CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sohonos (palovarotene) — coverage criteria for fibrodysplasia ossificans progressiva

Policy governs coverage and authorization criteria for Sohonos (palovarotene) to reduce new heterotopic ossification volume in patients with fibrodysplasia ossificans progressiva (FOP) for Neighborhood Health Plan of Rhode Island Medicaid members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySohonos (palovarotene) — coverage criteria for FOP

Policy CodePolicy N/A

Change TypeMinor / no material changes

Effective Date08/01/2024

Next Review Date07/2025

Key ActionObtain prior authorization with documentation of genetically confirmed ACVR1 mutation, age criteria, and pregnancy prevention for those of reproductive potential.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization period

08/01/2024effective date

28–56quantity limits

F ≥8, M ≥10minimum ages

Coverage Criteria for Sohonos (palovarotene)

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Initial approval criteria

Covered for reduction in volume of new heterotopic ossification when ALL of the following are met:

FDA indication: Medication is prescribed for reduction in volume of new heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP)

FDA-approved indication

Diagnosis confirmation: Documented genetically confirmed diagnosis of FOP with genetic testing indicating an ACVR1 mutation

genetic test required

Age criteria: Patient meets age thresholds: female >= 8 years OR male >= 10 years

pediatric age limits per policy

Provider specialty: Prescribed by or in consultation with a physician experienced in the treatment of FOP (e.g., orthopedist, rheumatologist)

specialist involvement recommended

Reproductive safety: For members of reproductive potential, provider attestation of non-pregnancy and use of contraception beginning at least 1 month before treatment through 1 month after last dose

required for those of reproductive potential

Continuation therapy

Continuation of therapy — approvals of 6 months may be granted when ALL of the following are met:

Ongoing indication: Indication remains one listed in policy (FOP)

Age criteria: Member continues to meet age criteria (female >= 8 years, male >= 10 years)

Clinical benefit: Documentation of disease stability or improvement, e.g., reduction in volume of new heterotopic ossification

required for continuation approvals

All indications other than the FDA‑approved indication for reduction in volume of new heterotopic ossification in patients with fibrodysplasia ossificans progressiva (FOP) are considered experimental/investigational and are excluded from coverage.

Use of Sohonos (palovarotene) for any non‑FOP indication is not covered. Requests for treatment outside the FDA‑approved FOP indication will be denied as not medically necessary/experimental or investigational.

Dosing and Coding Notes

Flare-up dosing duration and escalation — INV-05

Total flare-up course12-week flare-up regimen: 20 mg daily for Weeks 1–4, then 10 mg daily for Weeks 5–12, followed by return to 5 mg daily maintenance

Week 1–4 dosing20 mg orally once daily for the first 4 weeks of a flare-up

Week 5–12 dosing10 mg orally once daily for Weeks 5 through 12 of the flare-up course

Extension of Week 5–12 doseIf flare-up symptoms have not resolved at end of 12 weeks, the Week 5–12 (10 mg) dose may be extended in 4-week intervals until symptoms resolve

Restarting flare-up regimenIf marked worsening of the original flare-up site or a new flare-up occurs, restart the 12-week flare-up dosing beginning with 20 mg daily

Return to maintenanceAfter completion of the flare-up course (or when appropriate), resume daily maintenance dosing of 5 mg

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Authorization of up to 6 months may be granted when all criteria for fibrodysplasia ossificans progressiva (FOP) are met. Prior authorization is required before initiation of Sohonos (palovarotene).

Approval duration: up to 6 months
Prior authorization required for initial and continuation requests

Denial Risk

Indication Restriction — Non‑FOP Uses Not Covered

Provider must attest and document that Sohonos is being prescribed for FOP (ACVR1 mutation) and not for any other indication. All non‑FOP uses are considered experimental/investigational and are not medically necessary.

Documentation Required

Required Documentation

Provider must document a genetically confirmed diagnosis of FOP with testing demonstrating an ACVR1 (activin receptor type I) mutation, clinical signs/symptoms (e.g., great toe malformation, abnormal vertebral morphology, ectopic ossification), and age criteria. For members of reproductive potential, include documented attestation of non‑pregnancy and plans for contraception starting at least 1 month prior to treatment through 1 month after the last dose.

Required: genetic test result confirming ACVR1 mutation
Required: clinical signs/symptoms consistent with FOP (document specifics)
Required: age documented (females ≥8 years; males ≥10 years)
Required: pregnancy test and contraception attestation for members of reproductive potential

Denial Risk

Diagnostic Confirmation Required — Denial Risk

Lack of genetically confirmed FOP with an ACVR1 mutation and absence of required clinical documentation or age criteria will result in claim denial as not medically necessary.

Denial triggers: no genetic confirmation of ACVR1 mutation
Denial triggers: missing clinical signs/symptoms documentation
Denial triggers: patient does not meet age thresholds (female <8 years, male <10 years)

Background on Fibrodysplasia Ossificans Progressiva and Sohonos

Fibrodysplasia ossificans progressiva (FOP) is a rare genetic disorder characterized by progressive heterotopic ossification. Sohonos (palovarotene) is FDA‑approved to reduce the volume of new heterotopic ossification in patients with FOP and is indicated for adults and pediatric patients meeting the policy age thresholds. Its therapeutic intent is to limit formation of new ectopic bone associated with FOP.

Definitions

FOP (fibrodysplasia ossificans progressiva) — INV-12

DefinitionFibrodysplasia ossificans progressiva (FOP) is a genetic condition causing progressive ectopic (heterotopic) bone formation

Diagnostic requirementDiagnosis requires documented genetically confirmed FOP with genetic testing indicating an ACVR1 (activin receptor type I) mutation

Clinical features supporting diagnosisClinical signs may include great toe malformation, abnormal vertebral morphology, and ectopic ossification in ligaments or muscle tissue

Treatment contextSohonos (palovarotene) is indicated to reduce the volume of new heterotopic ossification in patients with genetically confirmed FOP