HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
G-49-001
Topic:
Beremagene geperpavec-svdt (Vyjuvek)
Section:
Miscellaneous
Effective Date:
July 31, 2023
Issued Date:
July 31, 2023
Last Revision Date:
June 2023
Annual Review:
June 2023
 
 

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. 

 

Policy Position

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; and
  • Authorization is for six (6) months only.

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) not meeting the criteria as indicated in this policy is considered not medically necessary.

J3590

 

 

 

 

 

 


Q81.2

 

 

 

 

 

 


Place of Service: Outpatient

Beremagene geperpavec-svdt (Vyjuvek) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting. is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

The policy position applies to all commercial lines of business



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.