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Cabazitaxel for the Second-Line Treatment of Metastatic Hormone-Refractory Prostate Cancer: A NICE Single Technology Appraisal

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Abstract

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cabazitaxel (Jevtana®, sanofi-aventis, UK) to submit evidence of its clinical and cost effectiveness for the second-line treatment of metastatic hormone-refractory prostate cancer (mHRPC). The School of Health and Related Research Technology Appraisal Group (ScHARR-TAG) at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence for the clinical and cost effectiveness of the technology based upon the manufacturer’s submission to NICE. Clinical evidence was derived from a multinational randomized open-label phase III trial of cabazitaxel plus prednisone or prednisolone in men with mHRPC that had progressed during or following treatment with docetaxel. The comparator was mitoxantrone plus prednisone or prednisolone. Use of cabazitaxel was associated with a statistically significant improvement in overall survival, median progression-free survival and time to tumour progression. However, it was also associated with an increased incidence of adverse events such as neutropenia. Utility data were based on interim results from the early access programme for cabazitaxel. Data were only available for a small number of patients with stable disease, resulting in great uncertainty as to the effect of cabazitaxel on quality of life. For their economic evaluation, the manufacturer estimated that the use of cabazitaxel was associated with an incremental cost of £74,908 per QALY gained. However, the ERG disagreed with the manufacturer over two key methodological points. The first concerned modelling and extrapolating survival; the second point was concerned with the choice of patient population. The ERG altered the manufacturer’s evaluation to take into account these two points of disagreement. The resulting cost per QALY gained was £82,950. The NICE Appraisal Committee believed the analysis presented by the ERG to be more plausible, and likely to be an underestimate of the cost per QALY. They concluded that whilst the clinical effectiveness of cabazitaxel had been proven, it was not likely to represent a cost-effective use of NHS resources and so its use could not be recommended.

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Acknowledgments

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 10/49/01). See the HTA Programme website for further project information (http://www.hta.ac.uk). This summary of the ERG report was compiled after the AC’s review and has not been externally peer reviewed by PharmacoEconomics. The authors acknowledge the clinical advice provided by Dr. Stéphane Larré (consultant urological surgeon) and Dr. Satish Kumar (consultant medical oncologist). The authors also acknowledge Ruth Wong, who contributed to the work but did not meet the criteria for authorship. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of NICE or the Department of Health. The authors have no potential conflicts of interest.

Author Contributions

BK drafted the final version of the manuscript and takes responsibility as the overall guarantor of the content. MLJ drafted an initial version of the manuscript and revised it for important intellectual content. MS and CL revised the manuscript for important intellectual content. All authors have given their approval for the final version to be published.

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  1. School of Health and Related Research, University of Sheffield, Sheffield, S1 4DA, UK

    Ben Kearns, Myfanwy Lloyd Jones, Matt Stevenson & Chris Littlewood

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  1. Ben Kearns
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Correspondence to Ben Kearns.

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Kearns, B., Lloyd Jones, M., Stevenson, M. et al. Cabazitaxel for the Second-Line Treatment of Metastatic Hormone-Refractory Prostate Cancer: A NICE Single Technology Appraisal. PharmacoEconomics 31, 479–488 (2013). https://doi.org/10.1007/s40273-013-0050-9

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