A commentary published Friday on the HealthAffairs.org blog raises concerns about the possible impact of new cholesterol drugs on the U.S. health care system.
PCSK9 (proprotein convertase subtilisin/kexin 9) enzyme inhibitors are currently being developed to treat millions of Americans with high-cholesterol. The inhibitors are expected to receive U.S. Food and Drug Administration approval by the middle of this year. Clinical-trial results suggest that the treatments are well-tolerated and effective in reducing bad cholesterol.
Once the drug is approved, up to 15 million Americans eventually could be considered candidates for the new class of drugs. "High cholesterol is one of the most prevalent conditions in the developed world and with primary prevention of high cholesterol as the eventual target for manufacturers, PCSK9 inhibitors likely will be the highest-selling class of medications in history," Dr. William Shrank, chief scientific officer for CVS Health and co-author of the blog post, said.
The authors of the blog post said PCSK9 inhibitors come at a high cost to the health care system, with estimates of a year's supply for a patient ranging from $7,000 to $12,000. With an assumed cost average of $10,000 per year, familial hypercholesterolemia and severe hypercholesterolemia alone would create a $16 billion market, the authors said.
"With a robust pipeline of expensive specialty drugs, this is just the beginning, and the resilience and ability of our health care system to absorb such high costs will be tested if rigid cost-control mechanisms are not put in place," Shrank said.
The entire post can be found at http://healthaffairs.org/blog/2015/02/17/in-the-debate-about-cost-and-efficacy-pcsk9-inhibitors-may-....