ModifiedHealth NetPolicy CP PHAR.669

Clinical Policy: Birch Triterpenes (Filsuvez)

Covers medical necessity criteria and utilization management for Filsuvez to treat wounds associated with dystrophic and junctional epidermolysis bullosa for commercial, HIM, and Medicaid members.

Policy Summary

PayerHealth Net

PolicyBirch Triterpenes (Filsuvez) — Clinical Policy

Policy CodePolicy CP PHAR.669

Change TypeAdded exclusions and safety criterion

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with genetic confirmation of DEB or JEB and baseline target wound size documentation.

SourceLink

POLICY UPDATE CHANGES

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

Added initial approval criterion excluding members with current evidence or history of squamous cell carcinoma in the treatment area.

3 monthsinitial approval duration

6 monthscontinued therapy approval duration

DEB, JEBindications

1 tube/daymax dose

>=6 months

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Coverage Criteria

Initial Therapy (EB)

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

Initial Approval for EB: 1) Diagnosis of dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) confirmed by genetic testing; 2) Epidermolysis bullosa diagnosis meets internal EB criteria (see Appendix D); 3) Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist; 4) Target wounds are partial-thickness and have been present for ≥21 days and <9 months; 5) Patient age consistent with FDA indication (≥6 months); 6) Documentation of size of target wounds at baseline; 7) No current evidence or history of squamous cell carcinoma in the area that will undergo treatment; 8) Provider attestation that member is concomitantly receiving standard of care preventive or treatment wound therapies (e.g., polymeric membrane, superabsorbent dressings, soft-silicone foam, enzyme alginogel, protease); 9) For DEB, Filsuvez is not prescribed concurrently with Vyjuvek; 10) Dose does not exceed 1 tube per target wound per day; Approval duration: 3 months.

Continuation Therapy

Covered for Continued Therapy when ALL of the following are met:

Continued Therapy for EB: 1) Member is currently receiving medication via the benefit or previously met initial approval criteria; 2) Filsuvez is not applied on target wounds that have completely healed; 3) Evidence of clinical improvement (e.g., decrease in wound size or decrease in pain/itch severity associated with dressing changes); 4) If request is for a dose increase, new dose does not exceed 1 tube per target wound per day; 5) For DEB, Filsuvez is not prescribed concurrently with Vyjuvek; Approval duration: 6 months.

Initial approval criteria

Covered when ALL of the following are met

Indication: Member has dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) for which topical birch triterpenes (Filsuvez) are being prescribed.

Supported by dosing regimen references

Administration: Filsuvez is applied as a specified mm layer to the affected wound surface only (do not rub in) and the wound is covered with a sterile non-adhesive dressing or Filsuvez is applied directly to the dressing; continue application at dressing changes until the wound is healed.

Dosing and administration instructions in policy

Safety exclusion: Member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment.

Added to initial approval criteria during 1Q 2025 review

Requests for use of Filsuvez for indications that are not FDA‑approved and not addressed in this policy will not be authorized unless the provider supplies sufficient supporting documentation of efficacy and safety consistent with the payer’s off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents.

This policy explicitly excludes concomitant use of Filsuvez with Vyjuvek in dystrophic epidermolysis bullosa (DEB); requests that indicate concurrent prescribing of these products risk denial. The policy record notes that Vyjuvek is not FDA‑approved for junctional epidermolysis bullosa (JEB), and the exclusion for concomitant use with Vyjuvek was added to the policy and approved by P&T.

Use of Filsuvez that does not meet the documentation or clinical criteria listed in the policy—such as lacking genetic confirmation of DEB or JEB, missing baseline target wound size, absence of required provider attestation of concurrent standard wound care, or requests for non‑FDA indications without off‑label justification—may be considered not medically necessary and subject to denial under the referenced off‑label or non‑formulary policies.

Policy coverage is limited to the indications and clinical situations explicitly described elsewhere in this document. Providers should ensure all required elements for prior authorization are submitted (diagnosis confirmation, wound characteristics and duration, prescriber specialty, and absence of excluded conditions such as squamous cell carcinoma in the treatment area) because uses outside these parameters or lacking required documentation may be denied per the payer’s utilization management rules.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization before Filsuvez (birch triterpenes topical gel) will be covered. Requests must demonstrate that the member meets all clinical criteria for initial or continued therapy as specified in this policy.

Prior authorization required for initial and continued therapy
Approval durations: Initial = 3 months; Continued = 6 months

Denial Risk

Non‑FDA (Off‑Label) Indications

Requests for non–FDA approved (off‑label) indications will be considered only when the prescriber submits sufficient documentation of safety and efficacy consistent with applicable off‑label use policies (commercial: CP.CPA.09; Marketplace: HIM.PA.154; Medicaid: CP.PMN.53) or the plan's evidence of coverage. If adequate supporting evidence is not provided, the request may be denied.

Off‑label use must reference supporting clinical evidence and comply with the referenced off‑label policies

Definitions

Partial-thickness wound

DefinitionPartial-thickness wounds affect the epidermis and may extend into the dermis (wounds that do not extend through the dermis into adipose tissue).

EB-specific delayed healing thresholdIn epidermolysis bullosa, partial-thickness wounds present ≥21 days are considered delayed in healing and are candidates for treatment with Filsuvez.

Typical healing timelinePartial-thickness wounds normally heal within 1 to 3 weeks; persistence beyond 21 days indicates delayed healing in EB.

DEB / JEB

DEB (dystrophic epidermolysis bullosa)A rare EB subtype caused by mutation in the COL7A1 gene or PLOD3 gene; clinical diagnosis is supported by immunofluorescence mapping, transmission electron microscopy, or genetic testing.

JEB (junctional epidermolysis bullosa)

Background

Filsuvez is an oleogel formulation of birch triterpenes formulated as a topical gel (available as a 10% w/w, 25 mL tube) intended to accelerate re‑epithelialization of delayed partial‑thickness wounds in epidermolysis bullosa. The therapeutic intent is to promote keratinocyte differentiation and migration so that partial‑thickness wounds present ≥21 days (delayed healing) close more rapidly when applied per the labeled dosing and administration instructions.

Revision History

2024-03-05policy_edit

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

2025-02-25policy_editLatest

Added to initial approval criteria: exclusion for members with current evidence or history of squamous cell carcinoma in the treatment area (1Q 2025 annual review).

Policy Summary

PayerHealth Net

PolicyBirch Triterpenes (Filsuvez) — Clinical Policy

Policy CodePolicy CP PHAR.669

Change TypeAdded exclusions and safety criterion

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with genetic confirmation of DEB or JEB and baseline target wound size documentation.

SourceLink

On This Page

Concomitant therapy exclusion:

Concomitant use with Vyjuvek is excluded for dystrophic epidermolysis bullosa.

Policy explicitly added exclusion; Vyjuvek is not FDA-approved for JEB

Insufficient documentation may result in denial

Denial Risk

Concomitant Vyjuvek Exclusion

Filsuvez must not be prescribed concurrently with Vyjuvek for dystrophic epidermolysis bullosa (DEB). Concomitant use with Vyjuvek in DEB is excluded and may be denied.

Concomitant use with Vyjuvek in DEB is excluded
Vyjuvek is not FDA‑approved for junctional EB — do not combine therapies for DEB

Documentation Required

Required Documentation

Provider must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office/chart notes, genetic testing results confirming diagnosis (see Appendix D), baseline wound measurements and duration, wound care history, and any relevant pathology or imaging.

Office notes and chart documentation
Genetic testing confirming DEB or JEB
Baseline wound size and duration (target wounds ≥21 days and <9 months)
Documentation of absence of current or prior squamous cell carcinoma in treatment area
Evidence of standard wound care being used concurrently

Documentation Required

Required Documentation for Prescribing

Prescribers must document the specific indication (DEB or JEB), application instructions, and dosing details in the request. Include how Filsuvez will be applied (thin layer to affected wound surface or applied to dressing), frequency, number of target wounds, and total quantity requested (dose limit: ≤1 tube per target wound per day).

Indication: specify DEB or JEB
Application instructions and frequency (apply thin layer to wound or to dressing)
Number of target wounds and baseline wound size
Requested quantity and confirmation dose ≤1 tube per target wound per day

Note

Concurrent Therapy Restriction

Concurrent therapy restriction: Filsuvez may be used with standard wound care measures (e.g., polymeric membranes, superabsorbent dressings, soft‑silicone foam, enzyme alginogel, protease), but must not be used concurrently with Vyjuvek for DEB. This is not a step‑therapy requirement but an exclusion for simultaneous prescription with Vyjuvek.

Concurrent use with standard wound care is acceptable and should be documented
Do not prescribe Filsuvez concurrently with Vyjuvek for DEB

Step Therapy

There is no step therapy requirement for Filsuvez under this policy. Prior authorization decisions are based on meeting the specified initial or continued therapy clinical criteria rather than on failure of other specified agents.

No step therapy required
Coverage based on meeting clinical criteria and required documentation

A rare EB subtype caused by mutation in one of LAMA3, LAMB3, LAMC2, COL17A1, ITGA3, ITGA6, or ITGB4 genes; genetic testing is recommended for diagnosis.

Diagnostic recommendationPer 2020 clinical practice guidelines, genetic testing is always recommended for the diagnosis of EB; IFM and TEM are adjunctive methods when needed.

Filsuvez

Product descriptionTopical oleogel containing birch triterpenes (Filsuvez) that accelerates re-epithelialization by enhancing keratinocyte differentiation and migration.

Active concentration10% w/w (active concentration in available topical gel).

Container sizeSupplied as a 25 mL tube.

Indicated usesIndicated for treatment of wounds associated with dystrophic epidermolysis bullosa (DEB) and junctional epidermolysis bullosa (JEB); apply a specified mm layer to the affected wound surface and cover with a sterile non-adhesive dressing or apply directly to the dressing until wound healed.

EASE study

Study identifierEASE study — a Phase III randomized, double-blind efficacy and safety trial of oleogel (birch triterpenes) in epidermolysis bullosa (published in Br J Dermatol, 2023).

Publication referenceKern JS et al., Br J Dermatol. 2023;188(1):12-21. doi:10.1093/bjd/ljac001 (EASE study results).