CurrentAvMedPolicy N/A

Palovarotene (Sohonos) — Prior Authorization and Coverage Criteria

Defines pharmacy prior authorization, clinical criteria, dosing, and reauthorization requirements for palovarotene (Sohonos) for members with fibrodysplasia ossificans progressiva (FOP); applies to AvMed members and prescribing providers submitting specialty pharmacy requests.

Policy Summary

PayerAvMed

PolicyPalovarotene (Sohonos) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the AvMed pharmacy prior authorization form to the specialty pharmacy with complete clinical documentation to request approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial authorization duration

12 moReauthorization duration

5 mgAdult maintenance dose

20→10 mgFlare-up dosing

2.5–5 mgPediatric maintenance

Coverage Criteria

Policy Summary

PayerAvMed

PolicyPalovarotene (Sohonos) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the AvMed pharmacy prior authorization form to the specialty pharmacy with complete clinical documentation to request approval.

SourceLink

On This Page

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COVERAGE CRITERIA

Covered when ALL of the following are met (initial authorization — 6 months):

Age and prescriber

Age requirements: If female: at least 8 years of age OR if male: at least 10 years of age.
Specialist prescriber: Prescribed by or in consultation with a specialist with expertise in treating patients with fibrodysplasia ossificans progressiva (FOP).

Confirmed diagnosis

Clinical criteria: Clinical features such as congenital hallux valgus deformity, progressive heterotopic ossification, or limb reduction defects.
Diagnostic confirmation: Imaging demonstrating characteristic findings (short malformed first metatarsals, heterotopic ossification) OR molecular genetic testing identifying a heterozygous pathogenic ACVR1 variant (e.g., c.617G>A).

Intent and safety: Requested medication will be used for reduction in volume of new heterotopic ossification lesions; females of reproductive potential must have a negative pregnancy test within one week prior to initiation and periodically during therapy; member will avoid agents/circumstances predisposing to soft-tissue injury; no history of allergy or hypersensitivity to retinoids.

Baseline monitoring: Baseline assessment of skeletal maturity via hand/wrist and knee x-rays, growth curves, and pubertal staging with continued monitoring until skeletal maturity or final adult height.

Concomitant therapy restrictions: Member will avoid concomitant therapy with strong CYP3A4 inhibitors, strong or moderate CYP3A inducers, vitamin A, and tetracyclines; avoid excessive exposure to sun or artificial ultraviolet light and use sun protection when exposure cannot be avoided.

COVERAGE CRITERIA

Reauthorization criteria (12 months):

Continuation requirements

Ongoing eligibility: Member continues to meet all initial authorization criteria.
Safety assessment: Member has experienced an absence of unacceptable toxicity from the drug (examples include premature epiphyseal closure, severe mucocutaneous reactions, spinal fractures, severe or worsening psychiatric disorders, night blindness); members with signs of premature epiphyseal closure should be evaluated to assess benefits/risks of discontinuation until achievement of skeletal maturity.
Evidence of benefit (at least one): Reduction, stabilization, or slowing of annualized volume of new heterotopic ossification as assessed by low-dose whole body CT (excluding head) OR reduction/improvement in signs/symptoms or number of flare-ups compared to baseline.

Members must avoid excessive exposure to sun or artificial ultraviolet (UV) light; when avoidance is not possible they should use protective measures such as sunscreens, protective clothing, and sunglasses. Concomitant therapy with certain interacting agents must be avoided, including strong CYP3A4 inhibitors (example: grapefruit/pomelo juice, fluconazole, itraconazole), strong and moderate CYP3A inducers (example: rifampin, carbamazepine, St. John's Wort), and vitamin A or tetracyclines. These precautions are conditions for safe use and must be managed during therapy.

Requests lacking required documentation may be denied. For initial authorization, submit evidence confirming an established diagnosis of fibrodysplasia ossificans progressiva (clinical features and supporting imaging and/or molecular genetic testing), documentation that the medication will be used to reduce the volume of new heterotopic ossification lesions, and confirmation that the prescriber is an FOP specialist or consulted with one. Females of reproductive potential must have a negative pregnancy test within one week prior to initiation and periodic testing during therapy. A baseline assessment of skeletal maturity (hand/wrist and knee x‑rays, standard growth curves, and pubertal staging) with continued monitoring until skeletal maturity or final adult height must be provided. Also ensure complete submission of supporting records (labs, diagnostics, chart notes); failure to provide these items may result in denial.

Initial Therapy and Dosing

Initial therapy and dosing

Recommended dosing and initial authorization length (6 months).

Adult dosing (>=14 years): Maintenance: 5 mg daily. Flare-up: 20 mg daily for 4 weeks, then 10 mg daily for 8 weeks (total 12 weeks), then return to 5 mg daily.

Pediatric dosing (females 8–13; males 10–13): Maintenance: weight-based 2.5–5 mg daily (stop maintenance when flare-up dosing begins). Flare-up: weight-based initial dose once daily for 4 weeks, then lower flare-up dose once daily for 8 weeks (total 12 weeks), then return to daily maintenance dosing.

Initial authorization duration: Initial authorization length: 6 months.

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization (12 months) requires continued benefit and tolerability.

Reauthorization criteria: Member continues to meet initial authorization criteria, has absence of unacceptable toxicity, and demonstrates benefit by imaging or clinical improvement.

Evidence of benefit: Provide documentation of at least one of: reduction/stabilization/slowing of annualized volume of new HO by low‑dose whole body CT (excluding head) OR reduction/improvement in signs/symptoms or number of flare-ups compared to baseline.

Safety monitoring: Document absence of unacceptable toxicity (e.g., premature epiphyseal closure, severe mucocutaneous reactions, spinal fractures, severe/worsening psychiatric disorders, night blindness); if premature epiphyseal closure is suspected, reassess benefits/risks and consider holding therapy until skeletal maturity.

Coding and Age Limits

ICD-10 placeholderICD-10

ICD Code, if applicable (blank on form)

Age minimum — Sex-specific

Female minimum age8 years

Male minimum age10 years

Authorization length (initial)Initial authorization: 6 months

Provider Actions and Submission Requirements

Prior Authorization

Prior Authorization Required

Palovarotene requires prior authorization. Submit the AvMed pharmacy prior authorization form signed by the prescribing physician (preprinted stamps not valid) to the specialty pharmacy per form instructions (fax: 1-305-671-0200). Ensure phone and fax numbers on the request are correct to avoid delays.

Drug requested: Sohonos™ (palovarotene)
Fax: 1-305-671-0200
Prescribing physician signature required (no preprinted stamps)

Note

Samples and Prior Therapy Verification

Use of samples to initiate therapy does not satisfy step edit or preauthorization requirements. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

"Use of samples to initiate therapy does not meet step edit/ preauthorization criteria."
Previous therapies verified via pharmacy paid claims or chart notes

Documentation Required

Required Supporting Documentation

Submit supporting documentation confirming diagnosis and the clinical findings used to establish fibrodysplasia ossificans progressiva (FOP). Include relevant imaging, genetic testing results (if available), and a baseline assessment of skeletal maturity.

Clinical documentation (e.g., congenital hallux valgus, progressive heterotopic ossification, limb anomalies)
Imaging (radiographs showing malformed first metatarsals, heterotopic ossification; low-dose WBCT for monitoring)
Molecular genetic testing showing heterozygous pathogenic ACVR1 variant when available
Baseline skeletal maturity assessment (hand/wrist and knee x-rays, growth curves, pubertal staging)

Denial Risk

Submission Completeness — Avoid Delays or Denials

Incomplete, incorrect, or illegible information (including missing or incorrect phone/fax numbers) on the prior authorization form can delay processing or lead to denial. Ensure all required fields are completed and the prescribing physician has signed the form.

Ensure all form fields are complete and legible
Include correct phone and fax numbers to avoid unnecessary follow-up
Prescribing physician signature required

Denial Risk

Insufficient Supporting Documentation May Result in Denial

Failure to provide labs, diagnostics, and chart notes that substantiate each checked clinical criterion may result in denial. Provide documentation of pregnancy testing for females of reproductive potential, evidence of treatment benefit and absence of unacceptable toxicity for reauthorizations, and documentation of counseling regarding activity/medication precautions.

Labs/diagnostics/chart notes to support each checked criterion
Negative pregnancy test within one week prior to initiation for females of reproductive potential and periodic testing during therapy
For reauthorization: documentation of clinical benefit (e.g., reduction/stabilization of new HO on WBCT or fewer/less severe flare-ups) and absence of unacceptable toxicity

Definitions and Monitoring

Flare-Up Dose

Flare-up course total duration12 weeks (4 weeks initial higher dose then 8 weeks lower flare-up dose)

PurposeDefined higher‑dose treatment course for managing FOP flare‑ups before returning to maintenance dosing

Follow-upReturn to maintenance dosing after completion of the 12‑week flare‑up course

Skeletal maturity monitoring

Baseline assessmentsHand/wrist and knee x‑rays, standard growth curves, and pubertal staging

Ongoing monitoringContinued monitoring throughout therapy until skeletal maturity or final adult height

Documentation requirementSubmit documentation of baseline skeletal maturity assessment prior to initiation

Background

Palovarotene (Sohonos) is indicated for patients with fibrodysplasia ossificans progressiva (FOP) to reduce the volume of new heterotopic ossification lesions. Initial authorizations are for 6 months. The policy requires that recipients meet age thresholds (females ≥ 8 years; males ≥ 10 years), be prescribed by or in consultation with an FOP specialist, have documented clinical and imaging findings (and/or ACVR1 pathogenic variant on molecular testing), and meet safety and monitoring requirements including pregnancy testing for females of reproductive potential and baseline/ongoing skeletal maturity assessments.

Step Therapy and Prior Treatment Verification

Step	Requirement
1	Previous therapies will be verified through pharmacy paid claims or submitted chart notes; use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Quantity Limits

Palovarotene capsules strengths and dispensing guidance

Available capsule strengths1 mg, 1.5 mg, 2.5 mg, 5 mg, 10 mg

Dispensing guidance — 1, 1.5, 10 mg2 capsules daily for 1 mg, 1.5 mg, and 10 mg strengths

Dispensing guidance — 2.5, 5 mg1 capsule daily for 2.5 mg and 5 mg strengths

Site of Care / Specialty Pharmacy

Note

Specialty pharmacy dispensing (Proprium Rx)

This medication is dispensed through specialty pharmacy (Proprium Rx); route requests accordingly.

Documentation requirement:

To support each checked item, provide documentation including lab results, diagnostics, and/or chart notes; incomplete documentation may result in denial.