Vykat XR (diazoxide choline) — Blue Cross Blue Shield of New Mexico

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. The patient’s diagnosis has been 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 AND
• 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 for the requested agent OR
• B. There is support for using the requested agent for the patient’s age for the requested indication AND
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or has consulted with such a specialist AND
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent
• OR
• The request is for a BCBS NM Fully Insured or NM HIM member and ALL of the following:
• A. The patient does NOT have any FDA labeled contraindications to the requested agent AND
• B. The requested indication is a rare disease AND
• C. ONE of the following:
• 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. The patient has another indication supported in compendia for the requested agent and route of administration
• OR
• ALL of the following (for OH Fully Insured or HIM Shop members):
• A. The member resides in Ohio AND
• B. The plan is Fully Insured or HIM Shop (SG) AND
• C. The patient does NOT have FDA labeled contraindications to the requested agent AND
• D. ONE of the following:
• 1. The patient has another FDA labeled indication for the requested agent and route of administration OR
• 2. The patient has another indication supported in compendia (DrugDex level 1–2B; AHFS-DI supportive narrative; NCCN 1–2A; Clinical Pharmacology supportive; LexiDrugs evidence level A) OR
• 3. The prescriber has submitted TWO articles from major peer-reviewed medical journals (e.g., JAMA, NEJM, Lancet) showing safety and efficacy (case studies not acceptable)

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• 2. The patient has had clinical benefit with the requested agent AND
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist), or has consulted with such a specialist AND
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial: BCBSIL/BCBSMT 12 months; others 4 months; renewal 12 months