CurrentAlaska MedicaidPolicy N/A

Prior authorization criteria for Vyjuvek (beramagene geperpavec) for dystrophic epidermolysis bullosa wounds

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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.

Policy Summary

PayerAlaska Medicaid

PolicyPrior authorization criteria for Vyjuvek (beramagene geperpavec) for DEB wounds

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; provide documentation of baseline wound size and genetic confirmation of a COL7A1 mutation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval duration

6 moreauthorization duration

J3401HCPCS code

3.2 / 6.4 mLquantity limits

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CurrentAlaska MedicaidPolicy N/A

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.

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Policy Summary

PayerAlaska Medicaid

PolicyPrior authorization criteria for Vyjuvek (beramagene geperpavec) for DEB wounds

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; provide documentation of baseline wound size and genetic confirmation of a COL7A1 mutation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial approval duration

6 moreauthorization duration

J3401HCPCS code

3.2 / 6.4 mLquantity limits

Coverage Criteria for Vyjuvek (beremagene geperpavec)

Approval Criteria

Covered when ALL of the following are met

Vyjuvek approval criteria: 1. Patient meets FDA labeled age; 2. Prescribed by or in consultation with a dermatologist; 3. Diagnosis of dystrophic epidermolysis bullosa (DEB); 4. Mutation in the collagen type VII alpha 1 chain (COL7A1) confirmed by genetic testing; 5. Documentation of baseline size of target wounds has been provided; 6. Provider attestation that wounds to be treated meet ALL of the following: (a) adequate granulation tissue is present, (b) tissue is well vascularized, (c) no evidence of active infection, and (d) no evidence of squamous cell carcinoma.

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

Covered HCPCS CodesHCPCSCovered

J3401

Vyjuvek (beremagene geperpavec) HCPCS

Quantity limits by age

Quantity limit, ages 6 months to <3 years3.2 mL per 28 days

Quantity limit, ages ≥3 years6.4 mL per 28 days

Billing HCPCS codeJ3401 (report per quantity limits)

Provider Actions, Authorization, and Documentation

Prior Authorization

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

Step Therapy

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).

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

Vyjuvek (beremagene geperpavec) — overview

Drug class and mechanismHerpes-simplex virus type 1 (HSV-1) vector–based topical gene therapy

Indication summaryTreatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) due to COL7A1 mutations

FDA labeled agePatients 6 months of age and older

Key treatment requirementApplied to suitable wounds (per policy: adequate granulation tissue, well vascularized, no active infection or squamous cell carcinoma)