Pharmacy Prior Authorization Criteria

Leqselvi (deuruxolitinib) - PA, NF

Indications for Prior Authorization

Leqselvi (deuruxolitinib)

• For diagnosis of Alopecia Areata
  Indicated for the treatment of adult patients with severe alopecia areata.

  Limitations of use: Leqselvi is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Criteria

Leqselvi

*Leqselvi may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Alopecia Areata

• Diagnosis of alopecia areata
AND
• Patient has at least 50% scalp hair loss [1, 2]
AND
• Other causes of hair loss have been ruled out (e.g., androgenetic alopecia, trichotillomania, other scalp disease) [2]
AND
• Prescribed by or in consultation with a dermatologist
AND
• Not used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants*

Leqselvi

*Leqselvi may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Alopecia Areata

• Patient demonstrates positive clinical response to therapy
AND
• Not used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants*

Leqselvi

*Leqselvi may be used with concomitant methotrexate, topical or inhaled corticosteroids, and/or low stable dosages of oral corticosteroids For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed. For Non-Formulary review, please reference the State Mandate Reference Document.

Prior Authorization, Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Alopecia Areata

• Submission of medical records (e.g., chart notes) confirming a diagnosis of alopecia areata
AND
• Submission of medical records (e.g., chart notes) confirming the patient has at least 50% scalp hair loss [1, 2]
AND
• Other causes of hair loss have been ruled out (e.g., androgenetic alopecia, trichotillomania, other scalp disease) [2]
AND
• Prescribed by or in consultation with a dermatologist
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming a trial and failure, contraindication, or intolerance to one previous treatment for alopecia areata (e.g., topical, intralesional, or systemic corticosteroids [e.g., triamcinolone acetonide, prednisone], topical immunotherapy [e.g., diphenylcyclopropenone]) [3]
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming a minimum 3-month trial and failure, contraindication, or intolerance to one of the following:
• Litfulo (ritlecitinib)
• Olumiant (baricitinib)
AND
• Not used in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants*

P & T Revisions

2025-12-17, 2025-11-07, 2025-10-02, 2025-07-08

References

1. Leqselvi Prescribing Information. Sun Pharmaceutical Industries, Inc. Whippany, NJ. July 2024.
2. King B, Senna MM, Mesinkovska NA, et al. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). J Am Acad Dermatol. 2024; 91(5):880-888.
3. Meah N, Wall D, York K, et al. The Alopecia Areata Consensus of Experts (ACE) study: results of an international expert opinion on treatments for alopecia areata. J Am Acad Dermatol. 2020;83(1):123-130.

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Revision History

• 2025-12-17: no criteria changes, added IL statute operational note
• 2025-11-07: Added a 3-month trial duration to the steps through preferred alternatives in the NF criteria
• 2025-10-02: Removed step requirement through Litfulo or Olumiant for PA criteria; added NF criteria that includes the step requirement
• 2025-07-08: New program

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