A highlights the lack of price competition in brand-name cardiovascular drugs that significantly impacts patient care.
It confirms what I've noticed and been infuriated by when prescribing direct oral anticoagulants (DOACs) in clinical practice over the last 10 years.
When the first DOAC -- Boehringer Ingelheim's dabigatran (Pradaxa) -- was approved a decade ago, this oral direct thrombin inhibitor became the first new oral approved in the U.S. in more than 50 years. The RE-LY trial showed that 150 mg twice daily lowered the risk of stroke and systemic embolism by 35% beyond the reduction achieved with warfarin, which had been the standard of care for patients with .
A year later, became the second DOAC approved for Afib based on the ROCKET AF trial. In that trial, once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin.
I was so excited about DOACs that I gave paid talks on rivaroxaban to physicians for about a year. Realizing the bias and conflicts of interest inherent in accepting money or gifts from pharmaceutical companies, I stopped accepting any payments, food, gifts, or other emoluments from them in 2013 at the time I started the Skeptical Cardiologist blog.
The major downside of these drugs for my patients was cost. Therefore, when became the third DOAC approved, I was optimistic that price competition would make at least one of these more affordable.
Surely, I thought, one of these companies will price their drug significantly lower than the other two and that will immediately ratchet up their market share. Unfortunately, this did not happen. I began viewing these companies as engaged in collusion or price-fixing to the detriment of my patients.
There are now four DOACS approved for Afib in the U.S. that target the activity of thrombin or factor Xa: apixaban, dabigatran, edoxaban (Savaysa), and rivaroxaban. As a class, these drugs are superior to warfarin clinically, because they have less need for laboratory monitoring, minimal drug-drug and food interactions, and more predictable dosing.
DOAC usage rose and warfarin usage steadily dropped as DOACS were approved, as a looking at the U.S. nursing home population reported in the Journal of the American Heart Association.
If it wasn't for cost, I would have all my Afib patients who need anticoagulation taking apixaban rather than warfarin. If any one of these four DOAC makers had dropped their price significantly, I would prescribe their DOAC over apixaban.
For example, edoxaban, the last DOAC to be approved for Afib has almost no market share. I've never written a prescription for it or come across a patient on it. Why hasn't lowered its price for edoxaban to gain market share?
This graph from the JAMA Network Open research letter shows what has been happening with DOAC average whole prices over the last 5 years: They've been drifting up, seemingly in lock-step with each other!!!
The compound annual growth rates (CAGR) of these drugs were highly correlated with the other DOACS.
The study found high correlations between average wholesale prices among drugs within five classes used for chronic conditions for which there were multiple contemporaneously brand-name drugs from 2015 to 2020. "Moreover, the median CAGR in costs for each of these medication classes outpaced annual growth rate of the consumer price index for prescription drugs at 2.1% over the same time period. These results suggest there was little price competition among the sponsors of these products," the authors wrote.
Daiichi-Sankyo, I have a suggestion for you. Instead of wasting money on slick websites promoting edoxaban to the public, just lower its price! You will become a hero to doctors and patients everywhere.
Anthony C. Pearson, MD, is a noninvasive cardiologist and professor of medicine at St. Louis University School of Medicine. He blogs on nutrition, cardiac testing, quackery, and other things worthy of skepticism at , where a version of this post first appeared.