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New HTA Decisions in England
May 2020
Drug name
GAZYVARO® (obinutuzumab)
Company
Roche
Decision date
03/04/2020
Therapeutic area
Cancer
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended
Indication
Obinutuzumab with bendamustine followed by obinutuzumab maintenance is recommended as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen.
Decision Detail
It is recommended only if the company provides obinutuzumab according to the commercial arrangement. The company has a commercial arrangement (simple discount patient access scheme).
Summary
This appraisal reviews the evidence collected in the Cancer Drugs Fund for obinutuzumab with bendamustine for treating follicular lymphoma that did not respond or progressed with rituximab. Evidence from the Cancer Drugs Fund is limited but appears to support the clinical trial evidence. This evidence is in people who had rituximab as first-line treatment. The clinical effectiveness evidence came from GADOLIN, an open-label randomised controlled trial. It compared obinutuzumab with bendamustine induction treatment followed by obinutuzumab maintenance, against bendamustine induction therapy alone. The intention-to-treat population in GADOLIN was people with indolent non-Hodgkin lymphoma, of whom about 81% had follicular lymphoma. Patients were included in the trial if their disease was refractory to induction treatment with rituximab monotherapy, refractory to induction treatment with rituximab–chemotherapy, or relapsed during or within 6 months of completing 2‑year maintenance treatment with rituximab monotherapy. The current appraisal reviewed the most recent data from GADLOLIN. This showed statistically significant improvements in progression-free survival and overall survival, which is consistent with the primary analysis. Median overall survival was not reached in the obinutuzumab with bendamustine group and was 60.3 months in the bendamustine group (hazard ratio 0.71, 95% confidence interval 0.51 to 0.98, p=0.0343). This suggests a 29% reduction in the risk of death with obinutuzumab with bendamustine. The company's incremental cost-effectiveness ratios (ICERs) estimated using the Weibull survival functions with fixed or random change-points preferred by the committee (see section 3.8 and section 3.9) ranged from £15,587 per quality-adjusted life year (QALY) gained to £17,322 per QALY gained. Using the ERG's preferred random change-point models for both progression-free survival and overall survival, with an updated price for bendamustine, the ICER was £15,045 per QALY gained. Cost-effectiveness estimates for obinutuzumab with bendamustine are in the range usually considered a cost-effective use of NHS resources.