Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Beremagene geperpavec-svdt (Vyjuvek) may be considered medically necessary when ALL the following criteria are met:
- Individual is one (1) to 40 years of age at time of treatment decision; and
- Diagnosis of severe recessive dystrophic epidermolysis bullosa (DEB) confirmed by genetic testing indicating a mutation in the COL7A1 gene; and
- Prescribed by or in consultation with a specialist with experience and expertise in the treatment of DEB; and
- Provider attestation that individual is willing and able to comply with weekly healthcare provider administration; and
- Individual will continue with standard wound care following administration; and
- Weekly dose will not exceed the following:
- No more than 1.6 x 109 plaque forming units (PFU) for individuals younger than three (3) years of age; or
- No more than 3.2 x 109 PFU for individuals three (3) years of age and older; and
- Individual does not have ANY of the following:
- Current or a history of squamous cell carcinoma in the area that will undergo treatment; or
- Currently receiving chemotherapy or immunotherapy; or
- Received a skin graft within the past three (3) months.
Authorization: Six (6) months
Note: The safety and effectiveness of repeat administration of beremagene geperpavec-svdt (Vyjuvek) beyond six (6) months has not been evaluated. Therefore, coverage will be limited to six (6) months.
The use of beremagene geperpavec-svdt (Vyjuvek) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.