Pharmacy Prior Authorization Criteria

Cibinqo (abrocitinib)

Indications for Prior Authorization

Cibinqo (abrocitinib)

• For diagnosis of Atopic Dermatitis
  Indicated for the treatment of adults and pediatric patients 12 years of age and older 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.

Criteria

Cibinqo

*Cibinqo may be used with concomitant topical or inhaled corticosteroids

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• 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 [A]
AND
• Patient is 12 years of age or older
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Allergist/Immunologist
AND
• Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to at least ONE of the following:
• Medium or higher potency topical corticosteroid
• Pimecrolimus cream
• Tacrolimus ointment
• Eucrisa (crisaborole) ointment
AND
• One of the following:
• Trial and failure of a minimum 12-week supply of at least one systemic drug product for the treatment of atopic dermatitis (examples include, but are not limited to, Adbry [tralokinumab-ldrm], Dupixent [dupilumab], etc.)
OR
• Patient has a contraindication, intolerance, or treatment is inadvisable with both of the following FDA-approved atopic dermatitis therapies:
• Adbry (tralokinumab-ldrm)
• Dupixent (dupilumab)
AND
• Not used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators (e.g., Dupixent, Adbry), or other immunosuppressants (e.g., azathioprine, cyclosporine)*

Cibinqo

*Cibinqo may be used with concomitant topical or inhaled corticosteroids

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates 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 [A]
AND
• Not used in combination with other JAK inhibitors, biologic immunomodulators (e.g., Dupixent, Adbry), or other immunosuppressants (e.g., azathioprine, cyclosporine)*

P & T Revisions

2024-03-04, 2023-08-22, 2023-02-26, 2022-07-04, 2022-04-24, 2022-03-02, 2022-03-14, 2022-03-17, 2022-02-20

References

1. Cibinqo Prescribing Information. Pfizer Labs. New York, NY. December 2023.
2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023; Epub ahead of print.
3. European Task Force on Atopic Dermatitis. Severity scoring of atopic dermatitis: the SCORAD index. Consensus report of the European Task Force on atopic dermatitis. Dermatology. 1993; 186:23-31.
4. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet 2017; 389(10086)(suppl):2287-2303.
5. Oranje AP. Practical issues on interpretation of scoring atopic dermatitis: SCORAD index, objective SCORAD, patient-oriented SCORAD and three-item severity score. Curr Probl Dermatol. 2011; 41:149-55.

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End Notes

1. The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool for assessing the severity of atopic dermatitis lesions based on affected body area and intensity of plaque characteristics. [3, 4] The extent and severity of AD over the body area (A) and the severity of 6 specific symptoms (erythema, edema/papulation, excoriations, lichenification, oozing/crusts, and dryness) (B) are assessed and scored by the Investigator. Subjective assessment of itch and sleeplessness is scored by the patient (C). The SCORAD score is a combined score (A/5 + 7B/2 + C) with a maximum of 103. Higher scores indicate greater severity/worsened state. A score of 25 to 50 indicates moderate disease severity and greater than 50 indicates severe disease. [5]

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Revision History

• 2024-03-04: Annual review - no criteria changes; background updates
• 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-02-26: Annual review - updated indication and age criterion to include patients 12 years of age or older; background updates
• 2022-07-04: Reduced embedded step to a single topical agent; updated concomitant use criteria to align with the label
• 2022-04-24: Addition of an age criterion
• 2022-03-02: New program
• 2022-03-14: New program
• 2022-03-17: New program
• 2022-02-20: New program

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