Bimzelx (bimekizumab-bkzx) — Medica
Plaque psoriasis
Initial criteria
- Patient has tried and had an inadequate response to, or is intolerant to, at least one traditional systemic agent for psoriasis (e.g., methotrexate, cyclosporine, acitretin, or phototherapy); OR patient has a contraindication to methotrexate, as determined by the prescriber
- According to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy
- According to the prescriber, the patient does not have moderately severe to severe depression
- According to the prescriber, within the past 5 years, the patient does not have a history of suicidal ideation or suicidal behavior
- The medication is prescribed by or in consultation with a dermatologist
Reauthorization criteria
- Patient has been established on therapy for at least 3 months
- According to the prescriber, the patient has been evaluated for risks of suicidal ideation or behavior versus benefits of therapy
- According to the prescriber, the patient does not have moderately severe to severe depression
- According to the prescriber, the patient does not have suicidal ideation or suicidal behavior
- Patient experienced a beneficial clinical response, defined as improvement from baseline (prior to initiating Bimzelx) in at least one of the following: estimated body surface area, erythema, induration/thickness, and/or scale of areas affected by psoriasis
- Compared with baseline (prior to receiving Bimzelx), patient experienced an improvement in at least one symptom such as decreased pain, itching, and/or burning
Approval duration
initial 6 months, reauthorization 1 year