palovarotene — Blue Cross Blue Shield of Texas

fibrodysplasia ossificans progressiva (FOP)

Initial criteria

1. BOTH of the following:
A. ONE of the following:
1. The patient has a diagnosis of fibrodysplasia ossificans progressiva (FOP) AND ALL of the following:
A. Genetic analysis confirms mutation in the activin receptor IA (ACVR1) gene AND
B. The patient has signs of heterotopic ossification (HO) AND
C. The requested agent will be used to reduce the volume of new HO OR
2. The patient has another FDA labeled indication for the requested agent and route of administration AND
B. If the patient has an FDA labeled indication, then ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. There is support for using the requested agent for the patient’s age for the requested indication AND
2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
3. The patient does NOT have any FDA labeled contraindications to the requested agent.

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, rheumatologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent.

12 months