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 has dystrophic epidermolysis bullosa;
and
-
The requested medication must be prescribed by, or in consult with, a dermatologist or wound care specialist;
and
-
The member must meet FDA-approved label for use (e.g., use outside of studied population will be
considered investigational);
and -
As applicable, documentation must be attached to confirm serum marker or pathogenic gene variants
amenable to treatment;
and -
Documentation of the baseline symptoms (e.g., extensive skin blistering, number and size of wounds) that
can be utilized for comparison to show member has experienced clinical benefit upon renewal has been
submitted with request.
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