CurrentBlue Cross Blue Shield - IowaPolicy N/A

Sohonos (palovarotene) — Coverage Criteria for Fibrodysplasia Ossificans Progressiva

Defines coverage, prior authorization requirements, dosing limits, and continuation criteria for Sohonos (palovarotene) for members with genetically confirmed fibrodysplasia ossificans progressiva (FOP). Affects prescribers and pharmacists managing FOP therapy under Wellmark/Blue Cross Blue Shield - Iowa.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicySohonos (palovarotene) — Coverage Criteria for FOP

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 29, 2023

Next Review DateN/A

Key ActionObtain prior authorization with genetic testing confirming ACVR1 mutation and documentation of signs/symptoms and age criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12auth duration (months)

28/56qty limits per 28 days

F≥8, M≥10age criteria

Requiredgenetic confirmation

Coverage Criteria for Sohonos (palovarotene)

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.

Initial Therapy

Covered when ALL of the following are met:

Initial approval criteria: 1) Genetic testing confirming diagnosis of fibrodysplasia ossificans progressiva (FOP) with documented ACVR1 (activin receptor type 1) mutation; 2) Member has signs and symptoms of FOP (e.g., malformation of the great toe, abnormal vertebral morphology, ectopic ossification in ligament or muscle tissue); 3) Age criteria met: male >= 10 years OR female >= 8 years; 4) Prescribed by or in consultation with a physician experienced in FOP treatment.

Authorization may be granted for 12 months.

Continuation Therapy

Covered when ALL of the following are met:

Continuation approval criteria: 1) Member meets age criteria (male >= 10 years or female >= 8 years); 2) Member is experiencing benefit from therapy as evidenced by disease stability or improvement (e.g., reduction in the volume of new heterotopic ossification); 3) Documentation (chart notes or medical record) supports continued benefit.

Authorization of 12 months may be granted for continued treatment.

Benefits and coverage for Sohonos (palovarotene) are determined by the member's specific contract. Benefit determinations are based on the applicable contract language in effect at the time services were rendered, and exclusions, limitations, or exceptions may apply. Individual member benefits must be verified prior to authorization because this policy may not apply to the Federal Employee Program (FEP); benefits for FEP members are determined by the Federal Employee Program.

Sohonos (palovarotene) is considered not medically necessary for members who do not meet the coverage criteria described in this policy. Notably, members who fail to meet the age thresholds or who lack the required clinical or diagnostic evidence of fibrodysplasia ossificans progressiva (for example, genetic confirmation of an ACVR1 mutation and documented signs/symptoms) do not meet medical necessity requirements for therapy.

Coding and Quantity Limits

Procedures and billing instructionmixed

No codes listed

inv-06: Quantity limits by capsule strength — standard limits per 28 days and dosing guidance

Standard limit — 1.5 mg capsules56 capsules per 28 days

Standard limit — 10 mg capsules56 capsules per 28 days

Standard limit — 2.5 mg, 5 mg, and other listed strengths28 capsules per 28 days

Dosing guidance (FDA-recommended) — adults and patients ≥14 years5 mg once daily; flare-up dose 20 mg once daily for 4 weeks, then 10 mg once daily for 8 weeks

Dosing guidance (FDA-recommended) — pediatric ≤13 years2.5 mg to 5 mg once daily based on weight; flare-up dose 10–20 mg once daily for 4 weeks, then 5–10 mg once daily for 8 weeks based on weight

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sohonos (palovarotene). Submit documentation to initiate review including genetic testing results confirming a diagnosis of fibrodysplasia ossificans progressiva (FOP) with a documented ACVR1 (activin receptor type 1) mutation and clinical documentation of signs and symptoms of FOP (for example, malformation of the great toe, abnormal vertebral morphology, or ectopic ossification in ligament or muscle tissue).

Initial requests: genetic testing results confirming FOP with documented ACVR1 mutation (e.g., R206H).
Initial requests: clinical documentation of FOP signs and symptoms (e.g., malformed great toe, ectopic ossification).
Continuation requests: chart notes or medical records demonstrating benefit from therapy (disease stability or improvement such as reduction in new heterotopic ossification).
Authorization duration: up to 12 months for initial and continuation approvals when criteria met.

Note

Dosing Limits May Apply

Approvals are subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based practice guidelines.

Dosing and administration will follow FDA-approved labeling and may be limited accordingly.

Documentation Required

Required Documentation for Requests

For initial requests include genetic confirmation of FOP with ACVR1 mutation and clinical documentation as described above. For continuation (reauthorization) requests include recent chart notes or medical records showing clinical benefit (disease stability or improvement) and ongoing appropriateness of therapy.

Initial: genetic test report confirming ACVR1 mutation and baseline clinical documentation of FOP signs/symptoms.
Continuation: 2 chart notes or equivalent medical record documentation supporting benefit from therapy and ongoing need.

Denial Risk

Not Medically Necessary When Criteria Not Met

Sohonos (palovarotene) is considered not medically necessary when the criteria above are not met.

No genetic confirmation of FOP with ACVR1 mutation.
Lack of clinical documentation of FOP signs or symptoms.
No evidence of benefit on continuation requests (no chart notes showing disease stability or improvement).
Requests not meeting age criteria as specified in the clinical criteria.

Background

Fibrodysplasia ossificans progressiva (FOP) is a rare, genetically mediated disorder characterized by progressive heterotopic ossification and congenital malformations such as great toe anomalies. Palovarotene (Sohonos) is indicated to reduce the volume of new heterotopic ossification in patients with FOP and is used in adults and pediatric patients who meet defined age and diagnostic criteria. Treatment decisions require confirmation of the diagnosis (commonly genetic testing demonstrating an ACVR1 mutation) and clinical evidence of disease activity; authorization and benefit determinations are subject to the member's contract and may not apply to FEP.

Definitions

inv-12: FOP definition — genetically confirmed condition (ACVR1 mutation) and associated clinical features

DefinitionFibrodysplasia ossificans progressiva (FOP) is a genetically confirmed condition caused by an ACVR1 (activin receptor type 1) mutation resulting in heterotopic ossification.

Key associated clinical featuresMalformation of the great toe, abnormal vertebral morphology, and ectopic ossification in ligament or muscle tissue.

Diagnostic requirement for coverageGenetic testing confirming diagnosis of FOP with documented ACVR1 mutation must be submitted for prior authorization.

Age-related indicationFDA indication: treatment in females aged ≥8 years and males aged ≥10 years and older.