palovarotene — Blue Cross Blue Shield of Oklahoma

Initial criteria

• BOTH of the following:
• ONE of the following:
• The patient has a diagnosis of fibrodysplasia ossificans progressiva (FOP) AND ALL of the following:
• Genetic analysis confirms mutation in the activin receptor IA (ACVR1) gene AND
• The patient has signs of heterotopic ossification (HO) AND
• The requested agent will be used to reduce the volume of new HO OR
• 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:
• The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• 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, rheumatologist) or the prescriber has consulted with a specialist AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• The patient has had clinical benefit with the requested agent AND
• 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 AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months