CurrentConnectiCarePolicy C27686-A

Filsuvez Coverage for Epidolysis Bullosa Wounds

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This policy governs prior authorization and coverage of Filsuvez (birch triterpenes gel) for adults and pediatric patients with wounds associated with dystrophic or junctional epidermolysis bullosa. It establishes clinical eligibility, documentation, prescriber, quantity, duration, and continuation requirements.

Policy Summary

PayerConnectiCare

PolicyFilsuvez Coverage for Epidermolysis Bullosa Wounds

Policy CodePolicy C27686-A

Change TypeNo material clinical or coverage change

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit clinical documentation for review of the applicable initial or continuation coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 months+Minimum patient age

3 monthsInitial authorization

3 monthsContinuation authorization

1 tube every other dayStandard quantity limit

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CurrentConnectiCarePolicy C27686-A

Filsuvez Coverage for Epidolysis Bullosa Wounds

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Sign up for ConnectiCare Policy C27686-A alerts

Get alerted when Policy C27686-A changes without checking for updates manually.

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Policy Summary

PayerConnectiCare

PolicyFilsuvez Coverage for Epidermolysis Bullosa Wounds

Policy CodePolicy C27686-A

Change TypeNo material clinical or coverage change

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit clinical documentation for review of the applicable initial or continuation coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 months+Minimum patient age

3 monthsInitial authorization

3 monthsContinuation authorization

1 tube every other dayStandard quantity limit

DEB or JEBCovered subtypes

Coverage Criteria

Initial Therapy

Covered for epidermolysis bullosa when ALL of the following are met:

Initial therapy requirements

Covered diagnosis
- Member has a documented diagnosis of dystrophic epidermolysis bullosa (DEB).
- Member has a documented diagnosis of junctional epidermolysis bullosa (JEB).
Diagnostic confirmation: The diagnosis was confirmed by immunofluorescence, electron microscopy, or antigen mapping.
Documentation required.
Gene or cellular therapy status: The member has not received and is not being considered for gene therapy or investigational cellular therapy.
Standard wound therapy: The member is receiving standard-of-care wound therapy.
Open wound duration: Open partial-thickness wounds associated with DEB or JEB are present.≥ 21 days
Baseline evaluation: The prescriber documents a baseline wound evaluation, including lesion distribution, severity, body-surface area, or comparable measures, and treatment goals to evaluate efficacy at renewal.

Continuation Therapy

Continuation is covered when ALL of the following are met:

Continuation therapy requirements

Tolerability: The prescriber attests, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.
Positive clinical response
- Improved wound closure is demonstrated.
- Improved severity of wound infection is demonstrated.
- Improved total-body wound burden is demonstrated.
- Improved itching before wound dressing changes is demonstrated.

Coverage is not available when the member has received or is being considered for gene therapy or investigational cellular therapy. Documentation of this status is required with the coverage request.

All uses of Filsuvez other than the labeled treatment of wounds associated with dystrophic or junctional epidermolysis bullosa are considered experimental or investigational and are subject to the applicable off-label policy.

Coding and Utilization Parameters

HCPCS CodeHCPCS

NDCNDC

76431-310-01

Filsuvez (birch triterpenes) topical gel 10%, 25 mL tube

Open wound duration

Required durationAt least 21 days

Wound typeOpen partial-thickness wounds

Associated conditionsWounds associated with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB)

Affected body-surface area quantity exception

Exception thresholdAffected body-surface area greater than 12%

Standard quantity limitUp to 1 tube every other day

Exception

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for clinical review. Initial authorization is for 3 months, followed by 3-month continuation authorization periods.

Additional information may be requested case by case, including member-specific dosing data such as weight or body-surface area when applicable.

Documentation Required

General Medical-Necessity Documentation

Submit sufficient documentation to support medical necessity, the requested drug or service, and benefit eligibility. The plan may request additional information during coverage determination, quality improvement, or fraud, waste, and abuse review.

Patient records and relevant test results
Credentials of the provider ordering or performing the drug or service

Filsuvez and Epidermolysis Bullosa

Filsuvez (birch triterpenes gel) is a topical treatment indicated for wounds associated with dystrophic epidermolysis bullosa (DEB) or junctional epidermolysis bullosa (JEB) in adults and pediatric patients 6 months of age and older. The policy requires open partial-thickness wounds, standard-of-care wound therapy, and documentation supporting clinical response for continuation of treatment.

Key Definitions

Dystrophic epidermolysis bullosa (DEB)

AbbreviationDEB

Full termDystrophic epidermolysis bullosa

Coverage statusCovered epidermolysis bullosa subtype for wounds treated with Filsuvez

Junctional epidermolysis bullosa (JEB)

AbbreviationJEB

Full termJunctional epidermolysis bullosa

Coverage statusCovered epidermolysis bullosa subtype for wounds treated with Filsuvez

Filsuvez Initial Therapy

Initial authorization is for 3 months when ALL of the following criteria are met:

Filsuvez initial therapy requirements

Covered diagnosis
- Member has a documented diagnosis of dystrophic epidermolysis bullosa (DEB).
- Member has a documented diagnosis of junctional epidermolysis bullosa (JEB).
Diagnostic confirmation: The diagnosis was confirmed by immunofluorescence, electron microscopy, or antigen mapping.
Documentation required.

Filsuvez Continuation Therapy

Continuation authorization is for 3 months when ALL of the following criteria are met:

Filsuvez continuation therapy requirements

Tolerability: The prescriber attests, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity.
Positive clinical response
- Improved wound closure is demonstrated.
- Improved severity of wound infection is demonstrated.
- Improved total-body wound burden is demonstrated.

Quantity and Dispensing Limits

Filsuvez quantity limits

Standard quantity1 tube (23.4 grams) every other day

Maximum quantity351 grams per 30 days

Affected-BSA exceptionMore than 1 tube every other day may be allowed when affected body-surface area is greater than 12%

Site of Care and Administration

Note

Use the home setting

Topical medication is recommended for pharmacy benefit coverage and patient self-administration.

Policy Summary

PayerConnectiCare

PolicyFilsuvez Coverage for Epidermolysis Bullosa Wounds

Policy CodePolicy C27686-A

Change TypeNo material clinical or coverage change

Effective DateJune 6, 2026

Next Review DateApril 1, 2027

Key ActionSubmit clinical documentation for review of the applicable initial or continuation coverage criteria.

SourceLink

On This Page

Continuation beyond 9 months: For continuation past 9 months of continuous use, the medical record documents that improvement with Filsuvez is greater than improvement from historic previous therapies or concurrent therapies used by the member, providing medical justification for continued therapy.>9 months continuous use

Apply only when therapy continues past 9 months.

More than 1 tube every other day may be allowed when the affected body-surface area is greater than 12%

Target wound surface area

Target wound surface area10–50 cm²

Wound classificationPartial-thickness wound

Evaluation contextTarget wound selected for evaluation of the primary efficacy endpoint

Target wound duration before screening

Duration before screening21 days to 9 months

Wound evaluatedTarget wound

Study contextThe target wound was assessed at randomization before screening

Information demonstrating the service is medically necessary, not investigational or experimental, and within the member's benefits

Documentation Required

Diagnostic Confirmation Required

Document that the member has dystrophic or junctional epidermolysis bullosa (DEB or JEB), with diagnosis confirmed by an accepted diagnostic method.

Accepted confirmation methods include immunofluorescence, electron microscopy, or antigen mapping.

Documentation Required

Disease and Treatment History

Document that the member has not received and is not being considered for gene therapy or investigational cellular therapy, along with relevant prior, concurrent, and standard-of-care wound-treatment history.

Document that the member is receiving standard-of-care wound therapy.

Documentation Required

Baseline Wound Evaluation

Provide a prescriber-documented baseline wound evaluation and treatment goals to establish the starting point for assessing efficacy at renewal.

Include lesion distribution, wound severity, affected body-surface area, or comparable clinical measures.
Document open partial-thickness wounds associated with DEB or JEB that have been present for at least 21 days.

Documentation Required

Continuation Response Documentation

For continuation requests, submit documentation of a positive clinical response and confirm that there is no evidence of intolerable adverse effects or drug toxicity.

Positive response may be demonstrated by improved wound closure, reduced severity of wound infection, reduced total body wound burden, or improved itching before wound dressing changes.

Unsupported block type: documentation

Documentation Required

Consultation Notes Required

When Filsuvez is prescribed by a provider in consultation with a board-certified dermatologist, geneticist, or dermatopathologist, submit the consultation notes with the initial request and with each reauthorization request.

The prescriber must be or consult with a board-certified dermatologist, geneticist, or dermatopathologist.

Billing Rule

Quantity-Limit Exception

Requests for more than the standard quantity require documentation that the member's affected body-surface area is greater than 12%.

Standard limit: 1 tube (23.4 grams) every other day, with a maximum of 351 grams per 30 days.
When affected BSA is greater than 12% and documentation supports the exception, allow greater than 1 tube every other day.

Denial Risk

Insufficient or Inappropriate Documentation

Coverage or reimbursement may be denied, or other appropriate action may be taken, when submitted documentation does not support medical necessity, non-investigational status, benefit eligibility, or otherwise appropriate billing and utilization.

Inadequate documentation includes records that fail to support the initial determination or demonstrate inappropriate or excessive billing or other practice.

Denial Risk

Clinical Criteria Not Met

Requests may be denied when clinical criteria are not met or documentation is incomplete. The record must support the covered diagnosis, accepted diagnostic confirmation, required wound duration, and standard-of-care wound-therapy requirements.

Covered diagnosis: dystrophic or junctional epidermolysis bullosa.
Diagnostic confirmation by immunofluorescence, electron microscopy, or antigen mapping.
Open partial-thickness DEB or JEB wounds present for at least 21 days.
Member is receiving standard-of-care wound therapy.

Denial Risk

Non-Labeled Use

Use of Filsuvez outside the covered epidermolysis bullosa indication is considered experimental or investigational and is not covered under this policy.

Requests for non-labeled or otherwise non-covered indications may be denied.

Target wound

Wound typePartial-thickness wound

Surface area10–50 cm²

Duration before screening21 days to 9 months

Epidermolysis bullosa

ConditionAn inherited skin-fragility disorder

Primary manifestationSkin blistering

Other manifestationsPeeling, erosions, ulcerations, and wounds

Gene or cellular therapy status:

The member has not received and is not being considered for gene therapy or investigational cellular therapy.

Standard wound therapy: The member is receiving standard-of-care wound therapy.

Open wound duration: Open partial-thickness wounds associated with DEB or JEB are present.≥ 21 days

Baseline evaluation: The prescriber documents a baseline wound evaluation, including lesion distribution, severity, body-surface area, or comparable measures, and treatment goals to evaluate efficacy at renewal.

Improved itching before wound dressing changes is demonstrated.

Apply only when therapy continues past 9 months.