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 ONE 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 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 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 to 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 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 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 Codes
