studies

960A AASLD ABSTRACTS HEPATOLOGY, October, 2015
Disclosures:
George K. Lau - Consulting: Roche, Novartis, Roche, Novartis, Roche, Novartis,
Roche, Novartis
The following authors have nothing to disclose: Fan Li, Guofeng Chen, Qing
Shao, Dong Ji, Bing Li, Zhongbin Li, Jialiang Liu, Chunxiao Liu, Tingting Wang,
Qiaomin Wang, Jing Chen, Vanessa Wu, April Wong, Cheng Wang, Yudong
Wang
1538
The Value of Cure Associated with Treating Treatment-naïve
(TN) Chronic Hepatitis C (CH-C) Genotype 1
(GT1): Are the New All Oral Regimens a Good Value to
Society?
Zobair M. Younossi 1,2 , Haesuk Park 3 , Douglas Dieterich 4 , Sammy
Saab 5 , Aijaz Ahmed 6 , Stuart C. Gordon 7 ; 1 Center For Liver
Disease, Department of Medicine, Inova Fairfax Hospital, Falls
Church, VA; 2 Betty and Guy Beatty Center for Integrated Research,
Inova Health System, Falls Church, VA; 3 University of Florida,
Gainesville, FL; 4 Icahn School of Medicine at Mount Sinai, New
York City, NY; 5 University of California Los Angeles, Los Angeles,
CA; 6 Stanford University, Standford, CA; 7 Henry Ford Hospital,
Detroit, MI
Background and Aim: The approval of all-oral regimens has
led to substantially high cure rates. Our aim was to assess the
value of cure to society by treating HCV GT1. Methods: A Markov
model for HCV GT1 projected long-term health outcomes,
life-years (LYs), and quality-adjusted life-years (QALYs) gained
for a lifetime horizon. The model compared current therapies in
the US [2nd generation triple (sofosbuvir+PR & simeprevir+PR)
and all-oral therapy treatments (ledipasvir/sofosbuvir and
ombitasvir+paritaprevir/ritonavir+dasabuvir±ribavirin] with
no treatment option. Sustained virologic response (SVR) rates
were based on Phase III clinical trials. We assumed that 80%
and 95% of HCV GT1 patients are eligible for 2nd generation
triple and all-oral regimens. Transition probabilities, utility and
mortality were based on literature review and consensus by
hepatologists. Results: In 2015, 1.11 million individuals were
TN with HCV-GT1. The model estimated that treating all eligible
HCV GT1 patients with 2nd generation triple and all-oral
therapies can result in 1.8 million and 2.9 million additional
QALYs gained. Using a threshold of $50,000 to $150,000
for the value of a QALY, these regimens led to savings of $91-
$274 billion and $144-$432 billion. Also, the costs of these
regimens were $80 billion and $93 billion. The value of cure
was assessed by subtracting the costs of the regimens from the
economic gains associated with the value of QALYs. The value
of cure with 2nd generation triple and all oral regimens was
estimated at $12-$194 billion and $51-$340 billion. Each
HCV GT1 patient cured with 2nd generation triple and all oral
regimens could save the U.S. between $10,381-$174,473
and $46,141-$305,021. Conclusions: The recent evolution
of regimens for HCV GT1 has increased efficacy and value of
cure. Curing all eligible HCV-GT1 patients with all-oral regimen
leads to substantial savings to the U.S. society.
Disclosures:
Zobair M. Younossi - Advisory Committees or Review Panels: Salix, Janssen,
Vertex; Consulting: Gilead, Enterome, Coneatus
Haesuk Park - Consulting: Gilead Science
Douglas Dieterich - Advisory Committees or Review Panels: Gilead, BMS, Abbvie,
Janssen, Merck, Achillion
Sammy Saab - Advisory Committees or Review Panels: BMS, Gilead, Merck,
Janssen; Grant/Research Support: Gilead; Speaking and Teaching: BMS, Gilead,
Merck, Janssen, Salix, Onyx, Bayer, Janssen; Stock Shareholder: Achillion,
Johnson and Johnson, BMS, Gilead
Aijaz Ahmed - Consulting: Bristol-Myers Squibb, Gilead Sciences Inc., Roche,
AbbVie, Salix Pharmaceuticals, Janssen pharmaceuticals, Vertex Pharmaceuticals,
Three Rivers Pharmaceuticals; Grant/Research Support: Gilead Sciences
Inc.
Stuart C. Gordon - Advisory Committees or Review Panels: Janssen; Consulting:
Merck, Gilead, BMS, CVS Caremark, Amgen, AbbVie; Grant/Research Support:
Merck, Gilead, AbbVie, Intercept Pharmaceuticals, Exalenz Sciences, Inc., BMS
1539
Rethinking pricing policy of direct antiviral agents to
cure chronic hepatitis C infection at a population-level
Francois Girardin, Nathalie Vernaz, Nicolas Goossens, Francesco
Negro; Geneva University Hospital, Geneva, Switzerland
Background Although cost-effectiveness of new direct antiviral
agents for chronic hepatitis C viral infection (HCV) is a
prerequisite for reimbursement, a population-level cure would
induce staggering upfront costs. We investigated the correlation
between sustained virological response (SVR) and drug
costs. Methods We derived medication costs from Swiss public
reimbursement prices and extracted published SVR data of
currently available HCV therapies (ribavirin, pegylated interferon,
simeprevir, boceprevir, telaprevir, sofosbuvir, ledipasvir,
ombitasvir, paritaprevir, dasabuvir). We stratified cost-analysis
by HCV genotype and presence/absence of cirrhosis (in treatment
naïve patients). We measured the correlation between
the costs and SVR. All cost results are reported in USD or CHF,
as with the rounded exchange rate of 1 USD=1 Swiss franc
might be considered (2015). Results For both patient groups,
we found a correlation between SVR and cost, where R 2 was
higher for naive cirrhotic patients (67.8%) compared to naive
the non-cirrhotic patient group (56.4%) indicating that the
more one spends on a treatment strategy, the higher the SVR.
The costs extended between USD12,690 and USD133,750
per SVR (Fig.1). Discussion There is a significant correlation
between the rate of SVR and the costs of treatment strategy.
Payment per patient recovery, regardless of dose and treatment
duration, including risk-sharing with drug manufacturers
would allow better budget control and long-term projections.
Alternatively, pricing volume per year would also minimize
resources consumption and maximize health benefits and allow
the manufacturer to provide large amount of drug before the
era of DAA generics.