Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: PCSK9i 2574-A SGM P2023
Drug
PCSK9i
PRALUENT(alirocumab)
REPATHA(evolocumab)
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. Members with established atherosclerotic cardiovascular disease. B. Members with an untreated LDL-C of greater than or equal to 190 mg/dL. C. Members with familial hypercholesterolemia.
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Clinical atherosclerotic cardiovascular disease (ASCVD) Authorization of 12 months may be granted for treatment of ASCVD when all of the following criteria are met: 1. Member has a history of clinical atherosclerotic cardiovascular disease or has experienced a cardiovascular event. 2. Member has a current LDL-C level greater than or equal to 70 mg/dL. 3. Member is receiving maximally tolerated statin therapy or is statin intolerant.
B. Primary hyperlipidemia Authorization of 12 months may be granted for treatment of primary hyperlipidemia when all of the following criteria are met: 1. Member had an untreated (before any lipid-lowering therapy) LDL-C level greater than or equal to 190 mg/dL. 2. Member has a current LDL-C level greater than or equal to 100 mg/dL. 3. Member is receiving maximally tolerated statin therapy or is statin intolerant.
C. Familial hypercholesterolemia Authorization of 12 months may be granted for treatment of heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH) when all of the following criteria are met: 1. Member meets one of the following criteria: a. Member is 18 years of age or older and had an untreated (before any lipid-lowering therapy) LDL-C level greater than or equal to 190 mg/dL. b. Member is less than 18 years of age and had an untreated (before any lipid-lowering therapy) LDL-C level greater than or equal to 160 mg/dL. 2. Member has a current LDL-C level greater than or equal to 100 mg/dL. 3. Member is receiving maximally tolerated statin therapy or is statin intolerant.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for members who are continuing therapy with a PCSK9i.
Place of Service:
Outpatient
The above policy is based on the following references:
Repatha [package insert]. Thousand Oaks, CA: Amgen, Inc.; September 2021.
Praluent [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; April 2021.
Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. [published correction appears in Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8] [published correction appears in Circulation. 2015 Dec 22;132(25):e396]. Circulation. 2014;129(25 Suppl 2):S1-S45. doi:1161/01.cir.0000437738.63853.7a
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
Raal FJ, Honarpour N, Blom DJ, et al. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015;385(9965):341-350. doi:10.1016/S0140-6736(14)61374-X
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. N 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 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 predication of major adverse cardiac events in asymptomatic diabetic individuals. Atherosclerosis. 2014;232(2):298-304. doi:10.1016/j.atherosclerosis.2013.09.025
Robinson, JG, Rogers WJ, Nedergaard BS, et al. Rationale and Design of LAPLACE-2: A Phase 3, Randomized, Double-Blind, Placebo- and Ezetimibe-Controlled Trial Evaluating the Efficacy and Safety of Evolocumab in Subjects With Hypercholesterolemia on Background Statin Therapy. Clin Cardiol. 2014;37(4):195-203. doi:10.1002/clc.22252
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.doi: 10.1016/j.jacc.2018.11.003
McGowan MP, Hosseini Dehkordi SH, Moriarty PM, et al. Diagnosis and Treatment of Heterozygous Familial Hypercholesterolemia. J Am Heart Assoc. 2019; 8(24):e013225. DOI: 10.1161/JAHA119.013225.
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.
