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Bempedoic Acid Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1132
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
1/1/2024 |
10/1/2020 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Nexletol™ (bempedoic acid) Tablet |
Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitation of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. |
|
1 |
Nexlizet™ (bempedoic acid/ezetimibe) Tablet |
Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitation of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. |
|
2 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Familial hypercholesterolemia |
Familial hypercholesterolemia (FH) is a common yet underdiagnosed autosomal dominant disorder that affects 1 in 220 individuals globally. An individual who is heterozygous for FH (HeFH) has a 50% chance of passing the gene to his or her children. FH is characterized by lifelong elevation of low-density lipoprotein cholesterol (LDL-C) and, if untreated, leads to early-onset atherosclerosis and increased risk of cardiovascular events. Affected men and women who are untreated have a 30% to 50% risk of a fatal or nonfatal cardiac event by ages 50 and 60 years, respectively. FH is generally a silent disease. Given the broad range of causes of hypercholesterolemia and early-onset coronary artery disease (CAD), it is not surprising that FH is not always in the differential diagnosis for healthcare professionals when confronted with a patient presenting with early CAD. Although diagnosis can be made on the basis of clinical features, genetic testing may offer additional insight regarding cardiac risk and diagnosis. There are no internationally agreed-upon criteria for the diagnosis of FH, so useful diagnostic criteria have been developed. Two of the criteria, the UK Simon Broome system and the Dutch Lipid Clinic Network criteria incorporate genetic tests into their algorithm. (3) |
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Heterozygous familial hypercholesterolemia (HeFH) |
The Simon Broome Register criteria and Dutch Lipid Clinic Network criteria have been developed to aid in diagnosing HeFH.(5) Definitive diagnosis of HeFH according to Simon Broome diagnostic criteria requires the patient has one of the following:(3,5,10) A total cholesterol level greater than 6.7 mmol/L (260 mg/dL) or low-density lipoprotein cholesterol (LDL-C) level greater than 4.0 mmol/L (155 mg/dL) in a child younger than 16 years of age, or, a total cholesterol greater than 7.5 mmol/L (290 mg/dL) or LDL-C greater than 4.9 mmol/L (190 mg/dL) in an adult (levels either pre-treatment or highest on treatment) PLUS tendon xanthomas in the patient, or in first-degree relative (parent, sibling or child), or in second-degree relative (e.g., grandparent, uncle or aunt)
Dutch Lipid Clinic Network criteria for diagnosis of heterozygous familial hypercholesterolemia.(7)
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Atherosclerotic Cardiovascular Disease (ASCVD) - Secondary Prevention |
The AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline considers having at least one of the following as clinical ASCVD:(9,11)
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Safety |
Nexletol has no contraindication or box warnings.(1) Nexlizet has no box warnings, but has the following contraindication:(2)
|
REFERENCES
Number |
Reference |
1 |
Nexletol prescribing information. Esperion Therapeutics, Inc. June 2022. |
2 |
Nexlizet prescribing information. Esperion Therapeutics, Inc. September 2021. |
3 |
McGowan MP, Dehkordi SH, Moriarty PM, et. al. “Diagnosis and Treatment of Heterozygous Familial Hypercholesterolemia”. JAHA 8 (24) 2019. Available at: https://www.ahajournals.org/doi/10.1161/JAHA.119.013225 |
4 |
|
5 |
National Collaborating Centre for Primary Care (UK). Identification and Management of Familial Hypercholesterolaemia (FH) [Internet]. London: Royal College of General Practitioners (UK); 2008 Aug. (NICE Clinical Guidelines, No. 71.) 3, Diagnosis. Available from: https://www.nice.org.uk/guidance/CG71. |
6 |
|
7 |
Nordestgaard BG, Chapman MJ, Humphries ST, et al; for the European Atherosclerosis Society Consensus Panel. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease. Eur Heart J. 2013. doi.10.1093/eurheartj/eht273. https://pubmed.ncbi.nlm.nih.gov/23956253/ |
8 |
|
9 |
2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol. Journal of the American College of Cardiology. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000625 |
10 |
Henderson, R., O’Kane, M., McGilligan, V. et al. The genetics and screening of familial hypercholesterolaemia. J Biomed Sci 23, 39 (2016). https://doi.org/10.1186/s12929-016-0256-1 |
11 |
Writing Committee, Birtcher, K., Allen, L., et al., 2022 ACC Expert Consensus Decision Pathway for Integrating Atherosclerotic Cardiovascular Disease and Multimorbidity Treatment: A Framework for Pragmatic, Patient-Centered Care: A Report of the American College of Cardiology Solution Set Oversight Committee. Journal of the American College of Cardiology. 81 (3) 2023. https://www.jacc.org/doi/10.1016/j.jacc.2022.08.754 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Nexletol |
bempedoic acid tab |
180 MG |
M ; N ; O ; Y |
N |
|
|
Nexlizet |
bempedoic acid-ezetimibe tab |
180-10 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Nexletol |
bempedoic acid tab |
180 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Nexlizet |
bempedoic acid-ezetimibe tab |
180-10 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Nexletol |
bempedoic acid tab |
180 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Nexlizet |
bempedoic acid-ezetimibe tab |
180-10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Nexletol |
bempedoic acid tab |
180 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Nexlizet |
bempedoic acid-ezetimibe tab |
180-10 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following criteria are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence Length of approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
Prior Authorization with Quantity Limit |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of approval: 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Bempedoic Acid _PAQL _ProgSum_ 1/1/2024