Ronen Arbel1, Ariel Hammerman2, Noa Triki3, Dan Greenberg4. 1. 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. 2. Department of Pharmaceutical Technology Assessment, Chief Physician's Office, Clalit Health Services Headquarters, Tel-Aviv, Israel. 3. Department of Health Technology Policy, Maccabi Healthcare Services, Tel-Aviv, Israel. 4. 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.
Abstract
BACKGROUND/ OBJECTIVES: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 withPCSK9i 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.
RCT Entities:
BACKGROUND/ OBJECTIVES: 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 HCVpatient (~$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: Gregory P Hess; Pradeep Natarajan; Kamil F Faridi; Anna Fievitz; Linda Valsdottir; Robert W Yeh Journal: Circulation Date: 2017-10-30 Impact factor: 29.690