In a recent post, I discussed the drug Xarelto (chemically known as rivaroxaban) and the competition this product is running to Boehringer-Ingelheim’s (BI) flagship product, Pradaxa (dabigatran). The introduction of Xarelto in the U.K., a product produced by Bayer and in the U.S. by our old friends at Johnson and Johnson (J&J), forced BI to cut its prices in order to compete.
It’s less of an issue in the U.S., which, despite the reforms of the Affordable Care Act, has a dysfunctional health care system that continues to be held hostage by the profit motive. Despite the risks of fatal hemorrhaging, Pradaxa continues to be favored by many doctors because it’s much easier to use. Unlike the old standby Coumadin (warfarin), Pradaxa has far fewer interactions. Admittedly, this is a concern with elderly patients who often take many different medications (it’s rather like trying to arrange seating at a banquet in which no two people who have differing religious beliefs, dietary preferences, eye color, hair color, ethnic origins, sexual inclinations, gender, educational history and occupation are seated together).
In the U.S., Xarelto has not been approved for use in preventing clots in the same way as Pradaxa. Specifically, Xarelto is approved for patients who run the risk of developing clots as the result of joint surgery or because of arrhythmia (irregular heart beat) – not because of a heart valve defect, which is what Pradaxa is prescribed for. Therefore, in the U.S., Xarelto has not been a direct competitor of Pradaxa.
J&J is seeking to change that. They have already sought approval to market Xarelto to patients with heart valve issues. The FDA denied that application in June on the grounds that more information was necessary. Recently, J&J has submitted the application a second time. The new application is based on the results of a study, involving over 15,000 subjects, which demonstrates that Xarelto, adminstered in combination with low-dose aspirin and a second drug, could reduce the risk of cardiac events due to heart valve problems by up to 33%.
This would put Xarelto in direct competition with Pradaxa – and with costs to patients or their insurers running $250-$260 a month, both drugs are very profitable (compare this with the cost of Coumadin, which is approximately $10 a month – though the frequent monitoring required can add as much as $100 to that figure).
One of the problems with Xarelto – and the reason J&J’s first application was rejected by the FDA – is that potential side effects are unknown.
There is something else that’s making the CEOs of BI, Bayer and J&J sweat a little, and that’s the impending approval of a new drug called Eliquis (chemically known as apixaban). This drug, manufactured by Bristol-Meyer Squibb and Pfizer, is already available in Europe, but has not yet been approved in the U.S. That approval may be coming, however; according to medical experts, Eliquis may be more effective and less risky, partially because it is eliminated through the liver, not the kidney – and therefore may be a better choice for geriatric patients who frequently have kidney issues.
As you might expect, the marketing departments at BI, Bayer and J&J are all scrambling to get as many patients on Pradaxa and Xarelto in order to lock in their profits before Eliquis arrives to cut into their precious market share…