Criteria
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:
-
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;
and
-
If the individual has an FDA approved indication, then ONE of the following:
-
The individual's age is within FDA labeling for the requested indication for the requested agent;
or
-
The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication;
and
-
The individual does NOT have current evidence or a history of squamous cell carcinoma in the area that will undergo treatment;
and
-
The individual does NOT have an active infection in the area that will undergo treatment;
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 does NOT have any FDA labeled contraindications to the requested agent;
and
- The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication.
Initial Authorization:
Six (6) months
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 the requested agent through Blue Cross Blue Shield of North Dakota's precertification process;
and
-
The individual has had clinical benefit with the requested agent;
and
-
The individual does NOT have current evidence or a history of squamous cell carcinoma in the area that will undergo treatment;
and
-
The individual does NOT have an active infection in the area that will undergo treatment;
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 does NOT have any FDA labeled contraindications to the requested agent;
and
- The requested quantity (dose) does not exceed the maximum FDA labeled dose for the requested indication.
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