New class of cholesterol lowerers, PCSK9 inhibitors, too expensive, ICER draft report finds

A draft report released by the USA-based Institute for Clinical and Economic Review (ICER) has again focused on the cost of the new class of cholesterol lowering drugs known as PCSK9 inhibitors, with the independent non-profit organization concluding that these are too expensive for general use.

The report includes a comprehensive review of currently available evidence on the newly approved PCSK9 inhibitors alirocumab (Praluent, from Regeneron [Nasdaq: REGN] and Sanofi [Euronext: SAN]) and evolocumab (Repatha, from Amgen [Nasdaq: AMGN), and also provides analyses of cost-effectiveness and potential budget impact under different utilization assumptions. Based on these findings the report presents the draft ICER value-based price benchmark for these drugs; prices that reflect the magnitude of estimated improvements in long-term patient outcomes and a threshold for new drug costs that does not exceed growth in the overall national economy.

It has been estimated that as many as 3.5-15 million Americans with elevated cholesterol may be eligible and considered for treatment with PCSK9 inhibitors. But there is remaining uncertainty about interpretation of the existing evidence on the clinical effectiveness of these drugs for different types of patients. In addition, with a list price over $14,000 per year there are serious questions regarding the price at which these drugs would represent a sensible value to patients and to the health care system.