"The Next Chapter in Cost-Effectiveness Analysis: Lessons from the US Experience with PCSK9 Inhibitors"
PCSK9 inhibitors, two novel cholesterol-lowering agents approved by the FDA in 2015, set off alarms in policy circles because of their launch price of $14,500 per year. A series of cost-effectiveness analyses followed, showing that substantial price reductions would be required to meet conventional thresholds of cost-effectiveness. Patients voted with their feet, abandoning prescriptions at pharmacies due to high co-pays. Finally, in 2018, manufacturers relented and announced an unprecedented 60% reduction in price of PCSK9 inhibitors, but not before trying standard bait-and-switch tactics to justify the high initial price. What can we learn from this experience and can these insights be generalized to other drugs like high-cost biologics in the US or high-volume generics in low- and middle-income countries? Using the examples of the newly approved tafamidis in the US and the fixed-dose combination polypill in India, Nigeria, and Mexico, Dr. Kazi will argue that it is time for the next chapter in Cost-Effectiveness Analysis.
Dhruv S. Kazi, MD, MSc, MS, serves as the Associate Director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and the Director of the Cardiac Critical Care Unit at Beth Israel Deaconess Medical Center in Boston, Massachusetts. He is a general cardiologist and cost-effectiveness researcher who uses real-world data and mathematical modeling to examine the clinical and economic effects of new technologies and policies on the cardiovascular health of the population. He is interested in advancing analytic methods in the field of cost-effectiveness research, particularly its application to vulnerable populations in the US and overseas. When not torturing data, Dr. Kazi enjoys rock climbing, salsa dancing, and photography.