Bimzelx (bimekizumab-bkzx) — Medica
Ankylosing spondylitis
Initial criteria
- age > 18 years
- 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 rheumatologist
Reauthorization criteria
- established on therapy for at least 6 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 OR improvement in at least one symptom compared with baseline
Approval duration
initial 6 months, reauth 1 year