Inclisiran (Leqvio)

Policy ID: I-9022-004

Section: Injections

Effective Date: April 01, 2022

Revised Date: March 11, 2024

Revision Effective Date: May 01, 2024

Last Reviewed: March 19, 2024

Applies To: Commercial Only

Description

Inclisiran (Leqvio ^® ) is a double-stranded small interfering ribonucleic acid (siRNA), conjugated on the sense strand with triantennary N-Acetylgalactosamine (GalNAc) to facilitate uptake by hepatocytes. In hepatocytes, inclisiran utilizes the RNA interference mechanism and directs catalytic breakdown of mRNA for PCSK9. This increases LDL-C receptor recycling and expression on the hepatocyte cell surface, which increases LDL-C uptake and lowers LDL-C levels in the circulation.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

Initial Evaluation

Inclisiran (Leqvio) may be considered medically necessary when an individual meets ALL of the following criteria:

ONE of the following:
- The individual has the diagnosis of heterozygous familial hypercholesterolemia (HeFH) AND BOTH of the following:
  - ONE of the following:
    - Genetic confirmation of one mutant allele at the LDLR, Apo-B, PCSK9, or 1/LDLRAP1 gene ; or
    - Pre-treatment LDL-C greater than (>) 190 mg/dL (greater than 4.9 mmol/L) ; or
    - The individual has clinical manifestations of HeFH (e.g., cutaneous xanthomas, tendon xanthomas, corneal arcus) ; or
    - The individual has 'definite' or 'possible' familial hypercholesterolemia as defined by the Simon Broome criteria ; or
    - The individual has a Dutch Lipid Clinic Network Criteria score of greater than (>) five (5) ; or
    - The individual has a treated LDL-C level greater than or equal to (≥) 100 mg/dL after statin treatment with or without ezetimibe ; and
  - The prescriber is a specialist in the area of the individual's diagnosis (e.g., cardiologist, endocrinologist, lipid specialist, geneticist), or the prescriber has consulted with a specialist in the area of the individual's diagnosis ; or
- The individual has a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) AND has ONE of the following:
  - Acute coronary syndrome
  - History of myocardial infarction
  - Stable or unstable angina
  - Coronary or other arterial revascularization
  - Stroke
  - Transient ischemic attack
  - Peripheral arterial disease, including aortic aneurysm, presumed to be of atherosclerotic origin ; or
- The individual has a diagnosis of primary hyperlipidemia with a pre-treatment LDL-C level greater than or equal to 190 mg/dL (greater than or equal to (≥) 4.9 mmol/L) ; or
- The individual has another FDA labeled indication for the requested agent and route of administration ; or
- The individual has another indication that is supported in compendia for the requested agent and route of administration ; and
ONE of the following:
- The individual has tried and had an inadequate response after being adherent for at least 12 consecutive weeks of therapy with a PCSK9 inhibitor ; or
- The individual has an intolerance or hypersensitivity to a PCSK9 inhibitor ; or
- The individual has an FDA labeled contraindication to ALL PCSK9 inhibitors ; and
ONE of the following:
- The individual has been adherent to high-intensity statin therapy (i.e., atorvastatin 40-80mg, rosuvastatin 20-40 mg daily) for at least eight (8) consecutive weeks AND ONE of the following:
  - The individual's LDL-C level after this statin therapy remains greater than or equal to (≥) 70 mg/d ; or
  - The individual has not achieved a 50% reduction in LDL-C from this statin therapy ; or
  - If the individual has ASCVD at very high risk, ONE of the following:
    - The individual's LDL-C level after this statin therapy remains greater than or equal to (≥) 55 mg/dL ; or
    - The individual's non HDL-C level after this statin therapy remains greater than or equal to (≥) 85 mg/dL ; or
  - The individual has been determined to be statin intolerant by meeting ONE of the following:
    - The individual experienced statin-related rhabdomyolysis ; or
    - The individual experienced skeletal-related muscle symptoms (e.g., myopathy, myalgia) and BOTH of the following:
      - The skeletal-related muscle symptoms occurred while receiving separate trials of both atorvastatin and rosuvastatin ; and
      - When receiving separate trials of both atorvastatin and rosuvastatin, the skeletal-related muscle symptoms resolved upon discontinuation of each statin ; or
    - The individual experienced elevations in hepatic transaminase while receiving separate trials of both atorvastatin and rosuvastatin ; or
  - The individual has a hypersensitivity to atorvastatin AND rosuvastatin ; or
  - The individual has an FDA labeled contraindication to atorvastatin AND rosuvastatin ; and
If the individual has an FDA labeled indication, ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent ; or
- There is support for using the requested agent for the individual's age for the requested indication ; and
The individual will NOT be using the requested agent in combination with a PCSK9 inhibitor for the requested indication.

Inclisiran (Leqvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Code

J1306

Reauthorization Criteria

Continuation of therapy with inclisiran (Leqvio) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for inclisiran (Leqvio) through Blue Cross Blue Shield of North Dakota's precertification process [Note: individuals not previously approved for the requested agent will require initial evaluation review] ; and
The individual has had clinical benefit with the requested agent ; and
If the individual has a diagnosis of HeFH, the prescriber is a specialist in the area of the individual's diagnosis (e.g., cardiologist, endocrinologist, lipid specialist, geneticist), or the prescriber has consulted with a specialist in the area of the individual's diagnosis ; and
If the individual has ASCVD, HeFH, or hyperlipidemia, then ONE of the following:
- The individual is currently adherent to a high-intensity statin therapy (i.e., atorvastatin 40-80mg, rosuvastatin 20-40 mg daily) ; or
- The individual has been determined to be statin intolerant by meeting ONE of the following criteria:
  - The individual experienced statin-related rhabdomyolysis ; or
  - The individual experienced skeletal-related muscle symptoms (e.g., myopathy, myalgia) and BOTH of the following:
    - The skeletal-related muscle symptoms occurred while receiving separate trials of both atorvastatin AND rosuvastatin ; and
    - When receiving separate trials of both atorvastatin and rosuvastatin the skeletal-related muscle symptoms resolved upon discontinuation of each statin ; or
  - The individual experienced elevations in hepatic transaminase while receiving separate trials of both atorvastatin and rosuvastatin ; or
- The individual has a hypersensitivity to atorvastatin AND rosuvastatin ; or
- The individual has an FDA labeled contraindication to atorvastatin AND rosuvastatin ; and
The individual will NOT be using the requested agent in combination with a PCSK9 inhibitor for the requested indication ; and
The requested quantity (dose) is within FDA labeled dosing (or supported in compendia) for the requested indication

Inclisiran (Leqvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Code

J1306

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 Codes

E78.00

E78.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-23-2022 - Effective April 01, 2022

Adopted new precertification drug policy

Internal Medical Policy Committee 7-21-2022 Coding update - Effective July 01, 2022

Removed procedure code: J3490
Added procedure code: J1306

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

Added timeframe for inadequate response in the initial criteria - The individual has tried and had an inadequate response 'after being adherent for greater than or equal to 12 continuous weeks of therapy with' a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)
Added additional clinical benefit reauthorization criteria - The individual has had clinical benefit '[e.g., decrease of LDL-C from baseline (prior to treatment with inclisiran (Leqvio)]' with inclisiran (Leqvio)

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Updated initial and reauthorization criteria

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-9022-003

Section: Injections

Effective Date: April 01, 2022

Revised Date: July 17, 2023

Revision Effective Date: September 01, 2023

Last Reviewed: July 26, 2023

Archived Date: April 30, 2024

Applies To: Commercial Only

Description

Criteria

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

Initial Evaluation

Inclisiran (Leqvio) may be considered medically necessary when an individual meets ALL of the following criteria:

ONE (1) of the following:
- The individual has the diagnosis of heterozygous familial hypercholesterolemia (HeFH) AND ONE (1) of the following:
  - Genetic confirmation of one mutant allele at the LDLR, Apo-B, or PCSK9 gene; or
  - History of LDL-C greater than 190 mg/dL (greater than 4.9 mmol/L); or
  - The individual has clinical manifestations of HeFH (e.g., cutaneous xanthomas, tendon xanthomas, arcus cornea); or
  - The individual has 'definite' or 'possible' familial hypercholesterolemia as defined by the Simon Broome criteria; or
  - The individual has a Dutch Lipid Clinic Network Criteria score of greater than five (5); or
  - The individual has a treated low-density lipoprotein cholesterol (LDL-C) level greater than or equal to 100 mg/dL after treatment with antihyperlipidemic agents but prior to inclisiran (Leqvio) therapy; or
- The individual has a diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) AND has ONE (1) of the following:
  - Acute coronary syndrome; or
  - History of myocardial infarction; or
  - Stable or unstable angina; or
  - Coronary or other arterial revascularization; or
  - History of stroke; or
  - History of transient ischemic attack; or
  - Peripheral arterial disease, including aortic aneurysm, presumed to be of atherosclerotic origin; or
- The individual has another FDA approved indication for inclisiran (Leqvio) and route of administration; and
ONE of the following:
- The individual is 18 years of age or older; or
- The prescriber has provided information in support of using inclisiran (Leqvio) for the individual's age for the requested indication; and
ONE of the following:
- The individual has tried and had an inadequate response after being adherent for greater than or equal to 12 continuous weeks of therapy with a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)]; or
- The individual has an intolerance or hypersensitivity to PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)] therapy; or
- The individual has an FDA labeled contraindication to ALL PCSK9 inhibitors [e.g., Praluent (alirocumab), Repatha (evolocumab)]; and
ONE (1) of the following:
- The individual has been adherent to high-intensity statin therapy (i.e., rosuvastatin greater than or equal to 20 mg daily, atorvastatin greater than or equal to 40 mg daily) for greater than or equal to eight (8 )continuous weeks AND ONE of the following:
  - The individual's LDL-C level after this treatment regimen remains greater than or equal to 70 mg/dL; or
  - The individual has not achieved a 50% reduction in LDL-C from baseline (prior to treatment with high intensity statin therapy) after this treatment regimen; or
  - If the individual has ASCVD, the individual's non HDL-C level after this treatment regimen remains greater than or equal to 100 mg/dL; or
- The individual has been determined to be statin intolerant by meeting one of the following criteria:
  - The individual experienced statin-related rhabdomyolysis; or
  - The individual experienced skeletal-related muscle symptoms [e.g., myopathy (muscle weakness) or myalgia (muscle aches, soreness, stiffness, or tenderness)] and BOTH of the following:
    - The skeletal-related muscle symptoms (e.g., myopathy or myalgia) occurred while receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or as combination products); and
    - When receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or as combination products) the skeletal-related muscle symptoms (e.g., myopathy, myalgia) resolved upon discontinuation of each respective statin therapy (atorvastatin and rosuvastatin); or
  - The individual experienced elevations in hepatic transaminase while receiving separate trials of both atorvastatin and rosuvastatin (as single-entity or as combination products); or
- The individual has a hypersensitivity to atorvastatin and rosuvastatin; or
- The individual has an FDA labeled contraindication to atorvastatin and rosuvastatin; and
The individual will NOT be using inclisiran (Leqvio) in combination with a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)] for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., cardiologist, endocrinologist, lipid specialist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.

Inclisiran (Leqvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Code

J1306

Reauthorization Criteria

Continuation of therapy with inclisiran (Leqvio) may be considered medically necessary when the following criteria are met:

The individual has been previously approved for inclisiran (Leqvio) through Blue Cross Blue Shield of North Dakota's precertification process; and
The individual has had clinical benefit [e.g., decrease of LDL-C from baseline (prior to treatment with inclisiran (Leqvio)] with inclisiran (Leqvio); and
ONE (1) of the following:
- The individual is on a maximally tolerated statin containing lipid-lowering regimen (i.e., rosuvastatin in combination with ezetimibe OR atorvastatin in combination with ezetimibe); or
- The individual has an intolerance or hypersensitivity to a statin containing lipid-lowering regimen (i.e., rosuvastatin in combination with ezetimibe AND atorvastatin in combination with ezetimibe); or
- The individual has an FDA labeled contraindication to ALL statin containing lipid-lowering regimens; and
The individual will NOT be using inclisiran (Leqvio) in combination with a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)] for the requested indication; and
The prescriber is a specialist in the area of the individual's diagnosis (e.g., cardiologist, endocrinologist, lipid specialist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis.

Inclisiran (Leqvio) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J1306

Diagnosis Codes

E78.00

E78.01

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 3-23-2022 - Effective April 01, 2022

Adopted new precertification drug policy

Internal Medical Policy Committee 7-21-2022 Coding update - Effective July 01, 2022

Removed procedure code: J3490
Added procedure code: J1306

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

Added timeframe for inadequate response in the initial criteria - The individual has tried and had an inadequate response 'after being adherent for greater than or equal to 12 continuous weeks of therapy with' a PCSK9 inhibitor [e.g., Praluent (alirocumab), Repatha (evolocumab)
Added additional clinical benefit reauthorization criteria - The individual has had clinical benefit '[e.g., decrease of LDL-C from baseline (prior to treatment with inclisiran (Leqvio)]' with inclisiran (Leqvio)

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Inclisiran (Leqvio)

Description

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Criteria

Procedure Code

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

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Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

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Disclaimer