Obinutuzumab in Combination with Chemotherapy for the First-Line Treatment of Patients with Advanced Follicular Lymphoma

Frederick W. Thielen (), Nasuh C. Büyükkaramikli, Rob Riemsma, Debra Fayter, Nigel Armstrong, Ching-Yun Wei, Vanesa Huertas Carrera, Kate Misso, Gill Worthy, Jos Kleijnen and Isaac Corro Ramos
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Frederick W. Thielen: Erasmus University
Nasuh C. Büyükkaramikli: Erasmus University
Rob Riemsma: Kleijnen Systematic Reviews Ltd.
Debra Fayter: Kleijnen Systematic Reviews Ltd.
Nigel Armstrong: Kleijnen Systematic Reviews Ltd.
Ching-Yun Wei: Kleijnen Systematic Reviews Ltd.
Vanesa Huertas Carrera: Kleijnen Systematic Reviews Ltd.
Kate Misso: Kleijnen Systematic Reviews Ltd.
Gill Worthy: Kleijnen Systematic Reviews Ltd.
Jos Kleijnen: Kleijnen Systematic Reviews Ltd.
Isaac Corro Ramos: Erasmus University

PharmacoEconomics, 2019, vol. 37, issue 8, No 1, 975-984

Abstract: Abstract 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® Excel. The base-case incremental cost-effectiveness ratio (ICER) presented in the company submission was

Date: 2019
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DOI: 10.1007/s40273-018-0740-4

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