CurrentColorado Rocky Mountain Health PlansPolicy N/A

Filsuvez (birch triterpenes) topical gel — Prior Authorization and Medical Necessity Criteria

Defines prior authorization and medical necessity criteria for Filsuvez topical gel for treatment of wounds associated with dystrophic and junctional epidermolysis bullosa for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyFilsuvez topical gel — prior authorization and medical necessity criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJul 1, 2025

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with documentation of genetic mutation and qualifying wound characteristics; authorization issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=6 monthsMinimum patient age

10-50 cm2Eligible wound size

12 monthsAuthorization period

No VyjuvekConcomitant therapy exclusion

Coverage Criteria for Filsuvez (birch triterpenes) topical gel

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Initial Therapy

Covered when ALL of the following are met for initial authorization:

Age: Patient is at least 6 months of age

Diagnosis: One of the following diagnoses: Dystrophic epidermolysis bullosa (DEB) OR Junctional epidermolysis bullosa (JEB)

Genetic confirmation: Submission of medical records (e.g., chart notes, laboratory values) confirming a genetic mutation associated with DEB or JEB (e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)

Wound characteristics: At least one partial-thickness wound meeting all: size 10-50 cm2 AND present ≥ 3 weeks AND adequate granulation tissue AND excellent vascularization AND no evidence of active wound infection AND no evidence or history of basal or squamous cell carcinoma (SCC)

Prescriber: Prescribed by, or in consultation with, a dermatologist with expertise in the treatment of epidermolysis bullosa (EB)

Concomitant therapy exclusion: Patient is not receiving Filsuvez in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

Continuation / Reauthorization

Covered when ALL of the following are met for reauthorization:

Clinical response: Documentation of positive clinical response to Filsuvez therapy (e.g., complete wound closure, reduction in wound size, decreased procedural pain, less frequent dressing changes, decreased total body wound burden)

Wound ongoing criteria: Treated wound(s) meet all: adequate granulation tissue AND excellent vascularization AND no evidence of active wound infection AND no evidence or history of basal or squamous cell carcinoma (SCC)

Prescriber: Prescribed by, or in consultation with, a dermatologist with expertise in the treatment of epidermolysis bullosa (EB)

Concomitant therapy exclusion: Patient is not receiving Filsuvez in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

Use of Filsuvez in combination with Vyjuvek (beremagene geperpavec‑svdt) on the same wound(s) is excluded. Requests for coverage may be denied if the patient is receiving both therapies on the same wound(s).

This exclusion applies to both initial authorization and reauthorization determinations and is listed as a required condition for approval in the policy criteria.

Initial Therapy

Initial coverage is granted when all initial authorization criteria are met.

Age: Patient at least 6 months of age

Authorization will be issued for 12 months

Diagnosis: Dystrophic epidermolysis bullosa (DEB) or Junctional epidermolysis bullosa (JEB)

Genetic confirmation: Medical records confirming a genetic mutation associated with DEB or JEB (e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)

Wound characteristics: Wound 10-50 cm2, present ≥ 3 weeks, with adequate granulation tissue, excellent vascularization, no evidence of active infection, and no evidence or history of basal or squamous cell carcinoma (SCC)

Specialist involvement: Prescribed by, or in consultation with, a dermatologist with expertise in the treatment of epidermolysis bullosa (EB)

Concomitant therapy exclusion: Patient is not receiving Filsuvez in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

Reauthorization / Continuation

Reauthorization

Reauthorization requirements.

Clinical response: Documentation of positive clinical response to Filsuvez therapy is required for reauthorization (examples: complete wound closure, reduction in wound size, decreased procedural pain, less frequent dressing changes, decreased total body wound burden)

Wound criteria maintained: Treated wound(s) must continue to have adequate granulation tissue, excellent vascularization, no evidence of active wound infection, and no evidence or history of basal or squamous cell carcinoma (SCC)

Prescriber: Prescribed by, or in consultation with, a dermatologist with expertise in the treatment of epidermolysis bullosa (EB)

Concomitant therapy exclusion: Patient is not receiving Filsuvez in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s)

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required — Initial Criteria

Prior authorization required. Initial approval will be issued for up to 12 months when ALL of the following are met: patient is at least 6 months of age; diagnosis of dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB); submission of medical records confirming a genetic mutation associated with DEB or JEB (e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3); at least one partial-thickness wound meeting size, duration, and wound-healing characteristics; prescribed by or in consultation with a dermatologist experienced in EB; and patient is not receiving Filsuvez concurrently with Vyjuvek on the same wound(s).

Patient ≥ 6 months of age
Diagnosis: DEB or JEB
Genetic mutation documentation (e.g., COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3)
Wound size: 10–50 cm²
Wound duration: ≥ 3 weeks
Wound characteristics: adequate granulation tissue; excellent vascularization; no active wound infection
No evidence/history of basal or squamous cell carcinoma (SCC)
Prescribed by or in consultation with a dermatologist with EB expertise
Authorization duration: up to 12 months

Documentation Required

Reauthorization — Clinical Response Documentation

At reauthorization, documentation of a positive clinical response to Filsuvez is required and treated wounds must continue to meet wound-safety criteria. Reauthorization is contingent on both clinical improvement and ongoing wound suitability.

Document positive clinical response (e.g., complete wound closure, reduction in wound size, decreased procedural pain, less frequent dressing changes, decreased total body wound burden)
Treated wound(s) must have adequate granulation tissue and excellent vascularization
No evidence of active wound infection
No evidence/history of basal or squamous cell carcinoma (SCC)
Prescribed by or in consultation with a dermatologist with EB expertise

Note

Automated Approval Note

Automated approval or re-approval processes may be used in some programs. UnitedHealthcare (or delegated program) may approve initial or reauthorization requests solely based on prior claims/medication history, diagnosis codes (ICD‑10), and claim logic.

Use of automated approval varies by program and therapeutic class
Approvals may rely on prior claim/medication history and ICD‑10 diagnosis codes

Denial Risk

Concomitant Therapy and Documentation Risk

Concomitant use risk — requests may be denied if the patient is receiving Filsuvez in combination with Vyjuvek (beremagene geperpavec-svdt) on the same wound(s). Verify and document that the same wound(s) are not being treated with both products.

Do not treat the same wound(s) concurrently with Filsuvez and Vyjuvek
If records show concomitant use on the same wound(s), authorization may be denied

Denial Risk

Clinical Criteria Not Met — Denial Risk

Denial risks — initial or reauthorization requests may be denied if the wound(s) do not meet required size, duration, granulation, vascularization, infection-free status, or carcinom a history conditions.

Wound size outside 10–50 cm²
Wound present for < 3 weeks (initial)
Inadequate granulation tissue
Poor vascularization
Evidence of active wound infection
History or evidence of basal or squamous cell carcinoma (SCC)

Definitions

inv-15: DEB / JEB — Definitions for dystrophic and junctional epidermolysis bullosa and common genetic causes.

DEB definitionDystrophic epidermolysis bullosa (DEB): an inherited blistering disorder associated with mutations such as COL7A1

JEB definitionJunctional epidermolysis bullosa (JEB): an inherited blistering disorder associated with mutations such as LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3

Genetic causes listedExamples of associated genes: COL7A1, LAMA3, LAMB3, LAMC2, COL17A1, ITGA6, ITGB4, ITGA3

inv-16: Eligible wound — Partial thickness wound definition including size, duration, granulation and vascularization criteria.

Granulation requirementAdequate granulation tissue must be documented

Vascularization requirementExcellent vascularization must be documented

Infection and carcinoma exclusionNo evidence of active wound infection and no evidence or history of basal or squamous cell carcinoma (SCC)

Background

Filsuvez (birch triterpenes) topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (DEB, JEB) in patients aged 6 months and older. Eligibility for coverage focuses on confirmed DEB or JEB diagnosis, documentation of a causative genetic mutation, and wound characteristics.

Covered wounds must meet specified criteria including being a partial‑thickness wound between 10–50 cm2, present for at least 3 weeks, demonstrating adequate granulation tissue and excellent vascularization, and having no active infection or history/evidence of basal or squamous cell carcinoma. Therapy should be prescribed by, or in consultation with, a dermatologist experienced in epidermolysis bullosa.

OpenPayer

Filsuvez (birch triterpenes) topical gel — Prior Authorization and Medical Necessity Criteria

Coverage Criteria for Filsuvez (birch triterpenes) topical gel

Initial Therapy

Reauthorization / Continuation

Key Clinical & Coding Parameters

Provider Actions, Documentation, and Denial Risks

Definitions

Background