TY - JOUR
T1 - Obinutuzumab in Combination with Chemotherapy for the First-Line Treatment of Patients with Advanced Follicular Lymphoma
T2 - An Evidence Review Group Evaluation of the NICE Single Technology Appraisal
AU - Thielen, Frederick W.
AU - Bueyuekkaramikli, Nasuh C.
AU - Riemsma, Rob
AU - Fayter, Debra
AU - Armstrong, Nigel
AU - Wei, Ching-Yun
AU - Carrera, Vanesa Huertas
AU - Misso, Kate
AU - Worthy, Gill
AU - Kleijnen, Jos
AU - Ramos, Isaac Corro
N1 - Funding Information:
Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Program (project number 16/112/02 STA) [see the HTA program website for further information—http://www.hta.ac.uk]. This summary of the ERG report was compiled after the AC’s review. The views and opinions expressed are the authors’ and do not necessarily reflect those of the HTA Programme, NICE, NIHR, NHS, or the Department of Health.
Funding Information:
Frederick W. Thielen acted as a health economist on this assessment, critiqued the company’s economic evaluation, wrote the manuscript and acted as overall guarantor for the overall content of this article. Nasuh C. Büyükkaramikli, Nigel Armstrong and Ching-Yun Wei acted as health economists on this assessment, and critiqued the company’s economic evaluation. Rob Riemsma acted as project lead and systematic reviewer on this assessment and critiqued the clinical effectiveness methods and evidence. Isaac Corro Ramos acted as health economic project lead and critiqued the company’s economic evaluation. Debra Fayter and Vanesa Huertas Carrera acted as systematic reviewers and critiqued the clinical effectiveness methods and evidence. Gill Worthy acted as statistician and critiqued the analyses in the company’s submission. Kate Misso critiqued the search methods in the submission. Jos Kleijnen critiqued the company’s definition of the decision problem and their description of the underlying health problem and current service provision and supervised the project. All authors contributed to the conception and planning of the work, to the writing of the ERG report, and critically revised and approved the final submitted version of the manuscript. This summary has not been externally reviewed by PharmacoEconomics.
Publisher Copyright:
© 2018, The Author(s).
PY - 2019/8
Y1 - 2019/8
N2 - The National Institute for Health and Care Excellence (NICE), as part of the institute's single technology appraisal (STA) process, invited the company that makes obinutuzumab (Roche Products Limited) to submit evidence of the clinical and cost effectiveness of the drug in combination with chemotherapy, with or without obinutuzumab as maintenance therapy for adult patients with untreated, advanced follicular lymphoma (FL) in the UK. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG). This paper describes the company's submission, the ERG review, and NICE's subsequent decisions. The clinical evidence was derived from two phase III, company-sponsored, randomised, open-label studies. Most evidence on obinutuzumab was based on the GALLIUM trial that compared obinutuzumab in combination with chemotherapy as induction followed by obinutuzumab maintenance monotherapy with rituximab in combination with chemotherapy as induction followed by rituximab maintenance monotherapy in previously untreated patients with FL (grades 1-3a). Long-term clinical evidence was based on the PRIMA trial, studying the benefit of two years of rituximab maintenance after first-line treatment in patients with FL. The cost-effectiveness evidence submitted by the company relied on a partitioned survival cost-utility model, implemented in Microsoft (R) Excel. The base-case incremental cost-effectiveness ratio (ICER) presented in the company submission was
AB - The National Institute for Health and Care Excellence (NICE), as part of the institute's single technology appraisal (STA) process, invited the company that makes obinutuzumab (Roche Products Limited) to submit evidence of the clinical and cost effectiveness of the drug in combination with chemotherapy, with or without obinutuzumab as maintenance therapy for adult patients with untreated, advanced follicular lymphoma (FL) in the UK. Kleijnen Systematic Reviews Ltd (KSR), in collaboration with Erasmus University Rotterdam, was commissioned to act as the Evidence Review Group (ERG). This paper describes the company's submission, the ERG review, and NICE's subsequent decisions. The clinical evidence was derived from two phase III, company-sponsored, randomised, open-label studies. Most evidence on obinutuzumab was based on the GALLIUM trial that compared obinutuzumab in combination with chemotherapy as induction followed by obinutuzumab maintenance monotherapy with rituximab in combination with chemotherapy as induction followed by rituximab maintenance monotherapy in previously untreated patients with FL (grades 1-3a). Long-term clinical evidence was based on the PRIMA trial, studying the benefit of two years of rituximab maintenance after first-line treatment in patients with FL. The cost-effectiveness evidence submitted by the company relied on a partitioned survival cost-utility model, implemented in Microsoft (R) Excel. The base-case incremental cost-effectiveness ratio (ICER) presented in the company submission was
KW - GROUP PERSPECTIVE
U2 - 10.1007/s40273-018-0740-4
DO - 10.1007/s40273-018-0740-4
M3 - (Systematic) Review article
C2 - 30547368
SN - 1170-7690
VL - 37
SP - 975
EP - 984
JO - Pharmacoeconomics
JF - Pharmacoeconomics
IS - 8
ER -