Cibinqo

Abrocitinib

• Brand(s): Cibinqo
• Dosage Form/Strength: 50 mg, 100 mg, 200 mg tablets
• Effective date: October 3, 2023

Initiation Criteria

For the treatment of moderate to severe atopic dermatitis in patients meeting the all the following criteria;

1. 12 years of age or older;
   AND
2. Diagnosed with moderate-to-severe atopic dermatitis (AD) by the Eczema Area and Severity Index (EASI) score equal to or greater than 16 points and the Investigators (Physician) Global Assessment score of 3 to 4;
   AND
3. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with phototherapy (where available);^1,2
   AND
4. Failure to maintain adequate control of their dermatitis with maximally tolerated medical topical therapies for AD combined with at least 1 of the 4 systemic immunomodulators (methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine).^1,2
5. Abrocitinib is prescribed by a dermatologist, allergist, pediatrician or clinical immunologist, or in consultation with one of these specialists. (Please include the consult note with the EAP application.)

Exclusion Criteria:

1. 1. Abrocitinib will not be funded if it is used in combination with phototherapy or any immunomodulatory drugs (including biologics³ or a Janus kinase [JAK] inhibitor treatment) for treatment of AD.

Notes:

¹For each treatment used, provide documentation of refractory disease and/or intolerance (including a description of the adverse effect and severity of reaction). If a patient is deemed to be ineligible or contraindicated to receive the treatment, provide the reason(s) for their ineligibility.

²An adequate trial for patients with AD who undergo therapy with phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine is defined as follows:

• For phototherapy: the typical duration would be considered 12 weeks (3 times per week).
• For methotrexate: an adequate trial would be 10 mg to 20 mg per week for 12 weeks.
• For cyclosporine: an adequate trial would be 2.5 mg/kg to 5 mg/kg per day for 12 weeks.
• For mycophenolate mofetil: an adequate trial would be 1 g twice daily for 12 weeks.
• For azathioprine: an adequate trial would be 1.5 to 2.5 mg/kg/day for 12 weeks

³The concurrent use of abrocitinib used in combination with other biologics used for other conditions will be considered on a case-by-case basis.

⁴Funding of patients who meet the above criteria and who are experiencing inadequate response using another systemic treatment (e.g. biologics, steroids) for AD will be considered on a case-by-case basis.

Renewal Criteria:

First renewal:

Renewal of funding will be considered in patients with documentation of benefit from treatment. Benefit from treatment is defined as a 75% or greater improvement from baseline in the Eczema Area and Severity Index (EASI) score (EASI-75) in the first 20 weeks of treatment initiation with abrocitinib.

Subsequent renewals:

Subsequent renewal of funding will be considered in patient who maintain the 75% or greater improvement in EASI score response from baseline.

Duration of Approval for initial requests: 6 months

Duration of Approval for first and second renewal: 6 months

Duration of Approval for 3rd and subsequent renewals: 1 year

Approved dose: Up to 200 mg orally once daily.

Please refer to the product monograph for dose adjustment recommendations.