Format

Send to

Choose Destination
Clinicoecon Outcomes Res. 2017 Feb 27;9:163-172. doi: 10.2147/CEOR.S117650. eCollection 2017.

Optimizing choice of oral interferon-free treatment for genotype 1 hepatitis C virus using testing for NS5A resistance: a cost-utility analysis from the perspective of the Italian National Health Service.

Author information

1
Pharmerit BV, Marten Meesweg, Rotterdam, the Netherlands.
2
Janssen EMEA, Turnhoutseweg, Beerse, Belgium.
3
Janssen-Cilag SpA, Via Michelangelo Buonarroti, Cologno Monzese, Italy.
4
JB Medical Ltd, Old Brickworks, Little Cornard, United Kingdom.

Abstract

BACKGROUND:

Patients with genotype-1 hepatitis C virus infection who have failed to respond to standard therapy or who relapse following treatment may be considered for an interferon-free regimen incorporating a nonstructural protein 5A (NS5A) inhibitor. Sustained virologic response (SVR) with these regimens is typically >90%, but this is reduced in patients with NS5A resistance. European Association for Study of the Liver guidelines recommend simeprevir + sofosbuvir ± ribavirin (SMV+SOF±R) for re-treating patients failing an NS5A inhibitor-containing regimen. An alternative strategy would be to test for NS5A resistance prior to treatment, with therapy optimized based on the results. This study investigates the cost-effectiveness of this strategy.

MATERIALS AND METHODS:

A Markov model was used to estimate disease progression for treatment-experienced genotype 1 patients with severe fibrosis or compensated cirrhosis. Targeted treatment with either SMV+SOF±R or sofosbuvir + ledipasvir ± ribavirin (SOF+LDV±R) based on pretreatment NS5A resistance testing was compared to routine SOF+LDV±R without testing. Treatment duration was 12 or 24 weeks for patients with severe fibrosis or compensated cirrhosis (Metavir F3/F4). SVR data for the treatment options were based on the results of published clinical trials. The analysis was carried out from the perspective of the Italian National Health Service.

RESULTS:

Optimized treatment using NS5A resistance testing yielded 0.163 additional QALYs and increased costs of €2,789 per patient versus no testing. The incremental cost-effectiveness ratio (ICER) was €17,078/QALY. Sensitivity analysis identified the SVR attributable to each of the treatment regimens as the most sensitive determinant of ICER (range: €10,055/QALY-€43,501/QALY across plausible range). Probabilistic sensitivity analysis demonstrated that, at a willingness-to-pay threshold of €30,000/QALY, the probability that NS5A-directed treatment will be cost-effective is 81.4%.

CONCLUSION:

Optimizing therapy with either SMV+SOF±R or SOF+LDV±R based on pretreatment NS5A resistance testing was cost-effective from the perspective of the Italian National Health Service, in treatment-experienced patients with severe fibrosis or compensated cirrhosis.

KEYWORDS:

NS5A inhibitor; health economics; hepatitis C; ledipasvir; simeprevir; sofosbuvir

Conflict of interest statement

Disclosure At the time this analysis was carried out, Kirsten Y Westerhout, Walter Bouwmeester, Marjanne A Piena, and Maarten Treur were employed by Pharmerit BV, who received payment from Janssen EMEA to carry out the economic analysis described in this paper. Inge Duchesne, Marta Pisini, and Beatrice Gueron were employed by Janssen EMEA and Francesco Damele was employed by Janssen-Cilag SpA (Italy), sponsors of this analysis. Jonathan Belsey was employed by JB Medical Ltd, who received payment from Janssen EMEA to write the paper. The authors report no other conflicts of interest in this work.

Supplemental Content

Full text links

Icon for Dove Medical Press Icon for PubMed Central
Loading ...
Support Center