CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyjuvek (beremagene geperpavec-svdt) topical for dystrophic epidermolysis bullosa

Policy governs coverage, dosing, and renewal criteria for topical Vyjuvek for members (Medicaid, Commercial, Medicare‑Medicaid Plan) with dystrophic epidermolysis bullosa and COL7A1 mutations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyjuvek (beremagene geperpavec-svdt) topical for dystrophic epidermolysis bullosa

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization; initial approvals are for six months and may be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization length

1 vial/7 daysMaximum dosing frequency

65% vs 26%Wound closure at 24 weeks

≥6 monthsMinimum patient age

Q81.2Covered diagnosis

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Initial Therapy

Covered when ALL of the following are met

Age: Patient is at least 6 months of age>=6 months

Prior therapies: For MMP members previously treated within the prior 365 days, therapy step requirements do not apply

(see prior authorization)

Universal/graft history: Patient has not received a skin graft within the prior 3 monthsclinical history

Diagnosis of dystrophic epidermolysis bullosa confirmed by detection of mutation(s) in the COL7A1 (type VII alpha 1 chain) gene on molecular testingmolecular confirmation

Wound characteristics: Treated cutaneous wound(s) are clean with adequate granulation tissue, well vascularized, and not infectedclinical assessment

Wounds to be treated must not be currently healed

Clinical manifestations: Patient has clinical manifestations of DEB (for example, extensive skin blistering, skin erosions, scarring)clinical exam

Cancer history: No history of squamous cell carcinoma in the affected wound(s) to be treatednone

Prescriber: Vyjuvek is prescribed by, or in consultation with, a wound care specialist experienced in treating DEBspecialist involvement

Concomitant therapy restriction: Vyjuvek will not be administered in combination with Filsuvez (birch triterpenes)no combination therapy

Vyjuvek will not be administered to wounds that are currently healed

Renewal Therapy

Renewal is provided when ALL of the following are met

Continued indication: Patient continues to meet the original indication-specific criteria identified in the initial approval sectionongoing confirmation

Tolerability: Absence of unacceptable toxicity or severe medication reactions that warrant discontinuationno severe toxicity

Examples include severe reactions warranting therapy discontinuation

Response: Documentation of disease response defined as improvement (healing) of treated wound sites and/or reduction in skin infectionsclinical improvement

Vyjuvek will not be administered to wounds that are currently healed. The product also must not be used in combination with Filsuvez (birch triterpenes).

Treatment with Vyjuvek is not medically necessary when the diagnosis of dystrophic epidermolysis bullosa is not confirmed by molecular testing demonstrating mutations in the COL7A1 gene. Vyjuvek is also not indicated for wounds that are infected or for wounds with a history of squamous cell carcinoma in the target area.

Billing and Coding

HCPCS CoveredHCPCSCovered

J3401

beremagene geperpavec-svdt for topical administration containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml

NDCNDCCovered

82194-0510-XX

Vyjuvek 1.0 mL extractable volume in a single-use, single-dose vial containing 5x109 PFU /mL

Covered Diagnosis CodesICD-10Covered

Q81.2

Epidermolysis Bullosa Dystrophic

Maximum weekly PFU and volume by weight band

<20 kg4 x 10^8 PFU — 0.2 mL per week

20 to <40 kg8 x 10^8 PFU — 0.4 mL per week

40 to 60 kg1.2 x 10^9 PFU — 0.6 mL per week

>60 cm^2 wound area (calculation note)For wound area >60 cm^2, calculate total dose using the table above and apply until the maximum weekly dose for the patient’s weight band is reached

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiation of therapy. Initial approvals are for six months. Renewal/continuation beyond the initial approval requires documentation of ongoing benefit and that renewal criteria are met. Members of the Medicare‑Medicaid Plan (MMP) who received this medication within the prior 365 days are not subject to step-therapy requirements but still require prior authorization.

Initial approval length: 6 months
Renewal requires documentation of continued medical necessity
Prior authorization required for all lines of business

Note

Therapy Requirements

Therapy must be for an FDA‑approved or compendia‑supported indication and consistent with P&T‑approved clinical criteria. Review must include prior therapies where applicable; MMP members with prior receipt in the past 365 days bypass step requirements but must meet other coverage criteria.

Must align with FDA labeled use or compendia/P&T criteria
Review of prior therapies and step requirements (unless MMP member received drug within 365 days)

Documentation Required

Documentation to Support Medical Necessity

To support medical necessity, submit documentation that includes: diagnosis confirmation by molecular testing for COL7A1 (mutation detection), targeted genetic testing results, detailed wound assessments (location, size, cleanliness, granulation, vascularization, absence of infection), clinical disease manifestations (extent of blistering/erosions/scarring), and documentation that the prescribing clinician is or consulted with a DEB/wound care specialist.

Molecular test report confirming COL7A1 mutation(s)
Targeted genetic testing results and interpretation
Wound documentation: photos, size, granulation status, vascularization, absence of infection
Clinical notes describing extent of skin blistering, erosions, and scarring
Evidence of specialist involvement (consultation notes)

Denial Risk

Denial Risk: Missing Molecular Testing or Contraindicating History

There is a high risk of denial if required molecular testing confirming COL7A1 mutations is not provided. Treatment may also be denied if wound documentation is inadequate or if there is a history of squamous cell carcinoma in the wound(s) intended for treatment.

Absence of COL7A1 molecular testing → denial risk
History of squamous cell carcinoma in target wound(s) → denial

Background and Clinical Context

Vyjuvek (beremagene geperpavec-svdt) is an FDA‑approved topical gene therapy indicated for treatment of cutaneous wounds in patients with dystrophic epidermolysis bullosa due to mutations in the COL7A1 gene. Use is authorized for patients aged ≥6 months and must be prescribed by, or in consultation with, a wound care specialist experienced in DEB. Clinical trial evidence supporting approval demonstrated superior wound closure compared with placebo in the pivotal randomized intra‑subject trial.

OpenPayer

Vyjuvek (beremagene geperpavec-svdt) topical for dystrophic epidermolysis bullosa

Coverage and Medical Necessity Criteria

Billing and Coding

Prior Authorization, Documentation, and Provider Responsibilities

Background and Clinical Context

Definitions