Biologics

(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 Daxxify^®, Myobloc®, or Xeomin®, 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: 
  • Spasticity associated with:
    • Cerebral palsy; or
    • Paralysis; or
    • Generalized weakness/incomplete paralysis; or
    • Larynx; or
    • Anal fissure; or
    • Esophagus (achalasia and cardiospasms); or
    • Eye and eye movement disorders; or 
  • Cervical dystonia. 
• Myobloc^® or Xeomin^® will be covered for a diagnosis of chronic sialorrhea. 

Botox® only criteria

Botox^® (OnabotulinumtoxinA) Approval Criteria [Chronic Migraine Diagnosis*]:

• FDA indications are met:
  • Member is 18 years of age or older; and
  • Member has documented chronic migraine headaches:
    • Frequency of ≥15 headache days per month with ≥8 migraine days per month and occurring for >3 months; and
    • Headache duration of ≥4 hours per day; and
• Member has been evaluated for all of the following, as defined by the American Headache Society, and these conditions have been ruled out and/or have been treated:
  • Red flags; and
  • Possible indicators of secondary headache; and
  • Medication overuse; and 
• Member has no contraindications to Botox^® injections; 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) for oral medications and at least 3 months in duration for injectable medications (or documented adverse effects). This includes, but not limited to:
  • Select antihypertensive therapy (e.g., beta blockers); or
  • Select anticonvulsant therapy; or
  • Select antidepressant therapy [e.g., tricyclic antidepressants (TCA), serotonin and norepinephrine reuptake inhibitors (SNRI)]; or
  • Select calcitonin gene-related peptide (CGRP) inhibitors (e.g., Aimovig^®, Ajovy^®, Emgality^®); 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
• Member will not use the requested medication concurrently with a calcitonin gene-related peptide (CGRP) inhibitor for the prevention of migraine headaches. 
  

Botox^® (OnabotulinumtoxinA) Approval Criteria [Neurogenic Detrusor Overactivity (NDO) Diagnosis*]:

• Diagnosis of 1 of the following:
  • Urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury, multiple sclerosis] in adult members; or
  • NDO in pediatric members; and
• Underlying pathological dysfunction subtype confirmed by:
  • Urodynamic studies to determine pathology and serve to provide objective evidence of bladder and external sphincter function; and
• Member 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
• Botox^® must be administered by a urologist.

* Other botulinum toxins will not be approved for this diagnosis

Botox^® (OnabotulinumtoxinA) Approval Criteria [Non-Neurogenic Overactive Bladder Diagnosis*]:

• Member must have severe disease (≥5 urinary incontinence episodes per day on medication) and specific pathology determined via urodynamic studies; and
• Member must have participated in behavioral therapy for ≥12 weeks that did not yield adequate clinical results; and
• Member must have had compliant use of ≥3 anti-muscarinic or beta-3 adrenoceptor agonist medications for ≥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
• Botox^® must be administered by a urologist.

*Other botulinum toxins will not be approved for this diagnosis

Prior Authorization Form - Botulinum Toxins   

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 hematologist, oncologist, 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
• Member must not be receiving Empaveli® in combination with another complement inhibitor used to treat PNH (i.e., Fabhalta®, Piasky®, Soliris®, Ultomiris®, Voydeya®); 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
• Member must not be receiving Enspryng® in combination with other immunomodulators to treat NMOSD (i.e., Soliris®, Ultomiris®, Uplizna®); 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.

 

Fabhalta® (Iptacopan) Approval Criteria [Immunoglobulin A Nephropathy (IgAN) Diagnosis]:

• An FDA approved indication to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression; and
• The diagnosis of primary IgAN must be confirmed by the following:
  • Kidney biopsy; and
  • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); and
• Member must be 18 years of age or older; and
• Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); and
• Member must be at risk of disease progression as demonstrated by proteinuria ≥0.5g/day; and
• Member must be on a stable dose of a maximally tolerated angiotensin convert enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB), unless contraindicated or intolerant; and
• Prescriber and pharmacy must be enrolled in the Fabhalta® 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.

 

Fabhalta® (Iptacopan) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:

• An FDA approved diagnosis of PNH; and
• Member must be 18 years of age or older; and
• Fabhalta® must be prescribed by, or in consultation with, a hematologist, oncologist, or a specialist with expertise in the treatment of PNH; and
• Prescriber and pharmacy must be enrolled in the Fabhalta® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• For members switching from Soliris® (eculizumab) to Fabhalta®, the prescriber must verify the member will start Fabhalta® no later than 1 week after the last dose of Soliris^®; and
• For members switching from Ultomiris® (ravulizumab-cwvz) to Fabhalta®, the prescriber must verify the member will start Fabhalta® no later than 6 weeks after the last dose of Ultomiris®; and
• Member must not be receiving Fabhalta® in combination with another complement inhibitor used to treat PNH (i.e., Empaveli®, Piasky®, Soliris®, Ultomiris®, Voydeya®); 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.

 

Piasky® (Crovalimab-akkz) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:

• An FDA approved diagnosis of PNH; and
• Member must be 13 years of age or older and must weigh ≥40kg; and
• Piasky® must be prescribed by, or in consultation with, a hematologist, oncologist, 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 Piasky® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• For members switching from another C5 inhibitor (i.e., Soliris® or Ultomiris®), the prescriber must verify the first intravenous (IV) loading dose of Piasky® will be administered no sooner than the time of the next scheduled C5 inhibitor dose and member will be monitored for Type III hypersensitivity reactions; and
• Member must not be receiving Piasky® in combination with another complement inhibitor used to treat PNH (i.e., Empaveli®, Fabhalta®, Soliris®, Ultomiris®, Voydeya®); and
• A quantity limit override for the loading dose will be approved upon meeting Piasky® approval criteria. A quantity limit of 6mL per 28 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.

 

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®) or with another neonatal Fc receptor blocker used to treat gMG (i.e., 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.

 

Bkemv™ (Eculizumab-aeeb), Epysqli® (Eculizumab-aagh), and 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
• Bkemv™, Epysqli®, or 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 Bkemv™, Epysqli®, or Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• For use of Bkemv™ or Epysqli®, a patient-specific, clinically significant reason why the member cannot use Soliris® must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products; and
• Member must  not be receiving Bkemv™, Epysqli®, or Soliris® in combination with another complement inhibitor used to treat aHUS (i.e., 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.

 

Bkemv™ (Eculizumab-aeeb), Epysqli® (Eculizumab-aagh), and 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
• Bkemv™, Epysqli®, or 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 Bkemv™, Epysqli®, or Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• For use of Bkemv™ or Epysqli®, a patient-specific, clinically significant reason why the member cannot use Soliris® must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products; and
• Use of Bkemv™, Epysqli®, or Soliris® will require a patient specific, clinically significant reason why the member cannot use Ultomiris® (ravulizumab-cwvz); and
• Member must not be receiving Bkemv™, Epysqli®, or Soliris® in combination with a neonatal Fc receptor blocker (i.e., Rystiggo®, Vyvgart®, Vyvgart® Hytrulo) or another complement inhibitor used to treat gMG (i.e., 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 [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
• Member must not be receiving Soliris® in combination with other immunomodulators to treat NMOSD (i.e., Enspryng®, Ultomiris®, Uplizna®); 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.

 

Bkemv™ (Eculizumab-aeeb), Epysqli® (Eculizumab-aagh), and 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
• Bkemv™, Epysqli®, or Soliris® must be prescribed by, or in consultation with, a hematologist, oncologist, 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 Bkemv™, Epysqli®, or Soliris® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• For use of Bkemv™ or Epysqli®, a patient-specific, clinically significant reason why the member cannot use Soliris® must be provided. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products; and
• Member must not be receiving Bkemv™, Epysqli®, or Soliris® in combination with another complement protein C5 inhibitor (i.e., Piasky®, Ultomiris®), complement protein C3 inhibitor (i.e., Empaveli®), or complement factor B inhibitor (i.e., Fabhalta®) used to treat PNH; 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
• Member must not be receiving Ultomiris® in combination with another complement inhibitor used to treat aHUS (i.e., Soliris®); 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) or another complement inhibitor used to treat gMG (i.e., Soliris®, 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.

 

Ultomiris^® (Ravulizumab-cwvz) 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 1 relapse in the last 12 months; and
• Member must have an Expanded Disability Severity Scale (EDSS) score ≤7; and
• Ultomiris^® 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 Ultomiris^® Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; and
• Member must not be receiving Ultomiris^® in combination with other immunomodulators to treat NMOSD (i.e., Enspryng^®, Soliris^®, Uplizna^®); 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 [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 hematologist, oncologist, 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 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
• Member must not be receiving Ultomiris® in combination with another complement protein C5 inhibitor (i.e., Piasky®, Soliris®), complement protein C3 inhibitor (i.e., Empaveli®), or complement factor B inhibitor (i.e., Fabhalta®) used to treat PNH; 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) 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
• 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
• Member must not be receiving Uplizna® in combination with other immunomodulators to treat NMOSD (i.e., Enspryng®, Soliris®, Ultomiris®); 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.

 

Veopoz® (Pozelimab-bbfg) Approval Criteria [CD55-Deficent Protein-Losing Enteropathy (PLE) Diagnosis]:

• An FDA approved diagnosis of CD55-deficient PLE confirmed by all of the following:
  • Genetic testing identifying biallelic pathogenic mutations in the CD55 gene (results of genetic testing must be submitted); and
  • A history of PLE; and
• Member has active disease defined by hypoalbuminemia (serum albumin concentration ≤3.2g/dL) with 1 or more of the following signs or symptoms within the last 6 months: abdominal pain, diarrhea, peripheral edema, or facial edema; and
• Member must be 1 year of age or older; and
• Prescriber must verify the member has received the meningococcal vaccine 2 weeks prior to treatment unless urgent treatment is needed; and 
• Veopoz® must be prescribed by, or in consultation with, a gastroenterologist, geneticist, hematologist, or other specialist with expertise in the treatment of CD55-deficient PLE; and
• Prescriber must verify that Veopoz® will be administered by a health care professional; 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
• 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 normalization of serum albumin or documentation of a positive clinical response to therapy. Subsequent approvals will be for 1 year.

 

Voydeya™ (Danicopan) Approval Criteria [Paroxysmal Nocturnal Hemoglobinuria (PNH) Diagnosis]:

• An FDA approved diagnosis of PNH; and
• Member must be 18 years of age or older; and
• Voydeya™ must be prescribed by, or in consultation with, a hematologist, oncologist, or a specialist with expertise in the treatment of PNH; and
• Member must have been treated with Soliris® (eculizumab) or Ultomiris® (ravulizumab-cwvz) for at least the previous 6 months; and
• Prescriber must verify member is experiencing clinically significant extravascular hemolysis (EVH) while on Soliris® or Ultomiris®; and
• Member must remain on treatment with Soliris® or Ultomiris® while on Voydeya™; and
• Member must not be receiving Voydeya® in combination with another complement protein C3 inhibitor (i.e., Empaveli®) or complement factor B inhibitor (i.e., Fabhalta®) used to treat PNH; and
• Prescriber must verify member does not have unresolved Neisseria meningitidis infection; and
• Prescriber must be enrolled in the Voydeya™ Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment through therapy; 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. Subsequent approvals will be for 1 year.

 

Vyvgart® Hytrulo (Efgartigimod Alfa/Hyaluronidase-qvfc) Approval Criteria [Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Diagnosis]:

• An FDA approved diagnosis of CIDP; and
• Member must be 18 years of age or older; and
• Vyvgart® Hytrulo must be prescribed by, or in consultation with, a neurologist (or an advanced care practitioner with a supervising physician who is a neurologist); and
• Member must have previously failed treatment with intravenous immunoglobulin (IVIG) or a patient specific, clinically significant reason why the member cannot use intravenous immunoglobulin (IVIG) must be provided; and
• Initial approvals will be for 12 weeks. 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 (MG-ADL) 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®) or with another neonatal Fc receptor blocker used to treat gMG (i.e., Rystiggo®); 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) or another complement inhibitor used to treat gMG (i.e., Soliris®, Ultomiris®); 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

Erythropoietin Stimulating Agents  

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.  

omalizumab (Xolair®)

palivizumab (Synagis®)

reslizumab (Cinqair®)

dupilumab (Dupixent®)

benralizumab (Fasenra®)

mepolizumab (Nucala®)

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 (PROLIA®)

teriparatide (Forteo®)

• Pharmacy  
• Physician/Outpatient Administered 

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-1 (DMARDs appropriate to disease state)	Tier-2*	Tier-3	Special Prior Authorization (PA)
6-mercaptopurine	adalimumab (Humira®)+ - Brand Preferred	abatacept (Orencia®, Orencia® ClickJect™)¤	adalimumab-aacf (Idacio®)±
azathioprine	adalimumab-aqvh (Yusimry™)±	certolizumab pegol (Cimzia®)	adalimumab-aaty (Yuflyma®)±
hydroxychloroquine	adalimumab-bwwd (Hadlima™)±	deucravacitinib (Sotyktu™)	adalimumab-adaz (Hyrimoz®)±
leflunomide	anakinra (Kineret®)	golimumab (Simponi®, Simponi Aria®)	adalimumab-adbm (Cyltezo®)±
mesalamine	apremilast (Otezla®)ß	infliximab (Remicade®)±	adalimumab-afzb (Abrilada™)±
methotrexate	etanercept (Enbrel®)	infliximab-abda (Renflexis®)±	adalimumab-atto (Amjevita™)±
minocycline	infliximab-dyyb (Inflectra®)±	infliximab-axxq (Avsola®)±	adalimumab-fkjp (Hulio®)±
NSAIDs	rituximab (Rituxan®)~	sarilumab (Kevzara®)§	adalimumab-ryvk (Simlandi®)±
oral corticosteroids	rituximab-abbs (Truxima®)±	tocilizumab-aazg (Tyenne®)±	anifrolumab-fnia (Saphnelo®)**
sulfasalazine	rituximab-arrx (Riabni®)±	tofacitinib (Xeljanz®, Xeljanz® XR, Xeljanz® oral solution)**	avacopan (Tavneos®)**
topical corticosteroids	rituximab-pvvr (Ruxience®)±	Vedolizumab intravenous (IV) (Entyvio®)**	baricitinib (Olumiant®)€
	ustekinumab-aekn (Selarsdi™)± - Branded only		belimumab (Benlysta®)**
	ustekinumab-kfce (Yesintek™)±		bimekizumab-bkzx (Bimzelx®)
	ustekinumab-srlf (Imuldosa®)±		brodalumab (Siliq®)**
	ustekinumab-stba (Steqeyma®)±		canakinumab (Ilaris®)¥
	ustekinumab-ttwe (Pyzchiva®)± - Branded Only		deuruxolitinib (Leqselvi™)€
			etanercept-szzs (Erelzi®)±
			etanercept-ykro (Eticovo®)±
			etrasimod (Velsipity™)
			guselkumab (Tremfya®)
			infliximab-dyyb (Zymfentra®)±
			ixekizumab (Taltz®)
			mirikizumab-mrkz (Omvoh™)
			rilonacept (Arcalyst®)**
			risankizumab-rzaa (Skyrizi®)
			ritlecitinib (Litfulo™)€
			secukinumab (Cosentyx®) Δ
			spesolimab-sbzo (Spevigo®)**
			tildrakizumab-asmn (Ilumya®)
			tocilizumab (Actemra®)π
			tocilizumab-bavi (Tofidence™)±
			upadacitinib (Rinvoq®, Rinvoq® LQ)#
			ustekinumab (Stelara®)±
			ustekinumab-aauz (Otulfi™)±
			ustekinumab-aekn (Selarsdi™)± -Unbranded Only
			ustekinumab-auub (Wezlana™)±
			ustekinumab-ttwe (Pyzchiva®)± -Unbranded Only
			vedolizumab subcutaneous (sub-Q) (Entyvio®)**
			voclosporin (Lupkynis®)**

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), 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).

Δ Unique criteria applies for a diagnosis of hidradenitis suppurativa (HS).

^**Unique criteria applies to this medication for approval.

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 1 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 1 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 medications (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
• Recent trials (within the last 360 days) of 1 Tier-1 medication (appropriate to the member’s disease state), at least 2 Tier-2 medications (appropriate to the member’s disease state), and 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).

 

Abrilada™ (Adalimumab-afzb), Amjevita™ (Adalimumab-atto), Cyltezo^® (Adalimumab-adbm), Hulio^® (Adalimumab-fkjp), Hyrimoz^® (Adalimumab-adaz), Idacio^® (Adalimumab-aacf), Simlandi® (Adalimumab-ryvk), and Yuflyma^® (Adalimumab-aaty) Approval Criteria:

• Member must meet Special Prior Authorization (PA) approval criteria; and
• A patient-specific, clinically significant reason why the member cannot use Hadlima™ (adalimumab-bwwd), Humira® (adalimumab), or Yusimry™ (adalimumab-aqvh) 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) and 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 Tyenne® (tocilizumab-aazg) 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 [Chimeric Antigen Receptor (CAR) T Cell-Induced Cytokine Release Syndrome (CRS) Diagnosis]:

• An FDA approved diagnosis of CAR T cell-induced CRS. 

 

Actemra^® (Tocilizumab) , Tofidence™ (Tocilizumab-bavi), and Tyenne® (Tocilizumab-aazg)  Approval Criteria [Giant Cell Arteritis (GCA) Diagnosis]:

• An FDA approved diagnosis of GCA; and
• Member must be 50 years of age or older; and
• 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 corticosteroids for a minimum of 4 weeks or a reason why this is not appropriate must be provided; and
• Must be taken in combination with a tapering course of corticosteroids 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
• Should not be initiated in members with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; and
• Requests for Actemra^® or Tofidence™ will require a patient-specific, clinically significant reason why the member cannot use Tyenne^®. Biosimilars and/or reference products are preferred based on the lowest net cost product(s) and may be moved to either preferred or non-preferred if the net cost changes in comparison to the reference product and/or other available biosimilar products; and
• Approval quantity will be based on package labeling and FDA approved dosing regimen(s).

 

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.

 

Arcalyst^® (Rilonacept) Approval Criteria [Cryopyrin-Associated Periodic Syndromes (CAPS) Diagnosis]:

• An FDA approved indication of CAPS verified by genetic testing. This includes familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) in adults and children 12 years of age 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
• Member must 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 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's recent 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
• Member must weigh ≥10kg; and
• Member must 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^® 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; 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
• Member has had at least 2 episodes of pericarditis; and
• Member has had 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
• Member must 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 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’s recent 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.

 

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.

 

Benlysta^® (Belimumab) Approval Criteria:

• The intravenous (IV) formulation will be covered as a medical only benefit while the subcutaneous (sub-Q) 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 (LN) who are receiving standard therapy; and
• Documented inadequate response to at least 2 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 central nervous system lupus; and
• Benlysta^® will not be approved for concomitant use with biologic therapies; and
• Benlysta^® will not be approved for concomitant use with IV cyclophosphamide (exception for induction treatment with IV cyclophosphamide for members with a diagnosis of LN).

 

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), Dupixent^® (dupilumab), or Ebglyss™ (lebrikizumab-lbkz) that resulted in inadequate response (or have a contraindication or documented intolerance); and
• Member’s body surface area (BSA) of atopic dermatitis involvement must be provided and the member must have a documented BSA involvement of ≥10% (can apply to member’s current BSA or a historical value prior to treatment); 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 kinas (JAK) inhibitors, biologic immunomodulators, or with other immunosuppressant medications; and
• For Rinvoq^®, a patient-specific, clinically significant reason why the member cannot use Cibinqo^® must be provided; and
• Initial approvals will be for the duration of 3 months. Reauthorization may be granted for the duration of 1 year 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.

 

Cosentyx^® (Secukinumab) Approval Criteria [Hidradenitis Suppurativa (HS) Diagnosis]:

• A diagnosis of moderate-to-severe HS; and
• Hurley Stage II or III disease; and
• Member must have at least 5 abscesses or inflammatory nodules; and
• Previous failure of at least 2 of the following categories:
  • Topical or systemic antibiotics; or
  • Oral or intralesional corticosteroids; or
  • Dapsone; or
  • Cyclosporine; or
  • Antiandrogens (e.g., spironolactone, oral contraceptives); or
  • Finasteride; or
  • Surgery; and
• Previous failure of Hadlima™ (adalimumab-bwwd), Humira^® (adalimumab), or Yusimry™ (adalimumab-aqvh) for at least 12 weeks at recommended dosing (or documented intolerance).

 

Entyvio^® (Vedolizumab) Approval Criteria:

• An FDA approved diagnosis of moderately-to-severely active Crohn’s disease (CD) or moderately-to-severely active ulcerative colitis (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 patient-specific, clinically significant reason (beyond convenience) why the member cannot continue to use the IV formulation must be provided; 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.

 

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.

 

Hadlima™ (Adalimumab-bwwd), Humira® (Adalimumab), or Yusimry™ (Adalimumab-aqvh)) Approval Criteria [Hidradenitis Suppurativa (HS) Diagnosis]:

• Diagnosis of moderate-to-severe HS; and
• Hurley Stage II or III disease; and
• Member must have at least 3 abscesses or inflammatory nodules; and
• Previous failure of at least 2 of the following categories:
  • Topical or systemic antibiotics; or
  • Oral or intralesional corticosteroids; or
  • Dapsone; or
  • Cyclosporine; or
  • Antiandrogens (e.g., spironolactone, oral contraceptives); or
  • Finasteride; or
  • Surgery.

 

Hadlima™ (Adalimumab-bwwd), Humira® (Adalimumab), or Yusimry™ (Adalimumab-aqvh) Approval Criteria [Noninfectious Intermediate and Posterior Uveitis or Panuveitis Diagnosis]:

• 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 why a trial of corticosteroid treatment is inappropriate for the member must be provided.

Ilaris^® (Canakinumab) Approval Criteria [Active Systemic Juvenile Idiopathic Arthritis (SJIA) or Adult-Onset Still’s Disease (AOSD) Diagnosis]:

• An FDA approved indication of SJIA or AOSD; and
• The member should not be using a tumor necrosis factor (TNF) blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra; and
• Ilaris^® should not be initiated in members 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; and
  • Weight-based dosing in members 2 years of age and older (the member’s recent weight must be provided): 
    • Body weight ≥7.5kg: 4mg/kg subcutaneous injection every 4 weeks (maximum 300mg/dose); and
• Recent trials of 1 Tier-1 medication and all appropriate Tier-2 medications 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; and
• Approvals will be for the duration of 1 year.

 

Ilaris^® (Canakinumab) Approval Criteria [Cryopyrin-Associated Periodic Syndromes (CAPS) Diagnosis]:

• An FDA approved indication of CAPS verified by genetic testing [which includes Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS)] in adult and pediatric members 4 years of age and older; and
• Member must not be using a tumor necrosis factor (TNF) blocking agent (e.g., adalimumab, etanercept, infliximab) or anakinra; and
• Ilaris^® should not be initiated in members with active or chronic infection including hepatitis B, hepatitis C, human immunodeficiency virus, or tuberculosis; and
• The following dosing requirements must be met:
  • Dosing should not be more often than once every 8 weeks; and
  • Weight-based dosing (the member’s recent weight must be provided): 
    • Body weight >40kg: 150mg; or
    • Body weight 15kg to 40kg: 2mg/kg (if inadequate response, dose may be increased to 3mg/kg); and
•  Approvals will be for the duration of 1 year.

 

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.

 

Ilaris^® (Canakinumab) Approval Criteria [Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), or Familial Mediterranean Fever (FMF) Diagnosis]:

• Diagnosis of TRAPS with chronic or recurrent disease activity defined as 6 flares per year; or
• Diagnosis of HIDS/MKD; or
• Diagnosis of 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.

 

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.

 

Leqselvi™ (Deuruxolitinib), 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 Leqselvi™ or 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 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
• 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).

 

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 package labeling; 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.

 

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.

 

Otezla^® (Apremilast) 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.

 

Otulfi™ (Ustekinumab-aauz), Unbranded Pyzchiva^® (Ustekinumab-ttwe), Unbranded Selarsdi™ (Ustekinumab-aekn), Stelara® (Ustekinumab), and Wezlana™ (Ustekinumab-auub) Approval Criteria:

• Member must meet Special Prior Authorization (PA) approval criteria; and
• A patient-specific, clinically significant reason why the member cannot use Imuldosa® (ustekinumab-srlf), branded Pyzchiva® (ustekinumab-ttwe), branded Selarsdi™ (ustekinumab-aekn), Steqeyma® (ustekinumab-stba), and Yesintek™ (ustekinumab-kfce)  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.

 

Rinvoq^® LQ (Upadacitinib Oral Solution) Approval Criteria:

• Member must meet Special Prior Authorization (PA) approval criteria; and
• An age restriction of 2 years of age to 10 years of age will apply. Members older than 10 years of age require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used.

 

Rituxan^® (Rituximab) Approval Criteria [Granulomatosis with Polyangiitis (GPA, Wegener’s Granulomatosis) or Microscopic Polyangiitis (MPA) Diagnosis]:

• An FDA approved diagnosis of GPA or MPA in adult and pediatric members 2 years of age and older; and
• Rituxan^® must be used in combination with corticosteroids; and
• Approval quantity will be based on package labeling and FDA approved dosing regimen(s).

 

Rituxan^® (Rituximab) Approval Criteria [Pemphigus Vulgaris (PV) Diagnosis]:

• Diagnosis of moderate-to-severe PV; and
• Rituxan^® must be used in combination with a tapering course of corticosteroids; and
• Initial approvals will be for (2) 1,000mg intravenous (IV) infusions separated by 2 weeks and a 500mg IV infusion at month 12. Subsequent approvals may be authorized based on 6-month evaluations or upon relapse no sooner than 16 weeks after the previous infusion.

 

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.

 

Siliq^® (Brodalumab) Approval Criteria:

• Member must meet Special Prior Authorization (PA) approval criteria; and
• Members must also be enrolled in the Siliq^® Risk Evaluation and Mitigation Strategy (REMS) program for approval; and
• Members with a concomitant diagnosis of Crohn’s disease will not be approved; and
• 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.

 

Spevigo^® (Spesolimab-sbzo) Approval Criteria [Intravenous (IV) Flare Dosing]:

• An FDA approved indication for the treatment of generalized pustular psoriasis (GPP) flares; and
• Prescriber must verify the member has presence of macroscopically visible sterile pustules on an erythematous base that is not restricted to the acral region or within psoriatic plaques:
• 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 12 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^®.

 

Spevigo^® (Spesolimab-sbzo) Approval Criteria [Subcutaneous (Sub-Q) Non-Flare Dosing]:

• An FDA approved indication for the treatment of generalized pustular psoriasis (GPP); and
• Prescriber must verify the member has presence of macroscopically visible sterile pustules on an erythematous base that is not restricted to the acral region or within psoriatic plaques; and
• Member must be 12 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 during treatment with Spevigo^®; and
• Initial approvals will be for the duration of 6 months. Subsequent approvals (for the duration of 1 year) may be approved if the prescriber documents the member is responding well to the medication.

 

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.

 

Xeljanz^® (Tofacitinib Oral Solution) Approval Criteria:

• Member must meet Tier-3 approval criteria; and
• An age restriction of 2 years of age to 10 years of age will apply. Members older than 10 years of age require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used.

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.

• Pharmacy  
• Physician/Outpatient Administered