diazoxide choline tab er 75 mg — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Initial approval when ALL of the following are met:
• 1. ONE of the following:
• A. Diagnosis of Prader-Willi syndrome AND BOTH:
• 1. Patient has hyperphagia AND
• 2. Diagnosis confirmed by genetic testing indicating mutation on chromosome 15 (medical records required)
• OR
• B. Patient has another FDA labeled indication for the requested agent and route of administration
• 2. If patient has an FDA labeled indication, then ONE of:
• A. Patient’s age is within FDA labeling for the requested indication and requested agent OR
• B. There is support for use at the patient’s age for the requested indication
• 3. Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist) OR has consulted with a specialist
• 4. Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval:
• • BCBSIL and BCBSMT: 12 months
• • ALL other plans: 4 months
• Additional approval also when ONE of the following policy-region combinations are met:
• 1. NM Fully Insured or NM HIM member AND ALL:
• A. No FDA labeled contraindications AND
• B. Requested indication is a rare disease AND
• C. ONE of:
• 1. Another FDA labeled indication and route of administration OR
• 2. Indication supported in compendia for the requested agent and route of administration
• 2. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND ALL:
• A. No FDA labeled contraindications AND
• B. ONE of:
• 1. Another FDA labeled indication and route of administration OR
• 2. Indication supported in compendia for the requested agent and route of administration OR
• 3. Prescriber submitted TWO peer-reviewed articles (JAMA, NEJM, Lancet) showing safety and efficacy; acceptable designs include randomized, double-blind, placebo-controlled trials (case studies not acceptable)
• Compendia accepted (non-oncology): DrugDex level 1, 2A, 2B or AHFS-DI (supportive text)
• Compendia accepted (oncology): NCCN 1 or 2A, AHFS-DI (supportive text), DrugDex level 1, 2A, 2B, Clinical Pharmacology (supportive text), LexiDrugs evidence level A, peer-reviewed literature
• Length of Approval: 12 months

Reauthorization criteria

• Renewal requires ALL:
• 1. Patient previously approved through prior authorization process
• 2. Patient has had clinical benefit with the requested agent
• 3. Prescriber is a specialist in the area of the diagnosis (e.g., endocrinologist, geneticist) OR has consulted with a specialist
• 4. Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: 12 months

Approval duration

initial 12 months (BCBSIL/BCBSMT), 4 months (others); renewal 12 months