ModifiedmhnPolicy CP.PHAR.669

Clinical Policy: Birch Triterpenes (Filsuvez)

This policy governs medical necessity criteria, prior authorization, and coverage conditions for Filsuvez (birch triterpenes) for treatment of wounds in patients with dystrophic or junctional epidermolysis bullosa, affecting commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Birch Triterpenes (Filsuvez)

Policy CodePolicy CP.PHAR.669

Change TypeMaterial coverage edits and exclusions

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, baseline wound size, application plan per label, and confirmation of absence of squamous cell carcinoma in the treatment area.

SourceLink

POLICY UPDATE CHANGES

Added exclusion of concomitant use with Vyjuvek in dystrophic epidermolysis bullosa.

For initial approval criteria, added 'member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment.'

References were reviewed and updated during 1Q 2025 and 1Q 2026 annual reviews.

≥6 monthsmin approved age

21 days–<9 moeligible wound duration

3 monthsinitial approval

6 months

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Coverage Criteria

Initial Therapy (Epidermolysis Bullosa)

Covered when ALL of the following are met

Initial Approval - EB: 1. Diagnosis of dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) confirmed by genetic testing (see Appendix D); 2. Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist; 3. Age ≥ 6 months; 4. Target wounds are partial-thickness and have been present for ≥ 21 days and < 9 months (see Appendix E); 5. Documentation of size of target wounds at baseline; 6. Provider attestation that member is concomitantly receiving standard of care preventative or treatment therapies for wound care (e.g., polymeric membrane, superabsorbent dressings, soft-silicone foam, enzyme alginogel, protease; see Appendix F); 7. Member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment; 8. For DEB, Filsuvez is not prescribed concurrently with Vyjuvek; 9. Dose does not exceed 1 tube per target wound per day.Approval duration: 3 months

See Appendix D for diagnostic methods and Appendix F for recommended wound care.

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Continuation Therapy (Epidermolysis Bullosa)

Covered when ALL of the following are met

Continued Therapy - EB: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) member is currently receiving medication and is enrolled in a state/product with applicable continuity-of-care regulations; 2. Filsuvez is not applied on target wounds that have completely healed; 3. Member is responding positively to therapy as evidenced by improvement in one or more of the following: (a) decrease in wound size; (b) decrease in pain or itch severity for target wound sites associated with dressing changes; 4. For DEB, Filsuvez is not prescribed concurrently with Vyjuvek; 5. If request is for a dose increase, new dose does not exceed 1 tube per target wound per day.Approval duration: 6 months

Response may be demonstrated by wound size reduction or symptom improvement.

Other Indications / Label Changes

Other diagnoses/indications (must meet 1 or 2)

Other Indications: 1. If this drug has undergone a recent label change (within the last 6 months) that is not yet reflected in this policy (e.g., new indication, age expansion, or dosing regimen), refer to the appropriate formulary/no-coverage or non‑formulary policy for the relevant line of business per policy listing; 2. If the requested use (e.g., diagnosis, age, dosing regimen) is not specifically listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (see policy references).

See policy references listed in the main document for line-of-business specific guidance (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53).

Initial therapy / coverage conditions

Covered when ALL of the following are met (as documented for prior authorization):

Filsuvez initial use requirements: 1) Member has a documented diagnosis of dystrophic or junctional epidermolysis bullosa (DEB or JEB). 2) Application plan follows labeling: apply a 1 mm layer of Filsuvez to the affected wound surface only (do not rub in) or apply directly to the dressing so the gel contacts the wound; cover with a sterile non‑adhesive dressing and continue with dressing changes until wound healing. 3) Member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment. 4) Not to be used concomitantly with Vyjuvek in dystrophic EB.

Derived from dosing/administration instructions and policy update excluding concurrent Vyjuvek use.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy for the member's line of business (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Concomitant use of Filsuvez with Vyjuvek in members with dystrophic epidermolysis bullosa (DEB) is excluded from coverage. This exclusion reflects that Vyjuvek is not FDA‑approved for junctional epidermolysis bullosa (JEB) and the policy was updated to operationalize this concurrent‑use exclusion.

Requests for use of Filsuvez in combination with Vyjuvek for dystrophic EB may be considered not medically necessary/outside coverage due to the explicit exclusion of concomitant use. Other conditions that are expressly designated as not medically necessary in this policy portion remain subject to the policy exclusions and off‑label use procedures.

Coding & Product Details

Product Availability / NDCNDC

NDC not listed

Topical gel tube: 25 mL (10% w/w of birch triterpenes) — specific NDC not provided in this document portion.

Maximum dosing per target wound

Maximum dosing per target wound1 tube per target wound per day

ScopeApplies to each individual target wound treated with Filsuvez

Authorization impactDose limit enforced for initial and continued therapy approvals (see initial approval #9 and continued therapy #5)

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization requires submission of documentation that initial or continued therapy criteria are met. Initial approvals are granted for 3 months; continued approvals per policy are granted for 6 months when continuation criteria are met.

Prior authorization must include office chart notes, wound measurements, and other clinical information demonstrating criteria are met.
Initial approval: 3 months. Continued approval: 6 months (per policy continuation criteria).

Prior Authorization

Prior Authorization Requirements: Indication & Dosing

Documentation of indication and dosing plan is required. Provider must document wound type (DEB or JEB), wound location, confirmation that the wound has been cleansed prior to application, and the application method — either apply a 1 mm layer of Filsuvez to the affected wound surface (do not rub in) or apply directly to the dressing so gel is in direct contact with the wound, per product labeling.

Document indication: Dystrophic EB (DEB) or Junctional EB (JEB).

Background

Epidermolysis bullosa (EB) refers to a group of rare genetic disorders characterized by fragile skin and mucous membranes that blister or erode with minimal trauma. Major subtypes relevant to this policy are dystrophic EB (DEB), most often associated with COL7A1 or PLOD3 mutations, and junctional EB (JEB), associated with defects in genes such as LAMA3, LAMB3, LAMC2, COL17A1, ITGA3, ITGA6, or ITGB4. Genetic testing is commonly used to confirm the subtype. In EB, wounds are classified by depth; partial‑thickness wounds (affecting the epidermis and possibly extending into dermis) that persist for ≥21 days are considered delayed in healing and are the primary target for topical Filsuvez therapy, which is intended to accelerate re‑epithelialization by enhancing keratinocyte differentiation and migration.

Definitions

DEB and JEB — Genetic mutation associations

DEB (Dystrophic Epidermolysis Bullosa)Caused by mutation in the COL7A1 gene or PLOD3 gene

JEB (Junctional Epidermolysis Bullosa)Caused by mutation in one of LAMA3, LAMB3, LAMC2, COL17A1, ITGA3, ITGA6, or ITGB4 genes

Diagnostic recommendationGenetic testing is always recommended for diagnosis of EB (per 2020 Clinical Practice Guidelines)

Partial-thickness wound — definition and relevance to EB

DefinitionPartial-thickness wound affects the epidermis and may extend into the dermis

Healing timeframePartial-thickness wounds normally heal within 1 to 3 weeks; in EB, partial-thickness wounds ≥21 days are considered delayed in healing