Note: Since we published this blog post a few months ago, our lawyers are now reviewing potential Pradaxa lawsuits. You can contact us at 800-553-8082 or get a free online consultation.
Pradaxa is a new blood-thinning medicine prescribed to lower the chance of blood clots forming in your body. Warfarin (Coumadin) has been the gold standard for years as a blood thinner. Coumadin has been available for more than 50 years. An estimated 26.7 million prescriptions for Coumadin were filled in the U.S. in 2006, with its use escalating in recent years. It is reported that Coumadin is one of the 20 most widely used drugs in the United States.
That is a big market that brings in a lot of money. What follows from a big market is other pharmaceutical companies chasing that big market and those dollars. Enter Dabigatran, called by the sexier name Pradaxa, manufactured by Boehringer Ingelheim, is a more recent blood thinner to emerge in the marketplace, gaining approval from the FDA in October 2010. The medication has been reported to lower the risk of stroke compared to Coumadin according to the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study which was used to obtain FDA approval.
Like Coumadin, there is a risk for hemorrhage. Are there more problems with Pradaxa than Coumadin? No one is sure. But here have been a lot of reports of serious, life-threatening, and bleeding-related adverse events with Pradaxa. Clinical trials show that the risk of bleeding per year of treatment with Pradaxa was 16.6% (one in six patients) when taking 150 mg twice daily and 14.7% (one in 6.8 patients) taking 110 mg twice daily, compared with 18.4% (one in 5.4 patients) for clinical trials the risk of bleeding per year of treatment with dabigatran was 16.6% (one in six patients) when taking 150 mg twice daily and 14.7% (one in 6.8 patients) taking 110 mg twice daily, compared with 18.4% (one in 5.4 patients) for warfarin. This study proves nothing: there is too little data. But it should give Pradaxa users cause for concern that maybe the problems with Pradaxa may be worse than with Coumadin.
Pradaxa certainly has some strengths that Coumadin does not. INR testing accompanies the use of Coumadin often several times a year, and some cases require weekly monitoring to ensure effectiveness. This need for frequent laboratory testing is unnecessary with the use of Pradaxa. Another advantage of Pradaxa that Boehringer is pushing is that patients are not required to change dietary habits, or adjust their other medications.
Prime Therapeutics, a pharmacy benefit management company owned by Blue Cross and Blue Shield (St. Paul, MN), and Health Care Service Corporation (Chicago, IL), conducted an analysis to determine the cost-effectiveness of Pradaxa compared to Coumadin. The results were presented at the Academy of Managed Care Pharmacy’s Educational Conference in Atlanta, Georgia.
The analysis showed that the reduction in lab tests did not outweigh Pradaxa’s higher cost. The study estimated that the net cost (medical and pharmacy costs) to avoid a stroke was $253, 210. Researchers reviewed medical and pharmacy claims and identified over 13,000 patients who met the following criteria:
• had a Coumadin claim in January 2009
• cumulative supply of at least 270 days
• at least one medical claim which indicates management/monitoring of Coumadin
There were 2,975 patients that met the Coumadin monitoring criteria and management costs were determined to be $544 per patient annually. Total Padaxa costs were $2,885 per patient annually. Though Warfarin was confirmed to have lower medical costs than Pradaxa due to the reduced need for monitoring INR ($496 vs. $118 per patient), higher pharmacy costs associated with Pradaxa ($2,467) versus Coumadin ($48). The discrepancy in medical costs is because Coumadin is a generic drug that has been on the market for several decades and thus is available at a lower cost.
Another analysis conducted by Veterans Affairs (VA) in Palo Alto and Stanford University previously reported that cost-effectiveness was related to the risk level of the patient, with Coumadin being cost-effective for low-risk individuals and Pradaxa being cost-effective only in high-risk individuals.
The Director of Clinical Outcomes Assessment at Prime Therapeutic, Patrick Gleason, stated “Dabigatran (Pradaxa) is attractive to patients because of its convenience and potential clinical benefit, but its convenience comes at a high cost…Even when we consider the savings from fewer blood tests, there is a substantial increase in cost to treat patients with Dabigatran (Pradaxa) compared to Coumadin to prevent one stroke. Health plans should weigh the benefits and added costs when making decisions about where Pradaxa should be placed on a formulary.”
Cost-effectiveness will be an important factor as new blood thinners enter the market. Bayer and Johnson & Johnson are looking to bring their own blood thinner, Xarelto, to market as wells as Pfizer and Bristol-Myers Squibb with Eliquis. Will these new treatments carry less risk and cost? Or more?
I don’t know the answer to these drugs or with Pradaxa, even after all of this data. Pradaxa may be a great innovative and cost-effective treatment, and it may cause excessive bleeding that leads to scores of lawsuits. The jury is still out. With new treatments comes uncertainty.