Selarsdi (ustekinumab-aekn subcutaneous injection) — Cigna

Initial criteria

• Diagnosis of Crohn’s disease AND condition is moderate to severe active
• Patient age ≥ 18 years
• According to prescriber, patient will receive a single induction dose with ustekinumab intravenous within 2 months of initiating ustekinumab subcutaneous
• Patient meets ONE of the following: (a) has tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR (b) has tried one conventional systemic therapy for Crohn’s disease (e.g., azathioprine, 6‑mercaptopurine, methotrexate); OR (c) has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR (d) had ileocolonic resection (to reduce recurrence)
• Medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

• Patient has been established on ustekinumab subcutaneous for ≥ 6 months
• If patient received < 6 months or is restarting, review under initial therapy criteria
• Patient meets at least ONE of the following: (a) has clinical benefit or continued response as determined by prescriber; OR (b) other documentation supporting continued need (explicit criteria continued in policy text)

Approval duration

initial 6 months; continuation 1 year