Vykat XR — Blue Cross Blue Shield of Montana

Initial criteria

• 1. ONE of the following: A. The patient has a diagnosis of Prader-Willi syndrome AND BOTH of the following: (1) The patient has hyperphagia AND (2) Diagnosis confirmed by genetic testing indicating mutation on chromosome 15 (medical records required) OR B. The patient has another FDA labeled indication for the requested agent and route of administration
• 2. If the patient has an FDA labeled indication, THEN ONE of the following: A. The patient’s age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for the patient’s age for the requested indication
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist) OR has consulted with a specialist in the area of the patient’s diagnosis
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate approval: (1) For BCBS NM Fully Insured or NM HIM member, ALL of the following: (A) No labeled contraindications AND (B) Requested indication is a rare disease AND (C) ONE of the following: (1) Another FDA labeled indication OR (2) Compendia-supported indication; OR (2) For member residing in Ohio with Fully Insured or HIM Shop plan, ALL of the following: (A) No labeled contraindications AND (B) ONE of the following: (1) Another FDA labeled indication OR (2) Compendia-supported indication OR (3) TWO peer-reviewed journal articles demonstrating safety and efficacy in accepted study designs; Non-oncology compendia allowed: DrugDex level 1, 2A, 2B, AHFS-DI; Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI, DrugDex 1, 2A, 2B, Clinical Pharmacology, or LexiDrugs A, with supportive narrative text

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (patients not previously approved require initial evaluation)
• 2. The patient has had clinical benefit with the requested agent
• 3. The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with a specialist
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial: 4–12 months (BCBSIL/MT 12 months; others 4 months); renewal: 12 months