CurrentCignaPolicy IP0596

Palovarotene (Sohonos) for Fibrodysplasia Ossificans Progressiva

Defines medical necessity, authorization duration, and coverage limits for palovarotene (Sohonos) when used to reduce new heterotopic ossification in individuals with fibrodysplasia ossificans progressiva, and guidance for prescribers and reauthorization.

Policy Summary

PayerCigna

PolicyPalovarotene (Sohonos) for Fibrodysplasia Ossificans Progressiva

Policy CodePolicy IP0596

Change TypeNo material change

Effective DateDec 15, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation of age eligibility, genetic confirmation of ACVR1 R206H, radiologic evidence of heterotopic ossification, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Up to 12 moAuthorization duration

F ≥8 / M ≥10Age limits

ACVR1 R206HRequired diagnostic test

FOPIndicated disease

COPD, osteochondromaNot-covered indications

Coverage Criteria for Palovarotene (Sohonos)

Initial Therapy

Covered when ALL of the following are met for fibrodysplasia ossificans progressiva:

Age requirement: ONE of the following: (i) individual is female and age >= 8 years OR (ii) individual is male and age >= 10 yearsfemale >= 8 yrs; male >= 10 yrs

From indication and age limits

Genetic confirmation: Genetic test confirming an R206H pathogenic variant in ACVR1 (ALK2) consistent with a diagnosis of fibrodysplasia ossificans progressivaACVR1 R206H pathogenic variant present

Required diagnostic confirmation

Radiologic confirmation:

Policy Summary

PayerCigna

PolicyPalovarotene (Sohonos) for Fibrodysplasia Ossificans Progressiva

Policy CodePolicy IP0596

Change TypeNo material change

Effective DateDec 15, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation of age eligibility, genetic confirmation of ACVR1 R206H, radiologic evidence of heterotopic ossification, and specialist involvement.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Chronic obstructive pulmonary disease (COPD) and osteochondroma(s) are explicitly listed as not covered. Sohonos (palovarotene) is not indicated for COPD; palovarotene was previously studied for COPD but was found to be ineffective for this condition. For osteochondromas, Sohonos is not indicated for treatment or prevention of osteochondroma; a Phase II study in pediatric multiple osteochondromas was terminated early and results are not available, so additional data are needed before this use could be considered. These uses are therefore considered experimental, investigational, or unproven and are not covered under this policy.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for palovarotene (Sohonos). Initial and reauthorization approvals are each up to 12 months.

Initial approval: up to 12 months
Reauthorization approval: up to 12 months

Note

Dose and Site of Care

Dose, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy.

Documentation Required

Required Documentation

Provider must document age eligibility, genetic testing, radiologic confirmation of heterotopic ossification, prescriber specialty, and other supportive documentation in the medical record. Documentation must include:

Age eligibility: female ≥ 8 years or male ≥ 10 years
Genetic test confirming ACVR1 R206H (ALK2) pathogenic variant consistent with FOP
Radiologic confirmation of heterotopic ossification (e.g., x-ray, CT, MRI, PET)
Medication prescribed by, or in consultation with, an endocrinologist or physician who specializes in bone disease
Evidence supporting dose, frequency, duration, and site of care
Receipt of sample product does not satisfy documentation or coverage requirements

Denial Risk

Off‑label / Not Covered Uses

Use of palovarotene (Sohonos) for any indication other than fibrodysplasia ossificans progressiva (FOP) is considered experimental, investigational, or unproven and may be denied. Examples of not covered uses include, but are not limited to: COPD and osteochondroma(s).

Chronic Obstructive Pulmonary Disease (COPD) — palovarotene is not indicated and was found ineffective in studies
Osteochondroma(s) — not indicated; available studies terminated early and lack sufficient data

Definitions

Fibrodysplasia ossificans progressiva (FOP) — definition and clinical context

DefinitionAn ultra-rare, autosomal dominant genetic disorder characterized by progressive heterotopic ossification (HO) that transforms soft connective tissues into mature bone, leading to disability, progressive immobility, and reduced quality/length of life.

Clinical featuresEpisodes of painful inflammatory soft-tissue swelling (flare-ups), spontaneous resolution in some episodes but most progress to heterotopic bone formation (plates, sheets, ribbons) that permanently replace muscle and connective tissue.

Diagnostic contextClinical diagnosis may be suggested by great toe malformations, tissue swelling, and heterotopic ossification, but genetic confirmation of an ACVR1 mutation is required for definitive diagnosis and for policy eligibility.

Prognosis/impactProgressive heterotopic ossification leads to permanent immobility as ectopic bone encases the patient, with substantial morbidity and reduced life expectancy and quality of life.

ACVR1 R206H pathogenic variant — description and genetic confirmation requirement

Variant descriptionA heterozygous single‑nucleotide change in the glycine‑serine activation domain of ACVR1 (the ACVR1 R206H variant) found in approximately 97% of FOP patients.

Role in diseaseACVR1 encodes a bone morphogenetic protein type I receptor kinase; the R206H pathogenic variant is the common causative mutation in FOP.

Policy requirementGenetic test confirming the ACVR1 R206H pathogenic variant is required by policy as diagnostic confirmation for palovarotene (Sohonos) eligibility.

Diagnostic implicationAlthough clinical features can suggest FOP (e.g., great toe malformations, flare‑ups, radiologic HO), genetic confirmation of ACVR1 R206H is needed for definitive diagnosis and coverage under this policy.

OpenPayer

Palovarotene (Sohonos) for Fibrodysplasia Ossificans Progressiva

Coverage Criteria for Palovarotene (Sohonos)

Provider Requirements and Actions

Background

Definitions