The availability of generic antiviral drugs to manage chronic hepatitis B resulted in significant savings to Medicare, despite an increase in prescriptions, according to an analysis by researchers at Weill Cornell Medicine and NewYork-Presbyterian. The findings were published July 8 in Gastroenterology.
About 1.6 million people in the United States live with chronic hepatitis B. There is no cure currently, but some medications can suppress the virus and limit liver damage. However, the high cost of brand-name drugs is often a barrier for many people who must take the drugs for life, leading to treatment non-compliance and subsequent health complications.
In 2014, the Food & Drug Administration (FDA) approved generic versions of entecavir. This was followed in 2017 with approval for tenofovir disoproxil fumarate (tenofovir DF). The hope was that the availability of these first-line chronic hepatitis B treatments would lower costs and more patients would take the medications consistently. The team analyzed publicly available Medicare Part D data to determine if this was the case.
The results showed that the brand name prescriptions dropped significantly after the generic drug approvals. The overall number of patients receiving hepatitis B treatments increased by over 50 percent between 2013 and 2020, while the total Medicare spending did not show an upward trend. Researchers estimated that generic medications can save Medicare around $300 million a year. They also pointed out that Vemlidy® (tenofovir alafenamide), a lower-dose chronic hepatitis B drug approved by the FDA in 2016, does not currently have a generic equivalent.
According to the authors, a limitation of the study was that they did not have access to dosing or indications for the medications prescribed. Still, they suggested that further studies be undertaken to evaluate the financial and clinical impacts of generic drugs.
Lead author: Dr. Xiaohan Ying
Senior author: Dr. Arun Jesudian