Medical Policy:
Talimogene Laherparepvec (Imlygic)
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
May 2017

Talimogene lapherarepvec (Imlygic™) is genetically modified viral therapy, from the Herpes Simplex Virus Type 1; and is used to treat malignant melanoma. The drug, which is injected directly into the tumor, is designed to replicate the virus, and to produce the immune stimulatory protein GM-CSF. Talimogene lapherarepvec (Imlygic) causes lysis of tumors, followed by release of tumor-derived antigens, which together with the GM-CSF may promote an antitumor immune response.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Talimogene laherparepvec (Imlygic) may be considered medically necessary when ALL of the following FDA approved criteria are met:


  • In individuals whose melanoma is recurrent after initial surgery; and
  • Is indicated for the local treatment of unresectable cutaneous, subcutaneous, and/or nodal lesions. 








Talimogene laherparepvec (Imlygic) may be considered medically necessary when ANY ONE of the following criteria is met:

  • Primary and/or second-line treatment of unresectable stage III melanoma with clinical satellite or in-transit metastases; or
  • Unresectable distant metastatic melanoma; or
  • Primary and/or second-line treatment of unresectable local, satellite and/or in-transit recurrence; or
  • Unresectable or incomplete resection of nodal recurrence.

The use of talimogene laherparepvec for all other indications is considered experimental/investigational, and therefore not covered, as the safety and effectiveness has not been evaluated or established.








NOTE: Dosage recommendations per the FDA label.

Covered Diagnosis Codes





























Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Talimogene Laherparepvec (Imlygic) 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

Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.


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.

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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
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    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.

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    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.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.