Sohonos (palovarotene) — Medica

Initial criteria

• Patient is female and age ≥ 8 years OR patient is male and age ≥ 10 years
• Patient has had a genetic test confirming a mutation in Activin A Type 1 Receptor (ACVR1)R206H consistent with a diagnosis of fibrodysplasia ossificans progressiva
• Patient has heterotopic ossification as confirmed by radiologic testing (e.g., x-ray, CT, MRI, or PET scan)
• Medication is prescribed by or in consultation with an endocrinologist or physician who specializes in bone disease

Approval duration

1 year