CurrentMass General Brigham Health PlanPolicy N/A

Leqselvi (deuruxolitinib) prior authorization for severe alopecia areata

Defines prior authorization, coverage criteria, and limits for Leqselvi (deuruxolitinib) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including specialty pharmacy dispensing requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLeqselvi (deuruxolitinib) prior authorization for severe alopecia areata

Policy CodePolicy N/A

Change TypeClarified (administrative wording)

Effective DateMay 1, 2026

Next Review DateMar 11, 2026

Key ActionSubmit medical records (e.g., chart notes) documenting diagnosis, baseline SALT ≥50, prior trial/failure of ritlecitinib or baricitinib, and clinical improvement for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Reworded reauthorization criterion to specify 'submission of medical records (e.g., chart notes)' and updated language for members new to the Plan.

≥50%SALT score threshold

18+Minimum age

36 wksInitial approval

12 moReauthorization

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Coverage Criteria for Leqselvi (deuruxolitinib)

Initial Therapy

Covered when ALL of the following are met:

Age: Member is 18 years of age or older

Diagnosis of severe alopecia areata

Disease severity: Member has at least 50% scalp hair loss (e.g., SALT score >= 50)SALT >= 50

Exclude other alopecia types: Other forms of alopecia have been ruled out (e.g., androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis)

Prior therapy requirement: Trial and failure, contraindication, or intolerance to one of: Litfulo (ritlecitinib) OR Olumiant (baricitinib)

Either agent satisfies this requirement

Specialty dispensing: Medication must be filled at a contracted specialty pharmacy

Continuation of Therapy

Reauthorization approved when ALL of the following are met:

Documentation: Submission of medical records (e.g., chart notes) documenting improvement in signs and symptoms of alopecia areata from baseline (e.g., increased hair on scalp, eyebrows, eyelashes)

Duration limits: Initial approvals: 36 weeks; Reauthorizations: 12 months

Leqselvi (deuruxolitinib) should not be used concurrently with other agents that have overlapping potent immunomodulatory effects. Specifically, concomitant use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants is not recommended. This restriction is a safety-based contraindication and applies regardless of disease severity when considering therapy combinations.

Therapy with Leqselvi is limited to patients who meet all clinical criteria: age ≥ 18 years, a diagnosis of severe alopecia areata, and SALT score ≥ 50 (≥ 50% scalp hair loss). Coverage requires documentation that other forms of alopecia have been excluded (for example, androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, or tinea capitis). Prior trial and failure, contraindication, or intolerance to either ritlecitinib (Litfulo) or baricitinib (Olumiant) is required before Leqselvi will be authorized. Use in patients who do not meet these age, diagnostic, severity, prior-therapy, or exclusion-of-other-alopecia criteria is considered not medically necessary under this policy.

Pharmacy Coding and Clinical Thresholds

Pharmacy product codingNDC

NDC	Leqselvi product codes (refer to pharmacy system for exact NDCs)

SALT score (key threshold)

SALT score thresholdMember has at least 50% scalp hair loss (SALT score ≥ 50)

Measurement toolSeverity of Alopecia Tool (SALT)

Coverage implicationSALT ≥ 50 required for initial authorization and reauthorization documentation

Provider Requirements, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization and Dispensing

Prior authorization is required for Leqselvi (deuruxilitinib). This medication is designated specialty and must be dispensed by a contracted specialty pharmacy. Initial approvals are granted for 36 weeks; reauthorizations for 12 months.

Program Type: Prior Authorization
Pharmacy Benefit: Specialty pharmacy dispensing required
Initial approval duration: 36 weeks
Reauthorization duration: 12 months

Step Therapy

Required Prior Trials

Authorization requires a prior trial with at least one of the following unless there is documented contraindication or intolerance: Litfulo (ritlecitinib) or Olumiant (baricitinib). This is not a formal step-therapy program but a required prior trial/failure criterion for initial approval.

Required prior trial: one agent from {Litfulo (ritlecitinib), Olumiant (baricitinib)}

Definitions

Severe alopecia areata — policy definition

Policy definitionSevere alopecia areata defined as at least 50% scalp hair loss (SALT score ≥ 50)

Age requirementApplies to adults (≥18 years) per coverage criteria

Exclusions to considerOther forms of alopecia must be ruled out (e.g., androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis)

Concomitant therapy — restriction

Concomitant therapy restrictionLeqselvi should not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants

Rationale sourceSafety and product guidance in policy overview: concomitant use is not recommended

Background

Alopecia areata is an autoimmune, non-scarring hair loss disorder; Leqselvi (deuruxolitinib) is an oral Janus kinase (JAK) inhibitor approved for adults with severe alopecia areata. The policy defines severe alopecia areata as at least 50% scalp hair loss (SALT ≥ 50). Because of its mechanism and immunomodulatory effects, concomitant use with other JAK inhibitors or potent immunosuppressants is not recommended and is excluded by the coverage criteria.

Documentation Required

Required Documentation

For members new to the plan (coverage effective date ≤ 90 days), submit medical records confirming the member is currently receiving the requested drug (excluding samples or manufacturer patient assistance programs). For all requests, include medical records demonstrating diagnosis, baseline severity, prior treatment history, and response for reauthorization.

New-to-plan member: medical records showing current treatment with the requested drug (coverage effective date ≤ 90 days)
Initial request: documentation of diagnosis (severe alopecia areata) and SALT score ≥ 50
Documentation of rule-out of other alopecia causes (e.g., androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis)
Evidence of trial and failure/contraindication/intolerance to required prior agent(s)
Reauthorization: chart notes showing improvement in signs/symptoms from baseline (increased scalp, eyebrow, or eyelash hair)