CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2025 P 1422-3

Litfulo (ritlecitinib) prior authorization

Defines prior authorization and reauthorization requirements for Litfulo (ritlecitinib) for treatment of severe alopecia areata for Colorado Rocky Mountain Health Plans members. Affects providers requesting coverage for Litfulo.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLitfulo (ritlecitinib) prior authorization

Policy CodePolicy 1 = 2025 P 1422-3

Change TypeAnnual review — wording updatesno change to clinical intent

Effective Date3/1/2026

Next Review Date12/2026

Key ActionSubmit prior authorization documenting diagnosis of severe alopecia areata and that patient is not receiving Litfulo with a biologic/JAK inhibitor or potent immunosuppressant.

SourceLink

POLICY UPDATE CHANGES

Program created as a prior authorization/notification program for Litfulo (ritlecitinib).

Annual review entries with updates to combination examples and language noted with no change to clinical intent.

Effective date for this version set to 3/1/2026.

12 monthsauthorization duration

≥12 yrsindicated age

1program #

3P&T approvals

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Coverage Criteria for Litfulo (ritlecitinib)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization criteria: (a) Diagnosis of severe alopecia areata

Initial Authorization criteria: (b) Patient is not receiving Litfulo in combination with either: (1) a biologic immunomodulator or JAK inhibitor (e.g., Adbry, Cibinqo, Dupixent, Ebglyss, Leqselvi, Nemluvio, Olumiant, Rinvoq) OR (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Authorization will be issued for 12 months

Initial therapy

Initial therapy authorization criteria

Initial therapy: Diagnosis of severe alopecia areata

Initial therapy: Patient is not receiving Litfulo in combination with specified biologic or JAK inhibitors or a potent immunosuppressant (e.g., azathioprine or cyclosporine)

12-month authorization

Reauthorization

Covered when ALL of the following are met

Reauthorization criteria: (a) Documentation of positive clinical response to Litfulo therapy

Reauthorization criteria: (b) Patient is not receiving Litfulo in combination with either: (1) a biologic immunomodulator or JAK inhibitor (e.g., Adbry, Cibinqo, Dupixent, Ebglyss, Leqselvi, Nemluvio, Olumiant, Rinvoq) OR (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Authorization will be issued for 12 months

Reauthorization

Reauthorization (continuation) requirements

Continuation requirement: Documentation of positive clinical response to Litfulo therapy

Authorization renewed for 12 months if met

Continuation requirement: Patient is not receiving Litfulo in combination with a biologic immunomodulator or JAK inhibitor, or a potent immunosuppressant (e.g., azathioprine or cyclosporine)

Authorization renewed for 12 months if met

Use of Litfulo (ritlecitinib) in combination with other immunomodulatory or potent immunosuppressive therapies is addressed explicitly in the coverage criteria. As a reminder of the policy position: combination therapy with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants is not recommended and is a disqualifying condition for approval. The initial and reauthorization criteria each require that the patient is not receiving Litfulo in combination with these agents (examples listed in the policy include Adbry, Cibinqo, Dupixent, Leqselvi, Olumiant, Rinvoq, and agents such as azathioprine or cyclosporine).

Providers requesting coverage should document current medication use and ensure that Litfulo is not being administered concurrently with the listed biologic immunomodulators, JAK inhibitors, or potent immunosuppressants. If combination therapy with any of these agents is present, the request does not meet the stated coverage criteria and may be denied.

Not recommended/limited: Litfulo must not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. The policy explicitly lists examples of biologic immunomodulators and JAK inhibitors (e.g., Adbry, Cibinqo, Dupixent, Ebglyss, Leqselvi, Nemluvio, Olumiant, Rinvoq) and gives azathioprine and cyclosporine as examples of potent immunosuppressants.

This restriction applies to both initial authorizations and reauthorizations; approval is contingent on the patient not receiving these concomitant therapies. Requests that involve concurrent use with the listed classes or agents are outside the coverage criteria and are subject to denial.

Actions Required from Providers

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Initial approval requires a diagnosis of severe alopecia areata and that the patient is NOT receiving Litfulo in combination with certain therapies. Authorization will be issued for 12 months.

Initial approval requires both: diagnosis of severe alopecia areata AND patient not receiving Litfulo with listed biologic/JAK inhibitors or potent immunosuppressants
Authorization duration: 12 months

Step Therapy

Program-level Step Therapy and Limits

Supply limits, Step Therapy, and/or Medical Necessity may be in place and could affect authorization. UnitedHealthcare may approve initial and reauthorization requests based on previous claim/medication history, diagnosis codes (ICD-10) and/or automated claim logic depending on program.

Supply limits and Step Therapy may apply
Automated approval/reauthorization may occur based on claims or medication history

Definitions and Limitations of Use

Limitations of Use

Limitations of useNot recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Examples included in limitationBiologic immunomodulators and other JAK inhibitors (see policy for examples).

Potent immunosuppressants specifiedIncludes agents such as cyclosporine (and other potent immunosuppressants).

Coverage implicationUse in combination with the listed agents is an exclusion and may result in denial of authorization.

Background on Litfulo (ritlecitinib)

Background: Litfulo (ritlecitinib) is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 years and older. The policy sets coverage under defined authorization criteria and includes specific limitations of use regarding combination therapy with certain immunomodulatory and immunosuppressive agents.

Indication and limitations summary: Coverage is available for severe alopecia areata when the initial or continuation criteria are met; however, use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants is not recommended and will exclude approval unless the combination requirement is resolved.

Step Therapy and Supply Limits

Program note
Supply limits, Step Therapy, and/or Medical Necessity may be in place and could affect authorization for Litfulo.
Notwithstanding coverage criteria, automated approval or re-approval based on prior medication/claim history, diagnosis codes, or claim logic may be used by the plan.