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
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