Sohonos — Medical Mutual

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) consistent with diagnosis of fibrodysplasia ossificans progressive [documentation required]
• Patient has heterotopic ossification as confirmed by radiologic testing (examples: x-ray, CT, MRI, PET scan) [documentation required]
• Medication is prescribed by or in consultation with an endocrinologist or physician who specializes in bone disease
• If the patient is a female of childbearing potential, documentation of a negative serum pregnancy test 1 week prior to therapy initiation AND patient is counseled to use at least 1 highly effective method of contraception or 2 effective methods at least 1 month prior to treatment, during treatment, and 1 month after the last dose

Reauthorization criteria

• Response to therapy is required for continuation

Approval duration

6 months initial, 6 months reauth