CIBINQO (abrocitinib)

CIBINQO (abrocitinib)

Self-Administration - oral

Diagnosis considered for coverage: 

• Treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable
• Limitations of Use:
  • Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

Coverage Criteria:

For diagnosis of moderate-to-severe atopic dermatitis:

• Documented diagnosis of moderate to severe atopic dermatitis, AND
• One of the following:
  • Involvement of at least 10% body surface area (BSA) 
  • SCORing Atopic Dermatitis (SCORAD) index value of at least 25, AND
• Prescribed by or in consultation with a dermatologist or an allergist/immunologist, AND
• Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to at least TWO of the following:
  • Medium or higher potency topical corticosteroid 
  • Pimecrolimus cream
  • Tacrolimus ointment 
  • Eucrisa (crisaborole) ointment, AND
• Trial and failure of a minimum 12-week supply, contraindication, or intolerance to at least one systemic drug product (e.g., Dupixent [dupilumab], Adbry [tralokinumab-ldrm], cyclosporine, azathioprine, methotrexate, mycophenolate mofetil), AND
• Not used in combination with biologic immunomodulators (e.g., Dupixent, Adbry) or other immunosuppressants (e.g., azathioprine, cyclosporine)

Reauthorization Criteria:

For diagnosis of moderate-to-severe atopic dermatitis:

• Documentation of a positive clinical response to therapy as evidenced by at least ONE of the following:
  • Reduction in body surface area involvement from baseline 
  • Reduction in SCORing Atopic Dermatitis (SCORAD) index value from baseline, AND
• Not used in combination with biologic immunomodulators (e.g., Dupixent, Adbry) or other immunosuppressants (e.g., azathioprine, cyclosporine)

Coverage Duration: 

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing:
  • Recommended dose: 100 mg orally once daily
  • Maximum dose: 200 mg orally once daily
• Mild renal impairment (60 – 89 mL/minute): 100 mg once daily
• Moderate renal impairment (30 – 59 mL/minute): 50 mg once daily
• Severe renal impairment and ESRD: not recommended
• Severe hepatic impairment: not recommended 
• Cibinqo initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of Cibinqo
• Cibinqo initiation is not recommended in patients with active hepatitis B or hepatitis C
• Cibinqo initiation is not recommended in patients with a platelet count <150,000/mm3, an absolute lymphocyte count <500/mm3, an absolute neutrophil count <1,000/mm3, or a hemoglobin value <8 g/dL
• Contraindications:
  • Cibinqo is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment
• Warnings: serious infections, mortality, malignancy and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, laboratory abnormalities, immunizations

Policy Updates:

• 4/5/2022 – New policy approved by P&T.

References:

• Cibinqo Prescribing Information. Pfizer Labs. New York, NY. January 2022.