HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
I-250-003
Topic:
Inclisiran (Leqvio)
Section:
Injections
Effective Date:
December 18, 2022
Issued Date:
December 18, 2022
Last Revision Date:
December 2022
Annual Review:
March 2022
 
 

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. 

Policy Position

Heterozygous Familial Hypercholesterolemia (HeFH) 

Inclisiran (Leqvio) may be considered medically necessary for Heterozygous Familial Hypercholesterolemia (HeFH) when the following criteria are met:

  • The individual is 18 years of age or older; and
  • Must be prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; and
  • There is clinical documentation of heterozygous familial hypercholesterolemia (FH) as defined by ONE of the following:
    • Genetic confirmation of pathogenic variant at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus; or
    • The individual has experienced ONE of the following physical signs of FH:
      • Tendon xanthomas; or
      • Corneal arcus prior to age 45 years; or
      • Tuberous xanthomas; or
      • Xanthelasma; or
    • Clinical diagnosis based on ONE of the following:
      • The WHO criteria/Dutch Lipid Clinical Network criteria with a score greater than 8 points (See Table Attachment A); or
      • The Simon Broome Register Diagnostic Criteria with a criterion for definite familial hypercholesterolemia (See Table Attachment B); or
      • Familial hypercholesterolemia possibility of “definite” on the Make Early Diagnosis to Prevent Early Deaths (MEDPED) tool or
    • The individual meets ONE of the following criteria:
      • Documentation of an untreated LDL-C greater than or equal to 190 mg/dL; or
      • Documentation of an untreated LDL-C greater than or equal to160 mg/dL if less than 20 years of age; and
  • The individual meets ONE of the following criteria:
    • The individual has an LDL-C greater than 100mg/dL, despite use with a maximally tolerated statin; or
    • The individual has an LDL-C greater than 100mg/dL and is statin intolerant defined as one of the following:
      • While receiving at least two (2) separate trials of different statins, the individual experienced ONE of the following:
        • Statin related rhabdomyolysis, which resolved upon discontinuation of the statins; or
        • Skeletal-related muscle symptoms, which resolved upon discontinuation of the statins; or
      • Individual experienced ONE of the following during any course of statin therapy :
        • Creatinine kinase (CK) increase to 10 times ULN; or
        • Liver function tests (LFTs) increase to 3 times ULN; or
        • Hospitalization due to severe statin-related adverse event (e.g., rhabdomyolysis); and
  • Individual has failure of proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor (e.g., alirocumab or evolocumab based upon FDA approval for age) for at least three (3) months; and
  • Individual will use as adjunct to maximally tolerated statin therapy, unless the member is statin intolerant; and
  • Initial authorization will be for a period of six (6) months.

Reauthorization Criteria

  • Documentation of LDL-C reduction from baseline; and
  • Reauthorization will be for a period of 12 months.

The use of inclisiran (Leqvio) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

J1306

 

 

 

 

 

 


Clinical Atherosclerotic Cardiovascular Disease (ASCVD)

Inclisiran (Leqvio) may be considered medically necessary for ASCVD when the following criteria are met:

  • The individual is 18 years of age or older; and
  • Must be prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist; and
  • Individual has documented history of ASCVD as defined by ONE of the following:
    • Acute coronary syndrome; or
    • Coronary or other arterial revascularization; or
    • History of myocardial infarction; or
    • History of stroke; or
    • History of transient ischemic attack; or
    • Peripheral arterial disease presumed to be of atherosclerotic origin; or
    • Stable or unstable angina; and
  • Serum LDL-C greater than 70 mg/dL; and
  • While receiving at least two (2) separate trials of different statins, the individual experienced ONE of the following:
    • Statin related rhabdomyolysis, which resolved upon discontinuation of the statins; or
    • Skeletal-related muscle symptoms, which resolved upon discontinuation of the statins; or
  • The individual experienced ONE of the following during any course of statin therapy:
    • Creatinine kinase (CK) increase to 10 times ULN; or
    • Liver function tests (LFTs) increase to 3 times ULN; or
    • Hospitalization due to severe statin-related adverse event (e.g., rhabdomyolysis); and
  • Individual has failure of proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor (e.g., alirocumab or evolocumab based upon FDA approval for age) for at least three (3) months; and
  • The individual will use as adjunct to maximally tolerated statin therapy, unless the member is statin intolerant; and
  • Initial authorization will be for a period of six (6) months.

Reauthorization Criteria

  • Documentation of an LDL-C reduction from baseline; and
  • Reauthorization will be for a period of 12 months.

The use of inclisiran (Leqvio) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

J1306

 

 

 

 

 

 


Quantity Level Limit

Diagnosis

Initiation Dose

Maintenance Dose

HeFH or ASCVD

Two (2) pre-filled syringes in the first three (3) months

One (1) pre-filled syringe every six (6) months

J1306

 

 

 

 

 

 


E78.01

I25.10

I25.110

I25.112

I25.118

I25.119

I25.810

I25.811

I25.812

 

 

 

 

 


Place of Service: Outpatient

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

Inclisiran (Leqvio) 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.