CurrentUnitedHealthcarePolicy N/A

Leqselvi (deuruxolitinib) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization requirements for Leqselvi (deuruxolitinib) for treatment of severe alopecia areata. Affects providers seeking coverage for members whose benefit plans permit Leqselvi.

Policy Summary

PayerUnitedHealthcare

PolicyLeqselvi (deuruxolitinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and include documentation of diagnosis and, for reauthorization, evidence of positive clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

severe alopecia areatarequired indication

majority excludedcoverage exclusion

10/2025P&T date

Coverage Criteria for Leqselvi (deuruxolitinib)

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Initial Authorization: a. Diagnosis of severe alopecia areata

Authorization issued for 12 months

Initial Authorization - Concomitant therapy restriction: b. Patient is not receiving Leqselvi in combination with either: (1) a systemic targeted immunomodulator (e.g., ritlecitinib, baricitinib) for treatment of the same indication, OR (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine).

Authorization issued for 12 months

inv-02: Reauthorization

Covered when ALL of the following are met

Reauthorization: a. Documentation of positive clinical response to Leqselvi therapy

Authorization issued for 12 months

Reauthorization - Concomitant therapy restriction: b. Patient is not receiving Leqselvi in combination with either: (1) a systemic targeted immunomodulator (e.g., ritlecitinib, baricitinib) for treatment of the same indication, OR (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine).

Authorization issued for 12 months

Coverage of Leqselvi (deuruxolitinib) may be limited by plan-specific exclusions. The product is excluded from coverage for the majority of UnitedHealthcare benefits; therefore providers must verify the member's benefit plan to determine whether Leqselvi is eligible for coverage under the member's specific plan.

Tried/failed or step therapy requirements and any applicable state or federal mandates may also affect whether a particular request can be approved. Consult the member's benefit details and plan-specific policies to confirm exclusion status before submitting prior authorization requests.

Initial Therapy

inv-11: Initial Therapy

Initial approval criteria

Initial Therapy: Diagnosis of severe alopecia areata

Authorization issued for 12 months

Initial Therapy - Concomitant therapy restriction: No concomitant use of Leqselvi with either: (1) a systemic targeted immunomodulator (e.g., ritlecitinib, baricitinib) for the same indication, or (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine).

Authorization issued for 12 months

Reauthorization / Continuation Criteria

inv-12: Reauthorization

Reauthorization criteria

Reauthorization: Documentation of positive clinical response to Leqselvi therapy

12-month authorization

Reauthorization - Concomitant therapy restriction: No concomitant use of Leqselvi with either: (1) a systemic targeted immunomodulator (e.g., ritlecitinib, baricitinib) for the same indication, or (2) a potent immunosuppressant (e.g., azathioprine or cyclosporine).

12-month authorization

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Leqselvi. When criteria are met, approvals are issued for 12 months.

Authorization duration: 12 months
Applies to initial and reauthorization approvals

Denial Risk

Combination Therapy Exclusion

Leqselvi must not be used in combination with other systemic targeted immunomodulators or potent immunosuppressants for the same indication. Coverage may be denied if used concurrently with these agents.

Examples of systemic targeted immunomodulators: Litfulo (ritlecitinib), Olumiant (baricitinib)
Examples of potent immunosuppressants: azathioprine, cyclosporine

Note

Plan Exclusion and Plan-Specific Rules

Coverage may be unavailable for some members due to plan-specific exclusions or benefit limits. Verify the member’s benefit plan and any state or federal mandates; tried/failed or step therapy requirements and supply limits may also apply.

Leqselvi may be excluded from coverage under many UnitedHealthcare benefits
Tried/failed and step therapy criteria or automated approval processes may affect decisions

Documentation Required

Required Clinical Documentation

Documentation that may be required at initial authorization and reauthorization includes diagnosis and evidence of response to therapy. UnitedHealthcare may also rely on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic for approvals.

Initial: diagnosis of severe alopecia areata
Reauthorization: documentation of positive clinical response to Leqselvi
UnitedHealthcare may use prior claims/medication history and ICD-10 codes for automated approval

Step Therapy and Benefit Verification

Step	Requirement	Notes
1	Verify member-specific step therapy requirements (may include tried/failed criteria or prior trials),	Step therapy and tried/failed criteria may be in place; plan-specific exclusions apply — Leqselvi is excluded from coverage for the majority of benefits. Refer to member benefit plan to confirm requirements and exclusion status.

Background

Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.

Per the labeling and limitations of use, Leqselvi should not be used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

UnitedHealthcare's policy implements prior authorization for Leqselvi when the member's plan permits coverage; authorization decisions must follow the documented criteria and plan-specific requirements.

Definitions

Severe alopecia areata — labeled indication definition

IndicationSevere alopecia areata — the labeled indication for which Leqselvi (deuruxolitinib) is indicated.

Drug classJanus kinase (JAK) inhibitor (Leqselvi — deuruxolitinib).

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

PopulationAdults with severe alopecia areata.

Policy relevanceDiagnosis of severe alopecia areata is required for prior authorization approval per UnitedHealthcare criteria.

Policy Summary

PayerUnitedHealthcare

PolicyLeqselvi (deuruxolitinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and include documentation of diagnosis and, for reauthorization, evidence of positive clinical response.

SourceLink

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