Fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer: an Evidence Review Group perspective of a NICE Single Technology Appraisal
Fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer: an Evidence Review Group perspective of a NICE Single Technology Appraisal
Clinical and cost-effectiveness evidence on fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer evidence was submitted to the single technology appraisal (STA) process of the National Institute for Health and Care Excellence (NICE) by the manufacturer of fulvestrant. The Southampton Health Technology Assessments Centre (SHTAC) was commissioned by NICE as an independent Evidence Review Group (ERG) to critique the company’s submitted evidence. Fulvestrant was compared directly with anastrozole in two RCTs and was compared indirectly by means of a network meta-analysis with anastrozole, letrozole and tamoxifen. This paper is a summary of the ERG’s review of the company’s submission and a summary of the guidance the NICE Appraisal Committee issued in January 2018. The ERG had several concerns, the most important of which related to the degree to which fulvestrant might confer a benefit in overall survival (OS). This was because mature data were not available from the key phase III trial FALCON. The economic model was sensitive to changes in OS and the ERG considered the incremental cost-effectiveness ratio (ICER) was uncertain and likely to increase once mature results from FALCON become available. The NICE Appraisal Committee concluded that fulvestrant could not be recommended for treating locally advanced or metastatic estrogen-receptor positive breast cancer in postmenopausal women who have not had previous endocrine therapy.
fulvestrant, breast cancer, Health technology assessment
Picot, Joanna
324d6f20-a105-49fd-9fb0-88791be84ada
Kalita, Neelam
da42f168-a3cc-44c9-bafb-2801ff57914b
Gaisford, Wendy C
f1f37a2e-d281-4577-8332-fef0f8b2c789
Harris, Petra B
a8bd143b-3e2c-4929-9279-510a4c60bd09
Onyimadu, Oluchukwu
ff168bd7-1c4f-4756-a34a-7e6b930ae29b
Cooper, Keith
ea064f58-d71d-404a-bcf3-49d243b8825b
Picot, Joanna
324d6f20-a105-49fd-9fb0-88791be84ada
Kalita, Neelam
da42f168-a3cc-44c9-bafb-2801ff57914b
Gaisford, Wendy C
f1f37a2e-d281-4577-8332-fef0f8b2c789
Harris, Petra B
a8bd143b-3e2c-4929-9279-510a4c60bd09
Onyimadu, Oluchukwu
ff168bd7-1c4f-4756-a34a-7e6b930ae29b
Cooper, Keith
ea064f58-d71d-404a-bcf3-49d243b8825b
Picot, Joanna, Kalita, Neelam, Gaisford, Wendy C, Harris, Petra B, Onyimadu, Oluchukwu and Cooper, Keith
(2018)
Fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer: an Evidence Review Group perspective of a NICE Single Technology Appraisal.
PharmacoEconomics.
(doi:10.1007/s40273-018-0725-3).
Abstract
Clinical and cost-effectiveness evidence on fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer evidence was submitted to the single technology appraisal (STA) process of the National Institute for Health and Care Excellence (NICE) by the manufacturer of fulvestrant. The Southampton Health Technology Assessments Centre (SHTAC) was commissioned by NICE as an independent Evidence Review Group (ERG) to critique the company’s submitted evidence. Fulvestrant was compared directly with anastrozole in two RCTs and was compared indirectly by means of a network meta-analysis with anastrozole, letrozole and tamoxifen. This paper is a summary of the ERG’s review of the company’s submission and a summary of the guidance the NICE Appraisal Committee issued in January 2018. The ERG had several concerns, the most important of which related to the degree to which fulvestrant might confer a benefit in overall survival (OS). This was because mature data were not available from the key phase III trial FALCON. The economic model was sensitive to changes in OS and the ERG considered the incremental cost-effectiveness ratio (ICER) was uncertain and likely to increase once mature results from FALCON become available. The NICE Appraisal Committee concluded that fulvestrant could not be recommended for treating locally advanced or metastatic estrogen-receptor positive breast cancer in postmenopausal women who have not had previous endocrine therapy.
Text
Fulvestrant_STA_pharmacoeconomics_submitted
- Accepted Manuscript
More information
Submitted date: 31 July 2018
Accepted/In Press date: 18 September 2018
e-pub ahead of print date: 17 October 2018
Keywords:
fulvestrant, breast cancer, Health technology assessment
Identifiers
Local EPrints ID: 425649
URI: http://eprints.soton.ac.uk/id/eprint/425649
ISSN: 1170-7690
PURE UUID: f438eb0e-6cac-4f05-940b-0af86414b15e
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Date deposited: 30 Oct 2018 17:30
Last modified: 11 Sep 2024 04:01
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Author:
Wendy C Gaisford
Author:
Petra B Harris
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