Biologics
Adbry™ (Tralokinumab-ldrm Injection) Approval Criteria:
- An FDA approved diagnosis of moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable; AND
- Member must be 18 years of age or older; AND
- Member must have a documented trial within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
- 1 medium potency to very-high potency Tier-1 topical corticosteroid; AND
- 1 topical calcineurin inhibitor [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; AND
- Adbry™ must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
- Requests for concurrent use of Adbry™ with other biologic medications will be reviewed on a case-by-case basis and will require patient-specific information to support the concurrent use (Adbry™ has not been studied in combination with other biologic therapies); AND
- Initial approvals will be for the duration of 16 weeks. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval.
(BOTOX® MYOBLOC® DYSPORT® XEOMIN®)*MEDICAL BILLING ONLY
Dysport® (abobotulinumtoxinA) and Botox® are now both preferred agents. Botulinum injections require a Prior Authorization for all diagnoses.
Botulinum Toxins Approval Criteria:
- For approval of Xeomin® or Myobloc®, a patient-specific, clinically significant reason the member cannot use Botox® or Dysport® must be provided; and
- Cosmetic indications will not be covered; and
- A diagnosis of chronic migraine (tension headaches are not a covered diagnosis), neurogenic detrusor overactivity, and non-neurogenic overactive bladder will require manual review (see specific criteria below); and
- The following indications have been determined to be appropriate and are covered:
a. Spasticity associated with:
i. Cerebral palsy; or
ii. Paralysis; or
iii. Generalized weakness/incomplete paralysis; or
iv. Larynx; or
v. Anal fissure; or
vi. Esophagus (achalasia and cardiospasms); or
vii. Eye and eye movement disorders; or
b. Cervical dystonia.
Botox® only criteria (effective April 24, 2013)
Consideration for approval requires the following critria for Botox for Prevention of Migraine Headaches (other botulinum toxins will not be approved for this use):
- Non-migraine medical conditions known to cause headache have been ruled out and/or have been treated. This includes but is not limited to:
- Increase intracranial pressure (e.g. tumor, pseudotumor cerebri, central venous thrombosis, etc.)
- Decrease intracranial pressure (e.g. post-lumbar puncture headache, dural tear after trauma, etc.) AND
- Migraine headache exacerbation secondary to other medical conditions or therapies have been ruled out and/or treated. This includes but is not limited to:
- Hormone replacement therapy or hormone-based contraceptives
- Chronic insomnia
- Obstructive sleep apnea; AND
- Member has no contraindications to Botox injections; AND
- FDA indications are met:
- Member is 18 or older; AND
- Member has a documented chronic migraine headaches
- Frequency of 15 or more headache days per month with 8 or more migraine days per month and occurring for more than 3 months; AND
- Duration of 4 hours per day or longer; AND
- The member has failed medical migraine preventive therapy including at least two 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 not limited to:
- Select antihypertensive therapy such as beta-blocker therapy
- Select anticonvulsant therapy
- Select antidepressant therapy ( e.g. TCA or SNRI); AND
- Member is not frequently taking medications which are known to cause medication overuse headaches (MOH or rebound headache) 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 product) (≥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 must have been evaluated within the last 6 months by a neurologist for chronic migraine headaches and Botox recommended as treatment. (Not necessarily prescribed or administered by neurologists.); AND
- Prescriber must verify that other aggravating factors that are contributing to the development of chronic migraine headaches are being treated when applicable (e.g., smoking); AND
- Member will not use the requested medication concurrently with a calcitonin gene-related peptide (CGRP) inhibitor for the prevention of migraine headaches.
Consideration for approval requires the following criteria for Botox® for Non-Neurogenic Overactive Bladder (other botulinum toxins will not be approved for this use):
- Member must have severe disease (≥ 5 urinary incontinence episode per day on medication) and specific pathology determined via urodynamic studies;
- Member must have participated in behavioral therapy for at least 12 weeks that did not yield adequate clinical results; AND
- Member must have had compliant use of at least 3 antimuscarinic medication(s) for at least 12 weeks each, alone or in combination with behavioral therapy, that did not yield adequate clinical results. One of those trials must have been an extended release formulation; AND
- Member must be 18 years of age or older, and have adequate hand function and sufficient cognitive ability to know when the bladder needs emptying and to self-catheterize, or have a caregiver able to catheterize the member when necessary; AND
- Only Urologists will be approved for administration of this procedure.
Consideration for approval requires the following criteria for Botox for Neurogenic Detrusor Overactivity (NDO) (other botulinum toxins will not be approved for this use):
- Diagnosis of 1 of the following:
- a. Urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury, multiple sclerosis] in adult members; or
- b. NDO in pediatric members; and
- Underlying pathological dysfunction subtype confirmed by:
- a. Urodynamic studies to determine pathology and serve to provide objective evidence of bladder and external sphincter function; AND
- b. A diary of fluid intake, incontinence, voiding, and catheterization times and amounts to provide a record of actual occurrences; AND
- Must have a clinically significant reason why anticholinergic medications are no longer an option for the member; AND
- Member must be 5 years of age or older, and have adequate hand function and sufficient cognitive ability to know when the bladder needs emptying and to self-catheterize, or have a caregiver able to catheterize the member when necessary; AND
- Only Urologists will be approved for administration of this procedure.
Prior Authorization Form - Botulinum Toxins
caplacizumab-yhdp (Cablivi®) Approval Criteria:
- An FDA approved diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP); AND
- Member must be undergoing plasma exchange therapy; AND
- Dates of initiation of plasma exchange therapy must be listed on the prior authorization request; AND
- Authorizations will be for the duration of plasma exchange and for 30 days after discontinuation of plasma exchange; AND
- Member must be utilizing immunosuppressant therapy; AND
- Cablivi® must be prescribed by, or in consultation with, a hematologist; AND
- A quantity limit of 11mg per day will apply. Initial approvals will be for the duration of plasma exchange plus 30 days. Reauthorization, after completing 30 days post-plasma exchange, may be considered if the prescriber documents sign(s) of persistent underlying disease remain. Reauthorization will be for a maximum of 28 days.
Prior Authorization Forms
Empaveli® (Pegcetacoplan) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:
- An FDA approved diagnosis of PNH; and
- Member must be 18 years of age or older; and
- Empaveli® must be prescribed by, or in consultation with, a gastroenterologist, hematologist, geneticist, or a specialist with expertise in the treatment of PNH; and
- For member self-administration or caregiver administration, the prescriber must verify the member or caregiver has been trained by a health care provider on proper administration and storage of Empaveli®; and
- Prescriber and pharmacy must be enrolled in the Empaveli® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- For members switching from Soliris® to Empaveli®, prescriber must verify the member will continue the current dose of Soliris® for 4 weeks before switching to Empaveli® as monotherapy; and
- For members switching from Ultomiris® to Empaveli®, prescriber must verify that Empaveli+ will be initiated no more than 4 weeks after the last dose of Ultomiris®; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Enspryng® (Satralizumab-mwge) Approval Criteria [Neuromyelitis Optica Spectrum Disorder (NMOSD) Diagnosis]:
- An FDA approved indication of NMOSD in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
- Member must be 18 years of age or older; and
- Member must have experienced at least 1 acute NMOSD attack in the prior 12 months; and
- Member must have an Expanded Disability Severity Scale (EDSS) score ≤6.5; and
- Prescriber must verify hepatitis B virus (HBV) and tuberculosis (TB) screening are negative before the first dose; and
- Approvals will not be granted for members with active HBV infection or active or untreated latent TB; and
- Enspryng® must be prescribed by, or in consultation with, a neurologist, ophthalmologist, or a specialist with expertise in the treatment of NMOSD; and
- Prescriber must verify liver function tests have been assessed prior to initiation of treatment with Enspryng® and levels are acceptable to prescriber; and
- Prescriber must agree to counsel the member to monitor for clinically significant active infection(s) prior to each dose (for active infections, the dose should be delayed until the infection resolves); and
- Prescriber must agree to monitor neutrophil counts 4 to 8 weeks after initiation of therapy and thereafter as clinically appropriate; and
- Prescriber must verify member has not received any vaccinations within 4 weeks prior to initiation of therapy; and
- Member and/or caregiver must be trained by a health care professional on subcutaneous administration and storage of Enspryng®; and
- A quantity limit override for the loading dose will be approved upon meeting the Enspryng® approval criteria. A quantity limit of 1 syringe per 28 days will apply for the maintenance dose, according to the package labeling; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Rystiggo® (Rozanolixizumab-noli) Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:
- An FDA approved diagnosis of gMG; and
- Member must be 18 years of age or older; and
- Member must have a positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle-specific tyrosine kinase (MuSK) antibodies; and
- Member must have a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification class II to IVa; and
- MG-Activities of Daily Living (MG-ADL) total score ≥3 (with at least 3 points from non-ocular symptoms); and
- Member must be on a stable dose of either an acetylcholinesterase (AChE) inhibitor or immunosuppressive therapies (ISTs) or a patient specific, clinically significant reason why the member cannot use an AChE inhibitor or an IST must be provided; and
- Rystiggo® must be prescribed by, or in consultation with, a neurologist, or a specialist with expertise in the treatment of gMG; and
- Member must not be receiving Rystiggo® in combination with a complement inhibitor (i.e., Soliris®, Ultomiris®, Zilbrysq®); and
- Initial approvals will be for the duration of 6 months, at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of 1 year.
Soliris® (Eculizumab) Approval Criteria [Atypical Hemolytic Uremic Syndrome (aHUS) Diagnosis]:
- An FDA approved diagnosis of aHUS; and
- Prescriber must confirm the member does not have Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HS); and
- Soliris® must be prescribed by, or in consultation with, a gastroenterologist, geneticist, hematologist, nephrologist, or a specialist with expertise in the treatment of aHUS; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Soliris® (Eculizumab) Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:
- An FDA approved diagnosis of gMG; and
- Member must have a positive serologic test for anti-acetylcholine receptor (anti-AChR) antibodies; and
- Member must have a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification class II to IV; and
- Member must have a MG-Activities of Daily Living (MG-ADL) total score ≥6; and
- Member must meet 1 of the following:
- Failed treatment over 1 year or more with 2 or more immunosuppressive therapies (ISTs) either in combination or as monotherapy; or
- Failed at least 1 IST and required chronic plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIg); and
- Soliris® must be prescribed by, or in consultation with, a neurologist or a specialist with expertise in the treatment of gMG; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- Use of Soliris® will require a patient specific, clinically significant reason why the member cannot use Ultomiris® (ravulizumab-cwvz); and
- Member must not be receiving Soliris® in combination with a neonata Fc receptor blocker (i.e., Rystiggo®, Vyvgart®, Vyvgart® Hytrulo); and
- Initial approvals will be for the duration of 6 months at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of 1 year.
Soliris® (Eculizumab) Approval Criteria [Neuromyelitis Optica Spectrum Disorder (NMOSD) Diagnosis]:
- An FDA approved indication of NMOSD in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
- Member must be 18 years of age or older; and
- Member must have a history of at least 2 NMOSD attacks in last 12 months or 3 attacks in the last 24 months, with at least 1 attack in the past 12 months; and
- Member must have an Expanded Disability Severity Scale (EDSS) score ≤7; and
- Soliris® must be prescribed by, or in consultation with, a neurologist, ophthalmologist, or a specialist with expertise in the treatment of NMOSD; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Soliris® (Eculizumab) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:
- An FDA approved diagnosis of PNH; and
- Member must be 18 years of age or older; and
- Soliris® must be prescribed by, or in consultation with, a gastroenterologist, geneticist, hematologist, or a specialist with expertise in the treatment of PNH; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Ultomiris® (Ravulizumab-cwvz) Approval Criteria [Atypical Hemolytic Uremic Syndrome (aHUS) Diagnosis]:
- An FDA approved diagnosis of aHUS; and
- Member must be:
- 1 month of age or older for the intravenous (IV) formulation; or
- 18 years of age or older for the subcutaneous (sub-Q) formulation; and
- Prescriber must confirm the member does not have Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HS); and
- Ultomiris® must be prescribed by, or in consultation with, a gastroenterologist, geneticist, hematologist, nephrologist, or a specialist with expertise in the treatment of aHUS; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Ultomiris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- For the sub-Q formulation, prescriber must verify the member or caregiver has been trained by a health care provider on the proper administration and storage of Ultomiris®; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Ultomiris® (Ravulizumab-cwvz) Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:
- An FDA approved diagnosis of gMG; and
- Member must be 18 years of age or older; and
- Member must have a positive serologic test for anti-acetylcholine receptor (anti-AChR) antibodies; and
- Member must have a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification class II to IV; and
- Member must have a MG-Activities of Daily Living (MG-ADL) total score ≥6; and
- Member must be on a stable dose of either an acetylcholinesterase (AChE) inhibitor or immunosuppressive therapies (ISTs) or a patient specific, clinically significant reason why the member cannot use an AChE inhibitor or an IST must be provided; and
- Ultomiris® must be prescribed by, or in consultation with, a neurologist or a specialist with expertise in the treatment of gMG; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled in the Ultomiris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- The subcutaneous (sub-Q) formulation of Ultomiris® will not be approved for a diagnosis of gMG; and
- Member must not be receiving Ultomiris® in combination with a neonatal Fc receptor blocker (i.e., Rystiggo®, Vyvgart®, Vyvgart® Hytrulo); and
- Initial approvals will be for the duration of 6 months, at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of 1 year.
Ultomiris® (Ravulizumab-cwvz) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:
- An FDA approved diagnosis of PNH; and
- Member must be:
- 1 month of age or older for the intravenous (IV) formulation; or
- 18 years of age or older for the subcutaneous (sub-Q) formulation; and
- Ultomiris® must be prescribed by, or in consultation with, a gastroenterologist, geneticist, hematologist, or a specialist with expertise in the treatment of PNH; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber must be enrolled int the Ultomiris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- For the sub-Q formulation, prescriber must verify the member or caregiver has been trained by a health care provider on the proper administration and storage of Ultomiris®; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Uplizna® (Inebilizumab-cdon) Approval Criteria [Neuromyelitis Optica Spectrum Disorder (NMOSD) Diagnosis]:
- An FDA approved indication of NMOSD in adult members who are anti-aquaporin-4 (AQP4) antibody positive; and
- Member must be 18 years of age or older; and
- Member must have experienced at least 1 acute NMOSD attack in the prior 12 months, or at least 2 attacks in the prior 24 months, requiring rescue therapy; and
- Member must have an Expanded Disability Severity Scale (EDSS) score ≤8; and
- Uplizna® must be prescribed by, or in consultation with, a neurologist, ophthalmologist, or a specialist with expertise in the treatment of NMOSD; and
- Prescriber must verify hepatitis B virus (HBV) and tuberculosis (TB) screenings are negative before the first dose; and
- Approvals will not be granted for members with active HBV infection or active or untreated latent TB; and
- Prescriber must agree to monitor member for clinically significant active infection(s) prior to each dose (for active infections, the dose should be delayed until the infection resolves); and
- Prescriber must verify testing for quantitative serum immunoglobulins has been performed before the first dose and levels are acceptable to prescriber; and
- Prescriber must agree to monitor the level of serum immunoglobulins during and after discontinuation of treatment with Uplizna® until B-cell repletion; and
- The infusion must be administered under the supervision of a health care professional with access to appropriate medical support to manage potential severe reactions, and the patient must be observed for at least 1 hour after the completion of each infusion; and
- Female members of reproductive potential must not be pregnant and must have a negative pregnancy test prior to initiation of treatment; and
- Female members of reproductive potential must use contraception while receiving Uplizna® and for 6 months after the last infusion; and
- Prescriber must verify member has not received any vaccinations within 4 weeks prior to initiation of therapy; and
- A quantity limit override for the loading dose will be approved upon meeting the Uplizna® approval criteria. A quantity limit of 30mL per 180 days will apply for the maintenance dose; and
- Initial approvals will be for the duration of 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Subsequent approvals will be for 1 year.
Vyvgart® (Efgartigimod Alfa-fcab) and Vyvgart® Hytrulo (Efgartigimod alfa/Hyaluronidase-qvfc) Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:
- An FDA approved diagnosis of gMG; and
- Member must be 18 years of age or older; and
- Member must have a positive serologic test for anti-acetylcholine receptor (AChR) antibodies; and
- Member must have a myasthenia Gravis Foundation of America (MGFA) Clinical Classification class II to IV; and
- MG-Activities of Daily Living (MGADL) total score ≥5; and
- Member must be on a stable dose of either an acetylcholinesterase (AChE) inhibitor or immunosuppressive therapies (ISTs) or a patient specific, clinically significant reason why the member cannot use an AChE inhibitor or an IST must be provided; and
- Vyvgart® or Vyvgart® Hytrulo must be prescribed by, or in consultation with, a neurologist, or a specialist with expertise in the treatment of gMG; and
- Member must not be receiving Vyvgart® or Vyvgart® Hytrulo in combination with a complement inhibitor (i.e., Soliris®, Ultomiris®, Zilbrysq®); and
- Initial approvals will be for the duration of 6 months, at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of 1 year.
Zilbrysq® (Zilucoplan) Approval Criteria [Generalized Myasthenia Gravis (gMG) Diagnosis]:
- An FDA approved diagnosis of gMG; and
- Member must be 18 years of age or older; and
- Member must have a positive serologic test for anti-acetylcholine receptor (AChR) antibodies; and
- Member must have a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification class II to IV; and
- MG-Activities of Daily Living (MG-ADL) total score ≥6; and
- Member must be on a stable dose of either an acetylcholinesterase (AChE) inhibitor or immunosuppressive therapies (ISTs) or a patient specific, clinically significant reason why the member cannot use an AChE inhibitor or an IST must be provided; and
- Zilbrysq® must be prescribed by, or in consultation with, a neurologist, or a specialist with expertise in the treatment of gMG; and
- Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
- Prescriber and pharmacy must be enrolled in the Zilbrysq® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
- Member must not be receiving Zilbrysq® in combination with a neonatal Fc receptor blocker (i.e., Rystiggo®, Vyvgart®, Vyvgart® Hytrulo); and
- For member self-administration or caregiver administration, the prescriber must verify the member or caregiver has been trained by a health care provider on proper administration and storage of Zilbrysq®; and
- Initial approvals will be for the duration of 6 months, at which time an updated MG-ADL score must be provided. Continued authorization requires improvement in the MG-ADL score from baseline. Subsequent approvals will be for the duration of 1 year.
Prior Authorization Form - Universal Petition for Medication Authorization
Prior Authorization Form - Outpatient Medication Petition
avatrombopag (Doptelet®) Approval Criteria [Chronic Liver Disease (CLD) Scheduled to Undergo a Procedure]:
- An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure; AND
- Date of procedure must be listed on the prior authorization request; AND
- Prescriber must verify the member will have the procedure within 5 to 8 days after the member receives the last dose of Doptelet®; AND
- Member must have a baseline platelet count <50 X 109/L (recent baseline platelet count must be provided); AND
- Must be prescribed by, or in consultation with, a hematologist, gastroenterologist, or hepatologist; AND
- Doptelet® must not be used in an attempt to normalize platelet counts; AND
- Female members must not be pregnant and must have a negative pregnancy test prior to therapy initiation; AND
- Prescriber must verify member is not breastfeeding; AND
- A quantity limit of 15 tablets per scheduled procedure will apply.
avatrombopag (Doptelet®) Approval Criteria [Chronic Immune Thrombocytopenia Diagnosis]:
- An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment; AND
- Member must be 18 years of age or older; AND
- Previous insufficient response with at least 1 of the following treatments:
- Corticosteroids; OR
- Immunoglobulins; OR
- Splenectomy; AND
- A patient-specific, clinically significant reason why the member cannot use an alternative thrombopoietin (TPO) receptor agonist available without a prior authorization must be provided; AND
- Prescriber must verify the degree of thrombocytopenia and clinical condition increase the risk for bleeding; AND
- Prescriber must verify platelet counts will be assessed weekly until a stable platelet count greater than 50 x 109/L has been achieved, and then obtained monthly thereafter; AND
- Must be prescribed by, or in consultation with, a hematologist or oncologist; AND
- Doptelet® must not be used in an attempt to normalize platelet counts; AND
- Female members must not be pregnant and must have a negative pregnancy test prior to therapy initiation; AND
- Prescriber must verify member is not breastfeeding; AND
- A quantity limit of 60 tablets per 30 days will apply.
Prior Authorization Forms
PA Criteria:
- An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure; AND
- Date of procedure must be listed on the prior authorization request; AND
- Prescriber must verify the member will have the procedure 2 to 8 days after the member receives the last dose of Mulpleta®; AND
- Member must have a baseline platelet count <50 X 109/L (recent baseline platelet count must be provided); AND
- Must be prescribed by, or in consultation with, a hematologist, gastroenterologist, or hepatologist; AND
- Mulpleta® must not be used in an attempt to normalize platelet counts; AND
- A quantity limit of 7 tablets per scheduled procedure will apply.
Prior Authorization Forms
Otrexup® and Rasuvo®(Methotrexate Injection Solutions) Approval Criteria:
- An FDA approved diagnosis of one of the following:
- Adults with severe, active rheumatoid arthritis (RA); OR
- Children with active polyarticular juvenile idiopathic arthritis (pJIA); OR
- Severe, recalcitrant, disabling psoriasis confirmed by biopsy or dermatologic consultation; AND
- A patient-specific, clinically significant reason why the oral tablets or and the generic injectable formulation cannot be used must be provided.
PA Criteria:
- An FDA approved diagnosis of acute lymphoblastic leukemia (ALL); AND
- An age restriction on members older than 10 years of age will apply. Members 10 years of age and younger would not require prior authorization for Purixan® therapy; AND
- Members older than 10 years of age would require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used.
CLOSTRIDIUM HISTOLYTICUM COLAGENASE(XIAFLEX®) *MEDICAL BILLING ONLY
PA Criteria:
- FDA approved indication of Dupytren's contracture with palpable cord, functional impairment and fixed-flexion contractures of the metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of 30 degrees or more.
- Must be 18 years or older.
- Not a candidate for needle aponeurotomy.
- Physician must be trained in treatment of Dupuytren's contractures and injections of the hand.
- Quantity limit of 3 doses (one dose per 4 weeks) per cord.
Xiaflex® (Collagenase Clostridium Histolyticum) Approval Criteria (Peyronie’s Disease):
- A diagnosis of stable Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees and less than 90 degrees at the start of therapy; AND
- Member must be 18 years or older; AND
- Member must have pain outside the circumstances of intercourse that is refractory to other available treatments; AND
- Peyronie’s plaques must not involve the penile urethra; AND
- Member must have intact erectile function (with or without the use of medications); AND
- Prescriber must be certified to administer Xiaflex® through the Xiaflex® REMS program; AND
- A maximum of 8 injection procedures will be approved.
DENOSUMAB (XGEVA®)*MEDICAL BILLING ONLY
PA Criteria:
- An FDA approved diagnosis of Multicentric Castleman’s Disease (also known as giant lymph node hyperplasia); AND
- Member must be Human Immunodeficiency Virus (HIV) and Human Herpesvirus-8 (HHV-8) negative; AND
- Member must be 18 years of age or older; AND
- The following FDA approved dosing restrictions will apply
- 11 mg/kg via intravenous (IV) infusion every three weeks until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression, or deterioration in performance status); AND
- Sylvant™ must be administered in a clinical setting able to provide resuscitation equipment, medications, and trained personnel; AND
- The prescriber must verify that a complete blood count (CBC) will be done prior to each dose for the first 12 months and for an additional three doses thereafter; AND
- Approvals will be for the duration of six months.
Targeted Immunomodulator Agents Tier-2 Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- A trial of at least one Tier-1 medication (appropriate to the member’s disease state) in the last 90 days that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Tier-2 medication documented within the last 100 days.
Targeted Immunomodulator Agents Tier-3 Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- Recent trials (within the last 360 days) of one Tier-1 medication (appropriate to the member’s disease state) and at least 2 Tier-2 medications (appropriate to the member’s disease state) that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Tier-3 medication documented within the last 100 days; OR
- A unique FDA-approved indication not covered by Tier-2 products (unique approval criteria may apply).
Targeted Immunomodulator Agents Special Prior Authorization (PA) Approval Criteria:
- An FDA approved diagnosis; AND
- Prescriber must confirm that all baseline assessments and follow-up monitoring (e.g., laboratory assessment, infectious disease screening) will be performed as recommended in the package labeling for the requested product; AND
- A recent trial (within the last 360 days) of 1 Tier-3 medication (appropriate to the member’s disease state) that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; OR
- Prior stabilization on the Special PA medication documented within the last 100 days; OR
- A unique FDA-approved indication not covered by lower-tiered medications (unique approval criteria may apply).
Additional criteria by for individual products:
apremilast (Otezla®) Approval Criteria [Behçet’s Disease (BD) Diagnosis]:
- An FDA approved indication for the treatment of oral ulcers associated with BD; AND
- Member must have had oral ulcers at least 3 times in the last 12 month period; AND
- Member must have had a 2 week trial of the following that resulted in inadequate efficacy or intolerable adverse effects (or be contraindicated for the member):
- Topical corticosteroids (applied topically to the mouth); AND
- Colchicine; AND
- Quantity limits according to package labeling will apply.
adalimumab (Humira®) Approval Criteria:
[Hidradenitis Suppurativa]
- A diagnosis of moderate-to-severe hidradenitis suppurativa (HS); AND
- Hurley Stage II or III disease; AND
- The member must have at least 3 abscesses or inflammatory nodules; AND
- Previous failure of at least two of the following: topical or systemic antibiotics, oral OR intralesional corticosteroids, dapsone, cyclosporine, antiandrogens (spironolactone OR oral contraceptives), finasteride, or surgery.
[Noninfectious Intermediate and Posterior Uveitis or Panuveitis]
- A diagnosis of noninfectious intermediate uveitis, posterior uveitis, or panuveitis in members 2 years of age and older; AND
- A failed trial with a corticosteroid injection or systemic corticosteroid in which member has had an inadequate response; OR
- A patient-specific, clinically significant reason a trial of corticosteroid treatment is inappropriate for the member.
Arcalyst® (Rilonacept) Approval Criteria [Cryopyrin-Associated Periodic Syndromes (CAPS) Diagnosis]:
- FDA approved indication of Cryopyrin-Associated Periodic Syndromes (CAPS) verified by genetic testing. This includes Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older; and
- A patient-specific, clinically significant reason the member cannot utilize Kineret® (anakinra) or Ilaris® (canakinumab) must be provided. Tier structure rules apply; and
- The member should not be using a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, and infliximab) or anakinra concomitantly with Arcalyst®;
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; and
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for members 18 years of age and older:
- Initial treatment: Loading dose of 320mg delivered as (2) 2mL subcutaneous (sub-Q) injections of 160mg each given on the same day at 2 different injection sites; and
- Continued treatment: (1) 160mg injection given once weekly; or
- Approved dosing schedule for pediatric members 12 to 17 years of age (must have member weight in kilograms):
- Initial treatment: Loading dose of 4.4mg/kg, up to a maximum of 320mg, delivered as 1 or 2 sub-Q injections, with a maximum single-injection volume of 2mL (given at 2 different injection sites if administered as 2 injections); and
- Continued treatment: 2.2mg/kg, up to a maximum of 160mg, given once weekly; and
- Approvals will be for the duration of 1 year.\
Arcalyst® (Rilonacept) Approval Criteria [Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Diagnosis]:
- An FDA approved indication of maintenance of remission of DIRA verified by genetic testing; and
- The member must weigh ≥10kg; and
- The member should not be using a tumor necrosis factor blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra concomitantly with Arcalyst®; and
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; and
- Arcalyst® will be used for maintenance of remission following treatment with Kineret® (anakinra); and
- A patient-specific, clinically significant reason the member cannot continue to utilize Kineret® (anakinra) instead of switching to Arcalyst®; 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
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for adults and pediatric members weighing ≥10kg is 4.4mg/kg up to a maximum of 320mg, delivered as 1 or 2 injections (2mL/injection) once weekly; and
- Approvals will be for the duration of 1 year.
Arcalyst® (Rilonacept) Approval Criteria [Recurrent Pericarditis Diagnosis]:
- An FDA approved indication of recurrent pericarditis and reduction in risk of recurrence in members 12 years of age and older; and
- The member has had at least 2 episodes of pericarditis; and
- Member has failure with colchicine, non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroids defined as symptomatic pericarditis recurrence; and
- A patient-specific, clinically significant reason the member cannot utilize Kineret® (anakinra) must be provided; and
- The member should not be using a tumor necrosis factor blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra concomitantly with Arcalyst®; and
- Documentation that the member does not have active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis must be provided; 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 for members 12 to 17 years of age; and
- The following dosing restrictions will apply:
- Dosing should not be more often than once weekly; and
- Approved dosing schedule for members 18 years of age and older:
- Initial treatment: Loading dose of 320mg delivered as (2) 2mL subcutaneous (sub-Q) injections of 160mg each given on the same day at 2 different injection sites; and
- Continued treatment: (1) 160mg injection given once weekly; or
- Approved dosing schedule for pediatric members 12 to 17 years of age (must have member weight in kilograms):
- Initial treatment: Loading dose of 4.4mg/kg, up to a maximum of 320mg, delivered as 1 or 2 sub-Q injections, with a maximum single-injection volume of 2mL (given at 2 different injection sites if administered as 2 injections); and
- Continued treatment: 2.2mg/kg, up to a maximum of 160mg, given once weekly; and
- Initial approvals will be for 6 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment as indicated by decreased recurrence of pericarditis or improvement in signs and symptoms of recurrent pericarditis (e.g., C-reactive protein, pericarditic chest pain, pericardial effusion). Subsequent approvals will be granted for the duration of 1 year.
Benlysta® (Belimumab) Approval Criteria:
- The intravenous (IV) formulation will be covered as a medical claim only benefit while the subcutaneous (subQ) formulation will be covered as a pharmacy only benefit; AND
- An FDA approved indication of 1 of the following:
- The treatment of members 5 years of age and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) already receiving standard therapy; OR
- The treatment of members 5 years of age and older with active lupus nephritis who are receiving standard therapy; AND
- Documented inadequate response to at least two of the following medications appropriate to the member's specific disease state:
- High-dose oral corticosteroids; OR
- Methotrexate; OR
- Azathioprine; OR
- Mycophenolate; OR
- Cyclophosphamide; OR
- Hydroxychloroquine/chloroquine; AND
- Member must not have severe active central nervous system lupus; AND
- Benlysta® will not be approved for combination use with biologic therapies; AND
- Benlysta® will not be approved for combination use with IV cyclophosphamide (exception for induction treatment with IV cyclophosphamide for members with a diagnosis of lupus nephritis).
brodalumab (Siliq™):
- Initial authorizations of Siliq™ (brodalumab) will be for the duration of 12 weeks at which time the prescriber must verify the member is responding to treatment. If an adequate response has not been achieved after 12 to 16 weeks of treatment with brodalumab, consideration should be given to discontinuing therapy.
- Members must also be enrolled in the Siliq™ REMS Program for approval.
- Members with a concomitant diagnosis of Crohn’s disease will not be approved.
canakinumab (Ilaris®) Approval Criteria:
Approval Criteria [Active Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still’s Disease (AOSD) Diagnosis]:
- An FDA approved diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still's Disease (AOSD); and
- Ilaris® will not be approved for concurrent use with a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, or infliximab) or anakinra; and
- Ilaris® should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; and
- Dosing should not be more often than once every 4 weeks.
- Two years of age and older and body weight greater than 7.5kg: 4mg/kg every 4 weeks; max dose 300mg/dose; and
- Recent trials of one Tier-1 product and all appropriate Tier-2 products that did not yield adequate relief of symptoms or resulted in intolerable adverse effects; or
- Prior stabilization on Ilaris® documented within the last 100 days.
- Approvals will be for the duration of one year.
Kevzara® (Sarilumab) Approval Criteria [Polymyalgia Rheumatica (PMR) Diagnosis]:
- An FDA approved diagnosis of PMR; and
- Member must be 18 years of age or older; and
- Prescriber must verify member has had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper; and
- Prescriber must verify Kevzara® will be used in combination with a tapering course of corticosteroids, unless contraindicated.
Litfulo™ (Ritlecitinib) and Olumiant® (Baricitinib) Approval Criteria [Alopecia Areata Diagnosis]:
- An FDA approved diagnosis of severe alopecia areata; and
- For Litfulo™, member must be 12 to 20 years of age; or
- For Olumiant®, member must be 18 to 20 years of age; and
- Prescriber must confirm the member or caregiver has been counseled regarding the covered age range for the requested product and that the medication will no longer be covered once the member turns 21 years of age; and
- Member’s baseline Severity of Alopecia Tool (SALT) score must be provided and must be ≥50; and
- Must be prescribed by a dermatologist (or an advanced care practitioner with a supervising physician who is a dermatologist); and
- Prescriber must agree to screen for tuberculosis and viral hepatitis prior to initiating treatment; and
- Prescriber must agree to evaluate lymphocyte and platelet counts at baseline, 4 weeks after initiation, and as clinically indicated thereafter; and
- Prescriber must provide documentation of patient-specific, clinically significant information (e.g., impacting member’s mental health or ability to function in day-to-day living, reason why no treatment or cosmetic solutions are not appropriate) to demonstrate the medical necessity of this medication for this member; and
- Member must have documented trials within the last 6 months that resulted in failure with at least 2 of the following therapies (or have a contraindication or documented intolerance to all alternatives):
- Medium potency to very-high potency Tier-1 topical corticosteroid used for at least 12 weeks; or
- Oral corticosteroid used for at least 6 weeks; or
- Cyclosporine; or
- Methotrexate; or
- Contact immunotherapy (e.g., diphenylcyclopropenone, squaric acid dibutyl ester); and
- Concurrent use with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants will not be approved; and
- Prescriber must verify female members are not breastfeeding; and
- If the member is pregnant or becomes pregnant, prescriber must verify member has been counseled on potential risks of this medication and will report the exposure to the pregnancy registry; and
- Initial approvals will be for a duration of 24 weeks of treatment; and
- Reauthorization may be considered if the prescriber documents the member is responding well to treatment as indicated by a reduction in the member’s SALT score (current SALT score must be provided).
Tavneos® (Avacopan) Approval Criteria:
- An FDA approved diagnosis as adjunctive treatment of adult members with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis [granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)] in combination with standard therapy including corticosteroids; AND
- Member must be 18 years of age or older; AND
- Tavneos® must be used in combination with standard immunosuppressive therapy including corticosteroids; AND
- Prescriber must agree to monitor liver function tests prior to initiating Tavneos®, every 4 weeks after the start of therapy for the first 6 months of treatment, and as clinically indicated thereafter; AND
- Prescriber must agree to screen the member for hepatitis B virus (HBV) infection prior to initiating treatment with Tavneos®; AND
- Prescriber must verify the member has no active, serious infections, including localized infections and will closely monitor member for the development of signs and symptoms of infection during and after treatment with Tavneos®; AND
- A quantity limit of 180 tablets per 30 days will apply.
Tofidence™ (Tocilizumab-bavi) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Actemra® (tocilizumab) 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.
[Cryopyrin-Associated Periodic Syndromes (CAPS)]
- FDA approved diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS) verified by genetic testing. This includes Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 4 and older.
- The member should not be using a tumor necrosis factor blocking agent (e.g. adalimumab, etanercept, and infliximab) or anakinra.
- Should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis.
[Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), or Familial Mediterranean Fever (FMF)]
- A diagnosis of tumor necrosis factor receptor associated periodic syndrome (TRAPS) with chronic or recurrent disease activity defined as six flares per year; OR
- A diagnosis of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD); OR
- A diagnosis of familial Mediterranean fever (FMF) with documented active disease despite colchicine therapy or documented intolerance to effective doses of colchicine; 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.
Avsola® (Infliximab-axxq), Remicade® (Infliximab), and Renflexis® (Infliximab-abda) Approval Criteria:
- Member must meet Tier-3 trial requirements; AND
- A patient-specific, clinically significant reason why the member cannot use Inflectra® (infliximab-dyyb) 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.
Orencia® (Abatacept) Approval Criteria [Acute Graft Versus Host Disease (aGVHD) Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Diagnosis]:
- An FDA approved indication for the prophylaxis of aGVHD in members undergoing HSCT; AND
- Member must be 2 years of age or older; AND
- Member is undergoing HSCT with a matched or 1 allele-mismatched unrelated donor; AND
- Must be used in combination with a calcineurin inhibitor and methotrexate.
Cibinqo™ (Abrocitinib) and Rinvoq® (Upadacitinib) Approval Criteria [Atopic Dermatitis (AD) Diagnosis]:
- An FDA approved diagnosis of moderate-to-severe AD not adequately controlled with other systemic drug products, including biologics, or when those therapies are not advisable; AND
- For Cibinqo™, member must be 12 years of age or older; AND
- For Rinvoq®, member must be 12 years of age or older; AND
- Member must have a documented trial within the last 6 months for a minimum of 2 weeks that resulted in failure with both of the following topical therapies (or have a contraindication or documented intolerance):
- 1 medium potency to very-high potency Tier-1 topical corticosteroid; AND
- 1 topical calcineurin inhibitor [e.g., Elidel® (pimecrolimus), Protopic® (tacrolimus)]; AND
- Member must have a documented 16 week trial with Adbry™ (tralokinumab-ldrm) or Dupixent® (dupilumab) that resulted in inadequate response (or have a contraindication or documented intolerance); AND
- Requested medication must be prescribed by a dermatologist, allergist, or immunologist or the member must have been evaluated by a dermatologist, allergist, or immunologist within the last 12 months (or an advanced care practitioner with a supervising physician who is a dermatologist, allergist, or immunologist); AND
- For Cibinqo™, prescriber must verify the member will not use antiplatelet therapies (e.g., clopidogrel, prasugrel, ticagrelor) concurrently with Cibinqo™, except for low-dose aspirin, during the first 3 months of treatment; AND
- Cibinqo™ and Rinvoq® will not be approved for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or with other immunosuppressant medications; AND
- Initial approvals will be for the duration of 3 months. Reauthorization may be granted if the prescriber documents the member is responding well to treatment. Additionally, compliance will be evaluated for continued approval; AND
- For Rinvoq®, the maximum approvable dose for AD is 30mg once daily.
rituximab (Rituxan®) Approval Criteria
[Pemphigus Vulgaris (PV) Diagnosis]:
- An FDA approved diagnosis of moderate-to-severe PV; AND
- Rituxan® must be used in combination with a tapering course of glucocorticoids; AND
- Initial approvals will be for two 1,000mg intravenous (IV) infusions separated by 2 weeks and a 500mg infusion at month 12. Subsequent approvals may be authorized based on 6-month evaluations or upon relapse. Subsequent infusions may be no sooner than 16 weeks after the previous infusion.
[Granulomatosis With Polyangiitis (GPA, Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) Diagnosis]:
- An FDA approved diagnosis of GPA or MPA in adult and pediatric patients 2 years of age and older; AND
- Rituxan® must be used in combination with corticosteroids; AND
- Approval quantity will be based on Rituxan® prescribing information and FDA approved dosing regimen(s).
Spevigo® (Spesolimab-sbzo) Approval Criteria:
- An FDA approved indication for the treatment of generalized pustular psoriasis (GPP) flares (GPP diagnosis should be verifiable in the member’s diagnosis history); AND
- Prescriber must verify at least 1 of the following:
- Member has experienced >1 flare (relapsing GPP); OR
- Member has symptoms persisting for >3 months (persistent GPP); AND
- Member must be currently experiencing a moderate-to-severe GPP flare meeting all the following criteria:
- Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score must be provided and must be ≥3; AND
- Presence of fresh pustules (new appearance or worsening of pustules); AND
- GPPPGA pustulation sub-score must be provided and must be ≥2; AND
- ≥5% of body surface area (BSA) covered with erythema and the presence of pustules; AND
- Member must be 21 years of age or older; AND
- Must be prescribed by a dermatologist or other specialist with expertise in the treatment of GPP (or an advanced care practitioner with a supervising physician who is a dermatologist or other specialist with expertise in the treatment of GPP); AND
- Prescriber must submit documentation of negative tuberculosis (TB) test or initiation of anti-TB therapy for latent TB prior to initiation of therapy with Spevigo®; AND
- Prescriber must verify the member does not have any clinically significant active infections and the member will be monitored for active infections prior to each dose of Spevigo®; AND
- Approvals will be for 1 dose of Spevigo®. A second dose of Spevigo® may be approved 1 week after the first dose if the prescriber submits documentation that the member has been evaluated and continues to experience GPP flare symptoms; AND
- A quantity limit of 2 doses per year will apply (the safety and efficacy of additional doses of Spevigo® have not been assessed); AND
- Requests for additional doses of Spevigo® to treat new GPP flares occurring within 1 year (after successful resolution of the previous flare) will be reviewed on a case-by-case basis and will require the prescriber to submit patient-specific, clinically significant information documenting the clinical necessity of additional treatment despite the lack of adequate safety and efficacy data; AND
- Subsequent requests for new GPP flares (after 1 year) will require the member to meet all initial approval criteria, and information regarding the member’s response to previous treatment with Spevigo® must be submitted. Members who did not experience resolution of pustules after previous treatment will not be approved for additional use of Spevigo®.
tocilizumab (Actemra®) Approval Criteria:
[Giant Cell Arteritis (GCA) Diagnosis]:
- An FDA approved diagnosis of GCA; AND
- Member must be 50 years of age or older; AND
- A history of erythrocyte sedimentation rate (ESR) of ≥30mm/hr or a history of C-reactive protein (CRP) ≥1mg/dL; AND
- Member should have a trial of glucocorticoids for a minimum of four weeks or a reason why this is not appropriate; AND
- Actemra® will be taken in combination with tapering course of a glucocorticoid upon initiation; AND
- Member must have baseline liver enzymes, absolute neutrophil count (ANC), lipid panel, and platelet count and verification that they are acceptable to prescriber; AND
- Member must not have severe hepatic impairment; AND
- Actemra® should not be initiated in patients with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; AND
- Approval quantity will be based on Actemra® prescribing information and FDA approved dosing regimen.
[Chimeric Antigen Receptor (CAR) T Cell-Induced Cytokine Release Syndrome (CRS) Diagnosis]:
- An FDA approved diagnosis of CAR T cell-induced CRS.
vedolizumab (Entyvio™) Approval Criteria
- An FDA approved diagnosis:
- For intravenous (IV) administration: Moderately-to-severely active Crohn’s disease (CD) or moderately-to-severely active ulcerative colitis (UC); or
- For subcutaneous (sub-Q) administration: Moderately-to-severely active UC; and
- Member must be 18 years of age or older; and
- A minimum of a 4 week trial of a Tier-2 tumor necrosis factor (TNF) blocker indicated for the treatment of CD or UC that did not yield adequate relief of symptoms or resulted in intolerable adverse effects. Current Tier-2 medications include the following:
- CD: Humira® (adalimumab), Inflectra® (infliximab-dyyb); or
- UC: Humira® (adalimumab), Inflectra® (infliximab-dyyb); or
- Prior stabilization on the medication documented within the last 100 days; and
- For Entyvio® sub-Q administration, member must have received at least 2 initial IV doses of Entyvio®; and
- A quantity limit of 300mg every 8 weeks will apply for the IV formulation and 108mg every 2 weeks will apply for the sub-Q formulation. Approvals will be granted for titration quantities required for initial dosing; and
- Initial approvals will be for the duration of 14 weeks as Entyvio® should be discontinued in patients who do not show evidence of therapeutic benefit by week 14.
Abrilada™ (Adalimumab-afzb), Amjevita™ (Adalimumab-atto), Cyltezo™ (Adalimumab-adbm), Hadlima™ (Adalimumab-bwwd), Hulio® (Adalimumab-fkjp), Hyrimoz™ (Adalimumab-adaz), Idacio® (Adalimumab-aacf), Yuflyma® (Adalimumab-aaty), and Yusimry™ (Adalimumab-aqvh) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Humira® (adalimumab) 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.
Actemra® (Tocilizumab) Approval Criteria [Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) Diagnosis]:
- An FDA approved diagnosis SSc-ILD; AND
- Member must be 18 years of age or older; AND
- Medication must be prescribed by, or in consultation with, a pulmonologist or pulmonary specialist (or an advanced care practitioner with a supervising physician who is a pulmonologist or pulmonary specialist); AND
- Approvals will be for subcutaneous administration using the FDA approved dosing of 162mg once weekly.
Erelzi® (Etanercept-szza) and Eticovo™ (Etanercept-ykro) Approval Criteria:
- Member must meet Special Prior Authorization (PA) approval criteria; and
- A patient-specific, clinically significant reason why the member cannot use Enbrel® (etanercept) 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.
Ilaris® (Canakinumab) Approval Criteria [Gout Flare Diagnosis]:
- An FDA approved indication for the treatment of gout flare; and
- Member must have had ≥3 gout flares in the previous year; and
- Member must meet 1 of the following:
- Inadequate response or intolerance to recent trials of oral colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids (oral, intraarticular, and/or intramuscular) used for the treatment of previous gout flare(s); or
- Colchicine, NSAIDs, and corticosteroids are contraindicated for the member (specific information regarding contraindication must be submitted); and
- A patient-specific, clinically significant reason why the member cannot use Kineret® (anakinra) must be provided; and
- Approvals will be for (1) 150mg dose at a time. Subsequent approvals will require documentation that the member responded well to previous treatment with Ilaris®; and
- Approvals will not be granted more often than once every 12 weeks.
Lupkynis™ (Voclosporin) Approval Criteria:
- An FDA approved indication for the treatment of adults with active lupus nephritis (LN) in combination with a background immunosuppressive therapy regimen; and
- Lupkynis™ must be used in combination with mycophenolate mofetil and low dose oral corticosteroids; and
- Member must be 18 years of age or older; and
- Lupkynis™ must be prescribed by a nephrologist, rheumatologist, or other specialist with expertise in the treatment of LN; and
- Member’s current urine protein-to-creatinine ratio (UPCR) must be provided and must be ≥1.5mg/mg; and
- Member’s current estimated glomerular filtration rate (eGFR) must be provided and must be >45mL/min/1.73m2 prior to initiating treatment with Lupkynis™; and
- Prescriber must agree to monitor renal function regularly during treatment with Lupkynis™ and modify the dose as needed in accordance with the Lupkynis™ Prescribing Information; and
- Member’s current blood pressure (BP) must be ≤165/105mmHg prior to initiating treatment with Lupkynis™; and
- Prescriber must agree to monitor BP regularly during treatment with Lupkynis™ and agree to discontinue treatment if BP is >165/105mmHg or member experiences a hypertensive emergency; and
- Member must not be taking strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) concomitantly with Lupkynis™; and
- Prescriber must verify member has been counseled on proper administration of Lupkynis™ including taking it on an empty stomach every 12 hours; and
- Lupkynis™ will not be approved in combination with biologic therapies or cyclophosphamide; and
- A quantity limit of 180 capsules per 30 days will apply; and
- Initial approvals will be for the duration of 6 months. Further approval may be granted if the prescriber documents that the member is responding well to treatment as indicated by a reduction in the member’s UPCR. If the member does not experience therapeutic benefit by 6 months, discontinuation of Lupkynis™ should be considered; and
- The safety and efficacy of Lupkynis™ have not been established beyond 1 year of treatment. For continued authorization consideration after 1 year of treatment, a patient-specific, clinically significant reason why a longer treatment duration is appropriate for the member must be provided.
Saphnelo™ (Anifrolumab-fnia) Approval Criteria:
- An FDA approved indication for the treatment of adult patients with moderate-to-severe systemic lupus erythematosus (SLE), who are receiving standard therapy; and
- Member must be 18 years of age or older; and
- Documented inadequate response to at least 1 of the following medications appropriate to member’s specific disease state:
- High-dose oral corticosteroids; or
- Methotrexate; or
- Azathioprine; or
- Mycophenolate; or
- Cyclophosphamide; or
- Hydroxychloroquine/chloroquine; and
- Member must not have severe active lupus nephritis (LN) or severe active central nervous system lupus; and
- Saphnelo™ will not be approved for combination use with biologic therapies or cyclophosphamide; and
- Initial approvals will be for the duration of 6 months. Further approval may be granted if the prescriber documents that the member is responding well to treatment.
Prior Authorization Forms:
Targeted Immunomodulator Agents* |
TIER 1 |
TIER 2 |
TIER 3 |
Special Authorization (PA) |
DMARDs appropriate to disease state:
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DMARDs = disease modifying anti-rheumatic drugs; NSAIDs = nonsteroidal anti-inflammatory drugs
*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). Products may be moved to a higher tier based on net cost if the manufacturer chooses not to participate in supplemental rebates.
±Biosimilars or reference products preferred based on lowest net cost product. Authorization of higher net cost biosimilars or reference products requires a patient-specific, clinically significant reason why the member could not use the preferred formulation.
+Unique criteria applies for a diagnosis of hidradenitis suppurativa (HS) and noninfectious intermediate and posterior uveitis and panuveitis.
β Unique criteria applies for a diagnosis of Behçet’s disease (BD).
¥Unique criteria applies for a diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), Familial Mediterranean Fever (FMF), Systemic Juvenile Idiopathic Arthritis (SJIA), Adult-Onset Still’s Disease (AOSD), or gout flare.
~Unique criteria applies for a diagnosis of pemphigus vulgaris (PV). Unique criteria applies for a diagnosis of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
πUnique criteria applies for a diagnosis of giant cell arteritis (GCA) and chimeric antigen receptor (CAR) T-cell-induced cytokine release syndrome (CRS), and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
¤Unique criteria applies for acute graft versus host disease (aGVHD) prophylaxis in hematopoietic stem cell transplant (HSCT) recipients.
#Unique criteria applies for a diagnosis of atopic dermatitis (AD).
€Unique criteria applies for a diagnosis of alopecia areata.
§Unique criteria applies for a diagnosis of polymyalgia rheumatica (PMR).
** Unique criteria applies to this medication for approval.
Tavalisse™ (Fostamatinib) Approval Criteria:
- An FDA approved indication for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment; AND
- Member must be 18 years of age or older (Tavalisse™ is not recommended for use in patients younger than 18 years of age because adverse effects on actively growing bones were observed in nonclinical studies); AND
- Member must have a clinical diagnosis of persistent/chronic ITP for at least 3 months; AND
- Previous insufficient response with at least 2 of the following treatments:
- Corticosteroids; OR
- Immunoglobulins; OR
- Splenectomy; OR
- Thrombopoietin receptor agonists; AND
- Degree of thrombocytopenia and clinical condition increase the risk for bleeding; AND
- Must be prescribed by, or in consultation with, a hematologist or oncologist; AND
- Prescriber must verify the member’s complete blood count (CBC), including platelet counts, will be monitored monthly until a stable platelet count (at least 50 X 109/L) is achieved and will be monitored regularly thereafter; AND
- Prescriber must verify liver function tests (LFTs) (e.g., ALT, AST, bilirubin) will be monitored monthly; AND
- Prescriber must verify member’s blood pressure will be monitored every 2 weeks until establishment of a stable dose, then monthly thereafter; AND
Female members must not be pregnant and must have a negative pregnancy test immediately prior to therapy initiation. Female members of reproductive potential must be willing to use effective contraception while on therapy and for at least 1 month after therapy completion; AND - Prescriber must verify member is not breastfeeding; AND
- Member must not be taking strong CYP3A4 inducers (e.g., rifampicin) concurrently with Tavalisse™; AND
- Initial approvals will be for the duration of 12 weeks; AND
- Discontinuation criteria:
- Platelet count does not increase to a level sufficient to avoid clinically important bleeding after 12 weeks of therapy; AND
- A quantity limit of 2 tablets daily will apply.
Prior Authorization Forms
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.
If you have questions please call the Pharmacy Help Desk at (800) 522-0114 option 4 or (405) 522-6205 option 4.