Anicka Slachta of Cardiovascular Business covers why the costs of developing new cardiovascular disease drugs are so high. In fact, a recent analysis found cardiovascular drugs can be 100X the average.
Why? First, according to one study authored by a team (led by Thomas J. Moore) senior scientists with the Institute for Safe Medication Practices, found the average clinical trial needed for a drug to earn FDA approval equals $19 million. How did they arrive at this number? They studied 59 novel therapeutic drugs in 130 pivotal clinical trials between 2015 and 2016. They derived an estimation of $5 million for studies without a control group for three orphan drugs and less than 15 patients to $346.8 million for noninferiority trial assessing a heart drug.
What drives up trial costs? The number of patients and sites as well as trial length. Moreover “drugs are more expensive to test when they have smaller effects that require observing more patients for longer periods of time” Moore quotes for CardiovascularBusiness. The high number also represents a linkage to “existing therapies driving the cost upward” notes Slachta. For example, the author looks at a trial concerning a novel sacubitril-valsartan combination drug for heart failure versus enalapril.
Slachta reports cardiovascular clinical trial costs were not always as high. Moore noted the growing large portfolio of cardiovascular drugs—many effective—and growing inexpensive generic options introduces more complexity when attempting to prove an incremental advancement.
The author quotes Moore that even with the average trial cost of $19 million, this doesn’t explain the rapid inflationary tendency in drug pricing today.
Thomas J. Moore, Senior Scientist