title: PCSK9 inhibitors may improve cardiovascular outcomes-Can we afford them?
abstract: OBJECTIVE
  Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) can significantly lower low-density lipoprotein (LDL) cholesterol levels. Early evidence suggests that use of PCSK9i also reduces the incidence of major adverse cardiovascular events (MACE). Our objective was to determine preliminary economic implications of PCSK9i use to avoid MACE, based on the current data from major phase III clinical trials.
  
  
  METHODS
  Outcome data of the 4529 patients treated with PCSK9i in the OSLER and ODYSSEY LONG TERM trials were collected from the published reports. Cost of preventing MACE was evaluated based on the existing outcome data and current US prices of PCSK9i. The pooled results were compared to the cost of curing Hepatitis C Virus (HCV) patients with novel HCV drugs.
  
  
  RESULTS
  PCSK9i treatment in the OSLER and ODYSSEY LONG TERM trials resulted in prevention of 35 MACE in a total of 4903 patient-years: 8 cardiovascular deaths, 22 myocardial infarctions, 0 strokes and 5 unstable anginas. The cost of PCSK9i drugs consumed during the trial's current follow-up period, could have reached $70,172,141. Therefore, the cost of preventing any MACE would be $2,004,918 and the cost of preventing one death would be $8,777,518. These figures are one hundred fold higher than the cost of curing one HCV patient (~$84,000).
  
  
  CONCLUSIONS
  According to the current published data, using PCSK9i to prevent MACE seems to be a very expensive strategy. If upcoming outcome trials will demonstrate similar results, it seems that at current prices, using these drugs would not be affordable for most healthcare systems.
authors.affiliation: Department of Health Systems Management, Faculty of Health Sciences and The Guilford-Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Technology Marketing, Sapir College, D.N. Hof Ashkelon 79165, Israel. Electronic address: ronen.arbel@gmail.com.
authors.forename: Ronen
authors.initials: R
authors.lastname: Arbel
authors.affiliation: Department of Pharmaceutical Technology Assessment, Chief Physician's Office, Clalit Health Services Headquarters, Tel-Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Hammerman
authors.affiliation: Department of Health Technology Policy, Maccabi Healthcare Services, Tel-Aviv, Israel.
authors.forename: Noa
authors.initials: N
authors.lastname: Triki
authors.affiliation: Department of Health Systems Management, Faculty of Health Sciences and The Guilford-Glazer Faculty of Business and Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
authors.forename: Dan
authors.initials: D
authors.lastname: Greenberg
mesh_terms: D002318:Cardiovascular Diseases / Q000191:economics / Q000517:prevention & control; D003362:Cost-Benefit Analysis; D016527:Drug Costs / Q000706:statistics & numerical data*; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy / Q000191:economics; D000960:Hypolipidemic Agents / Q000191:economics / Q000494:pharmacology; D054539:Medication Therapy Management / Q000191:economics*; D000091362:PCSK9 Inhibitors; D000071449:Proprotein Convertase 9
chemical_list: D000960:Hypolipidemic Agents; D000091362:PCSK9 Inhibitors; C472125:PCSK9 protein, human; D000071449:Proprotein Convertase 9
keywords: Affordability; Alirocumab; Budget-impact; Evolocumab; LDL cholesterol