Bortezomib for the treatment of multiple myeloma patients
Bortezomib for the treatment of multiple myeloma patients
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of bortezomib for the treatment of multiple myeloma patients at first relapse and beyond, in accordance with the licensed indication, based upon the evidence submission from Ortho Biotech to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer's definition of the decision problem were time to disease progression, response rate, survival and quality of life. The literature searches for clinical and cost-effectiveness studies were adequate and the one randomised controlled trial (RCT) included was of reasonable quality. Results from the RCT suggest that bortezomib increases survival and time to disease progression compared with high-dose dexamethasone (HDD) in multiple myeloma patients who have had a relapse after one to three treatments. Cost-effectiveness analysis based on the same trial and an observational study was reasonable and gave an estimated cost per life-year gained of £30,750, which ranged from £27,957 to £36,747 on sensitivity analysis. An attempt was made to replicate the results of the manufacturer's model and to compare the results to the Kaplan–Meier survival curve presented in the manufacturer's submission. In addition, a one-way sensitivity analysis and a probabilistic sensitivity analysis were undertaken, as well as additional scenario analyses. Based on these analyses the ERG suggests that the cost-effectiveness results presented in the manufacturer's submission may underestimate the cost per life-year gained for bortezomib therapy (versus high-dose dexamethasone) when potential UK practice and scenarios are considered. The guidance issued by NICE in June 2006 as a result of the STA states that bortezomib monotherapy for the treatment of relapsed multiple myeloma is clinically effective compared with HDD but has not been shown to be cost-effective and is not recommended for the treatment of progressive multiple myeloma in patients who have received at least one previous therapy and who have undergone, or are unsuitable for, bone marrow transplantation.
Green, Colin
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Bryant, J.
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Takeda, A.
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Cooper, K.
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Clegg, A.
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Smith, A.G.
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Stephens, M.
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June 2009
Green, Colin
c57c8e95-7870-4fb1-b3b1-6a2c7442cb30
Bryant, J.
508f497c-8b5a-468f-a37d-be9c26e4e49d
Takeda, A.
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Cooper, K.
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Clegg, A.
838091f5-39df-4dbe-a369-675b26f2301b
Smith, A.G.
8051e9d5-c35f-49c0-a2f0-91501f9aa72f
Stephens, M.
8114316d-c6ec-4a56-9fdc-3c1d9f27e0de
Green, Colin, Bryant, J., Takeda, A., Cooper, K., Clegg, A., Smith, A.G. and Stephens, M.
(2009)
Bortezomib for the treatment of multiple myeloma patients.
Health Technology Assessment, 13 (1), supplement 29-33.
(doi:10.3310/hta13suppl1/05).
(PMID:19567211)
Abstract
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of bortezomib for the treatment of multiple myeloma patients at first relapse and beyond, in accordance with the licensed indication, based upon the evidence submission from Ortho Biotech to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The outcomes stated in the manufacturer's definition of the decision problem were time to disease progression, response rate, survival and quality of life. The literature searches for clinical and cost-effectiveness studies were adequate and the one randomised controlled trial (RCT) included was of reasonable quality. Results from the RCT suggest that bortezomib increases survival and time to disease progression compared with high-dose dexamethasone (HDD) in multiple myeloma patients who have had a relapse after one to three treatments. Cost-effectiveness analysis based on the same trial and an observational study was reasonable and gave an estimated cost per life-year gained of £30,750, which ranged from £27,957 to £36,747 on sensitivity analysis. An attempt was made to replicate the results of the manufacturer's model and to compare the results to the Kaplan–Meier survival curve presented in the manufacturer's submission. In addition, a one-way sensitivity analysis and a probabilistic sensitivity analysis were undertaken, as well as additional scenario analyses. Based on these analyses the ERG suggests that the cost-effectiveness results presented in the manufacturer's submission may underestimate the cost per life-year gained for bortezomib therapy (versus high-dose dexamethasone) when potential UK practice and scenarios are considered. The guidance issued by NICE in June 2006 as a result of the STA states that bortezomib monotherapy for the treatment of relapsed multiple myeloma is clinically effective compared with HDD but has not been shown to be cost-effective and is not recommended for the treatment of progressive multiple myeloma in patients who have received at least one previous therapy and who have undergone, or are unsuitable for, bone marrow transplantation.
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Published date: June 2009
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Local EPrints ID: 152847
URI: http://eprints.soton.ac.uk/id/eprint/152847
ISSN: 1366-5278
PURE UUID: 1f905880-aa69-4c20-954d-2dcd2aa26b68
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Date deposited: 17 May 2010 13:32
Last modified: 14 Mar 2024 02:44
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Contributors
Author:
Colin Green
Author:
J. Bryant
Author:
A. Takeda
Author:
A.G. Smith
Author:
M. Stephens
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