CurrentAvMedPolicy N/A

Vyjuvek (beremagene geperpavec) prior authorization — coverage criteria

Defines prior authorization, dosing limits, clinical eligibility, and documentation requirements for Vyjuvek (beremagene geperpavec) for treatment of wounds in Dystrophic Epidermolysis Bullosa (DEB); applies to AvMed members and prescribing providers seeking medical coverage for this product.

Policy Summary

PayerAvMed

PolicyVyjuvek (beremagene geperpavec) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with baseline wound assessment, molecular confirmation of COL7A1 mutation, prescriber signature, and dosing calculation per Section A.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

26 weeksinitial authorization duration

650max units per auth

1/7 daysper-dose frequency

J3401HCPCS

82194-0510-02Product NDC

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Vyjuvek (beremagene geperpavec)

inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization Criteria: Member has NOT received a skin graft within the prior 3 months; Provider is a specialist in dermatology or has consulted with a specialist knowledgeable in the treatment of Dystrophic Epidermolysis Bullosa (DEB); Member's diagnosis of DEB confirmed by detection of mutation(s) in the COL7A1 gene on molecular genetic testing (laboratory documentation required); Evidence of cutaneous wound(s) that are clean with adequate granulation tissue, excellent vascularization, and do NOT appear infected (documentation required); Provider documents no current evidence or history of squamous-cell carcinoma at wound sites; Provider submits baseline wound assessment including member age, wound size/measurements, body surface area location, and calculated dosing volume per Section A; Provider confirms a negative pregnancy test and members of childbearing potential will use reliable contraception throughout treatment and for 3 months after last dose.Initial authorization: 6 months (26 weeks), maximum dose 650 billable units

Dose and volume must be calculated from Section A (age and wound area table); typical per-dose supply: 1 vial (25 billable units, 2.5 mL) every 7 days.

inv-02: Reauthorization (6 months) — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Reauthorization Criteria: Member continues to meet all initial authorization criteria; Member has experienced an absence of unacceptable toxicity from the drug (e.g., no severe medication reactions requiring discontinuation); Member has demonstrated positive disease response to treatment (healing/improvement of treated wounds, reduction in skin infections) with supporting documentation; Provider submits updated wound assessment including body surface area location, wound size/measurements, and dosing requirement.Reauthorization period: 6 months (26 weeks), maximum dose 650 billable units

Documentation of clinical benefit and updated wound measurements required to continue therapy.

Therapy with Vyjuvek will not be approved when any of the following disqualifying medical conditions or recent treatments are present: history of thymoma or other neoplasms of the thymus; history of thymectomy within 12 months prior to intended treatment; MGFA Class I or myasthenic crisis at initiation of treatment; receipt of rituximab within 6 months prior to treatment; receipt of IVIG or plasmapheresis (PE) within 4 weeks prior to treatment; any unresolved systemic bacterial or other significant infections not treated with appropriate antibiotics; or unresolved meningococcal disease.

Coding, Dosing and Quantity Limits

Covered HCPCS CodeHCPCSCovered

J3401

Vyjuvek (beremagene geperpavec-svdt) (Medical)

Product NDCNDC

82194-0510-02

Vyjuvek single-dose vial NDC

Maximum weekly dose by wound area and age

<3 years — Wound area <20 cm2Maximum weekly dose: 2 x 10^9 PFU; Maximum weekly volume: 1 mL (dose per application 4 x 10^8 PFU; per‑application volume 0.2 mL)

<3 years — Wound area 20 to <40 cm2Maximum weekly dose: 4 x 10^9 PFU; Maximum weekly volume: 2 mL (dose per application 8 x 10^8 PFU; per‑application volume 0.4 mL)

<3 years — Wound area 40 to 60 cm2Maximum weekly dose: 4 x 10^9 PFU; Maximum weekly volume: 2 mL (dose per application 1.2 x 10^9 PFU; per‑application volume 0.6 mL)

>60 cm2 (all ages)For wound area over 60 cm2, calculate total dose using the table above until overall maximum weekly dose is reached

≥3 years — Wound area <20 cm2Maximum weekly dose: 2 x 10^9 PFU; Maximum weekly volume: 1 mL (per‑application dose 4 x 10^8 PFU; per‑application volume 0.2 mL)

≥3 years — Wound area 20 to <40 cm2Maximum weekly dose: 4 x 10^9 PFU; Maximum weekly volume: 2 mL (per‑application dose 8 x 10^8 PFU; per‑application volume 0.4 mL)

Vyjuvek (beremagene geperpavec) dosing and units

Dosing frequency1 vial every 7 days

Vial size and contentSingle‑dose vial 2.5 mL containing 5 x 10^9 PFU/mL

Billable unit conversion1 vial = 25 billable units

Overall authorization maximumMaximum 650 billable units per authorization period (initial or reauthorization)

Provider Actions and Documentation Requirements

Prior Authorization

Prescriber Signature and Contact

Prior Authorization Required: Requests require a signed prescriber signature and complete prescriber contact information. The prescribing physician must hand-sign and clearly print their name on the request (preprinted stamps are not valid). Include prescriber phone and fax numbers and NPI. Incomplete, illegible, or missing information may delay or result in denial of authorization.

Prescriber signature (hand-signed) and printed name — preprinted stamps not accepted
Prescriber contact: office contact name, phone number, fax number, NPI

Step Therapy

Samples and Prior Therapy Verification

Samples do not satisfy step-edit or prior authorization requirements. Prior therapies will be verified via pharmacy paid claims or chart notes; document prior treatment history in the request to support coverage decisions.

Use of samples to initiate therapy does not meet step-edit/preauthorization criteria
Previous therapies will be verified through pharmacy paid claims or submitted chart notes

Documentation Required

Required Clinical Documentation

Submit complete baseline wound assessment and related clinical documentation with the request. Include member age, wound size (area in cm2), calculated required volume, body surface area location, wound measurements, and dosing calculations (see dosing table in Section A). Provide photos, lab results, diagnostic reports, genetic test results confirming COL7A1 mutation when applicable, documentation of wound appearance (clean, granulation, well vascularized, not infected), and documentation that treated sites have no current or prior squamous cell carcinoma.

Baseline wound assessment: member age, wound size, calculated volume, body surface area location
Dosing calculations per Section A (maximum weekly PFU and volume based on age and wound area)
Photos of wound sites and wound measurements
Laboratory/diagnostic documentation (including molecular genetic testing for COL7A1 when applicable)
Documentation of no current/history of squamous cell carcinoma at treated sites

Denial Risk

Documentation Completeness

Incomplete, incorrect, or illegible information may delay or result in denial of authorization. Ensure all required fields on the authorization form are completed — member identifiers, prescriber information, baseline wound assessment, dosing calculations, and supporting clinical records — prior to submission.

Authorization may be delayed or denied if information provided is not complete, correct, or legible
Include all supporting chart notes, lab results, and photos to avoid denial

Definitions and Baseline Requirements

DEB confirmation (COL7A1 testing)

Required molecular confirmationDetection of mutation(s) in the COL7A1 gene on molecular genetic testing (laboratory documentation must be submitted)

Diagnosis referencedDystrophic Epidermolysis Bullosa (DEB)

Documentation requirementLaboratory report of COL7A1 mutation(s) must be provided with the authorization request

Baseline wound assessment — required data elements

Required baseline elementsMember age, wound size (cm2), body surface location of wounds, and calculated dosing volume per Section A must be submitted

Wound measurementsDocument wound size and calculated required volume (per the age/wound area table) at baseline

Wound statusEvidence that wounds are clean, have adequate granulation tissue, excellent vascularization, and are not infected must be provided

Additional documentationProvider must confirm no current evidence or history of squamous‑cell carcinoma at treated sites

Initial Therapy Clinical and Dosing Requirements

inv-15: Initial Therapy (medical) — Initial authorization clinical and dosing requirements (nested criteria)

Initial authorization clinical and dosing requirements

Initial Therapy Drug Criteria: Molecular confirmation of COL7A1 mutation is provided; Baseline wound assessment submitted documenting member age, wound size/measurements, body surface area location, and calculated dosing volume per Section A; No skin graft within prior 3 months; Provider is a dermatologist or has consulted/coordinates with a DEB-knowledgeable specialist; Wounds are clean with adequate granulation tissue, well vascularized, and not infected; No current evidence or history of squamous-cell carcinoma at treated sites; Negative pregnancy test for members of childbearing potential and reliable contraception required during treatment and for 3 months after last dose.

Initial authorization duration: up to 6 months (26 weeks); maximum 650 billable units. Dosing/volume determined from Section A table (age and wound area). Typical per-dose unit: 1 vial = 25 billable units (2.5 mL) every 7 days; calculate total weekly dose from table until weekly maximum reached.

Reauthorization / Continuation Criteria

inv-16: Reauthorization — Reauthorization requirements for continued coverage

Reauthorization requirements for continued coverage

Continuation Therapy: Member continues to meet all initial authorization criteria; No unacceptable toxicity from therapy; Documented clinical improvement of treated wounds (healing or reduction in infections) with supporting documentation; Provider submits updated wound assessment including body surface area location, wound size/measurements, and dosing requirement.

Reauthorization period: 6 months (26 weeks), maximum 650 billable units.

Requirement	Details
Samples used to initiate therapy	Use of samples to initiate therapy does not meet step-edit/preauthorization criteria.
Verification of prior therapies	Previous therapies will be verified through pharmacy paid claims or submitted chart notes.