As the American College of Cardiology’s annual meeting kicked off in Orlando, all eyes turned to Sanofi and Regeneron, who reported that their PCSK9 med Praluent reduced the risk of cardiovascular events by 15%—as well as all-cause mortality by 15%—in the outcomes trial Odyssey. In conjunction with the data announcement, Sanofi disclosed that it’ll incorporate a new cost-effectiveness review by ICER in future payer negotiations as it fights for market share with rival Amgen and its PCSK9 treatment Repatha. The analysis concludes that Praluent is worth $4,460 to $7,975 for certain patients. If payers are willing to reduce barriers to access, Sanofi said it will lower the med’s net price to within ICER’s range. The program will use a “precision medicine approach” to home in on high-risk patients.
“Too many patients in urgent need of additional treatment options on top of statins have faced tremendous hurdles to gain access to this important medicine,” Sanofi CEO Olivier Brandicourt said in a statement. “We are prepared to change this by improving access and affordability, eliminating these burdensome barriers for high-risk patients in need.” In the much anticipated Odyssey trial, Praluent reduced the risk of a composite endpoint of heart attack, stroke, death from coronary heart disease or unstable angina requiring hospitalization by 15%, investigators reported, meeting its primary endpoint. The med also cut the risk of death from any cause by 15%. For high-risk patients with LDL levels of 100 mg/dL or higher, the benefit was larger: a 24% reduction in risk of MACE and a 29% drop in all-cause mortality.
Dr. Gregory Schwartz, another lead researcher for the trial, said that after working in the field for “nearly a quarter of a century, it’s very gratifying to find something that will have a great impact on the patients that we treat and see every day in our work.”
Odyssey tested Praluent in nearly 19,000 patients who experienced an acute coronary event the year before their enrollment. The participants were on the highest statin dose they could tolerate and received either placebo or Praluent in addition to their statin therapy. While Amgen and Sanofi and Regeneron battle it out with the PCSK9s, another competitor could be lurking in Esperion. The drugmaker’s cholesterol met phase 3 endpoints in results released this week, and CEO Tim Mayleben has previously said the company is planning to charge $9 or $10 per day, which would fall below the low end of the range ICER suggested for Sanofi’s Praluent. Sanofi, Regeneron and Amgen initially rolled their drugs out with prices of more than $14,000 per year before rebates and discounts.
Source : www.fiercepharma.com
Published on: March 14, 2018