Ledipasvir-Sofosbuvir for Treating Chronic Hepatitis C: A NICE Single Technology Appraisal-An Evidence Review Group Perspective

PharmacoEconomics
Praveen ThokalaP Harrison

Abstract

The National Institute for Health and Care Excellence (NICE) invited Gilead, the company manufacturing ledipasvir-sofosbuvir (LDV/SOF), to submit evidence for the clinical effectiveness and cost effectiveness of LDV/SOF for treating chronic hepatitis C. The School of Health and Related Research (ScHARR) Technology Assessment Group was commissioned as the Evidence Review Group (ERG). This paper describes the company's submission (CS), the ERG review and the subsequent decision of the NICE Appraisal Committee (AC). The ERG produced a critical review of the clinical effectiveness and cost-effectiveness evidence of LDV/SOF based upon the CS. The clinical effectiveness data for LDV/SOF were taken from ten trials: three phase III trials and seven phase II trials. Trials compared different durations of LDV/SOF, with and without ribavirin (RBV). There were no head-to-head trials comparing LDV/SOF with any comparator listed in the NICE scope. Data from the trials were mostly from populations with genotype 1 (GT1) disease, although some limited data were available for populations with genotypes 3 and 4. For GT1 treatment-naïve patients, sustained viral response for 12 weeks (SVR12) rates for LDV/SOF ranged from 93.1 to 99.4 % for subgrou...Continue Reading

References

Jun 6, 2006·Health Technology Assessment : HTA·M WrightUNKNOWN UK Mild Hepatitis C Trial Investigators
Jan 14, 2010·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Michelle Martinot-PeignouxPatrick Marcellin
Apr 12, 2014·The New England Journal of Medicine·Kris V KowdleyUNKNOWN ION-3 Investigators
Apr 15, 2014·The New England Journal of Medicine·Nezam AfdhalUNKNOWN ION-2 Investigators
Apr 15, 2014·The New England Journal of Medicine·Nezam AfdhalUNKNOWN ION-1 Investigators

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Citations

Sep 19, 2017·The Cochrane Database of Systematic Reviews·Janus C JakobsenChristian Gluud
Aug 24, 2017·Journal of Gastroenterology and Hepatology·Ian C Roberts-Thomson, Thomas Lung
Jul 10, 2019·Social Justice Research·Victoria Charlton, Annette Rid
Sep 11, 2018·Frontiers in Immunology·Samantha A YostJoseph Marcotrigiano
Jun 7, 2017·The Cochrane Database of Systematic Reviews·Janus C JakobsenChristian Gluud

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