SILIQ (brodalumab)

SILIQ (brodalumab)

Self-Administration – subcutaneous (SC) injection

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 and have failed to respond or have lost response to other systemic therapies.

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 Siliq 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): 

• 210 mg by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

Coverage Duration:

• Initial: 6 months
  • If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.
• 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 Committee.

Additional Information:

• Siliq is contraindicated in patients with Crohn’s disease because Siliq may cause worsening of disease

Review History:

• 07/01/2020: Original review 
• 01/01/2023 – Update prerequisite drugs for PsO; add symptom requirements for PsO; update duration requirements for use of prerequisite drugs for PsO; add reauthorization criteria for PsO; update initial coverage duration for PsO.
• 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. Siliq Prescribing Information. Valeant Pharmaceuticals Int. Bridgewater, NJ. April 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.