A new analysis published by manufacturers Janssen Pharmaceutical and Bayer AG shows that the Novel Oral Anticoagulant (NOAC) Xarelto (rivaroxaban) is safer and less expensive than its competitors in patients affected by cancer.
The research that was presented at the 2016 American Society of Hematology (ASH) Annual Meeting provided evidence that found how most cancer patients treated with the blood thinner could avoid emergency room (ER) visits to initiate therapy, saving the health care system from additional expenses.
Cancer patients are significantly more at risk of venous thromboembolisms (VTE), especially if treated with some chemotherapy agents, and blood clots are currently the second leading cause of death in this population. The standard of care to reduce the risk of blood clots is currently a daily regimen of injectable low-molecular-weight heparin (LMWH). These injections are, however, very painfully, and often significantly reduce the patients’ quality of life compared to a much more convenient oral formulation.
According to the study, a smaller amount of subjects required an ER visit before starting treatment with rivaroxaban compared to those who used the LMWH. Although during the first six months the percentages of patients sent to the ER was comparable (71 percent for Xarelto vs. 63 percent for LMWH), this number significantly decreased over time to just 42 percent at one year, and 34 percent at 18 months. Researchers speculate that as soon as patients became more familiar with the new drug, their compliance increased accordingly. The reduction in overall patients visits, hospitalizations and total hospital days also positively affected the economic outcomes by decreasing the healthcare resources utilization.
The manufacturing companies also provided additional evidence that further validates the medication’s safety and efficacy profile in real-world settings. Researchers analyzed data from a post-marketing safety surveillance study that evaluated over 10 million clinical records from the U.S. Department of Defense Military Health System and found that the number of major bleeding accidents in cancer patients was low and comparable to the one observed in healthy subjects.
Although this data aims at reaffirming Xarelto’s safety profile, the oral anticoagulant still is one of the most controversial drugs of the last decade. Among the various heated arguments, earlier this year the U.S. Food and Drug Administration (FDA) had to review data from rivaroxaban’s pivotal clinical trial: the ROCKET-AF study. According to the investigation panel, in fact, a device that was used to test the patient’s ability to coagulate later proved to be defective, leading to a mismatched interpretation of the drug’s safety data. Despite that, the regulator later reaffirmed the blood thinner’s effectiveness and alleged superiority over its counterpart Warfarin.
The product liability litigation against Janssen and Bayer kept growing steadily in 2016 and recently reached a total of almost 14,000 cases filed in court, thus becoming one of the largest pharmaceutical litigations in history. Following the trail of the Pradaxa litigation that eventually led Boehringer Ingelheim to pay $650 million to settle over 4,000 cases, plaintiffs who filed a Xarelto lawsuit claim that the pharmaceutical companies failed to adequately warn the public about the new anticoagulant’s dangerous side effects. The effects of the various NOACs (which include Pradaxa and Eliquis) cannot, in fact, be reversed since no antidote is available. Even a simple fall or bleeding accident may thus cause a potentially fatal hemorrhage that doctors cannot stop in any way. Because of that, many patients who switched to the new blood thinner suffered serious injuries or even died, leading to a storm of claims being filed in the centralized Multidistrict Litigation Number 2592 in the Eastern District of Louisiana.
Bayer and Janssen are still scavenging for more real-world data that proves their medication superiority over all its counterparts with the ongoing CALLISTO and EXPLORER prospective clinical programs that include more than 275,000 total patients.
Article by Dr. Clauido Butticè, Pharm.D.
