BIMZELX (bimekizumab)

BIMZELX (bimekizumab)

Self-Administration – injectable

Diagnosis considered for coverage:

• PsO: Indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

Coverage Criteria:

For diagnosis of PsO:

• Diagnosis of moderate to severe plaque psoriasis; AND
• One of the following:
  • At least 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
• Prescribed by or in consultation with a dermatologist; AND
• Both of the following:
  • Trial and failure, contraindication, or intolerance to TWO of the following:
    • Cimzia (certolizumab pegol) 
    • Enbrel (etanercept) 
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz, or Brand Adalimumab-adaz 
    • Skyrizi (risankizumab) 
    • Stelara (ustekinumab) 
    • Tremfya (guselkumab); AND
  • Trial and failure, contraindication, or intolerance to Taltz (ixekizumab)

Reauthorization Criteria:

For diagnosis of PsO:

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

Dosing:

PsO:

• 320 mg (given as 2 subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter
• For patients weighing ≥ 120 kg, consider a dosage of 320 mg every 4 weeks after Week 16

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:

• Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX 
• Test liver enzymes, alkaline phosphatase and bilirubin prior to initiating treatment with BIMZELX 
• Complete all age-appropriate vaccinations as recommended by current immunization guidelines 

Policy Updates:

• 3/1/2024 – New policy approved by WHA P&T Committee. (P&T, 2/20/2024)

References:

• Bimzelx Prescribing Information. UCB, Inc. Smyrna, GA. October 2023. 
• 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. 
• 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.