Prior authorization criteria for Vyjuvek (beramagene geperpavec) for dystrophic epidermolysis bullosa wounds
Customize your policy alerts
Sign up for all Alaska Medicaid policy alerts
Know when Alaska Medicaid releases new policies or updates existing guidance.
Monitor payer policy activity
Prior authorization criteria for use of Vyjuvek (beremagene geperpavec) to treat wounds in patients with dystrophic epidermolysis bullosa (DEB) with COL7A1 mutations; applies to Alaska Medicaid coverage decisions and providers seeking authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria for Vyjuvek (beremagene geperpavec)
Approval Criteria
Covered when ALL of the following are met
All conditions must be met for approval.
The safety of Vyjuvek in pregnancy and lactation has not been established. Exercise clinical caution when prescribing to pregnant or breastfeeding patients and weigh potential benefits against unknown risks. Additionally, avoid direct contact with the treated wound and with dressings of treated wounds for approximately 24 hours following application to minimize potential exposure.
Use will be denied if the patient fails to meet the listed approval criteria.
Coding and Quantity Limits
| J3401 | Vyjuvek (beremagene geperpavec) HCPCS |
Provider Actions, Authorization, and Documentation
Prior authorization required; time- and quantity-limited
Prior authorization is required for Vyjuvek (HCPCS J3401). Initial approvals and reauthorizations are limited to up to 6 months. Quantity limits vary by age: patients 6 months to <3 years — 3.2 mL per 28 days; patients ≥3 years — 6.4 mL per 28 days.
- HCPCS: J3401
- Initial Approval: up to 6 months
- Reauthorization Approval: up to 6 months
- Quantity limits — 6 months to <3 years: 3.2 mL / 28 days
- Quantity limits — ≥3 years: 6.4 mL / 28 days
Prescriber and patient eligibility requirements
The medication must be prescribed by or in consultation with a dermatologist. The patient must meet the FDA-labeled age and have a confirmed COL7A1 mutation and a diagnosis of dystrophic epidermolysis bullosa (DEB).
- Prescriber: must be or consult with a dermatologist
- Age: patient must meet FDA labeled age
- Diagnosis: dystrophic epidermolysis bullosa (DEB)
- Genetics: confirmed COL7A1 mutation by genetic testing
Required clinical documentation and provider attestation
Submit documentation of the baseline size of the target wounds and genetic testing confirming a COL7A1 mutation. Include a provider attestation that the wounds have adequate granulation tissue, are well vascularized, have no active infection, and have no evidence of squamous cell carcinoma.
- Documentation: baseline size of target wounds
- Genetic testing: confirmation of COL7A1 mutation
- Attestation: wounds have (a) adequate granulation tissue, (b) are well vascularized, (c) no active infection, (d) no evidence of squamous cell carcinoma
Denial risk for unmet criteria
Use will be denied if the patient does not meet all listed approval criteria.
- Failure to meet approval criteria results in denial of coverage
Background
Vyjuvek (beremagene geperpavec) is a herpes-simplex virus type 1 (HSV-1) vector–based topical gene therapy indicated to treat wounds in patients aged 6 months and older with dystrophic epidermolysis bullosa who have mutations in the COL7A1 gene. Treatment is intended for suitable wounds (those with adequate granulation tissue, good vascularization, no active infection, and no evidence of squamous cell carcinoma). Safety in pregnancy and lactation has not been established, and treated wounds/dressings should be avoided for approximately 24 hours after application.
Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.