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.

Last review date: March 1, 2024