adalimumab products — Medica

Initial criteria

• age ≥ 6 years
• EITHER (a) trial or contraindication to corticosteroids OR (b) trial of one conventional systemic therapy (azathioprine, 6-MP, or methotrexate) OR (c) presence of enterocutaneous/rectovaginal fistulas OR (d) prior ileocolonic resection
• prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

• patient established on therapy ≥ 6 months
• beneficial clinical response by objective measure (e.g., markers, imaging, endoscopy, or reduced steroid dose) OR improvement in symptoms (pain, fatigue, stool frequency, blood in stool) vs baseline

Approval duration

initial 6 months, reauth 1 year