CurrentCentenePolicy CP PHAR.592

Beremagene geperpavec-svdt (Vyjuvek) for dystrophic epidermolysis bullosa (DEB)

Defines medical necessity criteria, initial and continued approval, dosing, exclusions, appendices (diagnosis, dosing by wound size, wound care), coding implications, and product availability for Vyjuvek for members of Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyBeremagene geperpavec-svdt (Vyjuvek) for dystrophic epidermolysis bullosa (DEB)

Policy CodePolicy CP PHAR.592

Change TypeMultiple (coding added, criteria revised, exclusions added, dosing clarified)

Effective Date05.19.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, genetic testing confirming COL7A1 mutation, baseline wound size, and attestations described in criteria) to support that member meets all approval criteria.

POLICY UPDATE CHANGES

Added HCPCS code J3401.

Updated diagnosis criteria to confirmation of COL7A1 gene mutation via genetic testing only.

Added exclusion of concomitant use with Filsuvez.

Added exclusion of concomitant use with Zevaskyn.

Updated maximum dosing criteria as reflected in the Prescribing Information (PI).

1FDA-approved indication (DEB with COL7A1 mutation)

J3401Assigned HCPCS code

6Initial approval duration (months)

2Concomitant therapies explicitly excluded

Coverage Summary

Scope: Defines medical necessity criteria, initial and continued approval, dosing, exclusions, appendices (diagnosis, dosing by wound size, wound care), coding implications, and product availability for Vyjuvek for members of Centene-affiliated health plans (Commercial, HIM, Medicaid). Coverage stance: covered_with_criteria. Effective date: 05.19.23. Last review date: 08.25. Vyjuvek is FDA indicated for treatment of wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB) due to COL7A1 mutations. Coverage is provided only when the criteria below are met.

Key thresholds & quick facts

Initial approval duration6 months

Assigned HCPCS codeJ3401

Concomitant therapies explicitly excluded2 (Filsuvez, Zevaskyn)

FDA age labeled range>= 6 months

Initial Therapy Criteria

Initial Approval Criteria

Vyjuvek is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of dystrophic epidermolysis bullosa (DEB) as evidenced by COL7A1 gene mutation confirmed by genetic testing (see Appendix E).
Prescriber: Prescribed by or in consultation with a geneticist, dermatologist, or histopathologist.
Wound appearance attestation: Provider attestation that target wounds are clean in appearance with adequate granulation tissue, have excellent vascularization, and do not appear infected.
Age within FDA labeled range: 6 months or older.
Age-specific dosing specified in dosing section.

Approval Duration

Initial authorization duration: 6 months.

Continuation Therapy Criteria

Continued Therapy Criteria

For continuation of Vyjuvek therapy, member must meet one of the following and additional continued criteria:

Continued Therapy

One of
- Currently receiving: Member is currently receiving medication via Centene benefit.
- Prior initial approval: Member has previously met initial approval criteria.
Response to therapy: Member is responding positively to therapy as evidenced by improvement in parameters such as decrease in wound size or decrease in pain severity for target wound sites associated with dressing changes.

Unproven / Exclusions

Other Indications / Non-Formulary / Off-Label

Routing for non-meeting requests: Requests for uses not meeting the prior criteria: follow respective line-of-business policies for no-coverage, non-formulary, or off-label use: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid) for no coverage; CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid) for non-formulary; CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid) for off-label use.

Diagnoses/Indications Not Authorized

Non-authorized indications: Non-FDA approved indications are not authorized unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided.

Material changes: the policy adds specific concomitant use exclusions — exclusion of concomitant use with Filsuvez (added 03.05.24) and exclusion of concomitant use with Zevaskyn (added 04.15.25). These additions are documented as material changes to the policy.

Applicable Codes

HCPCS J-code for Vyjuvek (product-specific billing)HCPCSCovered

J3401

Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 PFU/mL gel

Provider Actions & Prior Authorization

Prior Authorization

Submit documentation for approval

Submit office chart notes, laboratory results, genetic testing confirming COL7A1 mutation, documentation of baseline target wound size, and required provider attestations described in the approval criteria to support that the member meets all approval requirements for Vyjuvek.

J3401

Documentation Required

Genetic testing requirement

Genetic testing confirming a COL7A1 gene mutation is required for diagnosis. See Appendix E for recommended no‑charge testing resources such as the Invitae Epidermolysis Bullosa panel and the Krystal Decode DEB program.

Clinical Evidence & References

Evidence referenced in this policy includes the key clinical trial and the product Prescribing Information: Trial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa, N Engl J Med. 2022;387(24):2211-2219 (key clinical trial) and Vyjuvek Prescribing Information. Krystal Biotech, Inc.; 2023 May. The policy references the PI, clinical trial data, and best-practice wound care guidelines.

Evidence / trial quick facts

Key clinical trial citationTrial of beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa. N Engl J Med. 2022;387(24):2211-2219.

Prescribing information (PI)Vyjuvek Prescribing Information. Krystal Biotech, Inc.; 2023 May.

Background

Background: Vyjuvek (beremagene geperpavec) is an HSV-1 vector-based topical gene therapy indicated for treatment of wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB) due to COL7A1 mutations. The policy includes appendices for diagnosis (Appendix E), dosing by wound size (Appendix F), recommended wound care (Appendix G), and product availability. The PI and best-practice wound care guidelines are referenced for clinical and dosing guidance.

Definitions

COL7A1Collagen type VII alpha 1 chain gene

DEBDystrophic epidermolysis bullosa

PFUPlaque forming units

Dosing Thresholds

Age-based maximum weekly dose: For ages 6 months to < 3 years the maximum weekly dose is 1.6 x 10^9 PFU (0.8 mL) topically once weekly; for age ≥ 3 years the maximum weekly dose is 3.2 x 10^9 PFU (1.6 mL) topically once weekly. See Appendix F for dose by wound size examples (e.g., 0–20 cm^2: 4 x 10^8 PFU (0.2 mL); 40–60 cm^2: 1.2 x 10^9 PFU (0.6 mL)); for wound area >60 cm^2 calculate total dose from the table until the age-based maximum weekly dose is reached.

Dosing thresholds

Age-based maximum weekly dose6 months to < 3 years: 1.6 x 10^9 PFU (0.8 mL) weekly; ≥ 3 years: 3.2 x 10^9 PFU (1.6 mL) weekly

Dose by wound size (Appendix F guidance)Examples: 0–20 cm^2: 4 x 10^8 PFU (0.2 mL); 20–40 cm^2: 0.4 mL; 40–60 cm^2: 1.2 x 10^9 PFU (0.6 mL); >60 cm^2: calculate total dose until maximum weekly dose reached.

Revision History

2023-10-27code_added

HCPCS code J3401 added (Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 PFU/mL gel).

2023-05-19policy_creation/initial

Policy effective date 05.19.23; initial criteria and requirements established per FDA labeling (including age ≥6 months, dosing, and clinical criteria).

unspecifiedcriteria_clarified

Initial criteria clarified to require genetic confirmation of COL7A1 mutation, added requirement to document baseline size of target wounds, and updated wording to refer to 'target wounds' consistent with Appendix E and Appendix F dosing guidance.

Policy Summary

PayerCentene

PolicyBeremagene geperpavec-svdt (Vyjuvek) for dystrophic epidermolysis bullosa (DEB)

Policy CodePolicy CP PHAR.592

Change TypeMultiple (coding added, criteria revised, exclusions added, dosing clarified)

Effective Date05.19.23

Next Review Date

On This Page

Baseline wound size: Documentation of size of target wounds at baseline (see Appendix F).

SCC exclusion: Member does not have current evidence or history of squamous cell carcinoma in the area that will undergo treatment.

Concurrent standard wound care: Provider attestation that member is concomitantly receiving standard of care preventative or treatment therapies for wound care (e.g., polymeric membrane, superabsorbent dressings, soft-silicone foam, enzyme alginogel, protease modulators; see Appendix G).

Concomitant product exclusions: Vyjuvek is not prescribed concurrently with Filsuvez or Zevaskyn.

Concomitant use with Filsuvez excluded (added 03.05.24) and with Zevaskyn (added 04.15.25).

Dose must meet ONE of the following age-based criteria

6 months to < 3 years: For ages 6 months to < 3 years: 1.6 x 10^9 PFU (0.8 mL) topically once weekly.
≥ 3 years: For age ≥ 3 years: 3.2 x 10^9 PFU (1.6 mL) topically once weekly.

Note: See Appendices for resources and practical guidance — Appendix E (diagnosis resources and recommended genetic testing), Appendix F (dosing guidance by wound size), and Appendix G (recommended wound care and dressings). Prescribing Information (PI) and dosing clarifications are referenced in the policy and reflected in appendices. Age-specific dosing is specified in the dosing section and the policy uses the following maximum weekly dose thresholds per policy thresholds: see dosing section and Appendix F for examples and calculation guidance.

Ongoing wound appearance attestation: Provider attestation that member continues to have incomplete wound closures that are clean in appearance with adequate granulation tissue, have excellent vascularization, and do not appear infected.

Not applied to healed wounds: Vyjuvek is not applied to target wounds that have completely healed.

Dose-limit for increases

6 months to < 3 years: For ages 6 months to < 3 years: 1.6 x 10^9 PFU (0.8 mL) weekly.
≥ 3 years: For age ≥ 3 years: 3.2 x 10^9 PFU (1.6 mL) weekly.

Concomitant product exclusions: Vyjuvek is not prescribed concurrently with Filsuvez or Zevaskyn.

Documentation Required

Baseline wound documentation

Document the size of target wounds at baseline per the dose-by-wound-size guidance in Appendix F to support dosing and eligibility.

Denial Risk

Concurrent product exclusion

Requests may be denied if Vyjuvek is prescribed concurrently with Filsuvez or Zevaskyn; concomitant use with these products is explicitly excluded.

Documentation Required

Wound care concurrent therapy

Provider must attest that the member is receiving standard‑of‑care wound therapies (for example polymeric membrane, superabsorbent dressings, soft‑silicone foam, enzyme alginogel, protease modulators) in accordance with Appendix G.

2023-2025dosing_clarification

Dose clarifications and Appendix F dosing by wound size added and maximum weekly dosing aligned with Prescribing Information (age-based maximums: 6 months to <3 years = 1.6 x 10^9 PFU weekly; ≥3 years = 3.2 x 10^9 PFU weekly).

2024-03-05exclusion_added

Concomitant use with Filsuvez excluded.

2025-04-15exclusion_added

Concomitant use with Zevaskyn excluded (P&T approval recorded 08.25).

2025-08-25policy_reviewLatest

Last review date 08.25 (3Q 2025 annual review) reflecting addition of Zevaskyn exclusion and references updated; policy status CURRENT.