CurrentMass General Brigham Health PlanPolicy N/A

Sohonos (palvarotene)

Prior authorization and quantity/ specialty pharmacy requirements for Sohonos (palvarotene) for treatment of fibrodysplasia ossificans progressiva (FOP) for specified pediatric and adult ages; includes initial and continuation criteria, quantity limit, approval duration, and specialty dispensing requirement.

Policy Summary

PayerMass General Brigham Health Plan

PolicySohonos (palvarotene)

Policy CodePolicy N/A

Change TypeClarified (no clinical changes)

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization required; submit genetic testing confirming ACVR1 mutation, clinical signs/symptoms of FOP, and documentation of prescriber specialty, and ensure dispensing at a contracted specialty pharmacy with a quantity limit of 1 capsule per day.

SourceLink

POLICY UPDATE CHANGES

Reviewed at August P&T with no clinical changes; effective date set to 09/01/2025.

12Approval Duration

1Quantity Limit (capsules/day)

SpecialtyDispensing Requirement

ACVR1Genetic Confirmation

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Prior authorization, specialty pharmacy dispensing, quantity limits, and continuation criteria for Sohonos (palvarotene) for treatment of fibrodysplasia ossificans progressiva (FOP) for specified pediatric and adult ages. Effective date: 09/01/2025. Status: CURRENT.

Key Policy Thresholds

Approval Duration12 months

Quantity Limit1 capsule/day

Dispensing RequirementSpecialty (must be filled at contracted specialty pharmacy)

Genetic ConfirmationACVR1 mutation required

Age RequirementsMales >= 10 years; Females >= 8 years