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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsFlorida AHCA Cibinqo Prior Auth Coverage | OpenPay…
    Ask Trek AI about this page
    CurrentAgency for Health Care AdministrationPolicy N/A

    Cibinqo (abrocitinib) Prior Authorization Criteria

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    This policy governs prior authorization for Cibinqo (abrocitinib) for patients with refractory moderate-to-severe atopic dermatitis. It establishes initial and continuation requirements, safety screening, drug-combination restrictions, dosing expectations, and a six-month authorization period.

    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCibinqo (abrocitinib) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming age, diagnosis, required prior therapies, safety screening, and tuberculosis monitoring before initiating Cibinqo.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsAuthorization length
    ≥12Minimum age
    3 monthsPhototherapy trial
    3 monthsSystemic-agent trial

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    50/100/200 mg
    Tablet strengths

    Coverage Criteria

    Initial Therapy Criteria

    Covered for initial therapy when all of the following are met.

    Initial therapy requirements

    • Clinical eligibility

      • Patient is at least 12 years of age and has refractory moderate-to-severe atopic dermatitis.Age ≥12 years
    • Required prior treatment

      • Patient has tried at least one preferred medium- to very-high-potency topical corticosteroid and experienced inadequate response or intolerance.At least 1 preferred topical corticosteroid
      • Patient has tried at least one preferred topical calcineurin inhibitor, including Elidel or Protopic, and experienced inadequate response or intolerance.At least 1 preferred topical calcineurin inhibitor
      • Patient did not respond adequately to, or is not a candidate for, a minimum three-month trial of phototherapy.Phototherapy trial ≥3 months
      • Patient did not respond adequately to, or is not a candidate for, a minimum three-month trial of at least one preferred systemic agent.Preferred systemic-agent trial ≥3 months

        Preferred systemic agents include cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or dupilumab.

    • Safety and monitoring

      • Individual risks and benefits have been considered before initiating or continuing therapy for a patient at higher risk for malignancy or major adverse cardiovascular events.
      • Patient is not considered to be at high risk for thrombosis and does not have an active infection, including a clinically important localized infection.
      • Patient has been evaluated and screened for latent tuberculosis infection before treatment, with ongoing monitoring for tuberculosis during treatment.
    • Combination-therapy restriction

      • Cibinqo will not be used in combination with other monoclonal antibody biologics, including tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tralokinumab, or with other non-biologic agents, including apremilast, baricitinib, tofacitinib, or upadacitinib.

    Continuation Therapy Criteria

    Covered for continuation therapy when all of the following are met.

    Continuation therapy requirements

    • Patient met the initial review criteria.
    • Documentation shows an improved clinical response, including clinical reduction in pruritus and flares.
    • Patient has not experienced treatment-restricting adverse effects.

      Treatment-restricting adverse effects include serious infections, tuberculosis, virus reactivation, malignancy or lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, lymphopenia, thrombocytopenia, neutropenia, anemia, and lipid elevation.

    • Dosing is appropriate according to product labeling or is supported by compendia.

    Cibinqo must not be used in combination with other monoclonal antibody biologics, including tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tralokinumab. Concurrent use with other non-biologic agents, including apremilast, baricitinib, tofacitinib, or upadacitinib, is also excluded.

    Treatment is excluded when the patient is considered to be at high risk for thrombosis or has an active infection, including a clinically important localized infection.

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Authorization Required

    Prior authorization is required before initiating Cibinqo (abrocitinib) for refractory moderate-to-severe atopic dermatitis. Initial authorization is limited to 6 months when all applicable review criteria are satisfied.

    • Submit documentation supporting the diagnosis, age, prior treatment history, safety screening, and proposed dosing.
    • Authorization length: 6 months.
    Prior Authorization

    Continuation Authorization

    Continuation authorization requires that the patient met the initial review criteria and continues to demonstrate clinical benefit without treatment-restricting adverse effects. Renewal must include updated clinical and dosing documentation.

    • Document improved clinical response, including reduction in pruritus and flares.
    • Confirm no treatment-restricting adverse effects and that dosing remains appropriate.

    Policy Background

    Cibinqo (abrocitinib) is used under this policy for patients at least 12 years of age with refractory moderate-to-severe atopic dermatitis. Coverage requires documented prior treatment experience or lack of candidacy, including topical therapy, phototherapy, and systemic therapy, together with appropriate safety screening.

    Cibinqo Initial Therapy

    Cibinqo Initial Therapy

    Initial therapy requires all of the following clinical, prior-treatment, safety, monitoring, and combination-therapy criteria.

    Cibinqo initial authorization

    • Clinical eligibility

      • Patient is at least 12 years of age and has refractory moderate-to-severe atopic dermatitis.Age ≥12 years
    • Topical treatment history

      • Patient has tried at least one preferred medium- to very-high-potency topical corticosteroid and experienced inadequate response or intolerance.At least 1 preferred topical corticosteroid

    Cibinqo Continuation

    Cibinqo Continuation

    Continuation therapy requires all of the following.

    Cibinqo continuation criteria

    • Initial review criteria were met.
    • The patient demonstrates an improved clinical response, including clinical reduction in pruritus and flares.
    • The patient has not experienced any treatment-restricting adverse effects.

      Treatment-restricting adverse effects include serious infections, tuberculosis, virus reactivation such as herpes zoster or hepatitis B or C, malignancy or lymphoproliferative disorders such as lymphoma, non-melanoma skin cancer, or other solid tumors, major adverse cardiovascular events, thrombosis such as pulmonary embolism, deep vein thrombosis, or arterial thrombosis, lymphopenia, thrombocytopenia, neutropenia, anemia, and lipid elevation.

    • Dosing is appropriate according to product labeling or is supported by compendia.

    Required Step Therapy

    StepRequired prior therapyMinimum durationRequired outcome
    1One preferred medium- to very-high-potency topical corticosteroidNot specifiedInadequate response or intolerance
    2One preferred topical calcineurin inhibitor (Elidel or Protopic)Not specifiedInadequate response or intolerance
    3PhototherapyMinimum 3 monthsInadequate response or patient is not a candidate
    4At least one preferred systemic agent (for example, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or dupilumab)Minimum 3 monthsInadequate response or patient is not a candidate
    Policy Summary
    PayerAgency for Health Care Administration
    PolicyCibinqo (abrocitinib) Prior Authorization Criteria
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation confirming age, diagnosis, required prior therapies, safety screening, and tuberculosis monitoring before initiating Cibinqo.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation RequirementsPolicy BackgroundCibinqo Initial TherapyCibinqo ContinuationRequired Step Therapy
    Step Therapy

    Required Prior Therapy

    Document inadequate response or intolerance to required preferred therapies before requesting initial authorization. The topical-treatment trials and subsequent treatment history must meet the policy requirements.

    • Trial of at least one preferred medium- to very-high-potency topical corticosteroid with inadequate response or intolerance.
    • Trial of at least one preferred topical calcineurin inhibitor, such as Elidel or Protopic, with inadequate response or intolerance.
    • Inadequate response or lack of candidacy for a minimum 3-month trial of phototherapy.
    • Inadequate response or lack of candidacy for a minimum 3-month trial of at least one preferred systemic agent, such as cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or dupilumab.
    Documentation Required

    Initial Clinical History

    The initial request must document the patient's clinical history, including age, diagnosis, and response or intolerance to prior treatments. The record should support refractory moderate-to-severe atopic dermatitis and the need for Cibinqo.

    • Patient must be 12 years of age or older.
    • Document a diagnosis of refractory moderate-to-severe atopic dermatitis.
    • Describe inadequate response or intolerance to required topical therapies and inadequate response or lack of candidacy for required phototherapy and systemic-agent trials.
    Documentation Required

    Safety Screening

    Before initiating or continuing therapy, document an individualized assessment of risks and benefits for patients at higher risk for malignancy or major adverse cardiovascular events (MACE). Screen for latent tuberculosis before treatment and monitor for tuberculosis during therapy.

    • Confirm the patient is not at high risk for thrombosis and does not have an active infection, including clinically important localized infection.
    • Document latent TB screening before initiation and ongoing monitoring during treatment.
    • Record the individual risk-benefit assessment for malignancy and MACE.
    Documentation Required

    Continuation Documentation

    Renewal requests must include documentation that the patient continues to meet eligibility requirements and is benefiting from treatment. Confirm clinical response, safety, dosing, and ongoing appropriateness of therapy.

    • Document improved clinical response, including clinical reduction in pruritus and flares.
    • Document absence of treatment-restricting adverse effects, including serious or opportunistic infections, TB, viral reactivation, malignancy, MACE, thrombosis, cytopenias, or lipid elevation.
    • Confirm dosing is consistent with product labeling or supported by compendia.
    Denial Risk

    Diagnosis, Age, or Topical Criteria Not Met

    Initial authorization may be denied when the patient does not meet the required diagnosis, age, or topical-treatment criteria.

    • Patient is younger than 12 years of age.
    • Diagnosis is not refractory moderate-to-severe atopic dermatitis.
    • Required preferred topical corticosteroid or topical calcineurin inhibitor trial is absent, inadequate, or lacks documented inadequate response or intolerance.
    Denial Risk

    Required Prior Therapies Not Completed

    Initial authorization may be denied when required prior therapies have not been completed or the minimum trial requirements are not adequately documented.

    • No documented minimum 3-month trial of phototherapy, unless the patient is not a candidate.
    • No documented minimum 3-month trial of at least one preferred systemic agent, unless the patient is not a candidate.
    • Prior therapy documentation does not establish inadequate response or intolerance where required.
    Denial Risk

    Safety or Combination-Therapy Restriction

    Authorization may be denied when safety requirements are not met or when Cibinqo is prescribed with prohibited concurrent therapy.

    • Patient is considered at high risk for thrombosis or has an active infection, including a clinically important localized infection.
    • Required latent TB screening before initiation or ongoing TB monitoring is not documented.
    • Cibinqo is used in combination with another monoclonal antibody biologic, such as dupilumab, or another non-biologic agent, such as apremilast, baricitinib, tofacitinib, or upadacitinib.
    Denial Risk

    Continuation Criteria Not Met

    Continuation authorization may be denied when the patient does not demonstrate benefit, experiences treatment-restricting adverse effects, or receives dosing that is inconsistent with labeling or unsupported by compendia.

    • No documented improved clinical response, including reduction in pruritus and flares.
    • Treatment-restricting adverse effects are present, including serious infection, TB, viral reactivation, malignancy, MACE, thrombosis, cytopenias, or lipid elevation.
    • Dosing is inappropriate under product labeling and is not supported by compendia.
    Patient has tried at least one preferred topical calcineurin inhibitor, including Elidel or Protopic, and experienced inadequate response or intolerance.At least 1 preferred topical calcineurin inhibitor
  1. Phototherapy and systemic therapy history

    • Phototherapy outcome

      • Inadequate response to a minimum three-month trial of phototherapy.
      • Patient is not a candidate for a minimum three-month trial of phototherapy.
    • Preferred systemic-agent outcome

      • Inadequate response to a minimum three-month trial of at least one preferred systemic agent.
      • Patient is not a candidate for a minimum three-month trial of at least one preferred systemic agent.
  2. Safety and monitoring

    • Individual risks and benefits have been considered before initiating or continuing therapy for a patient at higher risk for malignancy or major adverse cardiovascular events.
    • Patient is not considered to be at high risk for thrombosis.
    • Patient does not have an active infection, including a clinically important localized infection.
    • Patient has been evaluated and screened for latent tuberculosis infection before initiating treatment, with ongoing monitoring for tuberculosis during treatment.
  3. Combination-therapy restriction

    • Cibinqo will not be used in combination with other monoclonal antibody biologics, including tezepelumab, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, or tralokinumab, or with other non-biologic agents, including apremilast, baricitinib, tofacitinib, or upadacitinib.