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Alirocumab (Praluent®)– New Role in Lipid Lowering Therapy

Wednesday, May 23, 2018  
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Quynh-Nhu Truong, PharmD Candidate 2019, Philadelphia College of Pharmacy
Faculty Advisor: Laura Waite, PharmD, BCPS, CLS, BC-ADM, Associate Professor of Clinical Pharmacy

Although statins are one of the most effective lipid lowering pharmacologic agents, there is a need for lipid lowering therapy in patients who are not candidates for statin therapy or intolerant of statins. PCSK9 inhibitors have a novel mechanism of action which inhibits the degradation of the low-density lipoprotein receptor (LDLR).1-2 The first FDA-approved PCSK9 inhibitor is alirocumab (Praluent®).

The efficacy of alirocumab has been evaluated in five clinical studies, known as the ODYSSEY trials. The long-awaited ODYSSEY Outcomes trial findings were presented at the American College of Cardiology (ACC) 2018 Scientific Sessions. The randomized, double-blind, parallel-group, placebo-controlled clinical trial included 18,924 patients who had acute coronary syndrome (ACS) in the past 12 months.3 Patients were randomized to alirocumab 75 mg subcutaneously every two weeks or placebo in addition to maximally-tolerated statin therapy.3 The primary endpoint was time to first occurrence of coronary heart disease (CHD) death, nonfatal myocardial infarction (MI), unstable angina requiring hospitalization or ischemic stroke.3 Results showed that the occurrence of stroke was decreased by 27%, nonfatal MI by 14% and unstable angina by 39% in the alirocumab treatment arm compared to placebo.3 There was a 28% reduction in CHD death, 31% in cardiovascular (CV) death and 28% in all-cause mortality.3 This outcomes trial follows a similar trial (FOURIER) conducted with evolocumab (Repatha®), which showed improvement versus placebo in both the primary and secondary composite endpoints that included cardiovascular death, MI and stroke but did not demonstrate a difference in cardiovascular mortality alone.4 However, ODYSSEY Outcomes has a longer follow up duration, which could explain the difference in outcomes.4

In 2017, the ACC released updated recommendations for the use of non-statin therapy in patients with dyslipidemia. The consensus statement recommends that adults over 21 years old with clinical ASCVD and comorbidities on maximally tolerated statin should receive either ezetimibe or PCSK9 inhibitor, depending on the target LDL-C reduction, cost, and patient factors.5 However, there are many barriers to implementing alirocumab in common practice. Alirocumab costs $672 per pen-injector, which makes it one of the most expensive lipid lowering agents available.6 The manufacturer, Sanofi and Regeneron Pharmaceuticals Inc., offers several resources to help alleviate the costs and burden of prior authorization (PA) for patients. These resources include iAssist, which helps simplify access by directly sending completed PA forms to pharmacies and payers, and CoverMyMeds, a HIPAA-compliant tool that automates PA requests for many healthcare plans at no additional cost.7 PA requirements for alirocumab are generally similar across health plans. For example, CareMark requires patients to have a diagnosis of heterozygous familial hypocholesteremia (HeFH) with one of the following: documentation of confirmed diagnosis by LDL-R DNA Sequencing Test or APOB Mutation Analysis, Dutch Lipid Clinic Network Criteria score > 8 or Simon-Broome Diagnostic Criteria for definite familial hypercholesterolemia.8 Other requirements include baseline and/or current LDL-C level > 100 mg/dL in the past 2 months, 3 months prior therapy with at least one high-intensity statin in combination with ezetimibe, and a documented history of an ASCVD event.8 Based on these barriers, it is important for pharmacists to educate prescribers and patients on the importance of alirocumab as part of a lipid-lowering regimen.

References

  1. Chaudhary R, Garg J, Shah N, Sumner A. PCSK9 inhibitors: a new era of lipid lowering therapy. World J Cardiol. 2017 Feb 26; 9(2): 76–91.
  2. Praluent (alirocumab injection) prescribing information. Bridgewater, New Jersey: Sanofi-Aventis U.S.; 2015 Jul. Available at: http://products.sanofi.us/praluent/praluent.pdf. Accessed March 10, 2018.
  3. ODYSSEY outcomes: Results suggest use of PCSK9 inhibitor reduces CV events, LDL-C in ACS patients [Internet]. Washington (DC): American College of Cardiology, 2018 Mar 10 [cited 2018 Mar 12]. Available from: http://www.acc.org/latest-in-cardiology/articles/2018/03/05/15/53/sat-9am-odyssey-outcomes-cv-outcomes-with-alirocumab-after-acs-acc-2018
  4. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR. FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722.
  5. Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Daly DD Jr, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. J Am Coll Cardiol. 2017 Oct 3;70(14):1785-1822.
  6. IBM Micromedex® RED BOOK® [Internet]. Greenwood Village (CO): Truven Health Analytics; 2018 [cited 2018 May 9].
  7. Insurance & Patient Support [Internet]. Bridgewater (NJ): Sanofi US and Regeneron Pharmaceuticals Inc.; 2017 Dec [cited 2018 May 9].
  8. Praluent (alirocumab) [Internet]. Richardson (TX): CVS/CareMark; 2018 [cited 2018 May 9].


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