CurrentNeighborhood Health Plan of Rhode IslandPolicy Cmp_M_Vyjuvek_20240807

Vyjuvek (beremagene geperpavec-svdt) topical

Defines coverage, dosing limits, authorization length, initial and renewal medical necessity criteria, administration, coding (HCPCS/NDC), and applicable diagnosis codes for Vyjuvek across Medicaid, Commercial, and Medicare-Medicaid Plan members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyjuvek (beremagene geperpavec-svdt) topical

Policy CodePolicy Cmp_M_Vyjuvek_20240807

Change TypeRevised review dates (no material change)

Effective DateOct 1, 2023

Next Review Date

Key ActionObtain prior authorization for six months (may be renewed) and document COL7A1 molecular genetic testing plus wound characteristics and specialist involvement per criteria.

SourceLink

POLICY UPDATE CHANGES

Review dates listed: 9/14/2023, 12/07/2023, 01/04/2024, 08/07/2024; effective date 10/01/2023.

6 monthsMinimum age for use

1 vial/7 daysMaximum dosing frequency

Q81.2Covered diagnosis code

J3401Primary HCPCS code

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines coverage for Vyjuvek (beremagene geperpavec-svdt) topical across Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) members with specified clinical criteria, dosing limits, authorization length, and applicable coding. Effective date: 10/01/2023. Last review date: 08/07/2024.

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 6 months of age
Patient has not received a skin graft within the prior 3 months
Dystrophic Epidermolysis Bullosa (DEB) specific criteria
- Patient has a diagnosis of dystrophic epidermolysis bullosa established by detection of mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene on molecular genetic testing
- Patient has cutaneous wound(s) which are clean with adequate granulation tissue, excellent vascularization, and do not appear infected
- Patient has clinical manifestations of disease (e.g., extensive skin blistering, skin erosions, scarring)
- Patient does not have a history of squamous cell carcinoma in the affected wound(s) that will receive treatment
- Vyjuvek is prescribed by, or in consultation with, a wound care specialist who specializes in the treatment of DEB
- Vyjuvek will not be administered to wound(s) that are currently healed
- Vyjuvek will not be given in combination with Filsuvez (birch triterpenes)

MMP members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements

applies to Medicare-Medicaid Plan (MMP) members