Otezla — Medica

Initial criteria

• age ≥ 18 years
• patient has oral ulcers or other mucocutaneous involvement
• patient has tried at least one other systemic therapy (e.g., colchicine, systemic corticosteroids, azathioprine, thalidomide, interferon alpha, tumor necrosis factor inhibitors)
• prescribed by or in consultation with a rheumatologist or dermatologist

Reauthorization criteria

• patient has been established on therapy for at least 4 months
• patient experienced a beneficial clinical response from baseline when assessed by at least one objective measure (e.g., best-corrected visual acuity, serum markers, ulcer depth, number, and/or lesion size)
• compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain or improved visual acuity if ophthalmic manifestations)

Approval duration

initial: 4 months; reauth: 1 year