HCV Drug Costs: A Treatment Access Barrier

Posted on August 27, 2015

In a newly published, thought-provoking article in the journal Clinical Infectious Diseases, Stacey B. Trooskin and colleagues discuss how the high cost of newer hepatitis C therapies has become a major treatment access barrier in the US (Trooskin SB, et al. Clin Infect Dis. 2015 Aug 12 [Epub ahead of print]). Controversial insurance coverage restrictions and treatment rationing has resulted in national patient advocacy mobilization, US Congressional inquiry, and legal challenges. Authors of this article state that the establishment of a federal program, analogous to the successful AIDS Drug Assistance Programs (ADAP), would substantially reduce access barriers and facilitate focused price negotiations between pharmaceutical companies and payers.

A high proportion of US patients with chronic hepatitis C are, or will become, eligible for government funded healthcare through Medicaid, Medicare, incarceration, or the Veterans Administration (VA). Nationwide, despite the availability of price discounts and market competition, many individual state Medicaid programs have responded to the nexus between the price of the new HCV drugs and the vast size of the HCV infected population by restricting coverage and rationing treatment. Two Medicaid restrictions, established in several states, are particularly controversial. One imposes a sobriety requirement, while another denies treatment until after preventable liver deterioration occurs. Authors of a new, thought-provoking article in the journal Clinical Infectious Diseases, state that “rationing the newer HCV therapies in a manner that disproportionately impacts a stigmatized demographic crystallizes discussions about the value of a cure, the worth of a human life, and whose life is most worth saving” (Trooskin SB, et al. Clin Infect Dis. 2015 Aug 12 [Epub ahead of print]).

The authors of this article suggest that a lack of transparency regarding negotiations between payers and manufacturers, fuels ongoing controversy over what constitutes appropriate pricing. They also note that discounts, competition, exclusivity arrangements, and other negotiations have not created adequate access, but rather, have sharpened access disparities, with a patient’s ability to receive HCV treatment hinging upon factors such as state of residency or insurance plan.

Several stakeholders have been seeking federal action to increase access to the newer, more effective and safe HCV drugs, including the National Association of Medicaid Directors (NAMD), patient advocacy groups, and the VA. In the absence of federal solutions, a model for HCV treatment access could be based on the successful AIDS drug Assistance Programs (ADAP). The ADAP programs have contributed to improved health outcomes and drastically reduced treatment costs for those with HIV/AIDS. An ADAP analog for HCV treatment, currently championed by National Association of Medicaid Directors (NAMD) President Gordon and Public Citizen President Weisman, would accomplish similar goals by facilitating focused price negotiations, achieving transparency, and increasing access. It would also contain costs, a necessary step to protecting the viability of Medicare and Medicaid programs in the event that coverage restrictions are invalidated. Further, Weisman has specified at a Congressional hearing that an ADAP analog could be coupled with a non-voluntary acquisition of Gilead’s sofosbuvir patent by the US government based upon eminent domain principles. This would facilitate the production of generics at $3 per pill, thereby eliminating rationing.

Authors conclude the following: “The modest increases in access [to newer HCV therapies] have been reactive and inadequate. A pro-active, comprehensive solution such as the implementation of the ADAP analog for the HCV impacted population is urgently needed.”

HCV Knowledge Point

Chronic hepatitis C has been called “a disease of the marginalized” due to its disproportionately high prevalence among the homeless (22-53%), the severely mentally ill (19%), prisoners (23-41%), and intravenous drug users (58%). However, while the primary cause of new HCV infections in the US is illicit injection drug use, HCV also impacts those without traditional risk factors, with transmission resulting from transfusions prior to 1992; birth to an infected mother; sexual contact; or exposure in healthcare settings.

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