Access to Costly New Hepatitis C Drugs: Medicine, Money, and Advocacy

Clinical Infectious Diseases, Nov 2015

Hepatitis C affects >3 million people in the United States, and often leads to end-stage liver disease or death. In 2014, several new drugs to treat hepatitic C virus received US Food and Drug Administration approval, with remarkable cure rates exceeding 90%. Medicaid, however, is rationing these drugs, and other insurers have restricted coverage due to their exorbitant costs and the large size of the population in need. These access barriers and disparities have resulted in national patient advocacy mobilization, US congressional inquiry, and legal challenges. The US Department of Health and Human Services has been urged to intervene. We propose the establishment of a federal program, analogous to AIDS Drug Assistance Programs, to reduce access barriers and facilitate focused price negotiations. The federal government may further undertake a nonvoluntary acquisition of the pharmaceutical patents pursuant to federal statutory authority and principles of eminent domain. Projections indicate this proposal could lower costs by 90% and eliminate rationing.

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Access to Costly New Hepatitis C Drugs: Medicine, Money, and Advocacy

CID Access to Costly New Hepatitis C Drugs: Medicine, Money, and Advocacy Stacey B. Trooskin 2 3 Helen Reynolds 1 2 Jay R. Kostman 0 2 0 Division of Infectious Diseases, University of Pennsylvania Perelman School of Medicine , Philadelphia, Pennsylvania 1 School of Public Health, Drexel University 2 Received 11 March 2015; accepted 28 July 2015; electronically published 12 August 2015. Philadelphia, PA 3 Department of Infectious Diseases and HIV Medicine, Drexel University College of Medicine Hepatitis C affects >3 million people in the United States, and often leads to end-stage liver disease or death. In 2014, several new drugs to treat hepatitic C virus received US Food and Drug Administration approval, with remarkable cure rates exceeding 90%. Medicaid, however, is rationing these drugs, and other insurers have restricted coverage due to their exorbitant costs and the large size of the population in need. These access barriers and disparities have resulted in national patient advocacy mobilization, US congressional inquiry, and legal challenges. The US Department of Health and Human Services has been urged to intervene. We propose the establishment of a federal program, analogous to AIDS Drug Assistance Programs, to reduce access barriers and facilitate focused price negotiations. The federal government may further undertake a nonvoluntary acquisition of the pharmaceutical patents pursuant to federal statutory authority and principles of eminent domain. Projections indicate this proposal could lower costs by 90% and eliminate rationing. - In 2014, several remarkable new hepatitis C (HCV) drugs were launched, with cure rates exceeding 90% when used as components of antiviral treatment regimens. These breakthrough drugs are significant improvements over prior treatments, which were less effective and caused severe adverse effects [ 1–4 ]. However, the high prices of the 2014 HCV drugs create a treatment barrier, as many insurers reacted to the costs by rationing treatment [ 2, 5–10 ]. HCV is the most common blood-borne infection in the United States [ 1 ], impacting 3.2–5.2 million people nationwide [ 1, 11–13 ]. Approximately 80% of all HCVinfected individuals in the United States will progress to chronic infection; approximately 20% of such individuals will develop serious complications such as decompensated cirrhosis and/or hepatocellular carcinoma, requiring intensive treatment including medication, hospitalization, and liver transplant [ 1, 12 ]. For approximately 15 000 individuals annually, it will be fatal [ 1, 12 ]. Despite the great need for these effective new HCV drugs, their exorbitant pricing presents treatment barriers. The 2014 HCV drugs include sofosbuvir (Sovaldi, Gilead Sciences), ledipasvir/sofosbuvir (Harvoni, Gilead Sciences), simeprevir (Olysio, Janssen Pharmaceuticals), and ombitasvir/paritaprevir/ritonavir/dasabuvir tablets (Viekira Pak, AbbVie) (hereafter “2014 HCV drugs”). Although Sovaldi, introduced first, initially received considerable attention for its launch price of $1000 per pill, there are significant discounts that now make these drugs available for far less than the initial wholesale acquisition cost in most plans (a notable exception being state prison systems). The lack of transparency surrounding pricing is one of several issues to be addressed, as financial barriers impeding access to the 2014 HCV drug market as a whole remain significant. Sovaldi’s launch was the most lucrative on record [ 14 ], with its manufacturer, Gilead Sciences, Inc, reporting $12.4 billion in sales for 2014 [ 15 ]. At Sovaldi’s initial wholesale acquisition cost, the expense to treat 3 million people would have totaled >$250 billion dollars. By contrast, total US prescription drug spending was $263 billion for all conditions combined in 2011 [ 16 ]. Despite the ongoing controversy over Sovaldi’s cost, including congressional inquiries [ 8 ], patient advocacy [ 17 ], and insurance coverage restrictions, its price remains exorbitant [ 18 ]. The financial barriers to access are particularly troubling because the drug’s price is unrelated to any reasonable return on investment [ 2, 8 ] or cost of production, as the generic can be produced for <$3 per pill [19]. Moreover, the brand-name competitors, including Harvoni and Viekira Pak, demonstrate an oligopolistic similarity of pricing [ 8 ]. Initially, Sovaldi cost $84 000 for a 12-week regimen and must be taken with other drugs; Harvoni cost $94 500 for a 12-week regimen, with a potentially effective 8-week regimen costing $63 000; and Viekira Pak cost $83 319 for a 12-week regimen [ 4, 20 ]. Although discounting has occurred, there is a lack of transparency regarding negotiated prices, with confidentiality agreements between payers and manufacturers. IMPACT OF HEPATITIS C DRUG PRICING ON GOVERNMENT-FUNDED HEALTHCARE The 2011 national cost for HCV-related healthcare was approximately $6.5 billion [ 11 (...truncated)


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Stacey B. Trooskin, Helen Reynolds, Jay R. Kostman. Access to Costly New Hepatitis C Drugs: Medicine, Money, and Advocacy, Clinical Infectious Diseases, 2015, pp. 1825-1830, 61/12, DOI: 10.1093/cid/civ677