WHA

Opzelura (ruxolitinib)

Indications for Prior Authorization

Opzelura (ruxolitinib)
  • For diagnosis of Atopic Dermatitis
    Indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

    Limitation of Use: Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

  • For diagnosis of Nonsegmental Vitiligo
    Indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

    Limitation of Use: Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Criteria

Opzelura

Step Therapy

Length of Approval: 12 Month(s)

  • One of the following:
    • Both of the following:
      • Diagnosis of mild to moderate atopic dermatitis
        • AND
      • Trial and failure of a minimum 30-day supply (14-day supply for topical corticosteroids), contraindication, or intolerance to ONE of the following [2]:
        • Medium or higher potency topical corticosteroid
        • Generic topical calcineurin inhibitor (e.g., tacrolimus ointment)
      OR
    • Both of the following:
      • Diagnosis of nonsegmental vitiligo
        • AND
      • Trial and failure of a minimum 30-day supply, contraindication, or intolerance to ONE of the following [3]:
        • Medium or higher potency topical corticosteroid
        • Tacrolimus ointment

  • Guideline ID
    GL-164810

  • Formulary
    Premium

  • Effective date
    Mar 1, 2025

  • P&T approval date
    Nov 18, 2021

P & T Revisions

2025-02-09, 2024-09-08, 2024-04-04, 2023-09-01, 2022-09-08, 2022-04-06, 2022-03-03, 2021-11-06

  1. Opzelura Prescribing Information. Incyte Corp. Wilmington, DE. September 2023.
  2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. J Am Acad Dermatol. 2023;89(1):e1-e20.
  3. Taieb A, Alomar A, Bohm M, et al. Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol. 2013;168(1):5-19.
  4. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for vitiligo. J Am Acad Dermatol. 1996; 35(4):620-6.
  1. Opzelura should be discontinued when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be reexamined by their healthcare provider.
  2. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider.
  • 2025-02-09: Updated atopic dermatitis step verbiage to align with other agents, including reducing the trial duration for a topical corticosteroid from 30 days to 14 days; removed NF criteria for both indications
  • 2024-09-08: Removed pimecrolimus as a preferred step option for vitiligo; annual review - no additional criteria changes
  • 2024-04-04: Non-formulary criteria updated to include records requirements for diagnoses and for the criterion ensuring combination therapy is not being used with select drug classes. Vitiligo NF step increased to a trial of two agents with minimum durations of treatment.
  • 2023-09-01: Annual review - no criteria changes; background updates
  • 2022-09-08: Addition of criteria for nonsegmental vitiligo; annual review - background updates
  • 2022-04-06: Removed PA and added ST. Moved to non-specialty formulary.
  • 2022-03-03: Added a NF criteria section
  • 2021-11-06: New program