Expanding access to new cures for hepatitis C
Hepatitis C (HCV) afflicts more than five times as many people as HIV—approximately 185 million people worldwide. New drugs called direct acting antivirals (DAAs) have come to market, offering an unprecedented opportunity to eradicate HCV. However, they are extremely expensive: Sovaldi, for example, launched at $84,000 for a 12-week course of treatment.
Since 2014, GHJP has worked to expand access to these expensive, breakthrough HCV medications. With partners, we have conducted research and advocacy projects to address the epidemic in the United States and globally:
Poor access to the new HCV medications in state prisons
GHJP led the first peer-reviewed study in over a decade examining hepatitis C medical care in state prisons. The study, published in Health Affairs, found that less than 1% of 100,000+ state prisoners known to have hepatitis C receive treatment for the disease. Additionally, while many federal agencies get deep discounts on new HCV medications like Sovaldi and Harvoni, state prisons are among few government institutions that do not get those rebates, the research showed. The research team called on Gilead to offer more substantial price discounts to state prisons and urged state governments to allocate more prison funding for treating hepatitis C. GHJP carried out this project with the Association of State Correctional Administrators (ASCA) and physicians at Yale School of Medicine. (Read the press release and access the study data).
Expert meetings about reducing the cost of new HCV drugs in the United States
Without reductions in the price of these medicines, it is difficult to implement an evidence-based and public-health oriented approach to their provision. In the Spring of 2015, our clinic engaged in a project exploring potential strategies to reduce the prices of HCV drugs in the United States. We convened a meeting of key experts in public health, access to medicines, and HCV (including in the corrections setting) in Washington D.C. to explore the use of strategies such as collective bargaining by state Medicaid and prison programs, as well as the use of the federal "eminent domain" patent power, under 28 USC 1498. Clinic students prepared briefings on the current state of access to and pricing of HCV drugs in the US, and legal and policy options that could reduce the price. GHJP also convened a meeting, with Harvard Law School's Center for Health Law and Policy Innovation and HCV access advocates, to discuss ways to work jointly on pricing and access issues.
FOIA lawsuit to access clinical trial data for HCV drugs
On June 25, 2015, GHJP and Treatment Action Group (TAG) filed a Freedom of Information Act (FOIA) lawsuit seeking open access to clinical trial data from the US Food and Drug Administration on the new treatments for hepatitis C, Sovaldi and Harvoni, manufactured by Gilead Sciences. Both drugs promise unparalleled treatment success at unprecedented costs. Ordinary, twelve-week treatment plans for these drugs initially cost $84,000 and $94,500, respectively. However, neither the FDA nor the manufacturers have released the raw clinical trial data that the manufacturers submitted during the approval process for these drugs. The lawsuit, which is pending the U.S. District Court in Connecticut, seeks prompt disclosure of the clinical trial and related information. GHJP and TAG hope to make this data broadly available--with appropriate redactions to protect patient privacy--so that interested scientists can independently review that data. Such review is particularly important because the drugs are being widely prescribed to patient populations that may not have been adequately studied during clinical trials, and because health insurers are limiting access to the drugs on the basis of criteria that may have no basis in the evidence. GHJP and TAG are represented by the Media Freedom and Information Access Clinic (MFIA) at the Yale Law School. Read the complaint and other case documents here.
Report on the global HCV epidemic
GHJP published a report in 2015 entitled, “Ending an Epidemic: Overcoming the Barriers to an HCV-Free Future” (read it here). The HCV epidemic extends to both rich and poor countries, but the burden is greatest in middle-income countries (MICs). Nearly a half a million people die every year from HCV-related causes, including cirrhosis and liver cancer. As curing HCV becomes increasingly feasible, it is time for the global health community to take action to ensure that HCV treatment is affordable and accessible to all individuals infected with HCV, particularly disproportionately affected populations such as people who inject drugs (PWID). Towards this end, the GHJP working with the Treatment Action Group (TAG) and the Initiative for Medicines, Access and Knowledge (I-MAK) developed a policy paper that identified key steps that national and international actors must take in order for DAAs to deliver on their promise.
Beckman, A. et. al. "New Hepatitis C Drugs Are Very Costly And Unavailable To Many State Prisoners" Health Affairs (2016) (available here)
Heydari, S., Kembabzi, A., Monahan, C., and K. Ragins. “Ending an Epidemic: Overcoming the Barriers to an HCV-Free Future” Global Health Justice Partnership (2015) (available here)
Kapczynski, A. and A. Kesselheim “Government Patent Use’: A Legal Approach To Reducing Drug Spending” Health Affairs (2016) (available here)
Kapczynski, A. “The Trans-Pacific Partnership — Is It Bad for Your Health?” The New England Journal of Medicine (2015) (available here)
Brennan, Hannah and Kapczynski, Amy and Monahan, Christine H. and Rizvi, Zain. "A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health" Yale Law School, Public Law Research Paper No. 577; Yale Law & Economics Research Paper No. 560. (2016) (available here)