Stephen Congly, MD: Impact of Generic Nucelos(t)ide Analogues on HBV Treatment Spending

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Congly explains key findings from his cross-sectional study of costs associated with HBV treatment in patients on Medicaid and the economic impact of generic versus originator use.

Most patients infected with chronic hepatitis B virus (HBV) will require lifelong treatment with nucleoside/nucleotide analogues, underscoring the importance of understanding the economic impact of treatment for these patients.1

Findings from a recent study led by Stephen Congly, MD, MSc, clinical associate professor in the department of medicine at Cumming School of Medicine at the University of Calgary, are providing an overview of the costs associated with chronic HBV treatment in individuals eligible for Medicaid reimbursement based on data extracted from the Centers for Medicare and Medicaid Services database from 2012 to 2021.1

“We looked at what the implications are from the system perspective of spending on these very important agents, which are, at this point, indefinite and lifelong, and asked how could we potentially have savings with the use of generics and what the role of generics may be,” Congly said to HCPLive. “We show that with increasing use of generics, this may be an interesting and important policy shift for the greater economy of the US.”

The World Health Organization estimates that 254 million people were living with chronic hepatitis B infection in 2022, with 1.2 million new infections each year. In 2022, hepatitis B resulted in an estimated 1.1 million deaths, primarily from cirrhosis and hepatocellular carcinoma, underscoring the importance of linkage to care and adequate treatment for these patients.2 However, therapy with nucleoside and nucleotide analogues used for the treatment of chronic HBV is often prolonged and expensive.1

Indeed, Congly and colleagues found that from 2012 to 2021, the number of enrollees in Medicaid increased from 58.9 million to 86.3 million, with the total Medicaid spending on nucelos(t)ide analogues reaching $1.9 billion USD dollars for 1,682,132 claims. The number of claims submitted increased from 233,976 in 2012 and reached a peak in 2016 before trending downwards to a plateau of about 270,000 (2012-2015 annual percentage change, 8.0; 95% CI, 2.2 to 22.0; 2015-2021 annual percentage change, -1.7; 95% CI, -0.9 to 0.4).1

Similarly, investigators noted the spending for nucelos(t)ide analogues grew, reaching a peak of $289 million in 2016 before decreasing to $129 million in 2021 (2012-2016 annual percentage change, 11.1%; 95% CI, 0.5 to 39.90; 2016-2021 annual percentage change, -18.4; 95% CI, -34.2 to -11.7). They pointed out the reduced expenditure was attributable to decreased utilization of originator drugs (2015-2021 annual percentage change, -1.67; 95% CI, -9.9 to 0.4) with a linked spending decrease (2016-2021 annual percentage change, -21.0; 95% CI, -42.6 to -13.7) due to the introduction of generics, including adefovir in 2013, lamivudine and entecavir in 2014, and tenofovir disoproxil fumarate in 2017. Specific analysis of expenditures between 2014 and 2021 showed that a total of $669 million USD was saved with the use of generics, with $443 million of savings specifically from the use of generic tenofovir disoproxil fumarate.1

“We've looked at the national numbers, but I think it would be interesting to break it down by state and jurisdiction and to see the trends over time, because you can then get a better feel of the number of claims based on generic versus originator, and then sort of look at the policy, policy impact by state,” Congly explained. “This will also be a surrogate for access to care to some extent, and potentially can help inform policymakers and hopefully allow for equity for all patients living with chronic hepatitis B across the United States so they get the same level of treatment that's critical for overall outcomes and survival.”


  1. Congly SE, Brahmania M, Coffin CS. Spending on nucleos(t)ide analogues for hepatitis B in medicaid beneficiaries: 2012-2021. Annals of Hepatology.
  2. World Health Organization. Hepatitis B. Newsroom. April 9, 2024. Accessed June 7, 2024.