ustekinumab subcutaneous injection — Medica

Initial criteria

• age > 18 years
• patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating therapy with ustekinumab subcutaneous
• patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated OR patient has tried one conventional systemic therapy for Crohn’s disease OR patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas OR patient had ileocolonic resection
• medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

• patient has been established on the requested drug for at least 6 months
• when assessed by at least one objective measure, experienced a beneficial clinical response from baseline OR improvement in at least one symptom such as decreased pain, fatigue, stool frequency, and/or blood in stool

Approval duration

initial: 6 months; reauth: 1 year