Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Beremagene geperpavec-svdt (Vyjuvek) may be considered medically necessary when ALL the following criteria are met:
- The member must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
- The individual has a diagnosis of epidermolysis bullosa as confirmed by ONE of the following:
- Immunofluorescence mapping (IFM); or
- Transmission electron microscopy (TEM); or
- Genetic testing.
Reauthorization Criteria
Reauthorization of beremagene geperpavec-svdt (Vyjuvek) may be considered medically necessary when the following criteria are met:
- The individual has previously been approved for beremagene geperpavec-svdt (Vyjuvek) through Blue Cross Blue Shield of North Dakota's precertification process; and
- The individual has had clinical benefit with beremagene geperpavec-svdt (Vyjuvek); and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., dermatologist, geneticist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.
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.
Procedure Code
