Cabazitaxel for the second-line treatment of metastatic hormone-refractory
prostate cancer: a NICE single technology appraisal.
Author(s): Kearns B(1), Lloyd Jones M, Stevenson M, Littlewood C.
Affiliation(s): Author information:
(1)School of Health and Related Research, University of Sheffield, Sheffield S1 4DA,
UK. b.kearns@sheffield.ac.uk
Publication date & source: 2013, Pharmacoeconomics. , 31(6):479-88
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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