ILUMYA (tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn)

Office Administration – subcutaneous (SC) injection

Indication for Prior Authorization:

Plaque Psoriasis (PsO): Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Coverage Criteria:

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of moderate to severe PsO; AND
• Prescribed by or in consultation with a dermatologist; AND
• 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 Ilumya 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):

• 100 mg at Weeks 0, 4, and every twelve weeks thereafter.

Coverage Duration:

PsO:

• 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:

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Ilumya.
• Ilumya should only be given to you by a healthcare provider.

Policy Updates:

• 07/01/2020 – Criteria reviewed.
• 01/01/2023 – Updated prerequisite drugs and required duration of use for PsO; added symptom requirements for PsO; removed TB testing requirement; added reauthorization criteria; updated coverage duration of initial authorization.
• 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options. (P&T 08/15/2023) 
• 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

References:

1. Ilumya prescribing information. Merck & Co., Inc. Whitehouse Station, NJ. July 2020. 
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.