Abrocitinib (Cibinqo) Form

Abrocitinib (Cibinqo™) is a Janus kinase (JAK) inhibitor. FDA Approved Indication(s) Cibinqo is 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. Limitation(s) of use: Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Cibinqo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Atopic Dermatitis (must meet all):

1. Diagnosis of atopic dermatitis affecting one of the following (a or b): a. At least 10% of the member’s body surface area (BSA); b. Hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas;
2. Prescribed by or in consultation with a dermatologist or allergist;
   
   3. Age ≥ 12 years;
   4. Failure of both of the following (a and b), unless contraindicated or clinically significant adverse effects are experience:
      a. Two formulary medium to very high potency topical corticosteroids, each used for ≥ 2 weeks; b. One non-steroidal topical therapy used for ≥ 4 weeks: topical calcineurin inhibitor (e.g., tacrolimus 0.03% ointment, pimecrolimus 1% cream) or Eucrisa®; These agents may require prior authorization
3. Cibinqo is not prescribed concurrently with another biologic immunomodulators (e.g. Adbry™, Dupixent®) or a JAK inhibitor (Olumiant®, Rinvoq®, Cibinqo®, Opzelura™);

4. Dose does not exceed one of the following (a or b): a. Both of the following (i and ii): Page 1 of 8

   CLINICAL POLICY Abrocitinib i. 100 mg per day; ii. one tablet per day; b. Medical justification supports inadequate response to 100 mg daily after 12 weeks and both of the following (i and ii): i. 200 mg per day; ii. one tablet per day. Approval duration: 6 months
   B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Atopic Dermatitis (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy as evidenced by, including but not limited to, reduction in itching and scratching;
9. Cibinqo is not prescribed concurrently with another biologic immunomodulator (e.g. Adbry, Dupixent) or a JAK inhibitor (Olumiant, Rinvoq, Cibinqo, Opzelura);

10. Dose does not exceed one of the following (a or b): a. Both of the following (i and ii): i. 100 mg per day; ii. one tablet per day; b. Medical justification supports inadequate response to 100 mg daily after 12 weeks and both of the following (i and ii): i. 200 mg per day; ii. one tablet per day. Page 2 of 8

    CLINICAL POLICY Abrocitinib Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

11. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

12. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AD: atopic dermatitis
    BSA: body surface area
    FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Dose Limit/ Maximum Dose Very High Potency Topical Corticosteroids augmented betamethasone 0.05% (Diprolene AF) cream, ointment, gel, lotion clobetasol propionate 0.05% (Temovate ) cream, ointment, gel, solution Apply topically to the affected area(s) BID Varies
    Page 3 of 8

    CLINICAL POLICY Abrocitinib Drug Name Dosing Regimen Dose Limit/ Maximum Dose diflorasone diacetate 0.05% (Maxiflor, Psorcon E) cream, ointment halobetasol propionate 0.05% (Ultravate) cream, ointment High Potency Topical Corticosteroids diflorasone 0.05% (Florone, Florone E, Maxiflor,Psorcon E) cream fluocinonide acetonide 0.05% (Lidex, Lidex E) cream, ointment, gel, solution triamcinolone acetonide 0.5% (Aristocort, Kenalog) cream, ointment Medium Potency Topical Corticosteroids desoximetasone 0.05% (Topicort ) cream, ointment, gel fluocinolone acetonide 0.025% (Synalar) cream, ointment mometasone 0.1% (Elocon) cream, ointment, lotion triamcinolone acetonide 0.025%, 0.1% (Aristocort, Kenalog) cream, ointment Low Potency Topical Corticosteroids alclometasone 0.05% (Aclovate) cream, ointment desonide 0.05% (Desowen) cream, ointment, lotion fluocinolone acetonide 0.01% (Synalar) solution hydrocortisone 2.5% (Hytone) cream, ointment Other Classes of Agents Protopic (tacrolimus), Elidel (pimecrolimus) Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Apply topically to the affected area(s) BID Children ≥ 2 years and adults: Apply a thin layer topically to affected skin BID.
    Treatment should be discontinued if resolution of disease occurs. Page 4 of 8 Varies Varies Varies Varies

    CLINICAL POLICY Abrocitinib Drug Name Dosing Regimen Eucrisa® (crisaborole) Apply a thin layer topically to the affected areas BID Dose Limit/ Maximum Dose Varies Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): Antiplatelet therapies except for low-dose aspirin (< 81 mg daily), during the first 3 months of treatment.
    • Boxed warning(s): serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis Appendix D: General Information
    • Topically applied corticosteroids and emollients are the main stay of therapy for atopic dermatitis. Immunosuppressant calcineurin inhibitors are next used if topical steroids are not adequate.
    In severe, refractory cases, systemic options such as oral immunosuppressants or dupilumab (Dupixent®) may be used.
    • V. Dosage and Administration
    Indication Moderate-to- severe atopic dermatitis
    Dosing Regimen 100 PO QD Maximum Dose 200 mg/ day 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily VI. Product Availability
    Tablet: 50 mg, 100 mg, and 200 mg
    VII.