CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY

Cigna prior authorization policy for Leqselvi (deuruxolitinib tablets) covering FDA-approved indication of severe alopecia areata in adults and listing conditions not covered including concurrent use with specified biologics, targeted synthetic oral small molecule drugs, topical JAK inhibitors, and other potent immunosuppressants.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeConditions Not Covered updated; Appendix examples added

Effective DateAug 21, 2024

Next Review DateAug 20, 2025

Key ActionPrior Authorization is recommended for Leqselvi; approvals provided for initial 6 months and continuation 1 year with specialist involvement and required CYP2C9 testing.

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered: Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug was added.

Anzupgo (delgocitinib cream) added as an example of a topical JAK inhibitor not recommended for concomitant use; Ebglyss and Nemluvio added as examples of biologic immunomodulators not recommended concurrently.

2Approval Durations (initial, continuation)

4Concurrent Use Exclusions Listed

Coverage Summary

Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor covered with criteria for the FDA‑approved indication of severe alopecia areata in adults. Initial approvals are for 6 months and continuation approvals are for 1 year when continuation criteria are met. Coverage stance: covered with criteria.

Conditions Not Covered (Exclusions)

Conditions Not Covered (Not Medically Necessary)

Leqselvi is not medically necessary for concurrent use with the following therapies; combination therapy is generally not recommended due to higher adverse events and lack of supporting data. Appendix contains examples.

ALL of the following

Concurrent use with a biologic or with a targeted synthetic oral small molecule drug. Combination therapy not recommended due to a potentially higher rate of adverse events and lack of controlled clinical data supporting additive efficacy
See Appendix for examples of biologics and targeted synthetic oral small molecule drugs
Concurrent use with a topical Janus kinase inhibitor (JAKi)
Examples include Opzelura (ruxolitinib cream) and Anzupgo (delgocitinib cream). Combination therapy generally not recommended due to potential for higher adverse effects and lack of evidence for additive efficacy
Concurrent use with a biologic immunomodulator
Examples include Adbry (tralokinumab), Cinqair (reslizumab), Dupixent (dupilumab), Ebglyss (lebrikizumab), Nemluvio (nemolizumab), Fasenra (benralizumab), Nucala (mepolizumab), Tezspire (tezepelumab), and Xolair (omalizumab). Not recommended
Concurrent use with other potent immunosuppressants (e.g., cyclosporine, azathioprine) due to added immunosuppression and lack of evaluation

Applicable Codes

DrugNDCCovered

No codes listed

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for Leqselvi; approvals provided for specified durations (initial 6 months; continuation 1 year).

Initial approval: 6 months (1 month = 30 days)
Continuation approval: 1 year

Documentation Required

Specialist involvement

Initial approval requires Leqselvi to be prescribed by or in consultation with a dermatologist; prescriber must attest systemic therapy is still required for continuation.

Clinical Evidence & Definitions

Prescribing information: Leqselvi tablets [prescribing information], July 2024

Guideline: Alopecia Areata Consensus of Experts (ACE), J Am Acad Dermatol. 2020;83:123-30

Key thresholds and definitions

Age>= 18 years

Current episode duration>= 6 months

Scalp hair loss>= 50% scalp hair loss

Initial approval duration (definition)Initial therapy approvals are for 6 months (1 month = 30 days).

Established on Leqselvi (definition)Patient has received Leqselvi for at least 6 months prior to continuation approval.

Background

Leqselvi is a JAK inhibitor indicated for the treatment of severe alopecia areata in patients >18 years of age. JAK inhibitors are identified among therapies for extensive hair loss and are considered systemic steroid‑sparing agents by international expert opinion; first‑line treatments for adults include high‑ or super‑high potency topical corticosteroids and/or systemic corticosteroids.

This document is the Cigna prior authorization policy for Leqselvi (deuruxolitinib tablets) and specifies medical necessity criteria, approval durations (initial 6 months; continuation 1 year), and conditions not covered including concurrent use with specified biologics, targeted synthetic oral small molecule drugs, topical JAK inhibitors, and other potent immunosuppressants.

Revision History

2024-08-21material_changeLatest

Selected revision: Conditions Not Covered updated to add 'Concurrent Use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug.' Concomitant use language changed to specify 'Concurrent Use with a Topical Janus Kinase Inhibitor (JAKi)'. (Selected Revision noted in policy history.)

2024-08-21annual_revision

Annual revision: Appendix and Conditions Not Covered examples updated — Anzupgo (delgocitinib cream) added as an example of a topical JAK inhibitor not recommended for concomitant use; Ebglyss (lebrikizumab-lbkz) and Nemluvio (nemolizumab-ilto) added as examples of biologic immunomodulators not recommended concurrently with Leqselvi.