Currentmedical mutual - ohioPolicy N/A

Filsuvez (birch triterpenes topical gel) coverage criteria

Policy governing prior authorization and medical necessity criteria for pharmacy coverage of Filsuvez for treatment of wounds in epidermolysis bullosa patients ≥6 months, including initial and continuation therapy and conditions not recommended for approval.

Policy Summary

Payermedical mutual - ohio

PolicyFilsuvez (birch triterpenes topical gel) coverage criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateMar 19, 2026

Key ActionObtain prior authorization with prescription by or in consultation with a dermatologist or wound care specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6mmin age

10–50 cm2wound size

≥21d & <9mwound age

12 moapproval duration

Not recommendedJEB stance

Coverage Criteria for Filsuvez (birch triterpenes topical gel)

inv-01: Dystrophic Epidermolysis Bullosa - Initial Therapy

Approve for 12 months if ALL criteria below are met:

Initial Therapy (A): Patient is ≥ 6 months of age; patient has at least one clinical feature of dystrophic epidermolysis bullosa; patient has one or more open target wound(s) to be treated; target wound(s) are clean in appearance and do not appear to be infected; target wound(s) size 10 cm2 to 50 cm2; target wound(s) age ≥ 21 days and < 9 months; prescriber attests there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound(s); medication is prescribed by or in consultation with a dermatologist or wound care specialist.see thresholds

Examples of clinical features include but are not limited to blistering, wounds, and scarring.

inv-02: Patient Currently Receiving Filsuvez on Previously Treated Wound(s)

Approve for 12 months if ALL criteria below are met:

Continuation Therapy (B):

Policy Summary

Payermedical mutual - ohio

PolicyFilsuvez (birch triterpenes topical gel) coverage criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateMar 19, 2026

Key ActionObtain prior authorization with prescription by or in consultation with a dermatologist or wound care specialist.

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.

Key Coding and Treatment Parameters

inv-06: Target wound area

Allowed target wound area10 cm2 to 50 cm2

Measurement basisPrescriber assesses wound surface area to confirm within 10 cm2–50 cm2

Applies toOne or more open target wound(s) to be treated with Filsuvez

inv-07: Target wound age

Allowed wound age for initial therapy≥ 21 days and < 9 months

Assessment methodPrescriber documents wound age (time since wound onset) to confirm it meets the ≥21 days and <9 months requirement

Continuation vs initialIf treating a new or reopened recurrent wound, use initial therapy age criteria

inv-08: Minimum patient age

Minimum eligible patient age≥ 6 months

Indication age contextFilsuvez indication and authorization criteria apply to patients aged 6 months and older

Prescriber confirmationPrescriber must confirm patient meets minimum age when requesting therapy

Prescriber, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Prescriber Requirement

Prior authorization is recommended for pharmacy benefit coverage of Filsuvez. Because of the specialized skills required for evaluation, diagnosis, and monitoring, initial approval requires Filsuvez to be prescribed by or in consultation with a physician who specializes in the condition being treated. All approvals for initial therapy are provided for the initial approval duration noted in the policy; reauthorization (when allowed) requires documented response to therapy.

Prior authorization recommended for pharmacy benefit coverage
Initial approval requires prescriber specialty or documented consultation

Note

Combination Therapy Caution

Combination use of Filsuvez with Vyjuvek (beremagene geperpavec-svdt topical gel) is not supported by available data. Patients who had undergone gene therapy were excluded from the pivotal clinical trial; clinicians should avoid combining these therapies unless new evidence supports safety and efficacy.

Concurrent use with Vyjuvek is not recommended
Patients post-gene therapy were excluded from pivotal trial evidence

Documentation Required

Documentation Upon Request

The Company reserves the right to request additional documentation to support coverage determinations. Upon request, provide patient records, test results, and credentials of the provider ordering or performing the service to demonstrate medical necessity.

Provide medical records, relevant test results, and provider credentials upon request
Documentation must support medical necessity and the requested service

Denial Risk

Denial Risk Conditions

The Company may deny reimbursement when it determines the drug or services were not medically necessary, were investigational or experimental, were not within the member's benefit scope, or when billing or practice patterns are inappropriate or excessive. The Company also reserves the right to modify or interpret this policy at its sole discretion.

Denial possible if services are not medically necessary, investigational/experimental, or outside benefit scope
Denial possible for inappropriate or excessive billing patterns
Company may modify or interpret policy at its discretion

Definitions and Key Terms

inv-14: Filsuvez

Product descriptionSterile topical botanical gel containing birch triterpenes (a mixture of pentacyclic triterpenes)

Dosage form and routeTopical gel for application to cleansed wounds

Key handling guidanceApply to cleansed wounds with dressing changes until wound is healed; discontinue if wound becomes infected

inv-15: Target wound

DefinitionAn open wound(s) to be treated with Filsuvez that meets prescriber‑attested criteria for cleanliness, size, age, and absence of suspected squamous cell carcinoma

Clean and non‑infected requirementTarget wound(s) must be clean in appearance and not appear infected (per prescriber) before initiating therapy

Malignancy attestationPrescriber must attest there is no evidence or clinical suspicion of squamous cell carcinoma at the target wound(s)

OpenPayer

Filsuvez (birch triterpenes topical gel) coverage criteria

Coverage Criteria for Filsuvez (birch triterpenes topical gel)

Key Coding and Treatment Parameters

Prescriber, Prior Authorization, and Documentation Requirements

Background on the Therapy and Indication

Definitions and Key Terms