Inclisiran (Leqvio®) is a small interfering RNA (siRNA) that directs catalytic breakdown of mRNA for PCSK9 (proprotein convertase subtilisin kexin type 9) which leads to lower LDL-C levels. Inclisiran (Leqvio) is indicated as an add-on therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C.
Preferred Products
Antilipemic monoclonal antibodies targeting proprotein convertase substilisin kexin 9 (PCSK9), i.e. alirocumab (Praluent) or evolocumab (Repatha) are the preferred products required for members initiating new therapy for all shared indication(s) as the non-preferred product(s). The non-preferred product (inclisiran (Leqvio)) will be considered when the member has a documented therapy failure after an adequate therapeutic trial of a preferred product, or the preferred product has not been tolerated or is contraindicated.
Adequate therapeutic trial is defined as three (3) months following the injection series at Food and Drug Administration (FDA) or compendia based therapeutic doses of preferred product.
New therapy is defined as no previous utilization within the last 365 calendar days.
Approved Use
Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective when used for indications specified on the labeling. Please refer to product specific labeling for approved indications. Coverage is also dictated by National Coverage Determinations or the appropriate Local Coverage Determinations
Unlabeled Use
Inclisiran (Leqvio) may be considered medically necessary for treatment of ANY of the following:
Inclisiran (Leqvio) is considered not medically necessary for ANY of the following:
The use of inclisiran (Leqvio) not meeting the criteria as indicated in this policy is considered experimental/investigational, and therefore, not medically necessary.
J1306 |
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NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
E78.01 |
E78.5 |
E78.89 |
E78.9 |
I25.10 |
I25.110 |
I25.112 |
I25.118 |
I25.119 |
I25.810 |
I25.811 |
I25.812 |
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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:
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.
