caps*
Dual Acting Antidepressants
bupropion (Wellbutrin®, Wellbutrin SR®,  Wellbutrin XL®) duloxetine (Cymbalta ®) mirtazapine (Remeron®, Remeron SolTab®) trazodone 50mg, 100mg, & 150mg tabs (Desyrel®) venlafaxine (Effexor®, Effexor XR® capsules) venlafaxine ER 37.5mg, 75mg, & 150 mg tabs (Effexor XR®)	desvenlafaxine (Pristiq®)	desvenlafaxine (Khedezla®) levomilnacipran (Fetzima®)  nefazodone (Serzone®) vilazodone (Viibryd®)	bupropion ER (Aplenzin®, Forfivo XL®) duloxetine 40mg (Irenka™)* duloxetine (Drizalma Sprinkle™)* trazodone 300mg tablet (Desyrel®)* venlafaxine 112.5mg ER tabs* venlafaxine ER 225mg tablets (Effexor XR®)
Monoamine Oxidase Inhibitors (MAOIs)
		phenelzine (Nardil®) selegiline (Emsam®) tranylcypromine(Parnate®)	isocarboxazid (Marplan®)*
Unique Mechanisms of Action
		vortioxetine (Trintellix®)	dextromethorphan/ bupropion (Auvelity™)* esketamine nasal spray (Spravato™)* gepirone (Exxua™)* zuranolone (Zurzuvae™)*

*Unique criteria applies.

PAROXETINE MESYLATE (BRISDELLE®)

PA Criteria: An FDA approved diagnosis of moderate to severe vasomotor symptoms associated with menopause; AND Approvals for Brisdelle® will not be granted for psychiatric indications; AND Member must not have any of the contraindications for use of Brisdelle®; AND Two previous trials with either a selective serotonin reuptake inhibitor (SSRI) or a selective serotonin norepinephrine reuptake inhibitor (SNRI) or both, or a patient-specific, clinically significant reasoning why a SSRI or SNRI is not appropriate for the member; AND Authorization requires a patient-specific, clinically significant reason why paroxetine 10mg is not appropriate for the member; AND   A quantity limit of 30 capsules per 30 days will apply.  Prior Authorization form

 

• Anticonvulsants will be included in the current mandatory generic plan.
  • All brand-name anticonvulsants (with a generic equivalent) will require prior authorization.
• Prior authorization will be required for certain non-standard dosage forms of medications when the drug is available in standard dosage forms.
  • Members 12 and older must have a documented medical reason demonstrating need for non-standard dosage forms.
  • Criteria for approval of extended-release formulation. 
    • Previously stabilized on the short-acting formulation.
      
    • Dosing is not more than once daily.
    • Member must provide a reason why the short-acting formulation is not adequate.
  • Dose packs will not be approved if standard dosage forms are available.
• Quantity limit restrictions will be placed on lower strength tablets and capsules. The highest strengths will continue to have no quantity restrictions unless a maximum dose is specified for a particular medication.

Prior Authorization form

brivaracetam (Briviact®)
PA Criteria: An FDA approved indication for the treatment of partial-onset seizures; AND Initial prescription must be written by a neurologist; AND Member must have failed therapy with at least 3 other anticonvulsants; AND Members currently stable on Briviact® and who have a seizure diagnosis will be grandfathered; AND For Briviact® oral solution, an age restriction of 12 years and younger will apply. Members older than 12 years of age will require a patient-specific, clinically significant reason why the member cannot take the oral tablet formulation; AND Approval length for Briviact® injection will be for a maximum of seven days of therapy.  Further approval may be granted if prescriber documents an ongoing need for Briviact® intravenous (IV) therapy over oral Briviact® formulations. Prior Authorization form
cannabidiol Oral Solution (epidiolex®)
PA Criteria: Diagnosis of 1 of the following: Lennox-Gastaut syndrome (LGS); OR   Dravet syndrome; OR Tuberous sclerosis complex (TSC)-associated seizures; OR Intractable epilepsy; AND *The manufacturer has provided a supplemental rebate to allow Epidiolex claims to pay at the point of sale if the member has a reported diagnosis of LGS, Dravet syndrome, TSC-associated seizures, or intractable epilepsy within the past 12 months of claims history; however, Epidiolex will follow the original criteria if the manufacturer chooses not to participate in supplemental rebates.   Member must be 1 year of age or older; AND Members currently stable on Epidiolex® and who have a seizure diagnosis will be grandfathered.  Prior Authorization form
cenobamate (Xcopri®)
PA Criteria: An FDA approved diagnosis of partial-onset seizures; AND Initial prescription must be written by a neurologist; AND Member must have failed therapy with at least 3 other anticonvulsants. Prior Authorization form
clobazam Oral Film (Sympazan™)
PA Criteria: An FDA approved indication of adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in members 2 years of age and older; AND Previous failure of at least 2 non-benzodiazepine anticonvulsants; AND Previous failure of clonazepam; AND A patient-specific, clinically significant reason why the member cannot use clobazam oral tablets or clobazam oral suspension must be provided; AND Initial approvals will be for the duration of 3 months.  For continuation, the prescriber must include information regarding improved response/effectiveness of the medication. Prior Authorization form
Elepsia™ XR
Elepsia™ XR [Levetiracetam Extended-Release (ER) Tablet] Approval Criteria: An FDA approved diagnosis of partial-onset seizures; and A patient-specific, clinically significant reason (beyond convenience) why the member cannot use generic formulations of levetiracetam ER must be provided; and A quantity limit of 60 tablets per 30 days will apply.
Eprontia™
Eprontia™ (Topiramate Oral Solution) Approval Criteria: An FDA approved indication of 1 of the following: Partial-onset or primary generalized tonic-clonic (PGTC) seizures; or Adjunctive therapy in seizures associated with Lennox-Gastaut syndrome (LGS); or Prophylaxis of migraine headaches; and A patient-specific, clinically significant reason why the member cannot use topiramate tablets and sprinkle capsules must be provided; and An age restriction of 11 years of age and younger will apply. Members older than 11 years of age will require a patient-specific, clinically significant reason why a special formulation product is needed; and A quantity limit of 473mL per 29 days will apply.
eslicarbazeine acetate (Aptiom®)
PA criteria: An FDA approved diagnosis of partial-onset seizures; AND Member must not currently be taking oxcarbazepine (concurrent use is contraindicated); AND A patient-specific, clinically significant reason why member cannot use oxcarbazepine. A quantity limit of 30 per 30 days will apply on the lower strength tablets (200mg and 400mg) and 60 per 30 days on the higher strength tablets (600mg and 800mg).   Prior Authorization form
erolimus (Afinitor®)
Approval Criteria [Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures Diagnosis]: An FDA approved diagnosis of TSC-associated partial-onset seizures; AND Initial prescription must be written by a neurologist; AND Member must have failed therapy with at least three other medications commonly used for seizures; AND Afinitor® must be used as adjunctive treatment; AND The member must not be taking any P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) concurrently with Afinitor®; AND The member must not be taking St. John’s wort concurrently with Afinitor®; AND The prescriber must verify that Afinitor® trough levels and adverse reactions (e.g., non-infectious pneumonitis, stomatitis, hyperglycemia, dyslipidemia, thrombocytopenia, neutropenia, febrile neutropenia) will be monitored, and dosing changes or discontinuations will correspond with recommendations in the drug labeling; AND Verification from the prescriber that female members will use contraception while receiving Afinitor® therapy and for eight weeks after the last dose of Afinitor® and that male members with female partners of reproductive potential will use contraception receiving Afinitor® therapy and for four weeks after the last dose of Afinitor®; AND The member’s recent body surface area (BSA) must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling.  Initial approvals will be for the duration of three months. For continuation, the prescriber must include information regarding improved response/effectiveness of the medication. Prior Authorization - Afinitor PA
Felbatol® (Felbamate)
Felbatol® (Felbamate) Approval Criteria: Initial prescription must be written by a neurologist; and Member must have failed therapy with at least 3 other anticonvulsants.
Fintepla® (Fenfluramine)
Fintepla® (Fenfluramine) Approval Criteria: An FDA approved diagnosis of 1 of the following: Dravet syndrome; OR Lennox-Gastaut syndrome (LGS); AND Member must be 2 years of age or older; AND Initial prescription must be written by, or in consultation with, a neurologist; AND Member must not be taking monoamine oxidase inhibitors (MAOIs) within 14 days of administration of Fintepla®; AND Prescriber must verify the member’s blood pressure will be monitored; AND Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting Fintepla® therapy and throughout treatment; AND For a diagnosis of Dravet syndrome, member must have failed or be inadequately controlled with at least 2 other anticonvulsants; AND For a diagnosis of LGS, the member must have failed or be inadequately controlled with at least 3 other anticonvulsants; AND Pharmacy and prescriber must be certified in the Fintepla® Risk Evaluation and Mitigation Strategy (REMS) program; AND Member must be enrolled in the Fintepla® REMS program; AND Member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND Prescriber must verify that dose titration and maximum maintenance dose will be followed according to package labeling based on member weight and concomitant medications; AND Initial approvals will be for the duration of 3 months. For continuation, the prescriber must include information regarding improved response/effectiveness of the medication; AND A quantity limit of 360mL per 30 days will apply.
levetiracetam (Spritam®)
PA Criteria: An FDA approved diagnosis of partial-onset seizures, myoclonic seizures, or primary generalized tonic-clonic (PGTC) seizures; AND A patient-specific, clinically significant reason why the member cannot use generic formulations of levetiracetam.  A quantity limit of 60 tablets per 30 days will apply.  Prior Authorization form
Oxtellar XR® [Oxcarbazepine Extended-Release (ER)]
Oxtellar XR® [Oxcarbazepine Extended-Release (ER)] Approval Criteria: A patient-specific, clinically significant reason why the member cannot use the short-acting formulation must be provided; and A quantity limit of 30 tablets per 30 days will apply on the lower strength tablets (150mg and 300mg).
rufinamide (Banzel®)
PA Criteria: An FDA approved indication of adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut Syndrome; AND Initial prescription must be written by a neurologist; AND Member must have failed therapy with at least three other medications commonly used for seizures.  Authorization of generic rufinamide (in place of brand Banzel®) will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred); AND Members currently stable on Banzel® and who have a seizure diagnosis will be grandfathered.  Prior Authorization form
stiripentol (Diacomit®)
PA Criteria: An FDA approved indication of adjunctive therapy in the treatment of seizures associated with Dravet syndrome; AND Member must be 6 months of age or older and weigh ≥7kg; AND Initial prescription must be written by, or in consultation with, a neurologist; AND Member must have failed or be inadequately controlled with clobazam and valproate; AND Member must take clobazam and valproate concomitantly with Diacomit® or a reason why concomitant clobazam and valproate are not appropriate for the member must be provided; AND Members currently stable on Diacomit® and who have a seizure diagnosis will be grandfathered; AND The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND For Diacomit® powder for oral suspension, an age restriction of 12 years and younger will apply.  Members older than 12 years of age will require a patient-specific, clinically significant reason why the member cannot take the oral capsule formulation; AND Initial approvals will be for the duration of 3 months.  For continuation, the prescriber must include information regarding improved response/effectiveness of the medication. Prior Authorization form Motpoly XR™ [Lacosamide Extended-Release (ER) Capsule] Approval Criteria: An FDA approved diagnosis of partial-onset seizures; and Member must weigh ≥50kg; and A patient specific, clinically significant reason why the member cannot use the immediate-release tablets must be provided; and The following quantity limits will apply: Motpoly XR™ 100mg: 30 capsules per 30 days; or Motpoly XR™ 150mg and 200mg: 60 capsules per 30 days.
topiramate extended-release (Qudexy™XR)
PA criteria:  An FDA approved diagnosis of one of the following: partial onset or primary generalized tonic-clonic seizures; OR   As adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; OR Prophylaxis of migraine headache; AND   A member-specific, clinically significant reason why member cannot use the short-acting formulation, Topamax® (topiramate). A quantity limit of 30 per 30 days will apply on the lower strength capsules (25mg, 50mg, and 100mg) and 60 per 30 days on the higher strength capsules (150mg and 200mg).  Prior Authorization form
topiramate extended-release (Trokendi™XR)
PA criteria: An FDA approved diagnosis of one of the following: partial onset or primary generalized tonic-clonic seizures; OR   As adjunctive therapy in seizures associated with Lennox-Gastaut syndrome; OR Prophylaxis of migraine headache; AND A member-specific, clinically significant reason why member cannot use the short-acting formulation, Topamax® (topiramate); AND Members currently stable on Trokendi XR® (topiramate ER) and who have a seizure diagnosis will be grandfathered; AND A quantity limit of 30 per 30 days will apply on the lower strength capsules (25mg, 50mg, and 100mg) and 60 per 30 days on the higher strength capsules (200mg).  Prior Authorization form

Primidone 125mg Tablet Approval Criteria:

• An FDA approved diagnosis; and
• A patient-specific clinically significant reason why the member cannot split the 250mg tablet to achieve the 125mg dose must be provided.  

VIGABATRIN (SABRIL®)
PA Criteria: Consideration will be based on all of the following criteria (Brand Name Preferred):  FDA approved diagnosis of refractory complex seizures in adults and pediatric patients 2 years or older, OR infantile spasms in children ages 1 month to 2 years of age; AND Authorization of generic vigabatrin (in place of brand Sabril®) will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred); AND   Members with refractory complex seizures must have previous trials of at least three other antiepileptic medications; OR Prescription must be written by a neurologist; AND Member, prescriber, and pharmacy must all register in the SABRIL REMS program and maintain enrollment throughout therapy   Prior Authorization form
Zonisade™ (Zonisamide Oral Suspension)
Zonisade™ (Zonisamide Oral Suspension) Approval Criteria: An FDA approved indication of adjunctive treatment of partial-onset seizures; AND A patient-specific, clinically significant reason why the member cannot use zonisamide capsules must be provided; AND A quantity limit of 900mL per 30 days will apply.
Ztalmy® (Ganaxolone)
Ztalmy® (Ganaxolone) Approval Criteria: An FDA approved diagnosis of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD); AND Diagnosis must be confirmed by genetic testing identifying a mutation in the CDKL5 gene that is pathogenic or likely pathogenic; AND Member must be 2 years of age or older; AND The initial prescription must be written by, or in consultation with, a neurologist; AND Member must have failed at least 2 other anticonvulsants; AND Members currently stable on Ztalmy® and who have a CDD diagnosis confirmed by genetic testing will be approved for continuation of therapy; AND The member’s recent weight (kg), taken within the last 3 weeks, must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; AND Initial approvals will be for the duration of 3 months. For continuation, the prescriber must include information regarding improved response/effectiveness of the medication; AND Subsequent approvals will be for the duration of 1 year; AND A quantity limit of 1,100mL per 30 days will apply.

Tier 1 products are covered with no authorization necessary.

Tier 2 authorization requires:

• Trial of all available Tier 1 products with inadequate response or a patient-specific, clinically significant reason why a Tier-1 product is not appropriate for the member, OR
• Documented adverse effect to all the Tier 1 products, OR
• Previous success with a Tier 2 product within the last 60 days.

Tier 3 authorization requires:

• Trial of all available Tier 1 and Tier 2 products with inadequate response or a patient-specific, clinically significant reason why a lower tiered product is not appropriate for the member, OR
• Documented adverse effect to all the Tier 1 and Tier 2 products, OR
• Previous success with a Tier 3 medication within the last 60 days
• Use of any non-oral formulation will require a patient-specific, clinically significant reason why member cannot use the oral tablet formulation.

Anti-Migraine Medications Special Prior Authorization Approval Criteria:

• Use of any non-oral sumatriptan formulation will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation or lower-tiered triptan products. 
• Use of Zembrace™,SymTouch™, or Tosymra™ will require a patient-specific, clinically significant reason why the member cannot use all available generic formulations of sumatriptan (tablets, nasal spray, and injection) or lower-tiered triptan products. 
• Use of Migranal^® (dihydroergotamine nasal spray) will require a patient-specific, clinically significant reason why the member cannot use lower-tiered triptan products. 
• Use of D.H.E. 45^® (dihydroergotamine injection) or Trudhesa™ (dihydroergotamine nasal spray) will require a patient-specific, clinically significant reason why the member cannot use Migranal^® (dihydroergotamine nasal spray), and lower-tiered triptan medications.
• Use of ergotamine sublingual tablets (Ergomar®) will require a patient-specific, clinically significant reason why the member cannot use lower-tiered triptan medications; AND
  • Member must not have any of the contraindications for use of Ergomar® (e.g., coadministration with a potent CYP 3A4 inhibitor, women who are or may become pregnant, peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, sepsis, hypersensitivity to any of the components); AND
  • A quantity limit of 20 tablets per 28 days will apply.
• For use of Nurtec™ ODT [rimegepant orally disintegrating tablet (ODT)], Approval Criteria [Migraine Diagnosis (Acute Treatment)]⁺: member must have failed therapy with at least 2* triptan medications or a patient-specific, clinically significant reason why a triptan is not appropriate for the member must be provided; and
  • Nurtec™ ODT will not be approved for concurrent use with a prophylactic calcitonin gene-related peptide (CGRP) inhibitor; and
  • A quantity limit of 8 ODTs per 30 days will apply.
• Use of any non-oral zolmitriptan formulation will require a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation and lower-tiered triptan medications.
• Use of RizaFilm^® (rizatriptan film) will require a patient-specific, clinically significant reason why the member cannot use the ODT formulation and lower-tiered triptan medications.

(*The manufacturer of Nurtec™ ODT has currently provided a supplemental rebate to require a trial with 2 triptan medications and to be the preferred CGRP product for acute treatment over Reyvow^® ,Ubrelvy^®, and Zavzpret™ however, Nurtec™ ODT will follow the same criteria as Reyvow^® ,Ubrelvy^® , and Zavzpret™ if the manufacturer chooses not to participate in supplemental rebates.)

⁺Nurtec^® ODT approval criteria for the preventive treatment of episodic migraines can be found with the Aimovig^®, Qulipta™, and Vyepti^® approval criteria.

• Use of Reyvow™ (lasmiditan), Ubrelvy™ (ubrogepant), and Zavzpret™ (zavegepant nasal spray) will require a patient-specific, clinically significant reason why the member cannot use triptan medications and Nurtec™ ODT (rimegepant); and
  
  • Reyvow^®  , Ubrelvy^® , and Zavzpret™ will not be approved for concurrent use with a prophylactic calcitonin gene-related peptide (CGRP) inhibitor.

Prior Authorization form 

Nurtec® PA Form

 

ANTI-MIGRAINE
TIER 1	TIER 2	TIER 3	SPECIAL PA
ELETRIPTAN (RELPAX®)  naratriptan tablet (Amerge®) RIZATRIPTAN (MAXALT®, MAXALT MLT®) SUMATRIPTAN (IMITREX®) zolmitriptan tablet, ODT (Zomig®, Zomig-ZMT®)	frovatriptan tablet (Frova®)	ALMOTRIPTAN (AXERT®)  sumatriptan/ naproxen tablet (Treximet®)	DIHYDROERGOTAMINE INJECTION (D.H.E. 45®) DIHYDROERGOTAMINE NASAL SPRAY (MIGRANAL®)   ERGOTAMINE SUBLINGUAL TABLETS (ERGOMAR®)** LASMIDITAN (REYVOW™) RIMEGEPANT ODT (NURTEC™) ODT rizatriptan film (RizaFilm®) SUMATRIPTAN INJECTION (IMITREX®) SUMATRIPTAN INJECTION (ZEMBRACE™ SYMTOUCH™)*  SUMATRIPTAN NASAL POWDER (ONZETRA® XSAIL®) SUMATRIPTAN NASAL SPRAY (IMITREX®)  SUMATRIPTAN NASAL SPRAY (TOSYMRA™)  UBROGEPANT (UBRELVY™)  zolmitriptan nasal spray (Zomig® nasal spray) zavegepant nasal spray (Zavzpret™)

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

**no products available for coverage by SoonerCare currently

PA = prior authorization

Calcitonin Gene-related Peptide (CGRP)

Nurtec® ODT (Rimegepant)*, Qulipta™ (Atogepant)*, and Vyepti™ (Eptinezumab-jjmr) Approval Criteria:   An FDA approved indication for the preventive treatment of migraine in adults; AND Member must be 18 years of age or older; AND Member has documented chronic migraine or episodic migraine headaches:  Chronic migraine: 15 or more headache days per month with 8 or more migraine days per month; OR Episodic migraine: 4 to 14 migraine days per month on average for the past 3 months (*Nurtec® ODT is only FDA approved for the preventive treatment of episodic migraines); AND For episodic migraine, member must have had a history of migraines for a duration of 12 months or longer; AND   Member has been evaluated for red flags or possible indicators of secondary headache, as defined by the American Headache Society, and these conditions have been ruled out and/or have been treated; and  Migraine headache exacerbation secondary to other medication therapies or conditions have been ruled out and/or treated. This includes, but is not limited to:  Hormone replacement therapy or hormone-based contraceptives; AND Chronic insomnia; AND Obstructive sleep apnea; AND   The member has failed medical migraine preventive therapy with at least 3 agents with different mechanisms of action. Trials must be at least 8 weeks in duration (or documented adverse effects) within the last 365 days. This includes, but is not limited to:  Select antihypertensive therapy (e.g., beta-blocker therapy); OR Select anticonvulsant therapy; OR Select antidepressant therapy [e.g., tricyclic antidepressants (TCA), serotonin and norepinephrine reuptake inhibitors (SNRI)]; AND  Member is not frequently taking medications that are known to cause medication overuse headaches (MOH or rebound headaches) in the absence of intractable conditions known to cause chronic pain. MOH are a frequent cause of chronic headaches. A list of prescription or non-prescription medications known to cause MOH includes, but is not limited to:  Decongestants (alone or in combination products) (≥10 days/month for >3 months); AND Combination analgesics containing caffeine and/or butalbital (≥10 days/month for >3 months); AND Opioids (≥10 days/month for >3 months); AND Analgesic medications including acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) (≥15 days/month for >3 months); AND Ergotamine-containing medications (≥10 days/month for >3 months); AND Triptans (≥10 days/month for >3 months); AND   Member is not taking any medications that are likely to be the cause of the headaches; AND Member will not use requested medication concurrently with botulinum toxin for the prevention of migraine or with an alternative calcitonin gene-related peptide (CGRP) inhibitor; AND Other aggravating factors that are contributing to the development of episodic/chronic migraine headaches are being treated when applicable (e.g., smoking); AND For Vyepti®, prescriber must verify the medication will be prepared and administered according to the Vyepti® Prescribing Information; AND A patient-specific, clinically significant reason why member cannot use use Aimovig® (erenumab-aooe), Ajovy™ or Emgality® (galcanezumab-gnlm) must be provided (members currently taking Nurtec® ODT for acute migraine treatment are not exempt from this criteria requirement); AND  For consideration of Vyepti® at the maximum recommended dosing (300mg every 3 months), a patient-specific, clinically significant reason why other available CGRP inhibitors for migraine prophylaxis are not appropriate for the member must be provided; and Initial approvals will be for the duration of 3 months. Compliance and information regarding efficacy, such as a reduction in monthly migraine days, will be required for continued approval. Continuation approvals will be granted for the duration of 1 year; AND Quantity limits will apply based on FDA-approved dosing: For Nurtec® ODT, a quantity limit of 16 orally disintegrating tablets (ODTs) per 30 days will apply; and For Qulipta™, a quantity limit of 30 tablets per 30 days will apply; and For Vyepti®, a quantity limit of 3 vials per 90 days will apply. Aimovig® (Erenumab-aooe), Ajovy® (Fremanezumab-vfrm), and Emgality® (Galcanezumab-gnlm) Approval Criteria [Migraine Diagnosis]:* An FDA approved indication for the preventive treatment of migraine in adults; AND Member must be 18 years of age or older; AND Member has documented chronic migraine or episodic migraine headaches: Chronic migraine: 15 or more headache days per month with 8 or more migraine days per month; OR Episodic migraine: 4 to 14 migraine days per month on average for the past 3 months; AND For episodic migraine, member must have had a history of migraines for a duration of 12 months or longer; AND Member has been evaluated for red flags or possible indicators of secondary headache, as defined by the American Headache Society, and these conditions have been ruled out and/or have been treated; and  Migraine headache exacerbation secondary to other medication therapies or conditions have been ruled out and/or treated. This includes, but is not limited to:  Hormone replacement therapy or hormone-based contraceptives; AND Chronic insomnia; AND Obstructive sleep apnea; AND   The member has failed medical migraine preventive therapy with at least 2* agents with different mechanisms of action. Trials must be at least 8 weeks in duration (or documented adverse effects) within the last 365 days. (*The manufacturer of Ajovy® and Emgality® has currently provided a supplemental rebate to require a trial with 2 other migraine preventative therapies; however, Ajovy® and Emgality® will follow the original criteria and require trials with 3 other migraine preventative therapies if the manufacturer chooses not to participate in supplemental rebates.) This includes, but is not limited to:  Select antihypertensive therapy (e.g., beta-blocker therapy); OR Select anticonvulsant therapy; OR Select antidepressant therapy [e.g., tricyclic antidepressants (TCA), serotonin and norepinephrine reuptake inhibitors (SNRI)]; AND   Member is not frequently taking medications that are known to cause medication overuse headaches (MOH or rebound headaches) in the absence of intractable conditions known to cause chronic pain. MOH are a frequent cause of chronic headaches. A list of prescription or non-prescription medications known to cause MOH includes, but is not limited to:  Decongestants (alone or in combination products) (≥10 days/month for >3 months); AND Combination analgesics containing caffeine and/or butalbital (≥10 days/month for >3 months); AND Opioids (≥10 days/month for >3 months); AND Analgesic medications including acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) (≥15 days/month for >3 months); AND Ergotamine-containing medications (≥10 days/month for >3 months); AND Triptans (≥10 days/month for >3 months); AND Member is not taking any medications that are likely to be the cause of the headaches; AND Member will not use requested medication concurrently with botulinum toxin for the prevention of migraine or with an alternative calcitonin gene-related peptide (CGRP) inhibitor; AND Other aggravating factors that are contributing to the development of episodic/chronic migraine headaches are being treated when applicable (e.g., smoking); AND Prescriber must verify that member has been counseled on appropriate use, storage of the medication, and administration technique; AND Initial approvals will be for the duration of 3 months. Compliance and information regarding efficacy, such as a reduction in monthly migraine days, will be required for continued approval. Continuation approvals will be granted for the duration of 1 year; AND Quantity limits will apply based on FDA-approved dosing:  For Aimovig®, a quantity limit of 1 syringe or autoinjector per 30 days will apply; and For Ajovy® prefilled syringe and autoinjector, a quantity limit of 1 syringe or 1 autoinjector per 30 days will apply. Requests for quarterly dosing (675mg every 3 months) will be approved for a quantity limit override upon meeting Ajovy® approval criteria; and For Emgality®, a quantity limit of 1 syringe or pen per 30 days will apply. Requests for an initial loading dose (240mg administered as 2 consecutive 120mg injections) will be approved for a quantity limit override upon meeting Emgality® approval criteria.  *The manufacturers of Ajovy® and Emgality® have provided a supplemental rebate to be the preferred calcitonin gene-related peptide (CGRP) inhibitor(s); however, Ajovy® and Emgality® will follow the original criteria similar to the other CGRP inhibitors if the manufacturers chooses not to participate in supplemental rebates. Emgality® (Galcanezumab-gnlm) Approval Criteria [Episodic Cluster Headache Diagnosis]: An FDA approved indication for the treatment of episodic cluster headache in adults; AND Member must be 18 years of age or older; AND Member has a diagnosis of episodic cluster headache as defined by the International Headache Society (IHS) International Classification of Headache Disorders (ICHD) guideline and meets the following criteria: Member has a history of episodic cluster headache with at least 2 cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of ≥3 months; AND Member has been evaluated for red flags or possible indicators of secondary headache, as defined by the American Headache Society, and these conditions have been ruled out and/or have been treated; and  Member is not frequently taking medications that are known to cause medication overuse headaches (MOH or rebound headaches) in the absence of intractable conditions known to cause chronic pain. MOH are a frequent cause of chronic headaches. A list of prescription or non-prescription medications known to cause MOH includes, but is not limited to: Decongestants (alone or in combination products) (≥10 days/month for >3 months); AND Combination analgesics containing caffeine and/or butalbital (≥10 days/month for >3 months); AND   Opioids (≥10 days/month for >3 months); AND Analgesic medications including acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) (≥15 days/month for >3 months); AND Ergotamine-containing medications (≥10 days/month for >3 months); AND Triptans (≥10 days/month for >3 months); AND The member has failed prophylactic therapy with at least 1 other medication (e.g., verapamil, select anticonvulsants, glucocorticoids); AND Member will not use Emgality® concurrently with an alternative calcitonin gene-related peptide (CGRP) inhibitor; AND Prescriber must verify that member has been counseled on appropriate use, storage of the medication, and administration technique; AND Initial approvals will be for the duration of 3 months. Continuation approvals will be granted until the end of the cluster period if the prescriber documents that the member is responding well to treatment as indicated by a reduction in cluster headache attack frequency; AND A quantity limit of (3) 100mg/mL syringes per 30 days will apply. Prior Authorization Forms Aimovig PA Form Ajovy PA Form Emgality PA Form Nurtec® PA Form Qulipta™ PA Form Vyepti® PA Form

     

No Prior Authorization required:

• lorazepam (Ativan®)
• chlordiazepoxide (Librium®)
• oxazepam (Serax®)
• clorazepate dipotassium (Tranxene®)
• diazepam (Valium®)
• alprazolam (Xanax®)
• alprazolam XR (Xanax XR®)

Prior Authorization required:

• alprazolam rapdis (Niravam®)

Members 19 Years and Older will not require a petition

• Quantity limits apply on all benzodiazepine anxiolytic products.
• No request for dosing greater than 3 times daily will be approved unless a specific diagnosis exists; for these diagnoses the maximum allowed dosing is 4 times daily.
• The maximum covered dosing of benzodiazepine therapy is three times a day if a hypnotic medication is also prescribed.

Members 0-18 Years of Age will require a petition:

• No concurrent stimulant ADHD medications, and
• No Contraindicated Conditions, and
• Maximum dosing of 3 times daily.
  • For Members 12 or younger the same criteria applies and prescriptions for psychiatric conditions must originally be written by a psychiatrist.

Prior Authorization form

Loreev XR™ [Lorazepam Extended-Release (ER) Capsule] Approval Criteria:

• An FDA approved indication for the treatment of anxiety disorders; and
• Member must be 18 years of age or older; and
• Member must be receiving a stable, evenly divided, 3 times daily dosing regimen of lorazepam tablets; and
• A patient-specific, clinically significant reason (beyond convenience) why the member cannot use the immediate-release formulation must be provided; and
• A quantity limit of 30 capsules per 30 days will apply.

INSOMNIA MEDICATIONS
Tier 1 products are available without prior authorization for members age 19 or older. Prior authorization is required for all products for members under age 19. Tier 2 approval Criteria: Minimum of 30 day trial with at least two Tier 1 products and clinical documentation of attempts to correct any primary cause for insomnia. FDA approved diagnosis. Approvals granted for 6 months. No current anxiolytic benzodiazepine therapy greater than TID Tier 3 approval Criteria: An FDA approved diagnosis; AND A minimum of a 30-day trial with at least two Tier-1 medications and clinical documentation of attempts to correct any primary cause for insomnia; AND A minimum of a 30-day trial with at least two Tier-2 medications; AND If only one Tier-2 medication is available, a minimum of a 30-day trial with one Tier-2 medication will be required; AND   No concurrent anxiolytic benzodiazepine therapy greater than three times daily dosing; AND Approvals will be granted for the duration of six months. ramelteon (Generic Rozerem®) Approval Criteria:   A patient-specific, clinically significant reason why the member cannot use the brand formulation (Rozerem®) of ramelteon.  tasimelteon capsule (Hetlioz®) Approval Criteria:  An FDA approved diagnosis of 1 of the following: Non-24-Hour Sleep-Wake Disorder (Non-24) confirmed by a sleep specialist; OR Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) confirmed by a sleep specialist; AND  Member must be 18 years of age or older for a diagnosis of Non-24 or 16 years of age or older for a diagnosis of SMS; AND A failed trial of appropriately timed doses of melatonin; AND Initial approvals will be for the duration of 12 weeks. For continuation, the prescriber must include information regarding improved response/effectiveness of this medication. A quantity limit of 30 capsules for 30 days will apply.  Hetlioz LQ™ (Tasimelteon Oral Suspension) Approval Criteria: An FDA approved diagnosis of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) confirmed by a sleep specialist; and Member must be 3 to 15 years of age; and Member must have a failed trial of appropriately timed doses of melatonin; and The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to the Hetlioz LQ™ Prescribing Information; and Initial approvals will be for the duration of 12 weeks. For continuation, the prescriber must include information regarding improved response/effectiveness of this medication. Prior Authorization form
TIER 1	TIER 2	TIER 3	SPECIAL PA*
zolpidem tartrate (Ambien®) flurazepam (Dalmane®) triazolam (Halcion®) eszopiclone (Lunesta®) estazolam (ProSom®) temazepam (Restoril®) 15mg & 30mg ramelteon (Rozerem®) BRAND Preferred zaleplon (Sonata®)	zolpidem tartrate (Ambien CR®)	lemborexant (Dayvigo™)  suvorexant (Belsomra®)	quazepam (Doral®) zolpidem SL tabs (Edluar®) tasimelteon (Hetlioz®, Hetlioz LQ™)+ zolpidem SL tabs (Intermezzo®) temazepam (Restoril®) 7.5mg & 22.5mg zolpidem 7.5mg capsule daridorexant (Quviviq™) doxepin (Silenor®) Zolpidem Oral Spray (Zolpimist®)

*Medications in the Special PA Tier, including unique dosage formulations require a special reason for use in place of lower-tiered medications.

+ Individual criteria specific to tasimelteon.

Tier-1 products are available without prior authorization for members age five years and older.  Prior authorization requests for members younger than five years of age are reviewed by an OHCA or SoonerSelect Health Plan-contracted child psychiatrist.

Approval Criteria for Tier 2 Medication:

• A trial of a Tier 1 medication at least 14 days in duration, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.
  • Clozapine does not count towards a Tier 1 trial. 
• Members currently stable on a Tier-2 medication may be approved for continuation of therapy.

Approval Criteria for Tier-3 Medication:  

• A trial of a Tier 1 medication at least 14 days in duration, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects. 
  • Clozapine does not count towards a Tier 1 trial.; AND  
• Trials of 2 oral Tier-2 medications, at least 14 days in duration each, titrated to recommended dose, that did not yield adequate response or resulted in intolerable adverse effects.; AND
• Use of quetiapine 150mg tablet will require a patient-specific, clinically significant reason why the member cannot use the lower tiered quetiapine products, which are available without a prior authorization; AND 
• A manual prior authorization may be submitted for consideration of a Tier-3 medication when the member has had at least four trials of Tier-1 and Tier-2 medications that did not yield an adequate response or resulted in intolerable adverse effects. 
• Members currently stable on a Tier-3 medication may be approved for continuation of therapy; and
• Use of Versacloz™ (clozapine oral suspension) and Fazaclo® (clozapine orally disintegrating tablet) requires a patient-specific, clinically significant reason why the member cannot use the oral tablet formulation.
• Use of Secuado® (asenapine transdermal system) requires a patient-specific, clinically significant reason why the member cannot use the oral sublingual tablet formulation. Tier structure rules continue to apply.

Long-Acting Injectable (LAI) Products Tier-3 Approval Criteria:

• Use of LAI products will require a patient-specific, clinically significant reason (beyond convenience) why the member cannot use the lower tiered LAI products available for the medication being requested, which are available without a prior authorization; and
• Members currently stable on the requested medication may be approved for continuation of therapy.

Approval Criteria for Atypical Antipsychotics as Adjunctive Treatment for Major Depression Disorder (MDD) :

• Authorization of Symbyax® (olanzapine/fluoxetine) or Rexulti® (brexpiprazole) , or Vraylar^® (cariprazine) for a diagnosis of major depressive disorder requires current use of an antidepressant, and previous trials with at least two other antidepressants from both categories (an SSRI and dual acting medication) and a trial of aripiprazole tablets that did not yield adequate response.
• Members currently stable on the requested medication may be approved for continuation of therapy; and
• Tier structure applies. 

Clinical Exceptions:

• Members currently stabilized on a higher tiered medication defined by paid claim(s) for the higher tiered medication in the past 90 days will be approved. 
• Members being released from a hospital and stabilized on a higher tiered medication will be approved.
• Approvals will be granted for members with clinical conditions for which lower tiered drugs are contraindicated.
• Approvals will be granted for members whose current regimen includes drugs known to adversely interact with all lowered tiered drugs.
• Lurasidone (Latuda®) may be approved for pregnant women with appropriate diagnosis.

aripiprazole oral solution (Abilify® Oral Solution) Approval Criteria:

• Members older than 7 years of age require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used. 

Abilify MyCite® (Aripiprazole Tablet with Sensor) Approval Criteria:

• An FDA approved diagnosis; AND
• Member must not have dementia-related psychosis; AND
• A patient-specific, clinically significant reason why the member cannot use all oral or injectable Tier-1 or Tier-2 medications. Tier structure rules continue to apply. Please note, the ability of Abilify MyCite® to improve patient compliance or modify aripiprazole dosage has not been established; AND
• Previous use of aripiprazole tablets and a patient-specific, clinically significant reason why the Tier-1 aripiprazole tablets are no longer appropriate for the member must be provided; AND
• The prescriber agrees to closely monitor patient adherence; AND
• Patients should be capable and willing to use the MyCite® App and follow the Instructions for Use and ensure the MyCite® App is compatible with their specific smartphone; AND
• Approvals will be for the duration of 3 months. For continuation consideration, documentation demonstrating positive clinical response and patient compliance greater than 80% with prescribed therapy must be provided. In addition, a patient-specific, clinically significant reason why the member cannot transition to oral aripiprazole tablets or to any of the oral or injectable Tier-1 or Tier-2 medications must be provided. Tier structure rules continue to apply. 

Lybalvi™ (Olanzapine/Samidorphan) Approval Criteria:

• An FDA approved diagnosis; and
• Member must be 18 years of age or older; and
• Member must have a positive clinical response to olanzapine and gained ≥10% from baseline body weight after starting olanzapine (baseline and current weight must be provided); or
• A patient specific, clinically significant reason why the member cannot use a lower-tiered product with a lower weight gain profile must be provided; and
• Member must not be taking opioids or undergoing acute opioid withdrawal; and
• Initial approvals will be for 3 months. For continuation consideration, documentation that the member is responding well to treatment and any increase in body weight is <10% of baseline body weight (current weight must be provided) while on therapy must be provided. 

Rexulti^® (Brexpiprazole) Approval Criteria [Agitation Associated with Dementia Due to Alzheimer's Disease Diagnosis]:

• An FDA approved indication of the treatment of agitation associated with dementia due to Alzheimer's disease; AND
• Diagnosis must be confirmed by the following:
  • Mini-Mental State Exam (MMSE) score between 5 and 22; AND
  • Documentation of the member’s dementia due to Alzheimer's disease diagnosis [i.e., chart notes consistent with findings of a diagnosis of dementia due to Alzheimer's disease as per the National Institute on Aging and the Alzheimer’s Association (NIA-AA)]; AND
  • Other known medical or neurological causes of dementia have been ruled out (i.e., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Parkinson’s disease dementia); AND
  • Neuropsychiatric Inventory (NPI)/NPI-Nursing Home (NH) agitation/aggression score ≥4; AND
  • Exhibiting sufficient agitation behaviors warranting the use of pharmacotherapy; AND
• Prescriber must document a baseline evaluation using the Cohen-Mansfield Agitation Inventory (CMAI) total score; AND
• Prescriber must verify member will be closely monitored due to the risk of dementia-related psychosis; AND
• Initial approvals will be for 3 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by an improvement from baseline in the CMAI total score (a negative change in score indicates improvement) or documentation of a positive clinical response to therapy.

 Prior Authorization form

TIER 1	TIER 2	TIER 3
aripiprazole (Abilify®)¥ aripiprazole IM inj (Abilify Asimtufii®)^ aripiprazole IM inj (Abilify Maintena®)^ aripiprazole lauroxil IM inj (Aristada™)^ aripiprazole lauroxil IM inj (Aristada® INITIO™)^ clozapine (Clozaril®)◊ olanzapine (Zyprexa®) paliperidone palmitate IM inj (Invega Hafyera™)^ paliperidone palmitate IM inj (Invega Sustena®)^ paliperidone palmitate IM inj (Invega Trinza™)^ quetiapine (Seroquel®) quetiapine ER (Seroquel XR®) risperidone extended-release injectable (Perseris™)^ risperidone sub-Q inj (Uzedy™)^ ziprasidone (Geodon®)	asenapine (Saphris®) iloperidone (Fanapt®) lurasidone (Latuda®) paliperidone (Invega®)	aripiprazole tablet with sensor (Abilify MyCite®)~ asenapine transdermal system (Secuado®)+ brexpiprazole (Rexulti®) cariprazine (Vraylar™) clozapine (Fazaclo®)+ clozapine oral suspension (Versacloz®)+ lumateperone (Caplyta™) olanzapine/fluoxetine (Symbyax®)+ olanzapine/samidorphan (Lybalvi™)+ quetiapine 150mg tablets+ risperidone IM inj (Risperdal Consta®)^∞ risperidone IM inj (Risvan®)^∞ risperidone IM inj (Rykindo®)^∞

*Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC). Placement of products shown in blue is based on net cost after federal and/or supplemental rebates, and products may be moved to a higher tier if the net cost changes in comparison to other available products.

ER = extended-release; IM = intramuscular; inj = injection; ODT = orally disintegrating tablet;

susp = suspension; sub-Q = subcutaneous

^¥Aripiprazole (Abilify^®) orally disintegrating tablet (ODT) is considered a special formulation and requires a patient-specific, clinically significant reason why a special formulation product is needed in place of the regular tablet formulation.

^◊Clozapine does not count towards a Tier-1 trial.

^{^}Use of Invega Hafyera™ requires members to have been adequately treated with the 1-month paliperidone palmitate injection (Invega Sustenna^®) for at least 4 months or the 3-month paliperidone palmitate injection (Invega Trinza^®) for at least one 3-month cycle.

**Use of Invega Trinza^® requires members to have been adequately treated with the 1-month paliperidone palmitate injection (Invega Sustenna^®) for at least 4 months.

^~Unique criteria applies to Abilify MyCite^® (aripiprazole tablets with sensor).

⁺Unique criteria applies in addition to tier trial requirements.

∞Unique criteria applies to Tier-3 long-acting injectable (LAI) products.

SECOND OPINION PROCESS FOR CHILDREN 0-4 YEARS OF AGE AND UNUSUAL DOSING REQUESTS

Children less than 5 years of age will require a "second opinion" prior authorization to be reviewed by an OHCA or SoonerSelect Health Plan-contracted child psychiatrist. Current users will be allowed to remain on current medication until the petition is submitted and reviewed. The second opinion process is as follows: Clinical pharmacist reviews petition for necessary information including diagnosis and behavioral information to submit to on-call OHCA or SoonerSelect Health Plan psychiatrist. On-call psychiatrist at OHCA or Health Plan reviews submitted prior authorization request. OHCA or SoonerSelect Health Plan responds back within 24 hours. Clinical pharmacist issues appropriate response for petition based on the results

Approval Criteria for the Butalbital Medications [Dolgic Plus® (butalbital-acetaminophen-caffeine, 50-750-40 mg), Phrenilin Forte® (butalbital-acetaminophen 50-650 mg), Orbivan® (butalbital- acetaminophen-caffeine 50-300-40 mg), Orbivan® CF (butalbital-acetaminophen 50-300 mg), Esgic-Plus® (butalbital-acetaminophen-caffeine 50-500-40 mg), Allzital® (butalbital/acetaminophen 25mg/325mg)]:

• An FDA approved indication for the treatment of tension-type headache; AND
• Member must be 12 years of age or older; AND
• Failure within the previous 60 days of the following:
  
  • All available formulations of butalbital/acetaminophen medications that do not require prior authorization (medications available without prior authorization contain butalbital/acetaminophen/caffeine in the standard 50mg/325mg/40mg dose); AND
  • Trials of at least two nonsteroidal anti-inflammatory drugs (NSAIDs), unless contraindicated.

Esgic® capsules (butalbital/acetaminophen/caffeine 50mg/325mg/40mg) approval criteria:

• A patient-specific, clinically significant reason why the member cannot use Fioricet® tablets (butalbital/acetaminophen/caffeine 50mg/325mg/40mg). 
  

 Prior Authorization form

Evzio® (Naloxone Auto-Injector) Approval Criteria:

• An FDA approved diagnosis of potential or risk for opioid overdose; AND
• A patient-specific, clinically significant reason why the member cannot use other formulations of naloxone must be provided.

Tier 1 products are covered with no authorization necessary.

Tier-2 Approval Criteria:

• A documented, recent (within the last six months) trial of two Tier-1 medications (must include one trial with duloxetine) at least three weeks in duration that did not provide an adequate response or resulted in intolerable adverse effects; OR
• Contraindication(s) to all available lower tiered medications; OR
• Current stabilization on a Tier-2 medication.

Tier-3 Approval Criteria:

• A documented, recent (within the last six months) trial of two Tier-1 medications (must include one trial with duloxetine) and all available Tier-2 medications at least three weeks in duration that did not provide an adequate response OR resulted in intolerable adverse effects; OR
• Contraindication(s) to all available lower tiered medications; OR
• Current stabilization on a Tier-3 medication.   

pregabalin extended-release (ER) (Lyrica® CR ) Approval Criteria:

• An FDA approved diagnosis of one of the following:
  • Neuropathic pain associated with diabetic peripheral neuropathy (DPN); OR
  • Neuropathic pain associated with postherpetic neuralgia (PHN). 
• A patient-specific, clinically significant reason (beyond convenience) the member cannot use the immediate-release formulation must be provided; AND
• For a diagnosis of DPN, current Lyrica® immediate-release criteria will also apply; AND
• Requests exceeding once daily dosing will not be approved.

Prior Authorization form

TIER 1	TIER 2
amitriptyline cyclobenzaprine duloxetine HCI (Cymbalta ®) fluoxetine pregabalin (Lyrica®) tramadol	milnacipran (Savella ®)

 

GABAPENTIN (GRALISE®)

PA criteria:

• FDA-approved indication of postherpetic neuralgia.
• Must provide documented treatment attempts at recommended dosing or contraindications to at least one agent from two of the following drug classes:
  • Tricyclic antidepressants
  • Anticonvulsants
  • Topical or oral analgesics
• Must provide a clinically significant reason why the member cannot take the immediate-release formulation of gabapentin.

 Prior Authorization form

PA criteria:

• An FDA approved diagnosis of infantile spasms; AND  
  • Member must be two years of age or younger; AND
  • Must be prescribed by, or in consultation with, a neurologist or an advanced care practitioner with a supervising prescriber that is a neurologist; OR  
• An FDA approved diagnosis of multiple sclerosis (MS); and a. Member is experiencing an acute exacerbation; AND
  • Must be prescribed by, or in consultation with, a neurologist or an advanced care practitioner with a supervising prescriber that is a neurologist or a physician that specializes in MS; AND
  • Prescriber must rule out pseudo-exacerbation from precipitating factors (e.g., pain, stress, infection, premenstrual syndrome); AND  
  • Symptoms of acute exacerbation last at least 24 hours; AND
  • Member must be currently stable within the last 30 days on an immunomodulator agent, unless contraindicated; AND  
  • A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy (e.g. IV methylprednisolone, IV dexamethasone, oral prednisone). 
  • A quantity limit of daily doses of up to 120 units for up to 3 weeks for acute exacerbation will apply; OR 
• An FDA approved diagnosis of nephrotic syndrome without uremia of the idiopathic type or that is due to lupus erythematosus to induce a diuresis or a remission; and a. Must be prescribed by, or in consultation with, a nephrologist or an advanced care practitioner with a supervising prescriber that is a nephrologist; AND
  • A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy (e.g., prednisone); OR 
• An FDA approved diagnosis of the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; respiratory; and edematous states; and a. A patient-specific, clinically significant reason why the member cannot use alternative corticosteroid therapy.

Prior Authorization form

Suboxone® (buprenorphine/naloxone) films, brand and generic, will be non-preferred. Only generic buprenorphine/naloxone sublingual tablets will be preferred. Authorization of buprenorphine/naloxone films will require a patient-specific, clinically significant reason why generic buprenorphine/naloxone sublingual tablets are not appropriate. Members currently utilizing Suboxone® films will not be grandfathered.

Vivitrol® (naltrexone injection) is covered without a prior authorization for medication assisted treatment. 

Suboxone [buprenorphine/naloxone sublingual (SL) tablets and film], Subutex (buprenorphine SL tablets), Zubsolv (buprenorphine/naloxone SL tablets) Approval Criteria:  

• Generic buprenorphine/naloxone SL tablet is the preferred medication assisted treatment product. Zubsolv® and Suboxone® films (brand and generic) authorization requires a patient-specific, clinically significant reason why generic buprenorphine/naloxone SL tablets are not appropriate.
• Subutex® (buprenorphine) 2mg and 8mg tablets will only be approved if the member is pregnant, or has a documented serious allergy or adverse reaction to naloxone.
• Member must have an FDA approved diagnosis of opioid abuse/dependence; AND  
• Concomitant treatment with opioids (including tramadol) will be denied; AND  
• Approvals will be for the duration of 90 days to allow for concurrent medication monitoring; AND  
• The following limitations will apply:
  • Suboxone® 2mg/0.5mg and 4mg/1mg SL tablets and films: A quantity limit of 90 units per 30 days will apply.
  • Suboxone® 8mg/2mg SL tablets and films: A quantity limit of 90 SL units per 30 days will apply.
  • Suboxone® 12mg/3mg films: A quantity limit of 60 SL films per 30 days will apply.
  • Subutex® 2mg tablets: A quantity limit of 90 SL tablets per 30 days will apply.
  • Subutex^® 8mg SL tablets: A quantity limit of 90 SL tablets per 30 days will apply.
  • Zubsolv® 1.4mg/0.36mg and 2.9mg/0.71mg sublingual tablets: A quantity limit of 90 tablets per 30 days will apply.
  • Zubsolv® 5.7mg/1.4mg SL tablets: A quantity limit of 90 SL tablets per 30 days will apply.
  • Zubsolv® 8.6mg/2.1mg SL tablets: A quantity limit of 60 SL tablets per 30 days will apply.
  • Zubsolv® 11.4mg/2.9mg SL tablets: A quantity limit of 30 SL tablets per 30 days will apply.

High Dose Buprenorphine Products Criteria:

• Each request for greater than 24mg bioequivalent buprenorphine per day should be evaluated on a case-by-case basis.
• A taper schedule should be documented on the petition or dates of an attempted taper with reason for failure should be documented or a patient-specific, clinically significant reason a taper schedule or attempt is not appropriate for the member; AND
• Opioid urine drug screens should be submitted with high-dose requests that plan to continue high-dose treatment longer than the duration of one month.
  • Urine drug screens must show the absence of opioid medications other than buprenorphine products for continued approval; OR
  • Prescriber must document a patient-specific reason the member should continue therapy, reason for opioid use, and document a plan for member to discontinue opioid use; AND
• Symptoms associated with withdrawal at lower doses or symptoms requiring high doses should be listed on petition; AND
• Each approval will be for the duration of one month. If urine drug screen and other documentation are submitted indicating high-dose therapy is necessary an approval can be granted for the duration of three months.
• Continued high-dose authorization after the three month approval will require a new (recent) urine drug screen.

 

lofexidine (Lucemyra™) Approval Criteria:

• An FDA approved indication for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults; AND
• Date of opioid discontinuation must be listed on the prior authorization request; AND
• Prescriber must verify member has been screened for hepatic and renal impairment and that dosing is appropriate for the member’s degree of hepatic and renal function; AND
• Prescriber must verify member’s vital signs have been monitored and that the member is capable of and has been instructed on self-monitoring for hypotension, orthostasis, bradycardia, and associated symptoms; AND
• Member must not have severe coronary insufficiency, a recent myocardial infarction, cerebrovascular disease, chronic renal failure, or marked bradycardia; AND
• Member must not have congenital long QT syndrome; AND
• Prescriber must verify Lucemyra™ will be used in conjunction with a comprehensive management program for the treatment of opioid use disorder; AND  
• A patient-specific, clinically significant reason why clonidine tablets or patches cannot be used in place of Lucemyra™ to mitigate opioid withdrawal symptoms must be provided; AND
• Approvals will be for a maximum duration of 14 days; AND  
• A quantity limit of 12 tablets daily will apply.

Brixadi™ [Buprenorphine Extended-Release (ER) Injection] and Sublocade^® (Buprenorphine ER Injection) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe opioid use disorder; AND
• For Sublocade^®, Member must have initiated treatment with a transmucosal buprenorphine-containing product for a minimum of seven days; or
• For Brixadi™, member must have initiated treatment with a single dose of a transmucosal buprenorphine product or is currently treated with buprenorphine; and
• Concomitant treatment with opioids (including tramadol) will be denied; AND
• Medication should only be prepared and administered by a health care provider; AND
• A patient-specific, clinically significant reason why the member cannot use the preferred buprenorphine product(s) (buprenorphine/naloxone sublingual tablets) must be provided; AND
• In general, concomitant treatment with transmucosal buprenorphine will not be approved long term; AND
• Approvals will be for the duration of 90 days to allow for concurrent medication monitoring; AND
• A quantity limit of 1 monthly dose per 28 days or 4 weekly doses per 28 days will apply. 

Prior Authorization form 

deutetrabenazine (Austedo™) and Austedo^® XR [Deutetrabenazine Extended-Release (ER) Tablet] Approval Criteria [Huntington's Disease Diagnosis]:

• An FDA approved diagnosis of chorea associated with Huntington’s disease; AND
• Deutetrabenazine must be prescribed by a neurologist, or a mid-level practitioner with a supervising physician that is a neurologist; AND
• A previous trial of Xenazine® (tetrabenazine) or a patient-specific, clinically significant reason why the member cannot use brand Xenazine® (tetrabenazine); AND
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting deutetrabenazine therapy and throughout treatment; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter-2 (VMAT2) inhibitor (e.g., tetrabenazine, valbenazine) concurrently with deutetrabenazine; AND
• For members who are using deutetrabenazine concomitantly with other medications that are known to prolong the QTc interval [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval] the prescriber must agree to monitor the member for symptoms of prolonged QTc interval (e.g., syncope, palpitations, seizures) ; AND
• The member must not have congenital long QT syndrome or a history of cardiac arrhythmias; AND
• The daily dose of deutetrabenazine must not exceed 36mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) or if they are a known poor CYP2D6 metabolizer; AND
• Female members must not be pregnant or breastfeeding; AND 
• Approvals will be for the duration of six months at which time the prescriber must document that the signs and symptoms of chorea have decreased and the member is not showing worsening signs of depression.

deutetrabenazine (Austedo®) and Austedo^® XR [Deutetrabenazine Extended-Release (ER) Tablet] Approval Criteria [Tardive Dyskinesia Diagnosis]:   

• An FDA approved diagnosis of tardive dyskinesia meeting the following DSM-5 criteria:
  • Involuntary athetoid or choreiform movements; AND  
  • History of treatment with dopamine receptor blocking agent (DRBA); AND
  • Symptom duration lasting longer than 4 to 8 weeks; AND 
• Member must be 18 years of age or older; AND
• Deutetrabenazine must be prescribed by a neurologist or psychiatrist, or a mid-level practitioner with a supervising physician that is a neurologist or psychiatrist; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter 2 (VMAT2) inhibitor (e.g., tetrabenazine, valbenazine) concurrently with deutetrabenazine; AND  
• For members who are using deutetrabenazine concomitantly with other medications that are known to prolong the QTc interval [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval] the prescriber must agree to monitor the member for symptoms of prolonged QTc interval (e.g., syncope, palpitations, seizures) ; AND  
• The member must not have congenital long QT syndrome or a history of cardiac arrhythmias; AND
• The daily dose of deutetrabenazine must not exceed 36mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion) or if they are a known poor CYP2D6 metabolizer; AND
• Female members must not be pregnant or breastfeeding; AND
• Prescriber must document a baseline evaluation using the Abnormal Involuntary Movement Scale (AIMS); AND
• Approvals will be for the duration of six months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by an improvement from baseline in the AIMS total score (a negative change in score indicates improvement) or documentation of a positive clinical response to therapy.  

tetrabenazine (Xenazine®) Approval Criteria:

• A diagnosis of one of the following: 
  •  Chorea associated with Huntington’s disease; OR
  • Tardive dyskinesia; OR
  • Tourette syndrome; AND 
• Xenazine® must be prescribed by a neurologist or psychiatrist (or an advanced care practitioner with a supervising physician who is a neurologist or psychiatrist); and 
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting Xenazine® therapy and throughout treatment; AND
• Member must not have hepatic impairment; AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) or have taken an MAOI within the last 14 days; AND
• Member must not be taking reserpine or have taken reserpine within the last 20 days; AND
• Member must not use another vesicular monoamine transporter-2 (VMAT2) inhibitor (e.g., deutetrabenazine, valbenazine) concurrently with Xenazine®; AND
• Member must not be taking medications that are known to prolong the QTc interval concomitantly with Xenazine® [antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, or any other medications known to prolong the QTc interval]; AND
• Patients who require doses of tetrabenazine greater than 50mg per day must be tested and genotyped to determine if they are poor metabolizers (PMs), intermediate metabolizers (IMs), or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The following dose limits will apply based on patient metabolizer status: 
  • Extensive and Intermediate CYP2D6 Metabolizers: 100mg divided daily; OR
  • Poor CYP2D6 Metabolizers: 50mg divided daily; AND 
• The daily dose of Xenazine® must not exceed 50mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, bupropion); AND
• Approvals will be for the duration of six months at which time the prescriber must document that the signs and symptoms of chorea, tardive dyskinesia, or Tourette syndrome have decreased and the member is not showing worsening signs of depression. 

valbenazine (Ingrezza™) and and Ingrezza^® Sprinkle (Valbenazine) Approval Criteria [Tardive Dyskinesia Diagnosis]:

• An FDA approved diagnosis of tardive dyskinesia meeting the following DSM-5 criteria:
  • Involuntary athetoid or choreiform movements; AND
  • History of treatment with dopamine receptor blocking agent (DRBA); AND
  • Symptom duration lasting longer than 4 to 8 weeks; AND  
• Member must be 18 years of age or older; AND
• Ingrezza™ must be prescribed by a neurologist or psychiatrist, or a mid-level practitioner with a supervising physician that is a neurologist or psychiatrist; AND
• Use of Ingrezza^® Sprinkle will require a patient-specific, clinically significant reason why the member cannot use Ingrezza^®; and 
• The daily dose of Ingrezza® must not exceed 40mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine); AND
• The daily dose of Ingrezza™ must not exceed 40mg per day if the member is taking strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin); AND
• Member must not be taking strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort); AND
• Member must not be taking monoamine oxidase inhibitors (MAOIs) in the last 14 days; AND
• Member must not be taking other vesicular monoamine transporter 2 (VMAT2) inhibitors (e.g., tetrabenazine, deutetrabenazine); AND
• The daily dose of Ingrezza® must not exceed 40mg per day for members with moderate or severe hepatic impairment (Child-Pugh score 7 to 15); AND
• The member must not have congenital long QT syndrome or a history of arrhythmias associated with a prolonged QT interval; AND
• Female members must not be pregnant or breastfeeding; AND
• Prescriber must agree to monitor digoxin concentration when co-administering Ingrezza® with digoxin; AND
• Prescriber must agree to monitor the member for symptoms of prolonged QTc interval (e.g., syncope, palpitations, seizures); and 
• Prescriber must document a baseline evaluation using the Abnormal Involuntary Movement Scale (AIMS); AND
• A quantity limit of two 40mg capsules or a total dose of 80mg per day will apply; AND
• Approvals will be for the duration of six months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by an improvement from baseline in the AIMS total score (a negative change in score indicates improvement) or documentation of a positive clinical response to therapy. 

Ingrezza^® (Valbenazine) and Ingrezza^® Sprinkle (Valbenazine) Approval Criteria [Huntington’s Disease Diagnosis]

• An FDA approved diagnosis of chorea associated with Huntington’s disease; and
• Member must be 18 years of age or older; and
• Ingrezza^® must be prescribed by a neurologist (or an advanced care practitioner with a supervising physician who is a neurologist); and
• A previous trial of Xenazine^® (tetrabenazine) or a patient-specific, clinically significant reason why the member cannot use Xenazine^® (tetrabenazine) must be provided; and
• Use of Ingrezza^® Sprinkle will require a patient-specific, clinically significant reason why the member cannot use Ingrezza^®; and 
• Member must not be actively suicidal or have uncontrolled depression and prescriber must verify member will be monitored for depression prior to starting valbenazine therapy and throughout treatment; and
• The daily dose of Ingrezza^® must not exceed 40mg per day if the member is taking strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine); and
• The daily dose of Ingrezza^® must not exceed 40mg per day if the member is taking strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, clarithromycin); and
• Member must not be taking strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort); and
• Member must not be taking monoamine oxidase inhibitors (MAOIs) in the last 14 days; and
• Member must not be taking other vesicular monoamine transporter 2 (VMAT2) inhibitors (e.g., tetrabenazine, deutetrabenazine); and
• The daily dose of Ingrezza^® must not exceed 40mg per day for members with moderate or severe hepatic impairment (Child-Pugh score 7 to 15); and
• Member must not have congenital long QT syndrome or a history of arrhythmias associated with a prolonged QT interval; and
• Female members must not be pregnant or breastfeeding; and
• Prescriber must agree to monitor digoxin concentration when co-administering Ingrezza^® with digoxin; and
• Prescriber must agree to monitor the member for symptoms of prolonged QTc interval (e.g., syncope, palpitations, seizures); and 
• A quantity limit of 1 capsule per day will apply; and
• Approvals will be for the duration of 6 months at which time the prescriber must document that the signs and symptoms of chorea have decreased, and the member is not showing worsening signs of depression. 

Prior Authorization form        

Amypyra® (Dalfampridine) Approval Criteria:

• An FDA approved indication to improve walking in adult members with multiple sclerosis (MS); and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Kurtzke Expanded Disability Status Scale (EDSS) score between 3 and 7.5; and
• Initial approvals will be for the duration of 90 days. If the member has responded well to treatment and the prescriber states that the member has shown improvement or the drug was effective, the member may receive authorization for 1 year; and
• A quantity limit of 60 tablets for 30 days will apply.
• Ampyra^® may be used with other MS therapies. 

Aubagio® (Teriflunomide) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• All of the following will be required for initiation of treatment:
  • Verification that female members are not pregnant and are currently using reliable contraception; and
  • Verification that the member has no active infection(s); and
  • Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
  • Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; and
  • Blood pressure (BP) measurement and verification that BP is being monitored; and
  • Verification that the member does not have tuberculosis (TB), or completion of standard medical treatment for members with TB; and
• Initial approvals of Aubagio^® will be for 6 months, after which time all of the following will be required for further approval:
  • Medication compliance; and
  • Repeat CBC and verification that counts are acceptable to the prescriber; and
  • Repeat LFTs and verification that levels are acceptable to the prescriber; and
  • Verification that female members are not pregnant and will continue using reliable contraception; and
  • Verification that BP and signs of renal failure are being monitored; and
• Compliance will be checked for continued approval every 6 months; and
• A quantity limit of 30 tablets per 30 days will apply. 

Bafiertam™ (Monomethyl Fumarate) Approval Criteria: 

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• Verification from the prescriber that member has no serious active infection(s); and
• Complete blood counts (CBC), including lymphocyte count, and verification that levels are acceptable to the prescriber; and
• Liver function tests (LFTs) and total bilirubin levels and verification that levels are acceptable to the prescriber; and
• Intolerable adverse effects associated with a trial of Tecfidera^® (dimethyl fumarate) and Vumerity^® (diroximel fumarate) that are not expected to occur with Bafiertam^® or a patient-specific, clinically significant reason why trials of Tecfidera^® and Vumerity^® are not appropriate for the member must be provided; and
• Verification that CBC, including lymphocyte count, levels are acceptable to the prescriber in addition to compliance will be required for continued approval every 6 months; and
• A quantity limit of 4 capsules per day will apply.

Briumvi™ (Ublituximab-xiiy) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; AND
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); AND
• Member must have had at least 1 relapse in the previous 12 months; AND
• Approvals will not be granted for concurrent use with other disease-modifying therapies; AND
• Briumvi™ must be administered by a health care professional in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Approvals will not be granted for self-administration. Prior authorization requests must indicate how Briumvi™ will be administered; AND
  • Briumvi™ must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment; OR
  • Briumvi™ must be shipped via cold chain supply to the member’s home and administered by a home health care provider and the member or member’s caregiver must be trained on the proper storage of Briumvi™; AND
• Prescriber must confirm that member will be monitored for 1 hour following the first 2 infusions and as indicated for subsequent infusions; AND
• Prescriber must verify hepatitis B virus (HBV) testing has been performed prior to initiating Briumvi™ therapy and member does not have active HBV; AND
• Verification from the prescriber that member has no active infection(s); AND
• Verification from the prescriber that female members are not currently pregnant and will use contraception while receiving Briumvi™ therapy and for 6 months after the last infusion of Briumvi™; AND
• Approvals will be for the duration of 1 year, and compliance will be checked for continued approval.

Copaxone® (Glatiramer Acetate) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• Approvals for the 40mg strength of Copaxone^® will require a patient-specific, clinically significant reason why the member cannot use the 20mg strength; and
• Approvals for the generic formulation of either strength of Copaxone^®, including Glatopa^®, will require a patient-specific, clinically significant reason why the member cannot use the brand formulation (brand formulation is preferred); and
• Compliance will be checked for continued approval every 6 months.

Gilenya® (Fingolimod) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS)*, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; and 
  • Member has experienced at least 1 relapse in the previous 12 months or is transitioning from existing MS therapy; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• Prescriber must confirm that member will be observed in the prescriber’s office for signs and symptoms of bradycardia for 6 hours after the first dose; and 
• Verification from the prescriber that member has no active infection(s); and
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; and
• Compliance will be checked for continued approval every 6 months.

Tier 1	Tier 2
interferon β 1a (Avonex®)*	interferon β 1a (Rebif®)*
interferon β 1b (Betaseron®)*	interferon β 1b (Extavia®)*
peginterferon β - 1a (Plegridy®)*

*All medications including Tier-1 medications for MS require PA. 

Multiple Sclerosis (MS) Interferon Medications Approval Criteria:

• An FDA approved diagnosis of clinically isolated syndrome, relapsing forms of MS, or secondary progressive forms of MS; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Authorization of Tier-2 medications requires previous failure of preferred Tier-1 medication(s) defined as:
  • Occurrence of an exacerbation after 6 months; or
  • Significant increase in magnetic resonance imaging (MRI) lesion after 6 months; or
  • Adverse reactions or intolerable side effects; and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• Compliance will be checked for continued approval every 6 months. 

Lemtrada™ (Alemtuzumab) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include relapsing remitting disease and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must have had an inadequate response to 2 or more medications indicated for the treatment of MS; and
  • Lemtrada^® must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. The prescriber must agree that the member will be monitored for 2 hours after each infusion; and
• The prescriber must agree to monitor complete blood counts (CBC) with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose of Lemtrada^®; and
• The prescriber must agree that baseline and yearly skin examinations will be performed while the member is utilizing Lemtrada^® therapy; and
• Member, prescriber, pharmacy, and health care facility must all enroll in the Lemtrada^® Risk Evaluation and Mitigation Strategy (REMS) Program and maintain enrollment throughout therapy.

Kesimpta® (Ofatumumab) Approval Criteria: 

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must have had at least 1 relapse in the previous 12 months; and
• The prescriber must verify Hepatitis B virus (HBV) screening is performed before the first dose of Kesimpta^® and the member does not have an active HBV infection; and
• Prescriber must agree to monitor quantitative serum immunoglobulin level before, during, and after discontinuation of treatment with Kesimpta^® until B-cell repletion; and
• Prescriber must verify the member has no active infection(s); and
• Prescriber must verify the first injection of Kesimpta^® will be administered by a health care professional prepared to manage injection-related adverse reactions; and
• Kesimpta^® must be shipped via cold chain supply and the member or member’s caregiver must be trained on the proper storage and subcutaneous (sub-Q) administration of Kesimpta^®; and
• Female members must not be pregnant and must have a negative pregnancy test prior to initiation of treatment with Kesimpta^®; and
• Female members of reproductive potential must use an effective method of contraception during treatment and for 6 months after stopping Kesimpta^®; and
• A quantity limit of 1 syringe or prefilled Sensoready^® Pen per month will apply. Initial dosing titration will be approved for a quantity limit override upon meeting Kesimpta^® approval criteria; and
• Compliance will be checked for continued approval every 6 months.

Mavencald® (Cladribine ) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include relapsing remitting disease and active secondary progressive disease, in adults; and
• Requests for use in patients with clinically isolated syndrome (CIS) will not generally be approved; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must have had at least 1 relapse in the previous 12 months; and
• Member must have had an inadequate response to 2 or more medications indicated for the treatment of MS; and
• Prescriber must confirm that the member does not have any contraindications for use of cladribine; and
• Prescriber must confirm member does not have an active malignancy; and
• Prescriber must confirm that female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; and
• Prescriber must attest that female and male members of reproductive potential plan to use effective contraception during cladribine dosing and for 6 months after the last dose in each treatment course; and
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
• Verification from the prescriber that member has no active infection(s); and
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; and
• The member’s recent weight must be provided on the prior authorization request in order to authorize the appropriate amount of drug required according to package labeling; and
• Quantity limits according to package labeling will apply; and
• Approvals will be for 1 year of therapy (1 treatment course/2 cycles) at a time. Lifetime approval duration will be limited to a maximum of 2 treatment courses according to package labeling. 
  

Mayzent® (Siponimod) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; AND
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must have been assessed for CYP2C9 genotype: 
  • Members with a CYP2C9*3/*3 genotype will not generally be approved; OR
  • Members with a CYP2C9*1/*3 or *2/*3 genotype will not be approved for doses exceeding 1mg per day; OR
  • All other genotypes (CYP2C9*1/*1, *1/*2, or *2/*2) will be approved for 2mg per day; AND  
• Member must not have any contraindication for use of siponimod including: 
  • CYP2C9*3/*3 genotype; OR
  • Experienced myocardial infarction (MI), unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure (HF) requiring hospitalization, or class III/IV HF in the last 6 months; OR
  • Presence of Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, unless member has a functioning pacemaker; AND  
• Member must not have received prior treatment with alemtuzumab; AND
• Verification from the prescriber that member has no active infection(s); AND  
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; AND
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; AND
• Ophthalmic evaluation and verification that member will be monitored for changes in vision throughout therapy; AND
• Verification from the prescriber that the member has been assessed for medications and conditions that cause reduction in heart rate (HR) or AV conduction delays and that the member will be followed with appropriate monitoring per package labeling; AND
• Verification from the prescriber that the member has been assessed for previous confirmed history of chickenpox or vaccination against varicella. Members without history of chickenpox or varicella vaccination should receive a full course of the varicella vaccine prior to commencing treatment with Mayzent®; AND
• Verification from the prescriber that members with sinus bradycardia (HR <55 beats per minute), first- or second-degree AV block (Mobitz type I), or a history of HF or MI will be monitored following the first dose for a minimum of 6 hours; AND
• Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; AND
• Female members of reproductive potential must be willing to use effective contraception during treatment with Mayzent® and for at least 10 days after discontinuing treatment; AND
• Member must have had an inadequate response to Gilenya® (fingolimod) or a patient-specific, clinically significant reason why fingolimod is not appropriate for the member must be provided; AND
• Compliance will be checked for continued approval every 6 months; AND
• Quantity limits according to package labeling will apply.

Ocrevus™ (Ocrelizumab) Approval Criteria:

• An FDA approved diagnosis of primary progressive forms of multiple sclerosis (MS) or relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, in adults; AND
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease modifying therapies; AND  
• Ocrevus^® must be administered by a health care professional in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Approvals will not be granted for self-administration. Prior authorization requests must indicate how Ocrevus^® will be administered; and
  • Ocrevus^® must be shipped via cold chain supply to the facility where the member is scheduled to receive treatment; or
  • Ocrevus^® must be shipped via cold chain supply to the member’s home and administered by a home health care provider and the member or member’s caregiver must be trained on the proper storage of Ocrevus^®; and
• Prescriber must confirm that member will be monitored for 1 hour after each infusion; and
• Prescriber must verify hepatitis B virus (HBV) testing has been performed prior to initiating Ocrevus™ therapy and member does not have active HBV; AND  
  
• Verification from the prescriber that member has no active infection(s); AND
• Verification from the prescriber that female members are not currently pregnant and will use contraception while receiving Ocrevus™ therapy and for six months after the last infusion of Ocrevus™; AND
• Approvals will be for the duration of 1 year, and compliance will be checked for continued approval.  

Ponvory^® (Ponesimod) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must not have any contraindications for use of Ponvory^® including:
  • Myocardial infarction (MI), unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure (HF) requiring hospitalization, or NYHA Class III/IV HF in the last 6 months; or
  • Presence of Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, unless member has a functioning pacemaker; and
• Member must not have received prior treatment with alemtuzumab; and
• Member must not be concurrently using strong CYP3A4 and UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine); and
• Verification from the prescriber that the member has no active infection(s); and
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
• Verification from the prescriber that the member has undergone an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present before initiating Ponvory^®; and
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; and
• Verification from the prescriber that the member’s blood pressure will be monitored during treatment with Ponvory^®; and
• Verification from the prescriber that the member has undergone an ophthalmic evaluation prior to starting therapy with Ponvory^® and the member will be monitored for changes in vision throughout therapy; and
• Verification from the prescriber that the member has been assessed for medications and conditions that cause reduction in heart rate or AV conduction delays and the member will be followed with appropriate monitoring per package labeling; and
• Verification from the prescriber that the member has a previous confirmed history of chickenpox or vaccination against varicella. Members without a history of chickenpox or varicella vaccination should receive a full course of the varicella vaccine prior to commencing treatment with Ponvory^®; and
• Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; and
• Female members of reproductive potential must be willing to use effective contraception during treatment with Ponvory^® and for at least 1 week after discontinuing treatment; and
• Member must have had an inadequate response to Gilenya^® (fingolimod) or a patient-specific, clinically significant reason why fingolimod is not appropriate for the member must be provided; and
• Compliance will be checked for continued approval every 6 months; and
• A quantity limit of 30 tablets per 30 days will apply for the 20mg tablet. A quantity limit of 14 tablets per 14 days will apply for the Ponvory^® starter pack. 

Tascenso ODT^® [Fingolimod Orally Disintegrating Tablet (ODT)] Approval Criteria: 

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease; AND
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); AND
• Member must have had at least 1 relapse in the previous 12 months; AND
• Approvals will not be granted for concurrent use with other disease-modifying therapies; AND
• Prescriber must confirm that member will be observed in the prescriber’s office for signs and symptoms of bradycardia for 6 hours after the first dose; AND
• Verification from the prescriber that member has no active infection(s); AND
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; AND
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; AND
• A patient-specific, clinically significant reason why the member cannot use Gilenya^® (fingolimod) capsules must be provided; AND
• Compliance will be checked for continued approval every 6 months.

Tecfidera™ (Dimethyl Fumarate) Approval Criteria:

• An FDA approved diagnosis of clinically isolated syndrome, relapsing forms of multiple sclerosis (MS), or secondary progressive forms of MS in adults; and
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; and
• Verification from the prescriber that member has no active infection(s); and
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
• Liver function tests (LFTs) and total bilirubin levels and verification that levels are acceptable to the prescriber; and
• Compliance will be checked for continued approval every 6 months; and
• A quantity limit of 60 tablets per 30 days will apply. 
  

Tyruko® (Natalizumab-sztn) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, or Crohn’s disease in adults; and
• For a diagnosis of MS, the following criteria will apply:
  • Prescriber must be a neurologist or an advanced care practitioner with a supervising physician who is a neurologist; and
  • Approvals will not be granted for concurrent use with other disease-modifying therapies; or
• For a diagnosis of Crohn’s disease, the following criteria will apply:
  • Treatment with at least 2 different first-line therapeutic categories or Crohn’s disease that have failed to yield an adequate clinical response, or a patient-specific, clinically significant reason why the member cannot use all available first- and second-line alternatives must be provided; and
• A patient-specific, clinically significant reason why the member cannot use Tysabri® must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products; and
• Prescriber, infusion center, and member must enroll in the Tyruko® Risk Evaluation and Mitigation Strategy (REMS) program; and
• Compliance will be checked for continued approval every 6 months

Tysabri® (Natalizumab) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, in adults or Crohn’s disease; AND
• For a diagnosis of MS, the following criteria will apply:
  • Prescriber must be a neurologist or be an advanced care practitioner with a supervising prescriber that is a neurologist; AND
  • Approvals will not be granted for concurrent use with other disease-modifying therapies; OR  
• For a diagnosis of Crohn’s disease, the following criteria will apply:
  • Treatment with at least 2 different first-line therapeutic categories for Crohn’s disease that have failed to yield an adequate clinical response, or a patient-specific, clinically significant reason why the member cannot use all available first- and second-line alternatives must be provided; AND  
• Prescriber, infusion center, and member must enroll in the TOUCH Prescribing Program; AND
• Compliance will be checked for continued approval every 6 months.

Vumerity® (Dirozimel Fumarate) Approval Criteria:

• An FDA approved diagnosis of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease; AND
• Prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Approvals will not be granted for concurrent use with other disease-modifying therapies; AND
• Verification from the prescriber that member has no serious active infection(s); AND
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; AND
• Serum aminotransferase, alkaline phosphatase, and total bilirubin levels and verification that levels are acceptable to the prescriber; AND
• Verification from the prescriber that member does not have moderate or severe renal impairment; AND
• Verification from the prescriber that the member has been counseled on proper administration of Vumerity® including caloric and fat intake limits at the time of dosing; AND
• Compliance will be checked for continued approval every 6 months; AND
• A quantity limit of 120 capsules per 30 days will apply.

• An FDA approved diagnosis of 1 of the following in adults: 
  • relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, in adults; and
  • Moderately to severely active ulcerative colitis (UC); and
• For the diagnosis of MS, prescriber must be a neurologist (or an advanced care practitioner with a supervising physician that is a neurologist); and
• Member must not have any contraindications for use of Zeposia^® including:
  • Experienced myocardial infarction (MI), unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure (HF) requiring hospitalization, or NYHA Class III/IV HF in the last 6 months; or
  • Presence of Mobitz type II second-degree, third-degree atrioventricular (AV) block, or sick sinus syndrome, unless member has a functioning pacemaker; or
  • Severe untreated sleep apnea; or
  • Concurrent use of monoamine oxidase inhibitors (MAOIs); and
• Member must not have received prior treatment with alemtuzumab; and
• Member must not be concurrently using strong CYP2C8 inhibitors/inducers or breast cancer resistance protein (BCRP) inhibitors; and
• Verification from the prescriber that member has no active infection(s); and
• Complete blood counts (CBC) and verification that levels are acceptable to the prescriber; and
• Prescriber must conduct an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present before initiating Zeposia^®; and
• Liver function tests (LFTs) and verification that levels are acceptable to the prescriber; and
• Ophthalmic evaluation and verification that member will be monitored for changes in vision throughout therapy; and
• Verification from the prescriber that the member has been assessed for medications and conditions that cause reduction in heart rate or AV conduction delays and that the member will be followed with appropriate monitoring per package labeling; and
• Verification from the prescriber that the member has been assessed for previous confirmed history of chickenpox or vaccination against varicella. Members without a history of chickenpox or varicella vaccination should receive a full course of the varicella vaccine prior to commencing treatment with Zeposia^®; and
• Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of therapy; and
• Female members of reproductive potential must be willing to use effective contraception during treatment with Zeposia^® and for at least 3 months after discontinuing treatment; and
• For the diagnosis of MS, member must have had an inadequate response to Gilenya^® (fingolimod) or a patient-specific, clinically significant reason why fingolimod is not appropriate for the member must be provided; and
• For the diagnosis of UC, member must have had an inadequate response, loss of response, or intolerance to oral aminosalicylates, corticosteroids, immunomodulators (e.g., 6-mercaptopurine, azathioprine), and a biologic [e.g., tumor necrosis factor (TNF) blocker]. Tier structure applies; and
• Compliance will be checked for continued approval every 6 months; and
• A quantity limit of 30 capsules per 30 days will apply. 

• Only one long-acting and one short-acting agent can be used concurrently.
• Short-acting, solid dosage formulation products are limited to a quantity of 4 units per day or a quantity of 120 units per 30 days. An exception applies to members with a current oncology-related diagnosis, sickle cell disease diagnosis, or hemophilia diagnosis.
• An age restriction applies on oral liquid narcotic analgesic products for all members older than 12 years of age and oral solid dosage forms for all members younger than 10 years of age.
• An age restriction for all tramadol and codeine liquid and solid dosage form products for members younger than 12 years of age will apply.  Authorization would require a patient-specific, clinically significant reason for use of these products despite the medication being contraindicated for the member’s age.

Tier 1 medications are available without prior authorization.

Tier 2 authorization requires:

• Documented 30-day trial/titration period with at least one Tier-1 medication(s) within the last 90 days is required for a Tier-2 long-acting medication; and
• Clinically appropriate pain therapy requiring time-released medication. 
• A documented 30-day trial with at least two Tier-1 short-acting medications within the last 90 days is required for a Tier-2 short-acting medication; or
•  A documented allergy or contraindication(s) to all available Tier-1 medications.

 Tier 3 authorization requires:

• documented 30 day trial with at least two Tier-2 long acting medications within the last 90 days is required for a Tier-3 long acting medication and documented 30 day trial with at least two Tier-2 short acting medications within the last 90 days is required for a Tier-3 short acting medication, OR
• documented allergy or contraindication to all Tier 2 medications

Opioid Analgesics Special Prior Authorization (PA) Approval Criteria:

• Actiq^® and Fentora^® are approved for oncology-related diagnoses only.
• Unique Formulations and Strengths of Hydrocodone/Acetaminophen (APAP) Approval Criteria:
  • For hydrocodone/APAP 7.5mg-325mg/15mL oral solution (generic Hycet^®) or Xodol^® (hydrocodone/APAP 5mg/300mg, 7.5mg/300mg, and 10mg/300mg), a patient-specific, clinically significant reason why the member cannot use generic Norco^® (hydrocodone/APAP 5/325mg, 7.5/325mg, or 10/325mg) tablets must be provided; or 
  • For hydrocodone/APAP 7.5mg-325mg/15mL oral solution (generic Hycet®), a prior authorization is not required for members 14 years of age or younger. For members older than 14 years of age, a prior authorization is required, unless the prescription is written by an otolaryngologist or a dentist; and
  • For hydrocodone/APAP oral solution unit dose cups, a prior authorization is required for all members and a patient-specific, clinically significant reason why the member cannot use hydrocodone/APAP in bulk solution must be provided.
• ConZip^® [Tramadol Extended-Release (ER) Capsule] Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot use the ER tablet formulation must be provided. Tier structure rules apply.
• Acetaminophen (APAP)/Codeine Elixir and Solution Approval Criteria:
  • Authorization consideration for members younger than 12 years of age requires a patient-specific, clinically significant reason for use of these products despite the medication being contraindicated for the member’s age; or
  • For members older than 12 years of age, a patient-specific, clinically significant reason why the member cannot use the tablet formulation, which is available without a prior authorization, must be provided.
• Fioricet w/ Codeine (butalbital/APAP/caffeine/codeine 50mg/300mg/40mg/30mg) Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot take the 325mg APAP formulation (butalbital/APAP/caffeine/codeine 50mg/325mg/40mg/30mg), which is available generically, must be provided. 
• Levorphanol Tablet Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot use alternative treatment options for pain (e.g., non-opioid analgesics, lower-tiered opioid analgesics) must be provided.
• Methadone Oral Solution Approval Criteria:
  • For the lower strengths of methadone (5mg/5mL or 10mg/5mL), a prior authorization is not required for members 1 year of age and younger; or
  • For members older than 1 year of age, a patient specific clinically significant reason why the member cannot use methadone tablets and other lower-tiered opioid analgesics must be provided.
• Oxycodone/APAP Unique Formulations and Strengths Approval Criteria:
  • For Nalocet^® (oxycodone/APAP 2.5mg/300mg) tablet and Prolate^® (oxycodone/APAP 5mg/300mg, 7.5mg/300mg, and 10mg/300mg) tablets, a patient specific, clinically significant reason why the member cannot use generic Percocet^® (oxycodone/APAP 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, or 10mg/325mg) tablets must be provided; and
  • For Prolate^® (10mg-300mg/5mL) oral solution, a patient specific, clinically significant reason why the member cannot use generic oxycodone/APAP tablets and generic oxycodone/APAP (5mg-325mg/5mL) oral solution must be provided. 
• Oxymorphone ER Tablet Approval Criteria:
  • A patient specific, clinically significant reason why the member cannot use any other available extended-release opioid analgesic must be provided.  
• Tramadol 25mg and 100mg Tablet Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot use 2 tramadol 50mg tablets to achieve a 100mg dose or split a tramadol 50mg tablet to achieve a 25mg dose must be provided; and
  • An age restriction will apply for members younger than 12 years of age. For members younger than 12 years of age, the provider must submit patient-specific, clinically significant information supporting the use of tramadol despite the medication being contraindicated for the member’s age. 
• Qdolo™ (Tramadol 5mg/mL Oral Solution) Approval Criteria:
  • A patient-specific, clinically significant reason why the member cannot use tramadol 50mg tablets, even when tablets are crushed, must be provided; and
  • An age restriction will apply for members younger than 12 years of age. For members younger than 12 years of age, the prescriber must provide patient-specific, clinically significant information supporting the use of tramadol despite the medication being contraindicated for the member’s age; and
  • A quantity limit of 2,400mL per 30 days will apply.
• Seglentis^® (Celecoxib 56mg/Tramadol 44mg Tablet) Approval Criteria:
  • An FDA approved indication of acute pain in adults that is severe enough to require an opioid analgesic; and
  • A patient-specific, clinically significant reason why the member cannot use any other opioid medication for treatment of acute pain must be provided; and
  • A patient-specific, clinically significant reason why the member cannot use celecoxib and tramadol individual products in place of Seglentis^® must be provided; and
  • An age restriction will apply for members younger than 12 years of age. For members younger than 12 years of age, the provider must submit patient-specific, clinically significant information supporting the use of tramadol despite the medication being contraindicated for the member’s age; and
  • A quantity limit of 28 tablets for a 7-day supply will apply.

Oncology Only Products:

• Members with an oncology-related diagnosis are exempt from the prior authorization process, and do not require pain contracts. 

Approval Criteria for Greater than 12 Claims Per Year of Hydrocodone Products:

• Members may be approved for greater than 12 claims per year of hydrocodone products if the member has a pain contract with a single prescriber. A copy of the pain contract must be submitted with the prior authorization request. Requests outside of the plan outlined in the contract will not be approved.
• Members with a current oncology-related diagnosis, hemophilia diagnosis, or sickle cell disease diagnosis do not require a pain contract for additional approvals.
• Members in long-term care facilities do not require a pain contract for additional approvals.

Approval Criteria for Greater than the Opioid Morphine Milligram Equivalent (MME) Limit:

• SoonerCare has an opioid MME limitation of 90 MME per day. Members with a daily MME >90 will require prior authorization. Each request for >90 MME per day will be evaluated on a case-by-case basis; and
• Patient-specific, clinically significant reasoning for daily doses >90 MME must be provided; and
• Reasoning why tapering to below the SoonerCare MME limit is not appropriate for the member must be provided; and
  • A taper schedule, dates of an attempted taper with reason(s) for failure, or a patient-specific, clinically significant reason why a taper attempt is not appropriate for the member should be documented on the prior authorization request; and
• For members unable to taper to below the SoonerCare MME limit or for whom tapering to below the SoonerCare MME limit is not appropriate, the prescriber must attest to all of the following:
  • Other non-pharmacologic therapies have been ineffective (i.e., physical therapy); and
  • Other non-opioid pharmacologic therapies have been ineffective [i.e., non-steroidal anti-inflammatory drugs (NSAIDs)]; and
  • Risk factors for respiratory depression have been reviewed (i.e., concurrent benzodiazepine use, asthma); and
  • Counseling on opioid overdose has been provided and a prescription for naloxone has been offered to the member; and
  • Member has been evaluated for opioid use disorder; and
  • Pain treatment plan has been established and includes realistic goals for pain and function; and
  • Monitoring plan is established including random urine drug screens and review of the Oklahoma Prescription Monitoring Program (PMP); and
  • Dose reduction has resulted in loss of pain control and/or function; and
  • Further escalation in dose will not be allowed by provider. Authorization will only be granted at current MME; and
  • The benefits of high-dose opioid therapy for both pain and function in the member outweigh the risks to member safety; and
• Requests for members exceeding the 90 MME limit per day can be approved when there is documentation of pain associated with end-of-life care, palliative care, or hospice; and
• Members with oncology, sickle cell disease, or hemophilia diagnoses are excluded from the MME limit.

Prior Authorization form

TIER 1	TIER 2	TIER 3	SPECIAL PA	ONCOLOGY ONLY
LONG ACTING
buprenorphine patch (Butrans®)*BRAND Preferred   oxycodone ER 10mg, 15mg, 20mg only (Oxycontin®) *BRAND Preferred tapentadol ER tab 50mg (Nucynta® ER)	fentanyl patch (Duragesic®) morphine ER tab (MS Contin®) oxycodone ER 30mg, 40mg, 60mg, 80mg (Oxycontin®) *BRAND Preferred tapentadol ER tab 100mg, 150mg, 200mg, 250mg (Nucynta® ER)   tramadol ER (Ultram® ER, Ryzolt®)	buprenorphine buccal film (Belbuca®)  hydrocodone ER cap (Zohydro® ER) hydrocodone ER (Hysingla® ER) hydromorphone ER tab (Exalgo®) methadone tab (Dolophine® and Methadose™) morphine ER cap (Avinza®, Kadian®) oxycodone ER (Xtampza® ER)	oxymorphone ER tab (Opana®ER) tramadol ER caps (ConZip®) methadone soln (Dolophine®)
Short-Acting
APAP/butalbital/ caff/codeine cap 50mg/325mg/40mg/30mg  (Fioricet® with Codeine) ASA/butalbital/caffeine/ codeine cap (Fiorinal with Codeine®) codeine tab codeine/APAP tab (Tylenol® with Codeine) hydrocodone/ APAP tab (Norco®) hydrocodone/IBU tab 5/200mg, 7.5/200mg only (Vicoprofen®, Ibudone®, Reprexain™) hydromorphone tab & soln (Dilaudid®) meperidine tab & soln (Demerol®)  morphine IR tab & soln (MSIR®) oxycodone/APAP tab & soln (Percocet®) oxycodone/ASA tab (Percodan®) oxycodone IR cap (OxylR®) oxycodone IR tab & soln (Roxicodone®) tapentadol IR (Nucynta®) tramadol 50mg tab (Ultram®) tramadol/APAP tab (Ultracet®)	hydrocodone/IBU tab 10/200mg (Ibudone®, Reprexain™) oxymorphone IR tab (Opana®)	dihydrocodeine/APAP/caff cap (Trezix®) oxycodone tab (RoxyBond™)	levorphanol tartrate tab oxycodone/APAP tab (Nalocet®) oxycodone/APAP tab & soln (Prolate®) tramadol 25mg & 100mg tabs tramadol soln (Qdolo™) APAP/codeine elixir & soln  Seglentis®  hydrocodone APAP soln(Zamicet®, Liquicet®) hydrocodone/ APAP tab (Xodol®) APAP/butalbital/ caff/codeine cap 50mg/300mg/40mg/30mg  (Fioricet® with Codeine)	fentanyl buccal tab (Fentora®) fentanyl transmucosal lozenge (Actiq®)

*Special restrictions apply including age restriction

APAP = acetaminophen; ASA = aspirin; caff = caffeine; cap = capsule; ER = extended-release;  IBU = ibuprofen; IR = immediate-release; PA = prior authorization; SL = sublingual; soln = solution;   tab = tablet

PA criteria:

• An FDA approved diagnosis of Pseudobulbar Affect (PBA) secondary to a neurological condition (e.g., ALS, MS, Parkinson’s disease, stroke, traumatic brain injury); AND  
• Documentation of the neurological condition must be submitted; AND
• Member must be 18 years of age or older; AND
  Nuedexta® must be prescribed by, or in consultation with, a neurologist or psychiatrist (or be an advanced care practitioner with a supervising physician who is a neurologist or psychiatrist); AND
• Member must not have a contraindication to therapy [e.g., concomitant use with quinidine, quinine, or mefloquine; history of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions; known hypersensitivity to dextromethorphan; use with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI; prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure; complete atrioventricular (AV) block without implanted pacemaker, or at high risk of complete AV block; currently taking other drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide)]; AND
• Prescriber must document baseline number of PBA laughing or crying episodes per day; AND
• A quantity limit of 60 capsules per 30 days will apply; AND
• Initial approvals will be for the duration of one year 12 weeks. Reauthorizations may be granted if the prescriber documents the member is responding well to treatment as indicated by a reduction in the number of PBA episodes of laughing or crying per day compared to baseline. Current users must meet the revised approval criteria when reapplying for prior authorization continuation. 

Prior Authorization form   

amantadine extended-release (ER)(Gocovri™) Approval Criteria:

• An FDA approved indication for the treatment of dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy; AND
• Member must use Gocovri™ concomitantly with levodopa therapy; AND
• Member must not have end-stage renal disease (ESRD, CrCl <15mL/min/1.73m2); AND
• A minimum of a six-month trial of amantadine immediate-release (IR) that resulted in inadequate effects or intolerable adverse effects that are not expected to occur with amantadine ER; AND
• A patient-specific, clinically significant reason why amantadine IR products cannot be used must be provided; AND
• A patient-specific, clinically significant reason why Osmolex ER™ (amantadine ER) cannot be used must be provided; AND
• A quantity limit of one 68.5mg capsule or two 137mg capsules per day will apply.

amantadine extended-release (ER) (Osmolex ER™) Approval Criteria:

• An FDA approved indication for the treatment of Parkinson’s disease (PD) or drug-induced extrapyramidal reactions in adults patients; AND
• Member must not have end-stage renal disease (ESRD) [creatinine clearance (CrCl) <15mL/min/1.73m2]; AND
• A minimum of a 6-month trial of amantadine immediate-release (IR) that resulted in inadequate effects or intolerable adverse effects that are not expected to occur with amantadine ER; AND
• A patient-specific, clinically significant reason why amantadine IR products cannot be used must be provided; AND
• A quantity limit will apply based on FDA approved dosing regimen(s). 

carbidopa/levodopa enteral suspension (Duopa™) Approval Criteria:

• An FDA approved diagnosis of advanced Parkinson’s disease; AND
• For long-term administration, member or caregivers must be willing and able to administer Duopa® through a percutaneous endoscopic gastrostomy; AND
• Patients must be experiencing three hours or more of “off” time on their current Parkinson's disease drug treatment and they must have demonstrated a clear responsiveness to treatment with levodopa;  AND
• Approvals will be for a quantity of one cassette per day

carbidopa/levodopa extended-release capsules (Rytary™) Approval Criteria:

• An FDA approved diagnosis of Parkinson’s disease, post-encephalitic parkinsonism, or parkinsonism that may follow carbon monoxide intoxication or manganese intoxication; AND
• A patient-specific, clinically significant reason why the member cannot use other generic carbidopa/levodopa combinations including Sinemet® CR (carbidopa/levodopa extended-release tablets).

iIstradefylline tablet (Nourianz™) Approval Criteria:

• An FDA approved diagnosis of Parkinson’s disease (PD); AND
• Member must be taking carbidopa/levodopa in combination with istradefylline (istradefylline has not been shown to be effective as monotherapy for the treatment of PD); AND
• Prescriber must verify that the dose is appropriate for the member based on degree of hepatic impairment, concomitant strong CYP3A4 inhibitors, and smoking status of the member; AND
• Member must be experiencing at least 2 hours of “off” time per day; AND
• A quantity limit of 1 tablet per day will apply.

kynmobi™ [Apomorphine Sublingual (SL) Film] Approval Criteria:

• An FDA approved indication of acute, intermittent treatment of “off” episodes in members with Parkinson’s disease (PD); and
• Member must be taking carbidopa/levodopa in combination with Kynmobi™; and
• Member should be experiencing at least 1 well defined “off” episode per day with a total daily “off” time duration of ≥2 hours during the waking day; and
• Initial dose titration should occur in an “off” state and in a setting supervised by a health care provider to monitor blood pressure and heart rate; and
• Member must not use apomorphine concomitantly with 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron, palonosetron, alosetron); and
• Prescriber must verify the member has been counseled on separating doses by at least 2 hours; and
• The maximum single dose approvable is 30mg; and
• A quantity limit of 5 doses per day will apply.

levodopa Inhalation (Inbrija™) Approval Criteria:

• An FDA approved indication for the treatment of “off” episodes in patients with Parkinson’s disease (PD) treated with carbidopa/levodopa; AND
• Member must be taking levodopa/carbidopa in combination with Inbrija™. Inbrija™ has been shown to be effective only in combination with carbidopa/levodopa; AND
• The member must be experiencing motor fluctuations with a minimum of 2 hours of “off” time and demonstrate levodopa responsiveness; AND
• Member must not be taking nonselective monoamine oxidase inhibitors (MAOIs) concomitantly with Inbrija™ or within 2 weeks prior to initiating Inbrija™; AND
• A previous failed trial of immediate-release (IR) carbidopa/levodopa formulations alone or in combination with long-acting carbidopa/levodopa formulations or a reason why supplementation with IR carbidopa/levodopa formulations is not appropriate for the member must be provided; AND
• A quantity limit of 10 capsules for inhalation per day will apply. 

ongentys^® (Opicapone) Approval Criteria:

• An FDA approved indication of adjunctive treatment to levodopa/carbidopa in members with Parkinson’s disease (PD) experiencing “off” episodes; and
• Member must be taking levodopa/carbidopa in combination with Ongentys^®; and
• Member must not use non-selective monoamine-oxidase inhibitors (MAOIs) concomitantly with Ongentys^®; and
• Member must not have a history of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms; and
• Prescriber must verify member has been counseled to avoid eating food 1 hour before and at least 1 hour after taking Ongentys^®; and
• For members with moderate hepatic impairment, the prescriber must verify the dose of Ongentys^® will be reduced in accordance with package labeling; and
• Prescriber must agree to monitor member for changes in heart rate, heart rhythm, and blood pressure in members concurrently taking medications known to be metabolized by catechol-O-methyltransferase (COMT); and
• A patient-specific, clinically significant reason why the member cannot use entacapone must be provided; and
• A quantity limit of 30 capsules per 30 days will apply.

pimavanserin (Nuplazid™) Approval Criteria:  

• An FDA approved diagnosis of hallucinations and delusions associated with Parkinson’s disease psychosis; AND
• Member must have concomitant diagnosis of Parkinson’s disease; AND
• Member must not be taking concomitant medications known to prolong the QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin); AND
  
• The member must not have a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia, hypomagnesemia, and the presence of congenital prolongation of the QT interval; AND
• Nuplazid™ will not be approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis; AND
• Initial approvals will be for the duration of three months. For continuation, the prescriber must include information regarding improved response/effectiveness of this medication.
• A quantity limit of one tablet daily will apply.

rotigotine (Neupro)

• Parkinson's Disease
  • FDA approved indication for the treatment of signs and symptoms of Parkinson's Disease
  • Must be 18 years old or older
  • Failed treatment, intolerance, or clinically significant reason why member cannot use oral dopamine agonists
• Restless Leg Syndrome
  • FDA approved indication of Restless Leg Syndrome
  • Must be 18 years or older
  • Must provide documented treatment attempts at recommended dose with at least two of the following that did not yield adequate relief:
  • • carbidopa/levodopa
    • pramipexole
    • ropinirole

safinamide (Xadago®) Approval Criteria: 

• An FDA approved diagnosis of adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes; AND
• Member must be taking levodopa/carbidopa in combination with safinamide. Safinamide has not been shown to be effective as monotherapy for the treatment of PD; AND
• A patient-specific, clinically significant reason why the member cannot use rasagiline or other lower cost monoamine oxidase type B (MAO-B) inhibitors must be provided; AND
• Member must not have severe hepatic impairment; AND
• Member must not be taking any of the following medications concomitantly with safinamide:
  • Monoamine oxidase inhibitors (MAOIs); OR
  • Linezolid; OR
  • Opioid analgesics (including tramadol); OR
  • Selective norepinephrine reuptake inhibitors (SNRIs); OR
  • Tri- or tetra-cyclic or triazolopyridine antidepressants; OR
  • St. John’s wort; OR
  • Cyclobenzaprine; OR
  • Methylphenidate and its derivatives; OR
  • Amphetamine and its derivatives; OR
  • Dextromethorphan; AND 
• Prescriber must verify member has been counseled on avoiding foods that contain a large amount of tyramine while taking safinamide; AND
• A quantity limit of one tablet daily will apply.

Prior Authorization form

Smoking Cessation

• Smoking cessation products no longer require a prior authorization. 
• Smoking cessation products do not count against the 6 prescriptions/month limit.
• Smoking cessation products are available without a co-pay. 
• All nicotine replacement products (patches, gum, lozenges, inhalers), Zyban®, and Chantix® do not require prior authorization.
• Chantix® may be used for up to 180 days per calendar year. Chantix is not covered for members younger than 16 years of age.
• Oklahoma Tobacco Helpline - Smoking Cessation Program 

Veozah™ (Fezolinetant) Approval Criteria:

• An FDA approved diagnosis of moderate-to-severe vasomotor symptoms (VMS) due to menopause; and
• Member must not use CYP1A2 inhibitors (e.g., cimetidine, ciprofloxacin, ethinyl estradiol, fluvoxamine, mexiletine) concomitantly with Veozah™; and
• Member must not have a history of severe renal impairment, end-stage renal disease, or cirrhosis; and
• Prescriber must verify baseline renal function and member must have an estimated glomerular filtration rate (eGFR) ≥30mL/min/1.73m²; and
• Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored prior to the initiation of Veozah™, every 3 months for the first 9 months of treatment, and as clinically indicated thereafter; and
• A patient-specific, clinically significant reason why the member cannot use menopausal hormone therapy must be provided; and
• A patient-specific, clinically significant reason why the member cannot use other guideline supported non-hormonal therapy for VMS (e.g., gabapentin, paroxetine, venlafaxine) must be provided; and
• A quantity limit of 30 tablets per 30 days will apply.