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Vykat XR — Blue Cross Blue Shield of Texas

Other compendia-supported uses (if criteria met in Ohio Fully Insured or HIM Shop plans)

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 diagnosis is 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 the prescriber 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 approvals: 1. For BCBS NM Fully Insured or NM HIM members: ALL of the following: (A) The patient does NOT have any FDA labeled contraindications AND (B) The requested indication is a rare disease AND (C) ONE of: (1) Another FDA labeled indication OR (2) Another indication supported in compendia 2. For members residing in Ohio (Fully Insured or HIM Shop): ALL of the following: (A) Member resides in Ohio AND (B) Plan type as defined AND (C) No labeled contraindications AND (D) ONE of: (1) Another FDA labeled indication OR (2) Compendia-supported indication OR (3) Prescriber submitted two peer-reviewed journal articles supporting use

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent
  • 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 one
  • 4. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL and BCBSMT: 12 months; others: 4 months (initial); all renewal: 12 months