CurrentCignaPolicy IP0596

Sohonos (palovarotene) – Coverage Criteria

Defines prior authorization and coverage criteria for Sohonos (palovarotene) to reduce new heterotopic ossification in patients with fibrodysplasia ossificans progressiva; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySohonos (palovarotene) – Coverage Criteria

Policy CodePolicy IP0596

Change TypeMaterial criteria clarification and administrative updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide genetic test results confirming ACVR1 R206H and radiologic evidence of heterotopic ossification when requested.

SourceLink

POLICY UPDATE CHANGES

Criterion wording updated to specify 'Patient has had a genetic test confirming a pathogenic variant in Activin A Type 1 Receptor (ACVR1) R206H' with documentation required.

Policy title updated from 'Palovarotene' to 'Sohonos' and policy template updated.

Added an asterisk next to 'female' and 'male' to reference gender definitions in the policy statement.

Examples of radiologic testing moved to a Note.

1 yearinitial authorization duration

≥8 / ≥10minimum age for FDA indication

ACVR1 R206Hrequired pathogenic variant

Not alloweduses outside FOP

Policy Summary

PayerCigna

PolicySohonos (palovarotene) – Coverage Criteria

Policy CodePolicy IP0596

Change TypeMaterial criteria clarification and administrative updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide genetic test results confirming ACVR1 R206H and radiologic evidence of heterotopic ossification when requested.

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.

Coverage Criteria for Sohonos (palovarotene)

COVERAGE CRITERIA

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

FDA‑Approved Indication

A: Age and gender-specific minimums: Patient meets ONE of the following: (i) patient is female* and ≥ 8 years of age OR (ii) patient is male* and ≥ 10 years of agefemale >= 8 yrs OR male >= 10 yrs
Refer to the Policy Statement for gender definitions
B: Genetic confirmation: Patient has had a genetic test confirming a pathogenic variant in Activin A Type 1 Receptor (ACVR1) R206H consistent with a diagnosis of fibrodysplasia ossificans progressivaACVR1 R206H pathogenic variant
[documentation required]
C: Radiologic confirmation: Patient has heterotopic ossification as confirmed by radiologic testingradiologic evidence (e.g., x-ray, CT, MRI, PET)
Examples of radiologic testing: x-ray, computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)
D: Prescriber specialty: Medication is prescribed by or in consultation with an endocrinologist or physician who specializes in bone diseasespecialist prescriber or consult
Specialist requirement due to monitoring and evaluation needs

Approval duration: 1 year when all criteria A–D are met1 year

Prior authorization required

Sohonos (palovarotene) for any use other than treatment of fibrodysplasia ossificans progressiva (FOP) is considered not medically necessary. The policy explicitly lists non‑covered uses, which are not exhaustive and may be updated as new data become available.

Use of Sohonos for Chronic Obstructive Pulmonary Disease (COPD) is considered not medically necessary; palovarotene was previously studied for COPD but was found to be ineffective for that condition. Use of Sohonos for the treatment and/or prevention of osteochondroma(s) is also considered not medically necessary. A Phase II study of Sohonos for prevention of disease progression in pediatric multiple osteochondromas was terminated early and results are not available, and additional data are needed to support this use.

Coding and Age Indications

Covered CPT Codes (policy references billing requirements generically)mixed

No codes listed

inv-05: Age thresholds for FDA indication — Females ≥ 8 years; Males ≥ 10 years

FDA age thresholds (actionable)Female patients: ≥ 8 years; Male patients: ≥ 10 years (meets FDA‑approved indication for Sohonos)

Age threshold — female≥ 8 years

Age threshold — male≥ 10 years

Approval duration when criteria metApprove for 1 year

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Sohonos. Approvals are provided for the duration noted (approve for 1 year when criteria met). Because of specialized skills required for evaluation, diagnosis, and monitoring, Sohonos must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Note

Provider Action

Provider action: Prescribe Sohonos only after confirming the patient meets the documented clinical criteria and obtain prior authorization before initiating therapy. Ensure the prescribing clinician is a specialist in the treated condition or consults with one.

Documentation Required

Required Documentation

Background

Fibrodysplasia ossificans progressiva (FOP) is an ultra‑rare, autosomal dominant genetic connective tissue disorder characterized by progressive heterotopic ossification leading to severe disability. Most patients with FOP have a pathogenic variant in the ACVR1 gene (commonly the R206H variant); diagnosis is clinical with genetic confirmation. Sohonos (palovarotene) is indicated to reduce the volume of new heterotopic ossification in patients with FOP.

Definitions

inv-11: FOP — Definition of Fibrodysplasia ossificans progressiva and diagnostic note

DefinitionFibrodysplasia ossificans progressiva (FOP) is an ultra‑rare, autosomal dominant genetic connective tissue disorder characterized by progressive heterotopic ossification resulting in disability and immobility.

Genetic diagnostic noteDiagnosis is clinical but requires genetic confirmation of an ACVR1 pathogenic variant; approximately 97% of patients have the ACVR1 R206H variant.

Clinical featuresPatients experience painful inflammatory soft‑tissue flare‑ups that often progress to mature heterotopic bone replacing muscle and connective tissue.

Diagnostic limitationsThere are no formal diagnostic criteria; clinical findings (e.g., great toe malformations, tissue swelling, heterotopic ossification) plus genetic confirmation support diagnosis.