Sohonos (palovarotene) — CareFirst (Caremark)

Initial criteria

• Member has a genetically confirmed diagnosis of fibrodysplasia ossificans progressiva (FOP) with genetic testing indicating the patient has an activin receptor type 1 (ACVR1) mutation (e.g., R206H)
• Member has signs and symptoms of fibrodysplasia ossificans progressiva (e.g., malformation of the great toe, abnormal vertebral morphology, ectopic ossification in ligament or muscle tissue)
• Member is a male age ≥ 10 years OR a female age ≥ 8 years
• Medication must be prescribed by or in consultation with a physician experienced in the treatment of fibrodysplasia ossificans progressiva (e.g., orthopedist, rheumatologist)

Reauthorization criteria

• Member is a male age ≥ 10 years OR a female age ≥ 8 years
• Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., reduction in the volume of new heterotopic ossification)

Approval duration

12 months