Bimzelx (bimekizumab-bkzx) — Medica

Initial criteria

• age ≥ 18 years
• tried at least one other therapy such as intralesional or oral corticosteroids, systemic antibiotics, or isotretinoin
• evaluated for risks of suicidal ideation or behavior versus benefits of therapy
• no moderately severe to severe depression
• no history of suicidal ideation or behavior within the past 5 years
• prescribed by or in consultation with a dermatologist

Reauthorization criteria

• established on Bimzelx for at least 3 months
• evaluated for risks of suicidal ideation or behavior versus benefits of therapy
• no moderately severe to severe depression
• no suicidal ideation or suicidal behavior
• beneficial clinical response by at least one objective measure (e.g., Hurley staging, Sartorius score, Physician Global Assessment, or HS Severity Index)
• improvement in at least one symptom such as decreased pain or drainage of lesions, nodules, or cysts compared with baseline

Approval duration

initial 3 months, reauth 1 year