teduglutide (rdna) — Blue Cross Blue Shield of New Mexico

Initial criteria

• Diagnosis of short bowel syndrome (SBS) and ALL of the following:
• • Patient has <200 cm of functional small intestine [medical records required]
• • ONE of the following:
• A. Patient or prescriber documentation of stage four advanced, metastatic cancer use consistent with best practices OR
• B. Patient is currently treated and stable on requested agent [chart notes required] OR
• C. Tried and had inadequate response to maximal use of TWO anti-diarrheal agents (e.g., loperamide AND diphenoxylate) used with oral rehydration solution [chart notes required] OR
• D. Maximal use of TWO anti-diarrheal agents discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• E. Intolerance or hypersensitivity to maximal use of TWO anti-diarrheal agents [chart notes required] OR
• F. FDA-labeled contraindication to ALL anti-diarrheal agents [chart notes required] OR
• G. Maximal use of TWO anti-diarrheal agents expected to be ineffective, detrimental to adherence, worsen comorbid condition, hinder functional ability, or cause harm [chart notes required] OR
• H. Maximal use of TWO anti-diarrheal agents not in the best interest of patient based on medical necessity [chart notes required] OR
• I. Patient tried another drug in the same class as TWO anti-diarrheal agents and discontinued due to lack of efficacy or adverse event [chart notes required]
• • Patient is currently receiving parenteral nutrition/IV fluids ≥3 days per week [medical records including daily volume of PN/IV]
• • ONE of the following for age and procedure assessment:
• A. Pediatric patient ≥1 year of age AND BOTH:
• – Fecal occult blood test within 6 months prior to treatment AND
• – No new/unexplained blood in stool OR, if present, colonoscopy/sigmoidoscopy and upper GI endoscopy performed
• B. Adult AND BOTH:
• – Colonoscopy and upper GI endoscopy within 6 months prior to initiating treatment [records with date]; AND
• – If polyps were present, they were removed
• OR Patient has another FDA labeled indication for the requested agent and route of administration AND if so:
• • Patient’s age is within FDA labeling OR supported for that indication
• • Prescriber is a specialist (e.g., gastroenterologist) or consulted with one
• • No FDA-labeled contraindications
• • Requested dose within FDA-labeled dosing
• Special approval situations:
• • BCBS NM Fully Insured or NM HIM member AND no contraindications AND indication is rare disease AND indication is FDA-labeled or supported in compendia
• • Ohio Fully Insured or HIM Shop (SG) member AND no contraindications AND indication is FDA-labeled or supported in compendia OR supported by two peer-reviewed journal articles (no case studies)
• Compendia accepted: DrugDex level 1–2B, AHFS-DI supportive text; Oncology: NCCN 1–2A, AHFS-DI supportive, DrugDex level 1–2B, Clinical Pharmacology supportive, LexiDrugs A, peer-reviewed literature

Reauthorization criteria

• Previously approved through plan PA process
• Prescriber is or consulted a specialist (e.g., gastroenterologist)
• Patient has had clinical benefit with requested agent
• Patient has no FDA-labeled contraindications
• Requested dose within FDA-labeled dosing

Approval duration

initial: 6–12 months (plan-specific); renewal: 12 months