Foster Better Pharmaceutical Policy and Global Regulation
Foster Better Pharmaceutical Policy and Global Regulation
Hepatitis C Treatment Frameworks
Hepatitis C (HCV) is estimated to affect as many as 170 million people worldwide and an estimated 3.5 million people in the United States. Though HCV treatment has been in the news in recent years because of the breakthrough cures, treating Hepatitis C has always come with high costs when you include the onerous side effects of older therapies. Research conducted at the Schaeffer Center has analyzed the cost and value of these breakthrough drugs and their impact on the healthcare system and patients. For example:
- A central recommendation to come out of the phase two report issued by the National Academies of Science, Engineering and Medicine’s Committee for a National Strategy to Eliminate Hepatitis B and C- of which Neeraj Sood is a member- proposes for the federal government to establish a voluntary licensing agreement with a patent-holding pharmaceutical company to distribute specialty hepatitis C drugs to underserved communities. This novel strategy would save money while improving access according to Sood and his colleagues.
- A series of papers published in May 2016 in AJMC assessed the impact and value of HCV therapies on the healthcare system. The studies, co-authored by Darius Lakdawalla, found price of curing HCV in the long term is much cheaper than the ongoing expense of older therapies.
- Through the use of an innovative cost-benefit research design, Dana Goldman and his colleagues found that treating 5 percent of all HCV patients with the latest drugs would be more cost effective for reducing infections and health care costs than the current approach according to an analysis published in the journal Health Affairs in 2015.
- Separately, Jeff McCombs and his colleagues found an effective indicator of the disease’s progression. The indicator is highly predictive and shows the risks of deferring treatment for too long, making it a significant tool for “watchful waiting.” McCombs and his team have conducted a retrospective analysis of U.S. Veteran’s Administration electronic records to analyze when treatment began, along with its associated patient outcomes.
Fox, D. S., & McCombs, J. S. (2016). Optimizing HCV treatment–Moving beyond the cost conundrum. Journal of hepatology.
Jena, A. B., Stevens, W., Gonzalez, Y. S., Marx, S. E., Juday, T., Lakdawalla, D. N., & Philipson, T. J. (2016). The wider public health value of HCV treatment accrued by liver transplant recipients.The American journal of managed care, 22(6 Spec No.), SP212-9.
Lakdawalla, D. N., Linthicum, M. T., & Vanderpuye-Orgle, J. (2016). Does patient cost sharing for HCV drugs make sense?. The American journal of managed care, 22(6 Spec No.), SP188-90.
Linthicum, M. T., Gonzalez, Y. S., Mulligan, K., Moreno, G. A., Dreyfus, D., Juday, T., … & Brookmeyer, R. (2016). Value of expanding HCV screening and treatment policies in the United States. The American journal of managed care,22(6 Spec No.), SP227-35.
Matsuda, T., McCombs, J. S., Tonnu-Mihara, I., McGinnis, J., & Fox, D. S. The Impact of Delayed Hepatitis C Viral Load Suppression on Patient Risk: Historical Evidence from the Veterans Administration. In Forum for Health Economics and Policy.
Moreno, G. A., Mulligan, K., Huber, C., Linthicum, M. T., Dreyfus, D., Juday, T., … & Lakdawalla, D. N. (2016). Costs and spillover effects of private insurers’ coverage of hepatitis C treatment. The American journal of managed care, 22(6 Spec No.), SP236-44.
Tonnu-Mihara, I., Matsuda, T., McCombs, J., Saab, S., Hines, P., L’Italien, G., … & Yuan, Y. (2016). Five Laboratory Tests Predict Patient Risk and Treatment Response in Hepatitis C: Veterans Affairs Data from 1999-2010. Universal Journal of Medical Science, 4(1), 10-20.
Cheetham, T. C., Niu, F., Chiang, K., Yuan, Y., Kalsekar, A., Hechter, R., … & Nyberg, L. (2015). Factors Associated with Failure to Achieve SVR in Hepatitis C Genotype 3 Patients Within an Integrated Care Delivery System. Journal of managed care & specialty pharmacy, 21(8), 641-647.
Van Nuys, K., Brookmeyer, R., Chou, J. W., Dreyfus, D., Dieterich, D., & Goldman, D. P. (2015). Broad hepatitis C treatment scenarios return substantial health gains, but capacity is a concern. Health Affairs, 34(10), 1666-1674.
Matsuda, T., McCombs, J., Tonnu-Mihara, I., Saab, S., Hines, P., LItalien, G. J., … & Yuan, Y. (2014). The Impact Of Fibrosis On The Risk Of Long-Term Morbidity And Mortality In Chronic Hepatitis C Patients Treated In The Veterans Administration Health Care System. Value in Health, 17(3), A268.
McCombs, J., Matsuda, T., Tonnu-Mihara, I., Saab, S., Hines, P., L’Italien, G., … & Yuan, Y. (2014). The risk of long-term morbidity and mortality in patients with chronic hepatitis C: results from an analysis of data from a Department of Veterans Affairs Clinical Registry. JAMA internal medicine,174(2), 204-212.
McCombs, J. S., Yuan, Y., Shin, J., & Saab, S. (2011). Economic burden associated with patients diagnosed with hepatitis C. Clinical therapeutics,33(9), 1268-1280.
McHutchison, J. G., Manns, M., Patel, K., Poynard, T., Lindsay, K. L., Trepo, C., … & Albrecht, J. K. (2002). Adherence to combination therapy enhances sustained response in genotype-1–infected patients with chronic hepatitis C.Gastroenterology, 123(4), 1061-1069.
A Good Deal for Eliminating Hepatitis C: Saving Money and Lives
Health Affairs Blog
How to pay the bill for hepatitis C
The Los Angeles Times
A financial case for expanding access to costly hepatitis C drugs
Southern California Public Radio
It’s Easier to Measure the Cost of Health Care than Its Value
Harvard Business Review
Assistant Professor of Clinical Medicine, Keck School of Medicine of USC
Leonard D. Schaeffer Director’s Chair, Schaeffer Center
Distinguished Professor of Public Policy, Pharmacy, & Economics at School of Pharmacy & Sol Price School
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation,
School of Pharmacy
Director of Graduate Studies,
Clinical Pharmacy and Pharmaceutical Economics & Policy