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Obinutuzumab with Bendamustine for Treating Follicular Lymphoma Refractory to Rituximab: An Evidence Review Group Perspective of a NICE Single Technology Appraisal

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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.

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Acknowledgements

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number 14/177/09 STA). See the HTA programme website for further project information (http://www.hta.ac.uk). This summary of the ERG report was compiled after NICE issued guidance. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of NICE or the Department of Health. The authors also wish to thank Dr. Andrew McMillan for providing clinical advice and commenting on draft materials during the project. This summary was externally reviewed by PharmacoEconomics.

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Authors and Affiliations

  1. Health Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

    Rachid Rafia, Abdullah Pandor, Sarah Davis, John W. Stevens, Sue Harnan & Mark Clowes

  2. Consultant in Haematology, Barnsley Hospitals NHS Trust, Barnsley, S75 2EP, UK

    Youssef Sorour &  Robert Cutting

Authors
  1. Rachid Rafia
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  2. Abdullah Pandor
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  3. Sarah Davis
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  4. John W. Stevens
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  5. Sue Harnan
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  6. Mark Clowes
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  7. Youssef Sorour
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  8. Robert Cutting
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Contributions

RR, AP, SD drafted the manuscript and take responsibility as guarantors of the content. JWS, SH, MC, YS and RC revised the manuscript for important intellectual content or provided comments. All authors have given their approval for the final version to be published.

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Correspondence to Rachid Rafia.

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Funding

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number 14/177/09 STA). See the HTA programme website for further project information (http://www.hta.ac.uk).

Conflicts of Interest

RR, AP, SD, JWS, SH, MC, YS and RC have no conflicts of interest.

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Rafia, R., Pandor, A., Davis, S. et al. Obinutuzumab with Bendamustine for Treating Follicular Lymphoma Refractory to Rituximab: An Evidence Review Group Perspective of a NICE Single Technology Appraisal. PharmacoEconomics 36, 1143–1151 (2018). https://doi.org/10.1007/s40273-018-0645-2

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