Subject: Praluent 2519-A Enhanced SGM P2023
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indications
A. Praluent is indicated to reduce the risk of myocardial
infarction, stroke, and unstable angina requiring hospitalization
in adults with established cardiovascular disease.
B. Praluent is indicated as an adjunct to diet, alone or in
combination with other low-density lipoprotein cholesterol
(LDL-C)-lowering therapies, in adults with primary
hyperlipidemia, including heterozygous familial
hypercholesterolemia, to reduce LDL-C.
C. Praluent is indicated as an adjunct to other LDL-C-lowering
therapies in adult patients with homozygous familial
hypercholesterolemia (HoFH) to reduce LDL-C.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate
the prior authorization review:
A. Current LDL-C level for both initial requests and continuation
requests. The level must be dated within the six months
preceding the authorization request.
B. Untreated (before any lipid-lowering therapy) LDL-C level if
requesting Praluent to treat primary hyperlipidemia,
heterozygous or homozygous familial hypercholesterolemia.
C. Chart notes confirming clinical atherosclerotic cardiovascular
disease (ASCVD) if requesting Praluent to treat clinical
ASCVD (see Appendix A).
D. If member has contraindication or intolerance to statins,
chart notes confirming the contraindication or intolerance
(see Appendices B and C).
III. CRITERIA FOR INITIAL APPROVAL
A. Clinical atherosclerotic cardiovascular disease
(ASCVD)
Authorization of 6 months may be granted for treatment of
clinical atherosclerotic cardiovascular disease when both of
the following criteria are met:
1. Member has a history of clinical ASCVD (see Appendix A).
2. Member meets at least one of the following criteria:
i. Member has a current LDL-C level ≥ 70 mg/dL after
at least three months of treatment with a high-
intensity statin dose in combination with ezetimibe.
If the member is unable to tolerate a high-intensity
statin dose, a moderate-intensity statin dose may be
used.
ii. Member has a current LDL-C level ≥ 70 mg/dL with
contraindication or intolerance to statins (see
Appendices B and C).
B. Primary hyperlipidemia including heterozygous familial
hypercholesterolemia (HeFH)
Authorization of 6 months may be granted for treatment of
primary hyperlipidemia including heterozygous familial
hypercholesterolemia (HeFH) when both of the following
criteria are met:
1. Member had an untreated (before any lipid-lowering
therapy) LDL-C level ≥ 190 mg/dL in the absence of a
secondary cause.
2. Member meets at least one of the following criteria:
i. Member has a current LDL-C level ≥ 100 mg/dL after
at least three months of treatment with a high-
intensity statin dose in combination with ezetimibe.
If the member is unable to tolerate a high-intensity
statin dose, a moderate-intensity statin dose may be
used.
ii. Member has a current LDL-C level ≥ 100 mg/dL with
contraindication or intolerance to statins (see
Appendices B and C).
C. Homozygous familial hypercholesterolemia (HoFH)
Authorization of 6 months may be granted for treatment of
homozygous familial hypercholesterolemia when both of the
following criteria are met:
1. Member had an untreated (before any lipid-lowering
therapy) LDL-C level ≥ 190 mg/dL in the absence of a
secondary cause.
2. Member meets at least one of the following criteria:
i. Member has a current LDL-C level ≥ 100 mg/dL after
at least three months of treatment with a high-
intensity statin dose in combination with ezetimibe.
If the member is unable to tolerate a high-intensity
statin dose, a moderate-intensity statin dose may be
used.
ii. Member has a current LDL-C level ≥ 100 mg/dL with
a contraindication or intolerance to statins (see
Appendices B and C).
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment in members requesting reauthorization for an
indication listed in Section III who achieve or maintain an LDL-C
reduction (e.g., LDL-C is now at goal, robust lowering of LDL-C).
V. APPENDICES
APPENDIX A. Clinical ASCVD
• Acute coronary syndromes
• Myocardial infarction
• Stable or unstable angina
• Coronary or other arterial revascularization procedure (e.g.,
percutaneous coronary intervention [PCI], coronary artery
bypass graft [CABG] surgery)
• Stroke of presumed atherosclerotic origin
• Transient ischemic attack (TIA)
• Non-cardiac peripheral arterial disease (PAD) of presumed
atherosclerotic origin (e.g., carotid artery stenosis, lower
extremity PAD)
• Obstructive coronary artery disease (defined as fifty percent
or greater stenosis on cardiac computed tomography
angiogram or catheterization)
• Coronary Artery Calcium (CAC) Score ≥ 1000
APPENDIX B. Statin-associated muscle symptoms (SAMS) and
statin re-challenge
• Score of 7 or higher on the Statin-Associated Muscle
Symptom Clinical Index (SAMS-CI)
• Statin-associated elevation in creatine kinase (CK) level ≥ 10
times upper limit of normal (ULN)
NOTE: Statin re-challenge is NOT required for members who
have experienced an elevation of CK level ≥10 times ULN
after receiving lipid-lowering therapy (LLT) with a statin.
APPENDIX C. Contraindications to statins
• Active liver disease, including unexplained persistent
elevations in hepatic transaminase levels (e.g., alanine
transaminase (ALT) level ≥ 3 times ULN)
• Pregnancy or planned pregnancy
• Breastfeeding
Place of Service:
Outpatient
The above policy is based on the following references:
- Praluent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; April 2021.
- Lloyd-Jones DM, Morris PB, Ballantybe CM, et al. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee [published correction appears in J Am Coll Cardiol. 2023 Jan 3;81(1):104]. J Am Coll Cardiol. 2022;80(14):1366-1418. doi:10.1016/j.jacc.2022.07.006
- Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372(25):2387-2397. doi:10.1056/NEJMoa1410489
- Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 — full report. J Clin Lipidol. 2015;9:(2)129–169. doi:10.1016/j.jacl.2015.02.003
- Nordestgaard BG, Chapman MJ, Humphries SE, et al. Familial hypercholesterolaemia is underdiagnosed and undertreated in the general population: guidance for clinicians to prevent coronary heart disease. Consensus Statement of the European Atherosclerosis Society. [published correction appears in Eur Heart J. 2020 Dec 14;41(47):4517]. Eur Heart J. 2013;34(45):3478-90a. doi:10.1093/eurheartj/eht273
- Cuchel M, Bruckert E, Ginsberg HN, et al. Homozygous familial hypercholesterolaemia: new insights and guidance for clinicians to improve detection and clinical management. A position paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Eur Heart J. 2014;35(32):2146-2157. doi:10.1093/eurheartj/ehu274
- Banach M, Rizzo M, Toth PP, et al. Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci. 2015;11(1):1-23. doi:10.5114/aoms.2015.49807
- Sabatine MC, Giugliano RP, Keech AC, et al. Evolocumab and clinical outcomes in patients with cardiovascular disease. New Engl J Med. 2017;376(18):1713-1722. doi:10.1056/NEJMoa1615664
- Hulten EA, Carbonaro S, Petrillo SP, et al. Prognostic value of cardiac computed tomography angiography. J Am Coll of Cardiol. 2011;57(10):1237-1247. doi:10.1016/j.jacc.2010.10.011
- Min JK, Labounty TM, Gomez MJ, et al. Incremental prognostic value of coronary computed tomographic angiography over coronary artery calcium score for risk prediction of major adverse cardiac events in asymptomatic diabetic individuals. Atherosclerosis. 2014;232(2):298-304. doi:10.1016/j.atherosclerosis.2013.09.025
- Pandor A, Ara RM, Tumur I, et al. Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med. 2009;265(5):568-580. doi:10.1111/j.1365-2796.2008.02062.x
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC guideline on the management of blood cholesterol: report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2018.
- Beavers CJ, Kelly MS. Dyslipidemia.In: Murphy Je, Lee MW,eds. Pharmacotherapy Self-Assessment Program, 2019 Book 1. Cardiology. Lenexa, KS: American College of Clinical Pharmacy, 2019:41-42.
- Blom DJ, Harada-Shiba M, Rubba P, et al. Efficacy and Safety of Alirocumab in Adults With Homozygous Familial Hypercholesterolemia: The ODYSSEY HoFH Trial. J Am Coll Cardiol. 2020;76(2):131-142. doi:10.1016/j.jacc.2020.05.027
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
June 11, 2023
