Cost-Effectiveness of Obinutuzumab in Combination with Bendamustine Followed by Obinutuzumab Maintenance versus Bendamustine Alone in Treatment of Patients with Rituximab-Refractory Follicular Lymphoma in Norway. 2018

Fredrik Salvesen Haukaas, and Audun Ohna, and Tania Krivasi
Roche Norge AS, Brynsengfaret 6 B, 0667, Oslo, Norway. fredrik.haukaas@roche.com.

OBJECTIVE To evaluate the cost-effectiveness of obinutuzumab in combination with bendamustine followed by obinituzumab maintenance (Obin-Benda) compared to bendamustine alone (Benda) in patients with refractory follicular lymphoma (FL) in a Norwegian setting. METHODS A three-state area-under-the-curve (AUC) model was developed. The states included were progression-free-survival (PFS), progressed disease (PD), and death. Each state had costs and utilities assigned to it. The pivotal phase III randomized controlled trial GADOLIN was used for clinical input in the model along with Norwegian cost estimates. The trial demonstrated that Obin-Benda improved overall survival (OS), with a hazard ratio (HR) of 0.67 (95% CI 0.47-0.96), and reduced the likelihood of progression or death (HR 0.52, 95% CI 0.39-0.69) compared to Benda. The model used EQ-5D data collected in the GADOLIN trial, with UK tariffs assigned to the EQ-5D scores. RESULTS The total quality adjusted life-years (QALYs) for the patients on Obin-Benda were estimated to be 4.67, compared to 3.65 for Benda, while the total costs were estimated to be €98,849 and €51,570, respectively. Obin-Benda had an incremental gain of 1.02 QALYs compared to Benda, at an additional cost of €47,279. The estimated deterministic incremental cost-effectiveness ratio (ICER) was €46,438 per QALY gained, while the probabilistic ICER was €46,887 per QALY gained (95% CI €34,772-€59,443). The results were robust to changes in various sensitivity and scenario analyses. CONCLUSIONS The cost-effectiveness threshold in Norway is not public, but based on previous decisions it is estimated to be up to approximately €89,000 per QALY (NOK 800,000). The results of the analysis indicate that obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance may be cost-effective compared to bendamustine alone in Norway.

UI MeSH Term Description Entries
D008224 Lymphoma, Follicular Malignant lymphoma in which the lymphomatous cells are clustered into identifiable nodules within the LYMPH NODES. The nodules resemble to some extent the GERMINAL CENTER of lymph node follicles and most likely represent neoplastic proliferation of lymph node-derived follicular center B-LYMPHOCYTES. Brill-Symmers Disease,Follicular Lymphoma,Lymphoma, Giant Follicular,Lymphoma, Nodular,Follicular Large-Cell Lymphoma,Follicular Lymphoma, Giant,Follicular Lymphoma, Grade 1,Follicular Lymphoma, Grade 2,Follicular Lymphoma, Grade 3,Follicular Mixed-Cell Lymphoma,Giant Follicular Lymphoma,Histiocytic Lymphoma, Nodular,Large Lymphoid Lymphoma, Nodular,Large-Cell Lymphoma, Follicular,Lymphocytic Lymphoma, Nodular, Poorly Differentiated,Lymphocytic Lymphoma, Nodular, Poorly-Differentiated,Lymphoma, Follicular Large-Cell,Lymphoma, Follicular, Grade 1,Lymphoma, Follicular, Grade 2,Lymphoma, Follicular, Grade 3,Lymphoma, Follicular, Mixed Cell,Lymphoma, Follicular, Mixed Lymphocytic-Histiocytic,Lymphoma, Follicular, Mixed Small and Large Lymphoid,Lymphoma, Follicular, Small and Large Cleaved Cell,Lymphoma, Follicular, Small and Large Cleaved-Cell,Lymphoma, Histiocytic, Nodular,Lymphoma, Large Cell, Follicular,Lymphoma, Large Lymphoid, Nodular,Lymphoma, Large-Cell, Follicular,Lymphoma, Lymphocytic, Nodular, Poorly Differentiated,Lymphoma, Lymphocytic, Nodular, Poorly-Differentiated,Lymphoma, Mixed-Cell, Follicular,Lymphoma, Nodular, Large Follicular Center Cell,Lymphoma, Nodular, Large Follicular Center-Cell,Lymphoma, Nodular, Mixed Lymphocytic Histiocytic,Lymphoma, Nodular, Mixed Lymphocytic-Histiocytic,Lymphoma, Nodular, Mixed Small and Large Cell,Lymphoma, Small Cleaved Cell, Follicular,Lymphoma, Small Cleaved-Cell, Follicular,Lymphoma, Small Follicular Center-Cell,Lymphoma, Small Lymphoid, Follicular,Mixed-Cell Lymphoma, Follicular,Nodular Large Follicular Center-Cell Lymphoma,Small Cleaved-Cell Lymphoma, Follicular,Small Follicular Center-Cell Lymphoma,Brill Symmers Disease,Disease, Brill-Symmers,Follicular Large Cell Lymphoma,Follicular Large-Cell Lymphomas,Follicular Lymphomas,Follicular Lymphomas, Giant,Follicular Mixed Cell Lymphoma,Follicular Mixed-Cell Lymphomas,Giant Follicular Lymphomas,Histiocytic Lymphomas, Nodular,Large Cell Lymphoma, Follicular,Large-Cell Lymphomas, Follicular,Lymphoma, Follicular Large Cell,Lymphoma, Follicular Mixed-Cell,Lymphoma, Nodular Histiocytic,Lymphoma, Small Follicular Center Cell,Lymphomas, Follicular,Lymphomas, Follicular Large-Cell,Lymphomas, Follicular Mixed-Cell,Lymphomas, Giant Follicular,Lymphomas, Nodular,Lymphomas, Nodular Histiocytic,Mixed Cell Lymphoma, Follicular,Mixed-Cell Lymphomas, Follicular,Nodular Histiocytic Lymphoma,Nodular Histiocytic Lymphomas,Nodular Large Follicular Center Cell Lymphoma,Nodular Lymphoma,Nodular Lymphomas,Small Cleaved Cell Lymphoma, Follicular,Small Follicular Center Cell Lymphoma
D009664 Norway A country located in northern Europe, bordering the North Sea and the Atlantic Ocean, west of Sweden. The capital is Oslo. Kingdom of Norway
D003362 Cost-Benefit Analysis A method of comparing the cost of a program with its expected benefits in dollars (or other currency). The benefit-to-cost ratio is a measure of total return expected per unit of money spent. This analysis generally excludes consideration of factors that are not measured ultimately in economic terms. In contrast a cost effectiveness in general compares cost with qualitative outcomes. Cost and Benefit,Cost-Benefit Data,Benefits and Costs,Cost Benefit,Cost Benefit Analysis,Cost-Utility Analysis,Costs and Benefits,Economic Evaluation,Marginal Analysis,Analyses, Cost Benefit,Analysis, Cost Benefit,Analysis, Cost-Benefit,Analysis, Cost-Utility,Analysis, Marginal,Benefit and Cost,Cost Benefit Analyses,Cost Benefit Data,Cost Utility Analysis,Cost-Benefit Analyses,Cost-Utility Analyses,Data, Cost-Benefit,Economic Evaluations,Evaluation, Economic,Marginal Analyses
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069283 Rituximab A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS. CD20 Antibody, Rituximab,GP2013,IDEC-C2B8,IDEC-C2B8 Antibody,Mabthera,Rituxan,IDEC C2B8,IDEC C2B8 Antibody,Rituximab CD20 Antibody
D000069461 Bendamustine Hydrochloride A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA. Bendamustin,Bendamustine,Cytostasan,IMET 3393,Ribomustin,Treanda,Zimet 3393,Hydrochloride, Bendamustine
D000077982 Progression-Free Survival Length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but the disease does not get worse. Event-Free Survival,Event Free Survival,Progression Free Survival,Survival, Event-Free,Survival, Progression-Free
D000970 Antineoplastic Agents Substances that inhibit or prevent the proliferation of NEOPLASMS. Anticancer Agent,Antineoplastic,Antineoplastic Agent,Antineoplastic Drug,Antitumor Agent,Antitumor Drug,Cancer Chemotherapy Agent,Cancer Chemotherapy Drug,Anticancer Agents,Antineoplastic Drugs,Antineoplastics,Antitumor Agents,Antitumor Drugs,Cancer Chemotherapy Agents,Cancer Chemotherapy Drugs,Chemotherapeutic Anticancer Agents,Chemotherapeutic Anticancer Drug,Agent, Anticancer,Agent, Antineoplastic,Agent, Antitumor,Agent, Cancer Chemotherapy,Agents, Anticancer,Agents, Antineoplastic,Agents, Antitumor,Agents, Cancer Chemotherapy,Agents, Chemotherapeutic Anticancer,Chemotherapy Agent, Cancer,Chemotherapy Agents, Cancer,Chemotherapy Drug, Cancer,Chemotherapy Drugs, Cancer,Drug, Antineoplastic,Drug, Antitumor,Drug, Cancer Chemotherapy,Drug, Chemotherapeutic Anticancer,Drugs, Antineoplastic,Drugs, Antitumor,Drugs, Cancer Chemotherapy
D000971 Antineoplastic Combined Chemotherapy Protocols The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form. Anticancer Drug Combinations,Antineoplastic Agents, Combined,Antineoplastic Chemotherapy Protocols,Antineoplastic Drug Combinations,Cancer Chemotherapy Protocols,Chemotherapy Protocols, Antineoplastic,Drug Combinations, Antineoplastic,Antineoplastic Combined Chemotherapy Regimens,Combined Antineoplastic Agents,Agent, Combined Antineoplastic,Agents, Combined Antineoplastic,Anticancer Drug Combination,Antineoplastic Agent, Combined,Antineoplastic Chemotherapy Protocol,Antineoplastic Drug Combination,Cancer Chemotherapy Protocol,Chemotherapy Protocol, Antineoplastic,Chemotherapy Protocol, Cancer,Chemotherapy Protocols, Cancer,Combinations, Antineoplastic Drug,Combined Antineoplastic Agent,Drug Combination, Anticancer,Drug Combination, Antineoplastic,Drug Combinations, Anticancer,Protocol, Antineoplastic Chemotherapy,Protocol, Cancer Chemotherapy,Protocols, Antineoplastic Chemotherapy,Protocols, Cancer Chemotherapy

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