Cibinqo™

Drug - Cibinqo™ (abrocitinib) [Pfizer Inc.]

March 2025

Therapeutic Area - Cytokine and CAM Antogonists

Initial approval criteria

• Patient is at least 18 years of age; AND 
• Patient has been evaluated and screened for the presence of viral hepatitis prior to initiating treatment in accordance with clinical guidelines; AND 
• Patient is up to date with all vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND 
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND 
• Patient is not on concomitant antiplatelet therapies during the first 3 months of treatment (Note: Excludes the use of low-dose aspirin [≤ 81 mg daily]); AND 
• Patient does not have any clinically relevant laboratory abnormalities (i.e., platelet count < 150,000/mm3, an absolute lymphocyte count < 500/mm3, an absolute neutrophil count <1000/mm3, or a hemoglobin value < 8g/dL); ANDPatient has been evaluated to identify or rule out other causes of AD (e.g., hypersensitivity allergen identification, cutaneous lymphomas, etc.); AND

Universal Criteria

• Patient individual risks and benefits have been considered prior to initiating or continuing therapy in those at higher risk for malignancy and/or major adverse cardiovascular events (MACE); AND
• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND 
• Patient does not have an active infection, including clinically important localized infections; AND 
• Patient will not receive live vaccines during therapy; AND 
• Will not be used in combination with other monoclonal antibody biologics (e.g., tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tralokinumab, etc.) or another non-biologic agent (e.g., apremilast, baricitinib, tofacitinib, upadacitinib etc.); AND 
• Patient is not considered to be at high risk for thrombosis; AND 
• Patient does not have severe hepatic impairment (e.g., Child-Pugh C) or severe renal impairment (eGFR < 30 mL/min); AND 
• Patient will avoid concomitant therapy with all of the following: 
  • Coadministration with strong CYP2C19 inhibitors (e.g., amitriptyline, fluconazole, imipramine, etc.), if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND 
  • Coadministration with moderate to strong CYP2C19 and CYP2C9 inhibitors (e.g., fluconazole, fluvoxamine, voriconazole etc.); AND
  • Coadministration with strong CYP2C19 inducers (e.g., enzalutamide, rifampin, etc.) or CYP2C9 inducers (e.g., rifampin, carbamazepine, enzalutamide, etc.); AND 

Atopic Dermatitis (AD) 

• Patient has moderate-to-severe atopic dermatitis (AD) defined by at least 1 of the following: 
  • Involvement of at least 10% of body surface area (BSA); OR 
  • Eczema Area and Severity Index (EASI) score of 16 or greater; OR 
  • Investigator’s Global Assessment (IGA) score of 3 or more; OR 
  • Scoring Atopic Dermatitis (SCORAD) score of 25 or more; OR 
  • Pruritus Numerical Rating Scale (NRS) score of 4 or more; OR 
  • Incapacitation due to AD lesion location (i.e., head and neck, palms, soles or genitalia); AND 
• Patient did not respond adequately (or is not a candidate) to a 3-month minimum trial of topical agents [e.g., corticosteroids, calcineurin inhibitors (e.g., tacrolimus or pimecrolimus), crisaborole, etc.]; AND
• Patient did not respond adequately (or is not a candidate**) to a 3-month minimum trial of phototherapy (e.g., Psoralens with UVA light [PUVA], UVB, etc.)

**Examples of contraindications to phototherapy (PUVA or UVB) include the following:

• Xeroderma pigmentosum 
• Pregnancy or lactation (PUVA only) 
• Lupus Erythematosus 
• History of one of the following: photosensitivity diseases (e.g., chronic actinic dermatitis, solar urticaria), melanoma, non-melanoma skin cancer, extensive solar damage (PUVA only), or treatment with arsenic or ionizing radiation 
• Immunosuppression in an organ transplant patient (UVB only) 
• Photosensitizing medications (PUVA only) 
• Severe liver, renal, or cardiac disease (PUVA only)

Renewal criteria

• Patient continues to meet the universal and other indication-specific relevant criteria, such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc., identified in the initial approval criteria; AND 
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: serious infections (e.g., fungal, viral, or other opportunistic infections), tuberculosis, virus reactivation (e.g., herpes zoster, Hepatitis B, Hepatitis C), malignancy and lymphoproliferative disorders (e.g., lymphomas, non-melanoma skin cancer, or other solid tumors), major adverse cardiovascular events (MACE), gastrointestinal perforation, thrombosis (e.g., pulmonary embolism, deep vein thrombosis, arterial thrombosis), lymphopenia, neutropenia, anemia, lipid elevation, liver enzyme elevation, etc.; AND 
• Patient has NOT experienced a myocardial infarction or stroke; AND 
• Disease response as indicated by improvement in signs and symptoms compared to baseline in one or more of the following: pruritus, the amount of surface area involvement, EASI, IGA, SCORAD, and/or NRS; AND
  • Patient has achieved clear or almost clear skin defined as achievement of an IGA 0/1 or EASI-75 at Week 16; OR 
  • Patient has had an inadequate response to standard doses of therapy after an adequate trial of at least 12 weeks OR patient experienced a disease flare and will require higher dosing; AND 
    • Patient requires an increase in dose, in accordance with prescribing information recommended dosages below (i.e., up to 200 mg daily)

Quantity limits

• 200 mg daily

Background

Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppresants.

Questions

Provider Call Center (844) 575-7887