OPZELURA (ruxolitinib cream)

OPZELURA (ruxolitinib cream)

Self-Administration – topical

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of atopic dermatitis:

• Patient has a diagnosis of mild to moderate atopic dermatitis; AND
• Patient meets one of the following:
  • Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to one prescription strength topical corticosteroid, unless the affected area is sensitive (i.e., face, axillae, groin); OR
  • Trial and failure (of a minimum 30 day supply) or intolerance to one generic topical calcineurin inhibitor (e.g., tacrolimus ointment), unless the patient is not a candidate for therapy (e.g., immunocompromised)

For diagnosis of nonsegmental vitiligo:

• Patient has a diagnosis of nonsegmental vitiligo; AND
• Trial and failure of a minimum 30-day supply, contraindication, or intolerance to ONE of the following:
  • Medium or higher potency topical corticosteroid 
  • Pimecrolimus cream 
  • Tacrolimus ointment

Coverage Duration:

• Atopic dermatitis: 1 year
• Nonsegmental vitiligo: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• Recommended dose:
  • Atopic dermatitis: apply a thin layer of Opzelura twice daily to affected areas of up to 20% body surface area
  • Nonsegmental vitiligo: apply a thin layer of Opzelura twice daily to affected areas of up to 10% body surface area
• Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.
• For nonsegmental vitiligo: 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.
• Warnings and precautions include:
  • Serious infection
    • Avoid use in patient with an active, serious infection, including localized infections
      • Tuberculosis (TB) – Consider evaluating patients for latent and active TB infection prior to administration of Opzelura.  Monitor patients for the development of signs and symptoms of TB.
      • Viral reactivation – If a patient develops herpes zoster, consider interrupting Opzelura treatment until the episode resolves.
      • Hepatitis B and C – Opzelura initiation is not recommended in patients with active hepatitis B or hepatitis C.
  • Mortality-a higher rate of all-cause mortality, including sudden cardiovascular death was observed in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions.
  • Malignancy and lymphoproliferative disorders
  • Major adverse cardiovascular events (MACE)
  • Thrombosis
  • Thrombocytopenia, anemia and neutropenia
  • Lipid elevations
• 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.

Policy Updates:

• 02/15/2022 – New policy approved by P&T.
• 05/17/2022 - Updated trial and failure criteria to be in line with P&T's intent.
• 02/21/2023 - Added criteria for new indication nonsegmental vitiligo
• 06/1/2023 – Criteria updated due to class review for topical atopic dermatitis agents. Opzelura moved from PA to step therapy

References:

• Opzelura Prescribing Information. Incyte Corp. Wilmington, DE. September 2021.
• Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014; 71(1): 116-32.
• 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.