ModifiedCentenePolicy CP.PHAR.669

Birch Triterpenes (Filsuvez) for epidermolysis bullosa wounds

Defines medical necessity criteria, authorization rules, and supporting clinical information for coverage of Filsuvez (birch triterpenes) for patients with dystrophic or junctional epidermolysis bullosa; applies to Centene lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyBirch Triterpenes (Filsuvez) for epidermolysis bullosa wounds

Policy CodePolicy CP.PHAR.669

Change TypeMaterial coverage and exclusion updates

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming genetic diagnosis (DEB or JEB), wound characteristics, and provider attestation of concurrent standard wound care.

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'.

Clarified that Filsuvez should not be used concurrently on the same target wound as Zevaskyn and Vyjuvek and added no concurrent use with Zevaskyn.

3 moinitial approval duration

6 mocontinuation approval duration

≥6 momin patient age

21d–9mo

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≤1 tube/daymax dosing

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for Epidermolysis Bullosa (Initial Approval):

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. Patient age is ≥ 6 months; 4. Target wounds are partial-thickness and have been present for ≥ 21 days and < 9 months; 5. Documentation of size of target wounds at baseline is provided; 6. Provider attestation that the member is concomitantly receiving standard of care preventative or treatment wound therapies (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® or Zevaskyn™ on the same target wound; 9. Dose does not exceed 1 tube per target wound per day.initial approval duration = 3 months

See Appendix D for genetic testing details and Appendix F for recommended wound care.

Continuation Therapy

Covered when ALL of the following are met for Continuation/Renewal (EB):

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

Response assessment examples include wound size reduction or symptomatic improvement.

Not Authorized / Off-Label

Not Authorized Indications: Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

Refer to off‑label policies listed in policy.

Dosing and exclusions

Dosing and usage guidance (as provided); policy-level coverage exclusions updated

Dosing requirements: Apply a 1 mm layer of Filsuvez to the affected wound surface only; do not rub in the gel; cover the wound with a sterile non‑adhesive dressing or apply Filsuvez directly to the dressing so the gel contacts the wound; apply with dressing changes until the wound is healed.1 mm

From Dosage and Administration.

Concurrent use exclusions: Filsuvez must not be used concurrently on the same target wound as Zevaskyn or Vyjuvek; concomitant use with Vyjuvek in dystrophic EB is excluded.N/A

Policy changes added these exclusions (see References).

Use of Filsuvez for non‑FDA approved indications that are not expressly addressed in this policy is not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Policy exclusions clarify that Filsuvez must not be used concurrently on the same target wound with Zevaskyn or Vyjuvek. In addition, the policy specifically excludes concomitant use of Filsuvez with Vyjuvek in dystrophic epidermolysis bullosa.

Filsuvez must not be applied to target wounds that have completely healed. The policy also reiterates that Filsuvez should not be used concurrently on the same target wound with Zevaskyn or Vyjuvek, and providers should avoid overlapping applications of these products to the same wound surface.

For initial approval, members with current evidence or a history of squamous cell carcinoma in the area to be treated are excluded from coverage with Filsuvez.

Coding and Key Eligibility Parameters

Drug indication summarymixed

Filsuvez (birch triterpenes) — FDA approved for treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (DEB and JEB) in patients 6 months of age and older

Product availability / NDCNDC

NDC not listed

Topical gel tube: 25 mL (10% w/w of birch triterpenes)

Target wound age — eligible wound age constraints

Eligible target wound agePartial-thickness wounds present for ≥ 21 days and < 9 months

ContextPartial-thickness wounds in EB are considered delayed in healing when aged ≥ 21 days (Appendix E)

Approval linkageTarget wound age requirement is a condition of initial approval (approval duration = 3 months)

Maximum dosing per wound — ≤ 1 tube per target wound per day

Maximum dosing per target woundDose does not exceed 1 tube per target wound per day

Continuation requestsIf request is for a dose increase during continuation, new dose must not exceed 1 tube per target wound per day

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet the policy's Initial or Continuation criteria as applicable and include genetic confirmation for epidermolysis bullosa (see Appendix D) when indicated. Approval durations: initial = 3 months; continuation = 6 months.

Prior authorization required for Filsuvez (CP.PHAR.669).
Approval duration: Initial = 3 months; Continued therapy = 6 months.

Note

Prior Authorization Considerations

Policy changes may affect prior authorization approvals (for example, clarifications about concurrent-use exclusions and documentation expectations). Verify member’s current benefit status, previous approvals, and any state-specific continuity of care provisions.

If member currently receiving medication via Centene benefit or previously met initial approval criteria, refer to continuation criteria.
State/product continuity of care rules may apply — see state addendums CC.PHARM.03A and CC.PHARM.03B.

Background

Epidermolysis bullosa (EB) is a group of rare genetic disorders characterized by skin fragility. Two subtypes addressed in this policy are dystrophic EB (DEB) and junctional EB (JEB), which are caused by pathogenic variants in genes such as COL7A1 for DEB and several laminin/collagen genes for JEB. Filsuvez is a topical gel indicated to promote re‑epithelialization of eligible partial‑thickness EB wounds in patients aged ≥ 6 months.

Definitions

Genetic definitions of EB subtypes — DEB and JEB causative genes

DEB (Dystrophic EB) genesCOL7A1 or PLOD3

JEB (Junctional EB) genesLAMA3, LAMB3, LAMC2, COL17A1, ITGA3, ITGA6, or ITGB4

Diagnosis recommendationGenetic testing is recommended for diagnosis of EB (see Appendix D)

Partial-thickness wound (EB context) — definition and wound-age threshold

DefinitionPartial-thickness wounds affect the epidermis and may extend into the dermis

EB-specific wound-age thresholdIn EB, a partial-thickness wound aged ≥ 21 days is considered delayed in healing and eligible for treatment per policy

Revision History

2024-03-05exclusion_added

Added exclusion of concomitant use with Vyjuvek in dystrophic epidermolysis bullosa (note: Vyjuvek is not FDA‑approved for junctional EB).

2024-10-31criteria_added

For initial approval criteria, added 'member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment' per competitor analysis and EASE study trial design; references reviewed and updated.

2026-03-16clarification_added

Policy Summary

PayerCentene

PolicyBirch Triterpenes (Filsuvez) for epidermolysis bullosa wounds

Policy CodePolicy CP.PHAR.669

Change TypeMaterial coverage and exclusion updates

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming genetic diagnosis (DEB or JEB), wound characteristics, and provider attestation of concurrent standard wound care.

SourceLink

On This Page

Policy placementDosing limit is listed as a required condition in initial and continuation approval criteria

Minimum patient age — age ≥ 6 months per FDA indication

Minimum patient age (FDA)Age ≥ 6 months

ScopeApplies to adult and pediatric patients 6 months of age and older for DEB and JEB indications

Criteria linkageMinimum age is a required element in initial approval criteria

Denial Risk

Documentation / Indication Mismatch — Denial Risk

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. Lack of adequate supporting documentation or requests for non‑FDA indications without applicable off‑label justification may result in denial.

Required documentation must demonstrate the indication requested is consistent with policy criteria; off‑label requests require adherence to off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.
Denial risk if documentation is missing, incomplete, or inconsistent with the indication requested.

Billing Rule

Concurrent Product Exclusion

Filsuvez must not be prescribed concurrently with Vyjuvek or Zevaskyn on the same target wound in DEB; concurrent-use exclusions apply to the same target wound per policy.

Concurrent use exclusion applies when treating the same target wound.
Policy explicitly adds exclusion for concurrent use with Vyjuvek and Zevaskyn on the same target wound.

Documentation Required

Required Clinical Documentation

Provider must submit documentation to support the request including: office chart notes, baseline wound measurements and description (size and partial‑thickness status), genetic testing results (for DEB/JEB confirmation per Appendix D), history of wound duration (target wounds present ≥21 days and <9 months), and provider attestation of concurrent standard wound care.

Office chart notes documenting diagnosis and specialist involvement (geneticist, dermatologist, or histopathologist).
Genetic testing confirming DEB or JEB (see Appendix D).
Baseline wound measurements and documentation target wounds are partial‑thickness and have been present ≥21 days and <9 months (Appendix E).
Provider attestation that member is receiving recommended standard of care wound therapies (see Appendix F).
Documentation that member does not have current evidence or history of squamous cell carcinoma in the treatment area.

Note

Dosing and Product Information

Dosing and application instructions: apply a 1 mm layer of Filsuvez to the affected wound surface only; do not rub in the gel. Cover the wound with a sterile non‑adhesive dressing or apply Filsuvez directly to the dressing so gel contacts the wound. Apply to cleansed wounds with dressing changes until healed. Maximum dosing: do not exceed 1 tube per target wound per day.

Apply a 1 mm layer to the affected wound surface only; do not rub in.
Cover with sterile non‑adhesive dressing or apply directly to dressing so gel contacts wound.
Do not apply to wounds that have completely healed.
Maximum dose: 1 tube per target wound per day.

Prior Authorization

Concurrent Standard Wound Care Required

Provider attestation that member is concomitantly receiving standard of care preventative or treatment wound therapies (e.g., PolyMem, superabsorbent dressings, soft‑silicone foam, enzymatic alginogel, protease agents per Appendix F) is required for initial approval.

Attestation that recommended dressings and infection prevention measures are in use as appropriate.
Standard of care examples per Appendix F: PolyMem, Flaminal Hydro/Forte, Cutimed Siltec, Mepitel One, etc.

Filsuvez targets wounds delayed in re-epithelialization which are prone to become chronic in EB

Filsuvez — product description, concentration, tube size, and application layer thickness

Product descriptionFilsuvez — topical gel containing birch triterpenes

Concentration10% w/w of birch triterpenes

Tube size25 mL topical gel tube

Application instructionsApply a 1 mm layer to the affected wound surface only; do not rub in; cover with sterile non-adhesive dressing or apply directly to dressing so gel contacts wound; continue with dressing changes until healed

Clarified for initial approval and continuation that Filsuvez must not be used concurrently on the same target wound as Zevaskyn and Vyjuvek and added explicit exclusion for concurrent use with Zevaskyn.