Should the US government license hep C drugs?
- The National Academies of Sciences, Engineering and Medicine released a report about the burden of hepatitis C on public health and gave suggestions for eradicating the disease from the U.S. population by 2030.
- Hepatitis C kills thousands of people each year in the U.S., and can now be quickly cured through innovative, but costly medicines. The committee's report predicts that treating everyone with chronic hepatitis C could cut new infections by 90% and reduce liver cancer deaths by 65% by 2030.
- To improve access to expensive, potentially-curative drugs, the committee suggested voluntary licensing agreements between the government and pharmaceutical companies for underserved patient populations, leaving companies free to continue to sell the drugs to the wider community.
Chronic hepatitis C affects 2.7 million people in the U.S. While potentially-curative hepatitis C drugs are available, and are ultimately cost effective, their upfront price has created backlash, limiting treatment in some populations. Fewer than 1% of prisoners are treated, and almost half of Medicaid patients have been refused hepatitis C treatment, compared with 5% of Medicare patients and 10% of commercially-insured patients.
Patients who are not treated can continue to spread infection, and are at increased risk of cirrhosis, liver cancer and death.
"Viral hepatitis is simply not a sufficient priority in the United States," said Brian Strom of Rutgers Biomedical and Sciences, Rutgers University, who chaired the NASEM committee. "Despite being the seventh leading cause of death in the world – and killing more people every year than HIV, road traffic accidents, or diabetes – viral hepatitis accounts for less than 1% of the National Institutes of Health research budget."
NASEM believes that its strategy of unrestricted mass treatment of hepatitis C could potentially rid the U.S. of the disease as a public health problem by 2030. However, the costs of the drugs, especially before they come off patent (2029 at the earliest), make this financially unviable.
The committee's suggestion is that the U.S. government purchases a license or patent rights for just those groups where access is limited, for example in prisons or for people on Medicaid. This would allow the government lower cost access to the drug, and would benefit pharma companies by providing an income stream in a slowing market, without compromising the existing sales as it would focus on only those individuals who are unlikely to be able to access the drug under normal circumstances.
The market for the potentially-curative hepatitis C drugs grew fast and furious, but now it's in a bit of a slump, with sales of Gilead's blockbusters Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) falling by a third last year, and Merck writing down the value of uprifosbuvir, currently in clinical trials as part of an oral combination regimen, by $2.9 billion. While the drugs work extremely well, hepatitis C drugmakers are running out of patients to treat because they have been curing patients — thus the slowing of the market.
Creating a hepatitis C vaccine has been challenging. There is currently no approved hepatitis C vaccine, and few companies are working on vaccine development in this indication. Inovio, in collaboration with GeneOne Life Sciences, is developing INO-8000. This DNA-based hepatitis C vaccine has been assessed in a Phase 1 trial in Korea, with U.S. trials planned.
- National Academies of Sciences, Engineering and Medicine Statement
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