Beremagene geperpavec-svdt (Vyjuvek)

Policy ID: I-9049-001

Section: Injections

Effective Date: March 01, 2024

Last Reviewed: January 16, 2024

Applies To: Commercial Only

Description

Beremagene geperpavec-svdt (Vyjuvek) is for the treatment of wounds in individuals six (6) months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.

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

J3401

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

Q81.2

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-16-2024 Effective March 01, 2024

Adopted policy effective March 1, 2024, to replace I-49 same title
Added Policy Application

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-49-003

Section: Injections

Effective Date: August 01, 2023

Revised Date: November 14, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Archived Date: February 29, 2024

Applies To: Commercial and Medicaid Expansion

Description

Beremagene geperpavec-svdt (Vyjuvek) is a herpes-simplex virus type 1 (HSV-1) vector based topical gene therapy indicated for the treatment of wounds in individuals with dystrophic epidermolysis bullosa (DEB) with mutations in the collagen type VII alpha 1 chain (COL7A1) gene. Following the topical application of beremagene geperpavec-svdt by a healthcare provider, both keratinocytes and fibroblasts can be transduced through the transcription of COL7A1 genes and subsequent secretion of COL7 by the cells.

Dysytophic epidermolysis bullosa is a rare, inherited disorder that causes blisters to form on the skin and the moist inner lining of some organs and body cavities. Extensive skin blistering develops from minor trauma and can lead to significant scarring. Over time, repeated blistering and fibrosis can lead to squamous-cell carcinoma.

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:

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 10 ⁹ plaque forming units (PFU) for individuals younger than three (3) years of age; or
- No more than 3.2 x 10 ⁹ 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.

Procedure Code

J3401

Diagnosis Code

Q81.2

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Adopted precertification policy

Internal Medical Policy Committee 11-15-2023 Effective January 01, 2024

Added new code J3401

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Beremagene geperpavec-svdt (Vyjuvek)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Code

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer