Annals Internal Medicine, Author Interviews, Beth Israel Deaconess, Cost of Health Care, Heart Disease, Lipids / 02.01.2019

MedicalResearch.com Interview with: Dhruv S. Kazi, MD, MSc, MS Associate Director Richard A. and Susan F. Smith Center for Outcomes Research Boston MA 02215 Associate Director Cardiac Critical Care Unit Beth Israel Deaconess Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ODYSSEY Outcomes trial found that addition of alirocumab to statin therapy reduces the incidence of a composite of cardiovascular death, myocardial infarction, and stroke among patients with a recent history of a myocardial infarction and elevated low-density lipoprotein cholesterol. We modeled the cost-effectiveness of alirocumab and found that, at the March 2018 price of the drug, it would not be cost-effective (either relative to statin alone or statin + ezetimibe) for this indication. We found that a large price-reduction would be required to meet the cost-effectiveness threshold of $100,000 per quality-adjusted life year. Shortly after the preliminary findings of this study were released, both manufacturers of PCSK9 inhibitors announced large price reductions in order to improve access to these drugs. (more…)
Author Interviews, Heart Disease, Lipids, Sanofi / 29.11.2017

MedicalResearch.com Interview with: Dr. Jay Edelberg MD, PhD VP Head of CV Development and Head Global CV Medical Affairs Sanofi  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with heterozygous familial hypercholesterolemia (HeFH) are often not able to achieve their target low-density lipoprotein cholesterol (LDL-C) levels, and some may require lipoprotein apheresis (LA) to lower their “bad cholesterol.” Apheresis is a procedure similar to kidney dialysis, where bad cholesterol is mechanically removed from the blood. It is an invasive, expensive, and time-consuming treatment for patients, as well as physicians. The Phase III ESCAPE clinical study looked at the potential effect of LA on total Praluent, free and total PCSK9 concentrations, as well as the combined pharmacodynamics effect of total Praluent on LDL-C-lowering. Praluent levels remained unaffected by apheresis, and Praluent consistently suppressed free PCSK9 levels in patients with HeFH, regardless of LA treatment. This analysis further confirms clinical ESCAPE data that Praluent can be used in conjunction with LA and may reduce or potentially eliminate the need for LA in some patients. (more…)