teduglutide (rdna) — Blue Cross Blue Shield of Montana

Initial criteria

• Patient has diagnosis of short bowel syndrome (SBS) AND patient has less than 200 cm of functional small intestine (medical records required)
• AND ONE of the following: (A) patient has stage IV advanced metastatic cancer and agent is used to treat cancer or an associated condition AND use consistent with best practices and FDA-approved indications; OR (B) patient currently treated and stable on requested agent; OR (C) patient has tried and had inadequate response to maximal use of TWO anti-diarrheal agents (e.g., loperamide AND diphenoxylate) with oral rehydration solution; OR (D) anti-diarrheal therapy discontinued due to lack of efficacy/adverse event; OR (E) intolerance or hypersensitivity to anti-diarrheals; OR (F) FDA labeled contraindication to all anti-diarrheal agents; OR (G) anti-diarrheal therapy expected to be ineffective or cause harm based on clinical characteristics; OR (H) anti-diarrheal therapy not in best interest of patient based on medical necessity; OR (I) tried another drug in same pharmacologic class with inadequate response or adverse event
• AND patient currently receiving parenteral nutrition/intravenous fluids at least 3 days per week (medical records required)
• AND ONE of the following: (A) pediatric patient age ≥ 1 year AND fecal occult blood test within 6 months prior to initiation AND no new/unexplained blood in stool OR if present, colonoscopy/sigmoidoscopy and upper GI endoscopy performed; OR (B) adult patient AND colonoscopy and upper GI endoscopy within 6 months prior to initiation AND if polyps present, polyps removed
• OR patient has another FDA labeled indication for requested agent and route of administration AND age within or supported for labeled use
• AND prescriber is a specialist (e.g., gastroenterologist) or has consulted with a specialist
• AND patient does NOT have any FDA labeled contraindications
• AND requested quantity (dose) is within FDA labeled dosing
• Additional approval pathways: (1) For BCBS NM Fully Insured or NM HIM members meeting rare disease criteria with no FDA contraindications and labeled or compendia-supported indication; OR (2) For Ohio Fully Insured or HIM Shop (SG) members meeting no contraindication and having either FDA labeled indication, compendia-supported use, or two peer-reviewed journal articles supporting safety/effectiveness

Reauthorization criteria

• Patient previously approved through plan’s prior authorization process
• Prescriber is a specialist (e.g., gastroenterologist) or has consulted with a specialist
• Patient has had clinical benefit with requested agent
• Patient has no FDA labeled contraindications
• Requested dose within FDA labeling

Approval duration

12 months