CurrentMass General Brigham Health PlanPolicy N/A

Sohonos (palvarotene)

Pharmacy benefit prior authorization and quantity limit policy for Sohonos (palvarotene) for treatment of fibrodysplasia ossificans progressiva (FOP) in eligible pediatric and adult patients; includes specialty pharmacy requirement, clinical criteria for initiation and continuation, and a daily quantity limit.

Policy Summary

PayerMass General Brigham Health Plan

PolicySohonos (palvarotene)

Policy CodePolicy N/A

Change TypeAdministrative review

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization is required for Sohonos under the pharmacy benefit; specialty pharmacy fill is required and providers must submit genetic testing results documenting an ACVR1 mutation and evidence of FOP signs/symptoms.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed at August P&T with no clinical changes; effective 09/01/2025.

Policy created 02/14/2024 and became effective 03/01/2024.

1Covered Indication (FOP)

12 moApproval Duration

4/dayDaily Quantity Limit

YesSpecialty Pharmacy Required

Sohonos (palvarotene) is a retinoid indicated to reduce the volume of new heterotopic ossification in adults and pediatric patients with fibrodysplasia ossificans progressiva (FOP).

This policy applies to pharmacy benefit specialty fills (specialty pharmacy required) and requires genetic confirmation of FOP with a documented ACVR1 mutation (e.g., R206H), along with clinical signs or symptoms of FOP, for authorization.

Policy thresholds and limits

Approval duration12 months

Quantity limit4 capsules per day

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

Member has a diagnosis of fibrodysplasia ossificans progressive (FOP)
Genetic testing results confirming FOP with documented activin receptor type 1 (ACVR1) mutation (e.g., R206H)
Genetic confirmation required; provider must submit results.
Member has signs and symptoms of FOP (e.g., malformation of the great toe, abnormal vertebral morphology, ectopic ossification in ligament or muscle tissue)
Age criteria (ONE of)
- Male member aged 10 years of age or older
- Female member aged 8 years of age or older
Medication is prescribed by or in consultation with a physician experienced in the treatment of FOP (e.g., orthopedist, rheumatologist)
Specialist involvement required.

Grandfathering for members new to plan: Members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs) may be authorized

Continuation Therapy Criteria

Continuation (Reauthorization)

Requests for reauthorization will be approved when ALL of the following criteria are met:

ALL of the following

Age criteria (ONE of)
- Male member 10 years of age or older
- Female member 8 years of age or older
Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement (e.g., reduction in the volume of new heterotopic ossification)

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Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for Sohonos under the pharmacy benefit. This product is designated specialty and must be filled at a contracted specialty pharmacy.

Documentation Required

Genetic confirmation required

Provider must submit genetic testing results documenting an ACVR1 mutation (e.g., R206H) and evidence of FOP signs and symptoms.

Documentation Required

Specialist involvement

Medication must be prescribed by or in consultation with a physician experienced in the treatment of FOP (examples: orthopedist, rheumatologist).

Billing Rule

Quantity limit enforcement

Dispense is limited to 4 capsules per day.

Daily quantity limit: 4 capsules/day
Approval duration: 12 months

Prior Authorization

New-to-plan continuity

Members new to the plan within the past 90 days who are currently receiving Sohonos may be authorized under a grandfathering provision; this excludes products obtained as samples or via manufacturer's patient assistance programs.

Clinical Evidence & References

Prescribing Information: Sohonos (palovarotene) prescribing information, Ipsen Biopharmaceuticals Inc; March 2025.

Key Trial: MOVE study (An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva), ClinicalTrials.gov identifier NCT03312634.

Definitions & Background

Definitions: FOP = Fibrodysplasia ossificans progressiva; ACVR1 = activin receptor type 1 gene (mutation such as R206H required for genetic confirmation of diagnosis).

Additional background: Sohonos (palvarotene) is a retinoid indicated to reduce the volume of new heterotopic ossification in adults and pediatric patients; authorization requires genetic confirmation of an ACVR1 mutation and specialist involvement for prescribing.

Revision History

02/14/2024policy_created

Policy created 02/14/2024; became effective 03/01/2024. (Initial policy creation and approval at Feb P&T.)

08/13/2025administrative_updateLatest

Administrative update reviewed 08/13/2025 with no clinical policy statement changes; effective 09/01/2025.