1. Since February 2015, sofosbuvir and
sofosbuvir association with ledipasvir became
available in Portugal, as standard therapy for
hepatitis C patients, under centralized
supervision.
The term of the price agreement are not
public, but is subjacent that a population of
13.000 patients must be treated in a two years
period. The Sofosbuvir based therapy
associated costs are not known, and this
analysis is outdated.
COST-UTILITY OF SOFOSBUVIR-BASED
THERAPY FOR UNTREATED GENOTYPE 1
AND 3 HEPATITIS C PATIENTS
A. Alcobia, D. Dias, M. Garcia, A. Soares.
Hospital Garcia de Orta - Pharmacy Department.
HOSPITAL GARCIA DE ORTA
ALMADA - PORTUGAL
Background:
Hepatitis C virus infection constitutes a major public health problem
worldwide due to his long-term impact, ranging from extensive fibrosis to
hepatocellular carcinoma (HCC). Since the approval of direct-acting
antivirals (DDAs), naïve and experienced patients with compensated
disease could benefit from a broad choice of drug combinations.
Nowadays due to financial constrainments is recognized the need for an
economic evaluation of the innovative treatments.
Purpose:
Cost-utility analysis of sofosbuvir(SOF)-based therapy versus the standard
of care in our Hospital for naïve genotype 1 and 3 patients
(Ribavirin(RBV)/Peg-interferon(PEG-INF) followed by Boceprevir
(BOC)/RBV/PEF-INF in genotype 1 and RBV/PEG-INF in genotype 3).
Material and methods:
Review of recent literature data to evaluate the efficacy of the therapeutic options in analysis
and the quality of life associated to each disease stage. A decision-analytic Markov model
was used to estimate long-term health outcomes, and the direct costs of the drugs (2014
prices) were considered.
Leleu et al., 2014
Thornton, 2013
Hepatocellular
carcinoma
Liver transplant
Decompensated
cirrhosis
Post transplant
status
Cirrhosis +
SVR
No
Cirrhosis
No Cirrhosis
+ SVR
Treatment
7%
1%
6%
3%
1% 43%
6%
21%
13%
3%
Cirrhosis
Markov Model
Death related with HCV
Results:
The incremental cost-efficacy ratio calculated for sofosbuvir-based therapy for
untreated genotype 1 patients was 38.455€ (TABLE 1).
For untreated genotype 3 patients, the option RBV/PEG-INF is dominant versus
sofosbuvir-based therapy [RBV/PEG-INF(48W) - Sustained viral response (SRV) =
62,5% and SOF+RBV+PEG-INF(12W) – SRV = 55,7%]
TABLE 1: GENOTYPE 1
THERAPEUTIC OPTIONS
ASSOCIATED
QALY
ASSOCIATED
COSTS
MARGINAL
QALY
MARGINAL
COSTS
ICER/QALY
STANDARD THERAPY
RBV+PEG-INF (48W) followed by
BOC+RBV+PEG-INF (48W)
5,37 31.647 € - - -
SOFOSBUVIR BASED THERAPY
SOF+RBV+PEG-INF (12W) 6,19 63.180 € 0,82 31.533 € 38.455 €
Conclusions:
Sofosbuvir-based therapy can be considered a cost-effective option for genotype 1 patients, depending on willingness-to-pay for a
quality-adjusted life year. Equally a cost-utility evaluation should be assessed for more than two dozen possible therapeutic
schemes.
References:
European Association for the Study of the Liver Guidelines (EASL). 2014; Leleu H, Blachier M, Rosa I. Cost-effectiveness of sofosbuvir in the treatment of patients with hepatitis C
Journal of Viral Hepatitis. 2014 1-7; Hsu P C, Federico C A, Krajden M, Yoshida E M, Bremner K E, Anderson F H, Weiss A A, Krahn M D. Health utilities and psychometric quality of life
in patients with early- and late-stage hepatitis C virus infection. Journal of Gastroenterology and Hepatology. 2012 27:149-157; Rupp D, Baternschlager R. Targets for antiviral therapy
of hepatitis C. Semin Liver Dis. 2014 34:9-21; Schinazi R, Halfon P, Marcellin P, Asselah T. HCV direct-acting antiviral agents: the best interferon-free combinations. Liver Intenational.
2014 1478-3223; Pawlotsky J-M. New hepatitis C virus (HCV) drugs and the hope for a cure: concepts in anti-HCV drug development. Semin Liver Dis. 2014 34:22-29; deLemos AS,
Chung RT. Hepatitis C treatment: an incipient therapeutic revolution. Trends in Molecular Medicine. 2014 20:315-321; Conteduca V, Sansonno D, Russi S, Pavone F, Dammacco F.
Therapy of chronic hepatitis C virus infection in the era of direct-acting and host-targeting antiviral drugs. Journal of Infection. 2014 68:1-20; Pawlotsky J-M. New hepatitis C therapies:
the toolbox, strategies and challenges. Gastroenteroly 2014 146:1176-1192; McHutchison JG, Gordon S, Schiff ER, Shiffman ML, Lee W, Rustgi VK, Goodman ZD, Ling M-H, Cort S,
Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. NEJM. 1998 21:1485-1492.
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