Rafia, R. orcid.org/0000-0002-6914-1990, Pandor, A. orcid.org/0000-0003-2552-5260, Davis, S. orcid.org/0000-0002-6609-4287 et al. (5 more authors) (2018) Obinutuzumab with Bendamustine for Treating Follicular Lymphoma Refractory to Rituximab: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. Pharmacoeconomics, 36 (10). pp. 1143-1151. ISSN 1170-7690
Abstract
As part of its single technology appraisal process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of obinutuzumab (Roche) to submit evidence on its clinical and cost effectiveness when used in combination with bendamustine in patients with follicular lymphoma (FL) refractory to rituximab. The Evidence Review Group (ERG), the School of Health and Related Research Technology Appraisal Group at the University of Sheffield, produced a document summarising the key points from the company submission alongside a critical review. Efficacy for progression-free survival (PFS) and safety was positively demonstrated in the pivotal GADOLIN trial, which compared obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance (O-Benda+O) against bendamustine monotherapy. Data on overall survival were immature. The company submitted a model-based economic analysis, including a patient access scheme. The ERG identified a number of limitations, in particular the absence of subgroup analysis and the approach used by the company to estimate overall survival (OS), which was more favourable to the intervention arm. The key uncertainty was the duration of the treatment effect on OS. This uncertainty is expected to be reduced when the final analysis of the GADOLIN trial is reported. Consequently, the NICE appraisal committee recommended O-Benda+O in the population covered by the marketing authorisation within the Cancer Drug Fund until NICE is able to review the guidance following publication of the final analysis of GADOLIN.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2018 Springer. This is an author produced version of a paper subsequently published in PharmacoEconomics. Uploaded in accordance with the publisher's self-archiving policy. The final publication is available at Springer via https://doi.org/10.1007/s40273-018-0645-2. |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Funding Information: | Funder Grant number National Institute For Health Research 14/25/02 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 03 May 2018 14:31 |
Last Modified: | 18 Nov 2020 11:41 |
Status: | Published |
Publisher: | Springer Verlag |
Refereed: | Yes |
Identification Number: | 10.1007/s40273-018-0645-2 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:130271 |