High Costs and Caution Yield Slow Start for New Heart Drugs
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New heart medications sacubitril-valsartan and PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors have seen a very slow uptake despite predictions they would be blockbusters.
A variety of barriers, including the drugs’ high costs, payer restrictions, and limited real-world safety and efficacy data have likely contributed to a slower-than-expected embrace of the drugs despite promising results from the drugs’ clinical trials. But data are only just starting to emerge to explain these trends.
A landmark Institute of Medicine study found that it takes, on average, 17 years for a new drug to make it from clinical trials into routine practice, noted Robert Mentz, MD, assistant professor of medicine at Duke University. He and his colleagues have several studies underway to better understand the uptake of sacubitril-valsartan and how to facilitate appropriate use.
In the first year after its July 2015 approval, only 2 of every 100 eligible hospitalized patients received the drug, according to a study Mentz and his colleagues published in JACC: Heart Failure earlier this year.
“We were optimistic we would see greater use over time,” Mentz said. And they did see a modest uptick in use near the end of the study period to >3 in 100 patients. Moreover, the study, which analyzed data on >21 000 patients from hospitals across the country in the Get With the Guidelines-Heart Failure registry, found a wide variation in uptake across facilities, with hospital prescribing rates varying from 0.13% to 90% of eligible patients.
“When you look at numbers there are early adopters, but generally it is a bell curve,” Mentz said. “There are a lot of people in the middle who want to understand the use of the drug and its …