CurrentCignaPolicy N/A

Sohonos Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for Sohonos (palovarotene) prescription benefit coverage, including FDA-approved indication for fibrodysplasia ossificans progressiva and non‑covered uses.

Policy Summary

PayerCigna

PolicySohonos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain prior authorization and provide genetic and radiologic confirmation when requesting Sohonos.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Females ≥8; Males ≥10age eligibility for FDA indication

1 yearapproval duration for FDA-approved indication

ACVR1 R206H reqgenetic confirmation

Imaging reqradiologic confirmation

COPD / osteochondromanon-covered uses

Coverage Criteria for Sohonos (palovarotene)

FDA-Approved Indication Criteria

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

FDA-Approved Indication for FOP: A) Age requirement; B) Genetic confirmation; C) Radiologic confirmation of heterotopic ossification; D) Prescribed by or in consultation with an endocrinologist or bone disease specialistA-D all required

A: Age by sex: i. Patient is female and ≥ 8 years OR ii. Patient is male and ≥ 10 yearssex-specific ages

Refer to Policy Statement for gender definition.

B: Genetic confirmation: Patient has had a genetic test confirming a pathogenic variant in ACVR1 R206H consistent with a diagnosis of fibrodysplasia ossificans progressiva

Policy Summary

PayerCigna

PolicySohonos Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain prior authorization and provide genetic and radiologic confirmation when requesting Sohonos.

SourceLink

On This Page

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Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended and required for Sohonos. Approvals are provided for 1 year when criteria are met. Because of specialized skills required for evaluation, Sohonos must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., endocrinologist or physician who specializes in bone disease).

Approvals: 1 year when criteria are met
Prescriber requirement: prescribed by or in consultation with a specialist

Documentation Required

Required documentation includes a genetic test confirming an ACVR1 R206H pathogenic variant, radiologic evidence of heterotopic ossification (e.g., x-ray, CT, MRI, or PET), and documentation of patient age and biological sex to confirm age-based eligibility (female ≥ 8 years; male ≥ 10 years).

Genetic test confirming ACVR1 R206H pathogenic variant
Radiologic confirmation of heterotopic ossification (x‑ray, CT, MRI, or PET)
Patient age and biological sex documented to meet age criteria

Denial Risk

Denial Triggers

Requests may be denied if prior authorization is not obtained or if Sohonos is requested for non-covered indications such as COPD or osteochondroma(s).

Denial triggers: lack of prior authorization
Denial triggers: requests for non‑covered indications (e.g., COPD, osteochondroma)

Note

Provider Action

Provider note: In clinical criteria an asterisk (*) next to specified gender denotes biological sex definitions used for age thresholds (males = individuals with biological traits of a male; females = individuals with biological traits of a female).

Definitions

FOP — definition

Disorder descriptionFibrodysplasia ossificans progressiva (FOP) is an ultra-rare, autosomal dominant genetic connective tissue disorder characterized by progressive heterotopic ossification leading to disability, immobility, and reduced quality and length of life.

Clinical coursePatients experience painful inflammatory soft-tissue flare-ups that often transform connective tissues into mature heterotopic bone, resulting in progressive and permanent immobility.

Genetic basisAll patients with FOP have a mutation in the ACVR1 gene (activin A type 1 receptor); genetic confirmation is required for diagnosis.

Common pathogenic variantApproximately 97% of patients have the heterozygous single‑nucleotide ACVR1 R206H variant.

Diagnostic approachDiagnosis is clinical (e.g., great toe malformations, tissue swelling, heterotopic ossification) but requires genetic confirmation via DNA sequence analysis for an ACVR1 pathogenic variant.

Sex/Gender definition (for clinical criteria)

Specified gender definitionsMales are defined as individuals with the biological traits of a male, regardless of the individual's gender identity or gender expression.

Specified gender definitionsFemales are defined as individuals with the biological traits of a female, regardless of the individual's gender identity or gender expression.

Usage in criteriaThese sex-based definitions are used where the clinical criteria specify age thresholds by sex for Sohonos eligibility.

OpenPayer

Sohonos Prior Authorization Policy

Coverage Criteria for Sohonos (palovarotene)

Provider Actions, Authorization, and Documentation Requirements

Background

Definitions