SOTYKTU (deucravacitinib)

Self-Administration – oral tablet

 

Indications for Prior Authorization:

 

Plaque Psoriasis (PsO): Indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Limitations of Use: Sotyktu is not recommended for use in combination with other potent immunosuppressants

 

Coverage Criteria:

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of moderate to severe PsO; AND
  • Prescribed by or in consultation with a dermatologist 
  • One of the following:
    • Greater than or equal to 3% body surface area involvement 
    • Severe scalp psoriasis 
    • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
  • Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: 
    • corticosteroids (e.g., betamethasone, clobetasol) 
    • vitamin D analogs (e.g., calcitriol, calcipotriene) 
    • tazarotene 
    • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
    • anthralin 
    • coal tar; AND
  • One of the following:
    • Both of the following:
      • Trial and failure, contraindication, or intolerance to THREE of the following: 
        • Cimzia (certolizumab pegol) 
        • Enbrel (etanercept) 
        • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
        • Skyrizi (risankizumab) 
        • Stelara (ustekinumab) 
        • Tremfya (guselkumab)
      • Trial and failure, contraindication, or intolerance to Taltz (ixekizumab)
    • For continuation of prior Sotyktu therapy, defined as no more than a 45-day gap in therapy.

 

Reauthorization Criteria:

 

For diagnosis of PsO:

  • Documentation of positive clinical response to therapy as evidenced by one of the following:
    • Reduction the body surface area (BSA) involvement from baseline 
    • Improvement in symptoms (e.g., pruritus, inflammation) from baseline 

 

Dosing:

 

PsO (adults): 

  • 6 mg taken orally once daily.

 

Coverage Duration:

 

  • Initial: 6 months  
  • Reauthorization: 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:

 

Review History:
  • 11/15/2022 – New drug UM policy approved by P&T.
  • 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options. (P&T 8/15/2023)
  • 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

 

References:

  1. Sotuktu Prescribing Information. Bristol-Myers Squibb Co. Princeton, NJ. September 2022. 
  2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72. 
  3. Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.

Last review date: November 14, 2023