Vykat XR — Blue Cross Blue Shield of Illinois

Initial criteria

• 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 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 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 and requested agent OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• AND 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 the patient does NOT have any FDA labeled contraindications to the requested agent
• OR for BCBS NM Fully Insured or NM HIM member: 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 for Ohio Fully Insured or HIM Shop member: ALL of the following: (A) The member resides in Ohio AND (B) The plan is Fully Insured or HIM Shop (SG) AND (C) The patient does NOT have any 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 for the requested agent and route of administration OR (3) The prescriber has submitted TWO articles from major peer-reviewed professional medical journals supporting the proposed use(s) as generally safe and effective

Reauthorization criteria

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

Approval duration

12 months (BCBSIL and BCBSMT); 4 months (other plans)