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L.5.01.565
Nexletol (bempedoic acid)
Nexlizet (bempedoic acid/ezetimibe)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Bempedoic acid and its active metabolite, ESP15228, are activated by very long-chain acyl-CoA synthetase 1 (ACSVL1), which is expressed primarily in the liver. Inhibition of ACL by the activated bempedoic acid-CoA complex results in decreased cholesterol synthesis in the liver and lowers LDL-C in the blood via upregulation of low-density lipoprotein receptors.
Ezetimibe reduces blood cholesterol by inhibiting absorption of cholesterol by the small intestine. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of cholesterol, leading to a decrease in the delivery of intestinal cholesterol to the liver. This causes a reduction of hepatic cholesterol stores and an increase in LDL receptors, resulting in clearance of cholesterol from the blood.
Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) are indicated as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Nexletol (bempedoic acid) is also indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established cardiovascular disease (CVD) or a high risk for CVD event but without established CVD.
Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe) are considered not medically necessary as other treatment options are currently covered on formulary.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
08/06/2020: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
07/13/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and to add information regarding BCBSMS request for medical records. Removed investigative definition. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid/ezetimibe). Policy statement revised to remove "the use of these medications have not yet been addressed in treatment guidelines." Sources updated.
Nexletol prescribing information. Esperion Therapeutics, Inc. September 2021. Last accessed June 2025.
Nexlizet prescribing information. Esperion Therapeutics, Inc. June 2024. Last accessed June 2025.
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