ModifiedUnitedHealthcarePolicy 2025 P 2380-1

Leqselvi™ (deuruxolitinib) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare Commercial Plans' prior authorization and medical necessity criteria for Leqselvi (deuruxolitinib) for adults with severe alopecia areata, including initial authorization, reauthorization, combination therapy exclusions, prescriber requirements, and duration of approval. Notes that Leqselvi is excluded for the majority of benefits and plan-specific exclusions may apply.

Policy Summary

PayerUnitedHealthcare

PolicyLeqselvi™ (deuruxolitinib) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2380-1

Change TypeNew program

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document trials (drug, date, duration) demonstrating failure, contraindication, or intolerance to both Litfulo (ritlecitinib) and Olumiant (baricitinib); approval contingent on meeting all initial criteria.

SourceLink

POLICY UPDATE CHANGES

New program created for Prior Authorization/Medical Necessity for Leqselvi (deuruxolitinib) with P&T Approval Date 10/2025 and Effective Date 1/1/2026.

12 monthsAuthorization duration

>=50%Scalp hair loss threshold for coverage

2Required prior trials (ritlecitinib and baricitinib)

Majority excluded

Plan exclusion status

Coverage Summary

Initial Authorization

Leqselvi will be approved based on all of the following criteria:

ALL of the following

Diagnosis of severe alopecia areata
Other causes of hair loss have been ruled out (e.g., androgenetic alopecia, cicatricial alopecias, secondary syphilis, tinea capitis, triangular alopecia, and trichotillomania)
Patient has a current episode of alopecia areata with at least 50% scalp hair loss>= 50% scalp hair loss
Defined in policy as a current episode of alopecia areata with at least 50% scalp hair loss.
ALL of the following
- Litfulo (ritlecitinib)
- Olumiant (baricitinib)
ALL of the following
- ONE of
  - Systemic targeted immunomodulator (e.g., Litfulo (ritlecitinib), Olumiant (baricitinib)) for treatment of the same indication
  - Potent immunosuppressant (e.g., azathioprine or cyclosporine)
Prescribed by or in consultation with a dermatologist

Reauthorization

Leqselvi will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Leqselvi therapy
ALL of the following
- ANY of the following
  - Systemic targeted immunomodulator (e.g., Litfulo (ritlecitinib), Olumiant (baricitinib)) for treatment of the same indication
  - Potent immunosuppressant (e.g., azathioprine or cyclosporine)
Authorization will be issued for 12 months.

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required with documentation of prior trials

Prior authorization is required. Document the drug name, date, and duration of trials demonstrating failure, contraindication, or intolerance to both ritlecitinib and baricitinib before approval will be considered.

Document Litfulo (ritlecitinib): drug name, trial dates, duration, and reason for discontinuation (failure/contraindication/intolerance).
Document Olumiant (baricitinib): drug name, trial dates, duration, and reason for discontinuation (failure/contraindication/intolerance).

Documentation Required

Document exclusion of alternative causes

Document that alternative causes of hair loss have been excluded prior to approval.

Applicable Codes

Referenced ICD-10 diagnosis codes (example conditions to rule out)ICD-10

Document lists conditions to rule out: androgenetic alopecia, cicatricial alopecias, secondary syphilis, tinea capitis, triangular alopecia, trichotillomania. No specific ICD-10 codes were provided in the policy.

Clinical Evidence & References

Evidence includes the package insert: Leqselvi [package insert], Sun Pharmaceutical Industries, Inc; July 2024, and guideline: British Association of Dermatologists' guidelines for the management of alopecia areata 2012; Messenger et al.. Background: Leqselvi is a JAK inhibitor indicated for adults with severe alopecia areata. The product labeling and policy recommend against use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Background & Definitions

Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Coverage thresholds and definition

Scalp hair loss threshold>= 50% scalp hair loss

Authorization duration12 months

Required prior trials2: ritlecitinib and baricitinib

Severe alopecia areata (defined)Defined in policy as a current episode of alopecia areata with at least 50% scalp hair loss.

Revision History

2025-10AddedLatest

New program created for Prior Authorization/Medical Necessity for Leqselvi (deuruxolitinib) with P&T Approval Date 10/2025 and Effective Date 1/1/2026.

Policy Summary

PayerUnitedHealthcare

PolicyLeqselvi™ (deuruxolitinib) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2380-1

Change TypeNew program

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Androgenetic alopecia

Cicatricial alopecias

Documentation Required

Prescriber requirement

Ensure the prescription is written by or in consultation with a dermatologist; include consultation notes in the record.

Prior Authorization

Reauthorization requirements

For reauthorization, provide documentation of a positive clinical response to Leqselvi and confirm the patient is not using prohibited concomitant therapies. Authorizations will be issued for 12 months when criteria are met.

Documented positive clinical response to Leqselvi therapy.
No concomitant use with systemic targeted immunomodulators (e.g., Litfulo/ritlecitinib, Olumiant/baricitinib) for the same indication.
No concomitant use with potent immunosuppressants (e.g., azathioprine, cyclosporine).
Authorization duration: 12 months.

Billing Rule

Benefit exclusion may apply

Confirm member-specific plan coverage prior to prescribing. Leqselvi is excluded from coverage for the majority of UnitedHealthcare benefits; benefit exclusion or additional tried/failed criteria may apply.

Verify the member's benefit plan to determine whether Leqselvi is covered or excluded.
Refer to plan specifics for any additional tried/failed criteria or exclusion status.

Denial Risk

Combination therapy exclusion

Claims may be denied if Leqselvi is used concurrently with other JAK inhibitors, biologic immunomodulators, cyclosporine, other potent immunosuppressants, or systemic targeted immunomodulators for the same indication.

Concurrent use with other JAK inhibitors (e.g., ritlecitinib) may result in denial.
Concurrent use with biologic immunomodulators for the same indication may result in denial.
Concurrent use with cyclosporine or other potent immunosuppressants (e.g., azathioprine) may result in denial.
Concurrent use with systemic targeted immunomodulators for the same indication may result in denial.

Billing Rule

Automated approvals and supply limits

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and claim logic. Automated approvals and supply limits may be enforced depending on program rules.

Automated approvals may be based on previous claim/medication history and diagnosis codes.
Supply limits may be applied to Leqselvi.