CurrentBlue Cross Blue Shield - IowaPolicy 05.05.65

Leqselvi (deuruxolitinib) for severe alopecia areata — Coverage Criteria

Policy governs authorization and coverage criteria for Leqselvi for treatment of severe alopecia areata in adults, including required documentation, prescribing specialty, dosing limits, and continuation criteria for Blue Cross Blue Shield - Iowa members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLeqselvi (deuruxolitinib) for severe alopecia areata — Coverage Criteria

Policy CodePolicy 05.05.65

Change TypeMinor technical update

Effective DateOct 4, 2025

Next Review DateAug 1, 2025

Key ActionSubmit prior authorization with chart notes documenting ≥50% scalp hair loss (e.g., SALT ≥50) and records of prior corticosteroid therapy and response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization period

12 mocontinuation authorization period

60/30dquantity limit

≥50%severe AA threshold (SALT)

Coverage Criteria for Leqselvi (deuruxolitinib)

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Initial Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Initial Approval: 1) Diagnosis of severe alopecia areata (including alopecia totalis and alopecia universalis) defined as >=50% scalp hair loss (SALT >=50); 2) Duration of current episode of hair loss is less than 10 years; 3) Current episode lasting >6 months without spontaneous regrowth; 4) Other forms of alopecia have been ruled out (e.g., androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis); 5) No prior treatment with another JAK inhibitor (e.g., baricitinib, ruxolitinib, tofacitinib) resulting in inadequate response (absence of significant terminal hair growth after >=12 weeks of treatment); 6) Inadequate response to corticosteroids (intralesional and/or topical depending on severity and age); 7) Patient will not use Leqselvi in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.>= 50% scalp hair loss (SALT >=50)

Prescriber must be a dermatologist or in consultation with one.

Continuation Therapy

Authorization of 12 months may be granted for patients demonstrating a positive clinical response:

Continuation: Patients must meet the Initial Approval criteria and demonstrate positive clinical response to therapy as evidenced by at least 10% improvement in scalp hair coverage for initial continuation requests. Subsequent continuation requests (after at least 12 months of therapy) require achievement or maintenance of a positive clinical response.>= 10% improvement in scalp hair coverage

Applies to all patients, including new members.

Leqselvi (deuruxolitinib) is not recommended and is excluded from use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. Additionally, Leqselvi should not be administered to patients with active tuberculosis; see TB screening requirements before initiating therapy.

Leqselvi is considered not medically necessary for members who do not meet the criteria set forth in this policy.

Coding and Clinical Thresholds

Provider billing codesmixed

No codes listed

inv-06: Severity of Alopecia Tool (SALT) score threshold

SALT score thresholdSeverity of Alopecia Tool (SALT) score ≥ 50 (defines severe alopecia areata)

Clinical evidence requiredChart notes or medical record documentation supporting >50% scalp hair loss (e.g., SALT score of 50 or higher)

Includes clinical subtypesApplies to alopecia totalis and alopecia universalis as severe forms

inv-07: Continuation response threshold

Continuation response thresholdAt least 10% improvement in scalp hair coverage required to demonstrate positive clinical response for continuation

Documentation for continuationChart notes or medical record documentation supporting positive clinical response, including SALT score

Applies to new membersContinuation criteria apply to all patients, including new members who meet initial approval criteria

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals may be for up to 6 months. Approvals are subject to dosing and quantity limits per FDA labeling and plan rules (for example: Leqselvi 8 mg tablets — 60 per 30 days).

Prior authorization required for initial and continuation therapy
Initial authorization may be granted for 6 months
Approvals subject to dosing/quantity limits

Step Therapy

Prior Therapy Requirements

Documentation of prior therapies is required. For alopecia areata, member must have had an inadequate response to corticosteroids (intralesional, topical, and/or systemic as appropriate) and must not have had prior treatment with another JAK inhibitor with an inadequate response. Provide chart notes or medical record documentation of prior medications tried and response to therapy.

Document prior corticosteroid therapy and response
Document prior JAK inhibitor exposure and response (if applicable)
List prior medications tried with dates and clinical response

Documentation Required

Required Documentation for Requests

Submit chart notes or medical record documentation to support the request. For initial requests include documentation of >50% scalp hair loss (e.g., SALT score ≥50) and records of prior treatments tried and responses. For continuation requests include chart notes documenting positive clinical response (including current SALT score). Also provide tuberculosis (TB) screening results: a negative TST or IGRA within 12 months for persons naive to biologic/targeted synthetic drugs; if TB testing is positive, provide evidence of evaluation to exclude active disease (e.g., chest X‑ray) or documentation of latent TB treatment prior to initiation.

Initial: SALT score ≥50 or equivalent chart documentation of >50% scalp hair loss
Initial: documentation of prior medications and responses
Continuation: documentation of clinical benefit and current SALT score
TB screening: negative TST or IGRA within 12 months if biologic/targeted synthetic‑naive; if positive, further evaluation to exclude active TB or evidence of latent TB treatment

Denial Risk

Denial if Criteria Not Met

Denial if criteria not met. Leqselvi is considered not medically necessary for members who do not meet the policy criteria. Members receiving medication as samples or via manufacturer assistance must meet initial approval criteria to continue coverage.

Denial if medical necessity criteria are not satisfied
Samples or patient assistance program supply does not exempt requirement to meet criteria

OpenPayer

Leqselvi (deuruxolitinib) for severe alopecia areata — Coverage Criteria

Coverage Criteria for Leqselvi (deuruxolitinib)

Coding and Clinical Thresholds

Provider Requirements and Actions

Background

Definitions