FDA clears first generic versions of rivaroxaban—what it means for patient care
The U.S. Food and Drug Administration (FDA) has approved the first generic versions of rivaroxaban, marking a significant milestone in the availability of direct-acting oral anticoagulants (DOACs). While this approval could expand access to newer anticoagulation therapies, experts caution that the immediate impact may be limited.
The newly approved generics are a 2.5 mg dose of rivaroxaban, which is indicated for reducing the risk of major cardiovascular events in adults with coronary artery disease and peripheral artery disease (PAD). However, this dose is not intended to be used for the treatment and prevention of venous thromboembolism (VTE), where DOACs like rivaroxaban have largely replaced warfarin.
Potential impact of generic DOACs on cardiology
Dave Dixon, PharmD, chair of the department of pharmacotherapy and outcomes science at Virginia Commonwealth University School of Pharmacy, emphasized the importance of this approval, but noted its limited scope.
“I think the big thing is that the FDA approved the first generic for the 2.5 mg dose of rivaroxaban, which is used for secondary prevention,” Dixon explained. “This is not the dose used for the treatment and prevention of VTE, so its impact is relatively modest for now.”
Despite this, he acknowledged that the availability of a generic version could reduce financial barriers for some patients. He also noted that additional doses of rivaroxaban will likely become available as other patents expire on various doses or combinations of the these drugs, which could have a much greater impact.
DOACs vs. warfarin
The approval comes amid a long-term shift away from warfarin, a drug that has been widely used for decades but requires frequent monitoring and carries a higher risk of major bleeding events. DOACs, including rivaroxaban and apixaban, have been shown to be safer and equally or more effective in many cases.
“DOACs are generally preferred over warfarin due to their better safety profile, particularly in reducing major bleeding events,” said Dixon. “While warfarin is still necessary for certain patients, such as those with mechanical heart valves, the trend toward DOACs is clear.”
However, cost has remained a major barrier to wider DOAC adoption, particularly for uninsured or underinsured patients. Dixon said warfarin remains significantly cheaper, but it has associated costs, such as routine monitoring at Coumadin clinics, that patients and healthcare providers must also consider.
Future outlook on costs of DOACs
With generic DOACs beginning to enter the market, the financial burden of anticoagulation therapy may lessen over time. Dixon anticipates that the availability of generics will eventually lead to increased access and broader adoption, though it may take time for insurance companies to adjust coverage policies.
“There’s always a period where prices don’t immediately drop after a new generic enters the market,” he explained. “But for patients where cost has been a barrier, this is an important step.”
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com