Skeletal System

PA criteria:

• Approval requires FDA approved indication and clinical documentation of inability to take other generically available forms of cyclobenzaprine hydrochloride.
• A quantity limit of 30 capsules for 30 days placed on Amrix.
• A quantity limited of 90 tablets for 30 days placed on Fexmid.
• Prior Authorization form

colchicine capsules (Mitigare™), colchicine tablets (Colcrys®), and colchicine oral solution (Gloperba®) Approval Criteria:

• A quantity of six tablets for a three day supply is available without prior authorization for treatment of acute gouty attacks; AND
• Failure of allopurinol after six months of treatment defined by persistent gouty attacks with serum urate levels greater than 6.0mg/dL; AND
• Patient-specific, clinically significant reason why colchicine/probenecid would not be a viable option for the member; AND
• For authorization of Gloperba®, a patient-specific, clinically significant reason why the member cannot use colchicine tablets or capsules must be provided; AND
• A quantity limit of 60 tablets/capsules per 30 days or 300 mL per 30 days will apply for gout; AND   
• Members with the diagnosis of Familial Mediterranean Fever verified by genetic testing will be approved for up to 2.4mg per day.

lesinurad/allopurinol (Duzallo®) Approval Criteria:  

• Member must be 18 years of age or older; AND
• An FDA approved indication for the treatment of symptomatic hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone; AND
• Failure of allopurinol or febuxostat alone defined by serum urate levels greater than 6.0mg/dL; AND
• Prior to starting treatment with Duzallo®, member must be on at least 300mg of allopurinol daily, unless creatinine clearance (CrCl) is less than 60mL/min then 200mg daily is required. Duzallo® 200mg/200mg will only be approved for members with a CrCl less than 60mL/min; AND  
• Prescriber must verify that member has a CrCl greater than 45mL/min prior to initiating treatment. For continued approval, prescriber must verify CrCl is greater than 45mL/min and serum creatinine is not greater than two times baseline when Duzallo® was initiated; AND
• Prescriber must document member has no contraindications for use of Duzallo® including any of the following: Tumor lysis syndrome or Lesch-Nyhan syndrome, severe renal impairment (CrCl less than 30mL/min), end-stage renal disease, kidney transplant recipients, or patients on dialysis.
• A quantity limit of one tablet daily will apply. 

pegloticase (Krystexxa®) Approval Criteria:

• An FDA approved diagnosis of gout; AND  
• Member must have symptomatic gout with:
  • ≥3 gout flares in the previous 18 months; OR
  • ≥1 gout tophus; OR
  • Gouty arthritis; AND
• Failure of the following urate lowering therapies: allopurinol, febuxostat, lesinurad, AND probenecid titrated to the maximum tolerable dose for at least 3 months; AND
• Pegloticase must be administered in a health care setting by a health care provider prepared to manage anaphylaxis; AND
• Prescriber must attest that the member will be pre-medicated with antihistamines and corticosteroids to reduce the risk of anaphylaxis; AND
• Prescriber must document that member does not have glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to starting pegloticase; AND
• Member must discontinue oral urate-lowering agents prior to starting pegloticase; AND
• Member must receive gout flare prophylaxis with non-steroidal anti-inflammatory drug(s) (NSAIDs) or colchicine at least 1 week before initiation of pegloticase therapy and continue for at least 6 months unless medically contraindicated or member is unable to tolerate therapy.
• Approvals will be for the duration of 6 months. Reauthorizations may be granted if the prescriber documents the member is responding well to treatment, and member has not exceeded >4 consecutive weeks without therapy.  

febuxostat (ULORIC®) Approval Criteria:

• Failure of allopurinol defined by persistent gouty attacks with serum urate levels greater than 6.5 mg/dL
• Clinical Reason why allopurinol is not a viable option for the member.
  
• Quantity limit of 30 per 30 days will apply.

lesinurad (Zurampic™) Approval Criteria:

• Member must be 18 years of age or older; AND
  
• An FDA approved diagnosis of gout in patients who have not achieved target serum uric acid (sUA) levels with a xanthine oxidase inhibitor (XOI) alone; AND
• Failure of allopurinol or febuxostat alone defined by serum urate levels greater than 6.0mg/dL; AND
• Prescriber must verify that member has a creatinine clearance greater than 45mL/min prior to initiating treatment and for continued approval; AND
• Prescriber must verify that member will take Zurampic™ concomitantly with a XOI; AND
• Prescriber must document member is not taking more than 325mg of aspirin per day and member is not taking any epoxide hydrolase inhibitors; AND 
• Prescriber must document member has no contraindications for use of Zurampic™ including any of the following: Tumor lysis syndrome or Lesch-Nyhan syndrome, severe renal impairment (CrCl less than 30mL/min), end stage renal disease, kidney transplant recipients, or patients on dialysis.
• A quantity limit of one tablet daily will apply.

Prior Authorization form

PA Criteria:

• Generic chlorzoxazone 500mg tablets must be tried prior to consideration of Lorzone™; AND 
• A patient-specific, clinically significant reason why the member cannot use generic chlorzoxazone 500mg tablets must be provided; AND
• The following quantity limits apply:
  • Lorzone™ 375mg tablets: 120 tablets for 30 days
  • Lorzone™ 750mg tablets: 120 tablets for 30 days
• Prior Authorization form  

PA Criteria:

Tier 1 products are covered with no authorization necessary.

Tier 2 authorization criteria:

• Previous use of at least two Tier 1 NSAIDs (from different product lines) plus a PPI within the last 120 days, or
• For those with prior GI bleed who must have an NSAIDs, a Tier 2 product may be approved (Celebrex should also be taken with a PPI)

Special PA approval criteria:

• A unique indication for which a Tier-1 or Tier-2 medication is not appropriate, such as the diagnosis of gout for indomethacin; or
• Previous use of at least two Tier-1 NSAID products (from different product lines); and 
• A patient-specific, clinically significant reason why a special formulation is needed over a Tier-1 product.
• Additionally, use of Tivorbex™ will require a patient-specific, clinically significant reason why member cannot use other available generic indomethacin products.
• Additionally, use of Celebrex (celecoxib) 400mg capsules will require a diagnosis of Familial Adenomatous Polyposis (FAP) and a patient-specific, clinically significant reason why the member cannot use two celecoxib 200mg capsules to achieve a 400mg dose.

Meloxicam suspension for members older than 7 years of age will require a prior authorization.  A prior authorization request can be submitted for members older than 7 years of age requiring meloxicam suspension.  A reason why the member needs the liquid formulation and cannot use the oral tablet formulation should be provided with the prior authorization request.

Anjeso^® (Meloxicam Injection) Approval Criteria:

• An FDA approved diagnosis of management of moderate-to-severe pain, alone or in combination with non-nonsteroidal anti-inflammatory drug (NSAID) analgesics; and
• Member must be 18 years of age or older; and
• Prescriber must verify member will be well hydrated before Anjeso^® administration to reduce the risk of renal toxicity; and
• Anjeso^® should be used for the shortest duration consistent with individual patient treatment goals; and
• A patient-specific, clinically significant reason the member cannot use oral meloxicam tablets or other Tier-1 NSAIDs must be provided; and
• A quantity limit of 3 vials per 3 days will apply; and
• For consideration of a longer duration of use, a patient-specific, clinically significant reason why the member cannot transition to an oral Tier-1 NSAID must be provided, along with the anticipated duration of treatment.

NOTE: In order for previously utilized Tier 1 medications to count as trials toward a Tier 2 authorization, the member's NSAID therapy must have been continuous. Dates and dosing information for Tier 1 trials must be included on petition for authorization. Trials with OTC formulations of Tier 1 products must be dosed at full prescription strength.

Prior Authorization form

Tier 1	Tier 2	Special PA
celecoxib (Celebrex®) 50mg,100mg and 200mg caps diclofenac epolamine (Flector®) diclofenac sodium (Voltaren®) 50mg and 75mg  diclofenac sodium gel (Voltaren Gel®) etodolac (Lodine®) 400mg and 500mg tabs  flurbiprofen (Ansaid®) ibuprofen (Motrin®) meloxicam (Mobic®)  nabumetone (Relafen®)  naproxen (Naprosyn®) naproxen EC (Naprosyn EC®) sulindac (Clinoril®)	diclofenac ER (Voltaren XR®)  diclofenac sodium/misoprostol (Arthrotec®) diclofenac potassium (Cataflam®)  diclofenac sodium (Voltaren®) 25mg tabs  etodolac (Lodine®) 200mg and 300mg cap  etodolac ER (Lodine XL®) naproxen sodium (Anaprox®) 275mg and 550mg tabs oxaprozin (Daypro®) piroxicam (Feldene®)  tolmetin (Tolectin®)	celecoxib (Celebrex®) 400mg caps diclofenac (Zorvolex™)  diclofenac epolamine (Licart™) topical system diclofenac potassium (Zipsor®, Cambia®)  diclofenac injection (Dyloject™)  diclofenac sodium drops (Pennsaid®) fenoprofen (Nalfon®) ibuprofen injection (Caldolor®) ibuprofen/famotidine (Duexis®)  indomethacin (Tivorbex™) indomethacin susp and er caps (Indocin®)  ketoprofen (Orudis®) caps ketoprofen ER (Oruvail®) ketorolac tromethamine (Sprix®) nasal spray  mefanamic acid (Ponstel®) meclofenamate (Meclomen®) meloxicam (Anjeso®) inj meloxicam capsules (Vivlodex™)  meloxicam ODT (Qmiiz™ ODT) nabumetone 1,000mg (Relafen™ DS) naproxen sodium (Naprelan®)  naproxen/esomeprazole (Vimovo®)

caps = capsules; ER = extended-release; EC = enteric-coated; inj = injection; ODT = orally disintegrating tablet; PA = prior authorization; susp = suspension; tabs = tablets

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).

*Naproxen oral suspension is available without prior authorization for members 12 years of age and younger. Members older than 12 years of age will require a reason why a special formulation product is needed in place of the regular tablet formulation.

Tier 1 products are available with no authorization necessary.

PA Criteria:

*Calcitonin and raloxifene are not included as Tier-1 trials.

• Must be used at recommended doses in conjunction with Tier-1 bisphosphonate for trial to be accepted unless member has a recent laboratory result showing adequate Vitamin D or member is unable to tolerate calcium. OTC Calcium and Vitamin D are only covered for members with osteoporosis. See a list of covered calcium products.

Criteria for Moving to Higher Tiers:

• Treatment failure with all lower tiered products, or
• Contraindication to all lower tiered products, or
• Allergic reaction to all lowered tiered products, or
• Specific indication not covered by a lower tiered product.
• No concomitant use of bisphosphonate therapy will be approved.  No additional bisphosphonate therapy may be approved for 365 days following zoledronic acid infusion.

TIER 1	TIER 2	SPECIAL CRITERIA APPLY
alendronate (Fosamax®) calcium + vitamin D lbandronate (Boniva®) zoledronic acid (Reclast®)	alendronate +D (Fosamax +D®) risedronate (Actonel®)	abaloparatide (Tymlos™) alendronate (BinostoTM ) conjugated estrogens/bazedoxifene (Duavee®)  denosumab (Prolia®)  ibandronate (BonivaTM IV) risedronate 30mg Tabs (Actonel®) risedronate delayed release (Atelvia®) romosozumab-aqqg (Evenity®) teriparatide (Forteo®) teriparatide inj

tabs = tablets; inj = injection; soln = solution; DR = delayed-release; PA = prior authorization

*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).

^†OTC calcium and vitamin D must be used at recommended doses in conjunction with Tier-1 bisphosphonates for trial to be accepted unless member has a recent laboratory result showing adequate vitamin D or member is unable to tolerate calcium. OTC calcium and vitamin D are only covered for members with osteoporosis that are being treated with a bisphosphonate.

FORTEO® (Teriparatide) and Teriparatide

PA Criteria:  A diagnosis of one of the following: Treatment of postmenopausal women with osteoporosis at high risk for fracture; OR To increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture; OR Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture; OR Treatment of non-healing fracture (this indication only pertains to Forteo®); AND A minimum 12 month trial with a bisphosphonate plus adequate calcium and vitamin D or a patient-specific, clinically significant reason the member cannot use a bisphosphonate; AND Use of teriparatide will require a patient-specific, clinically significant reason why the member cannot use Forteo® (teriparatide); AND The diagnosis of non-healing fracture may be approved for six months; AND Treatment duration including other parathyroid hormone analogs has not exceeded a total of 24 months during the patient's lifetime; AND Approval will be for a maximum of 2 years of therapy.  Prior Authorization form

Evenity® (Romosozumab-aqqg) Approval Criteria:

An FDA approved diagnosis of osteoporosis in postmenopausal women at high risk for fracture; AND Member meets 1 of the following: History of osteoporotic fracture; OR Multiple risk factors for fracture (e.g., T-score ≤-2.5 at the total hip or femoral neck, smoking, corticosteroid use, rheumatoid arthritis); OR Failed or are intolerant to other available osteoporosis therapies; AND Prescriber must verify member has not had a myocardial infarction or stroke within the preceding year; AND Prescriber must verify calcium levels will be monitored and pre-existing hypocalcemia will be corrected prior to starting therapy; AND Prescriber must verify that the member will take adequate calcium and vitamin D supplements during treatment with Evenity® to reduce the risk of hypocalcemia; AND Evenity® must be administered by a health care provider; AND Approvals will be for a maximum total duration of 1 year of therapy.

      

ABALOPARATIDE (TYMLOS™)

abaloparatide (Tymlos™) Approval Criteria: A diagnosis of postmenopausal osteoporosis confirmed by the following: History of vertebral fracture(s) or low trauma or fragility fracture(s) [e.g., prior fracture from minor trauma such as falling from standing height or less] within the past 5 years; OR A Bone Mineral Density test (T-score at or below -2.5) within the last month in the spine, femoral neck, total hip, or 33% radius; OR Those with a T-score between -1.0 and -2.5 in the spine, femoral neck, total hip, or 33% radius, if the FRAX® 10-year probability for major osteoporotic fracture is ≥20% or the 10-year probability of hip fracture is ≥3%; AND   One of the following [if a 12-month bisphosphonate trial is inappropriate for the member, the member must have trial of Prolia™ or a selective estrogen receptor modulator [SERM] or a patient-specific, clinically significant reason why Prolia™ or a SERM is not appropriate]: A minimum 12-month trial with a bisphosphonate plus adequate calcium and vitamin D; OR A 12-month trial of Prolia™ (denosumab), unless contraindicated, intolerant, or allergic, that  did not yield adequate results; OR A 12-month trial of a SERM, unless contraindicated, intolerant, or allergic, that  did not yield adequate results; OR   A patient-specific, clinically significant reason why the member cannot use Forteo® (teriparatide); AND Treatment duration including other parathyroid hormone analogs has not exceeded a total of 24 months during the patient's lifetime; AND Approval will be for a maximum of 2 years of therapy; AND A quantity limit of one pen per 30-days will apply.  Prior Authorization form

 

DENOSUMAB (XGEVA®) *MEDICAL BILLING ONLY

CONSIDERATION FOR APPROVAL WILL BE BASED ON THE FOLLOWING CRITERIA:

• AN FDA APPROVED INDICATION OF ONE OF THE FOLLOWING:
  • PREVENTION OF SKELETAL-RELATED EVENTS IN PATIENTS WITH MULTIPLE MYELOMA AND IN PATIENTS WITH BONE METASTASES FROM SOLID TUMORS; OR
  • TREATMENT OF ADULTS AND SKELETALLY MATURE ADOLESCENTS WITH GIANT CELL TUMOR OF THE BONE (GCTB) THAT IS UNRESECTABLE OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY; OR 
• PRESCRIBER MUST DOCUMENT THAT TUMOR IS UNRESECTABLE OR THAT SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY.
  • TREATMENT OF HYPERCALCEMIA OF MALIGNANCY REFRACTORY TO BISPHOSPHONATE THERAPY.  
   
• MEMBER MUST HAVE ALBUMIN-CORRECTED CALCIUM OF GREATER THAN 12.5 MG/DL (3.1 MMOL/L) DESPITE TREATMENT WITH INTRAVENOUS BISPHOSPHONATE THERAPY IN THE LAST 30 DAYS PRIOR TO INITIATION OF XGEVA® THERAPY.

 

ProliaTM, Boniva® IV requires

ProliaTM, Boniva® IV requiresA MINIMUM 12 MONTH TRIAL WITH A TIER 1 OR TIER 2 BISPHOSPHONATE PLUS ADEQUATE CALCIUM AND VITAMIN D, ORPRIOR AUTHORIZATION CRITERIA:

• A MINIMUM 12 MONTH TRIAL WITH A TIER 1 OR TIER 2 BISPHOSPHONATE PLUS ADEQUATE CALCIUM AND VITAMIN D, OR
• CONTRAINDICATION TO OR INTOLERABLE ADVERSE EFFECTS WITH TIER 1 AND TIER 2 PRODUCTS. 

PRIOR AUTHORIZATION FORM

 

CONJUGATED ESTROGENS/BAZEDOXIFENE (DUAVEE®)

CONSIDERATION FOR APPROVAL WILL BE BASED ON THE FOLLOWING CRITERIA:

• AN FDA APPROVED DIAGNOSIS OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE OR FOR PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS; AND
• MEMBER MUST BE A FEMALE WITH AN INTACT UTERUS; AND  
• FOR A DIAGNOSIS OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE:
  • MEMBER MUST HAVE AT LEAST 7 MODERATE TO SEVERE HOT FLUSHES PER DAY OR AT LEAST 50 PER WEEK PRIOR TO TREATMENT; AND
   
• FOR A DIAGNOSIS OF PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS:
  • A TRIAL OF FOSAMAX® (ALENDRONATE), ACTONEL® (RISEDRONATE), BONIVA® (IBANDRONATE) OR RECLAST® (ZOLEDRONIC ACID) COMPLIANTLY USED FOR AT LEAST 6 MONTHS CONCOMITANTLY WITH CALCIUM + VITAMIN D, THAT FAILED TO PREVENT FRACTURE OR IMPROVE BMD SCORES; OR
  • CONTRAINDICATION TO, HYPERSENSITIVITY TO, OR INTOLERABLE ADVERSE EFFECTS WITH ALL BISPHOSPHONATES INDICATED FOR PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS; AND
   
• MEMBER MUST NOT HAVE ANY OF THE CONTRAINDICATIONS FOR USE OF DUAVEE®; AND
• MEMBERS GREATER THAN 65 YEARS OF AGE WILL GENERALLY NOT BE APPROVED WITHOUT SUPPORTING INFORMATION.
• APPROVALS WILL BE FOR THE DURATION OF 6 MONTHS TO ENSURE THE NEED FOR CONTINUED THERAPY IS REASSESSED PERIODICALLY AND THE MEDICATION IS BEING USED FOR THE SHORTEST DURATION POSSIBLE.
• A QUANTITY LIMIT OF 30 TABLETS PER 30 DAYS WILL APPLY.

Ozobax^® (Baclofen 5mg/5mL Oral Solution) Approval Criteria:

• An FDA approved diagnosis of spasticity resulting from multiple sclerosis (relief of flexor spasms and concomitant pain, clonus, and muscular rigidity) or spinal cord injuries/diseases; and
• Members older than 10 years of age require a patient-specific, clinically significant reason (beyond convenience) why the member cannot use baclofen oral tablets, even when tablets are crushed.

Tier 1 products are covered with no authorization necessary.

Tier 2 authorization requires:

• Documented trial of two Tier 1 medications within the last 90 days with no beneficial response after a minimum of 2 weeks of continuous therapy during which time the medication has been titrated to the recommended dose.

Baclofen 5mg Tablet Approval Criteria:

• A patient-specific, clinically significant reason why the member cannot use other appropriate Tier-1 products including splitting a baclofen 10mg tablet to achieve a 5mg dose must be provided.
  

Prior Authorization form

Tier 1	Tier 2	Special PA
cyclobenzaprine (Flexeril®) baclofen (Lioresal®) orphenadrine (Norflex®) chlorzoxazone (Parafon Forte, Paraflex®) methocarbamol (Robaxin®) tizanidine (Zanaflex®)	metaxolone (Skelaxin®)	baclofen 5mg (Lioresal®) carisoprodol 350mg w/aspirin carisoprodol 350mg, ASA, codeine cyclobenzaprine ER (Amrix®) Caps cyclobenzaprine 7.5mg (Fexmid®) Tabs chlorzoxazone (Lorzone™) carisoprodol (Soma®) 250mg, 350mg tizanidine (Zanaflex®) Caps

PA Criteria:

• A cumulative 90 therapy day window per 365 days will be in place for these products, further approval will be based on the following:
• An additional approval for 1 month will be granted to allow titration or change to a Tier1 muscle relaxant. Further authorizations will not be granted.
• Clinical exceptions may be made for members with the following diagnosis and approvals will be granted for the duration of one year:
  • Multiple Sclerosis
  • Cerebral Palsy
  • Muscular Dystrophy
  • Paralysis
   
• A quantity limit of 120 per 30 days will also apply for the carisoprodol and carisoprodol combination products.

Soma 250 Approval for coverage is based on the following criteria:

• Documentation regarding member's inability to use other skeletal muscle relaxants including carisoprodol 350 mg, and specific reason member cannot be drowsy for even a short time period. Member must not have other sedating medications in current claims history.
• A diagnosis of acute musculoskeletal pain, in which case, the approval will be for 14 days per 365 day period.  Conditions requiring chronic use will not be approved.
• Prior Authorization form

PA Criteria:

• Trizanidine tablets must be tried prior to consideration of the capsules. The capsules maybe considered for approval if there is supporting information as to why the member cannot take the tablets
• Prior Authorization form