Original Title: Elektrisk feltterapi (Optune, Tumor Treating Fields) - Indikasjon II

Authors' objectives: The commissioning forum for introduction of new methods in the specialist health care service in Norway (Nye metoder) has requested a new assessment of the method, either alone or in combination with drugs, for selected groups of glioblastoma patients, based on genome sequencing and biomarkers. However, after discussions with the supplier of the technology, it was confirmed that the supplier is unable to provide better clinical documentation for a subgroup based on the biomarkers and genome sequencing. In this report, we have therefore briefly summarized the relationship between health benefits and resource use associated with the method when applied to the whole population. Additionally, we have calculated the severity of the disease. The results of this simplified assessment will be used as a basis for price negotiations with the supplier of the technology.

Authors' results and conclusions: The difference in overall survival (OS) (HR 0.63, 95% CI 0.53 to 0.76) and progression-free survival (PFS) (HR 0.63, 95% CI 0.52 to 0.76) was statistically significant in favor of the intervention group for the whole population. In the clinical study, there was no significant difference between the groups regarding patients who experienced one or more grade III or IV side effects. The health economic analysis was conducted for the whole glioblastoma population. Therefore, the relation between the resource use and the health benefit associated with tumor treating fields (TTF, Optune) treatment for selected groups of glioblastoma patients based on MGMT promoter region methylation status is uncertain. The difference in OS in these subpopulations is however quite similar to the difference in OS for the overall population. PFS results were not presented. Results from the health economic analysis showed that Optune combined with TMZ resulted in an additional cost of NOK xxxxxx from an extended healthcare perspective, with a health gain of 0.44 quality-adjusted life years (QALYs), leading to a very high incremental cost effectiveness ratio (ICER) of NOK xxxxxx per QALY. We estimated that the disease for this population, treated with the current standard of care, results in an absolute shortfall of 14.15 - 21.85 QALYs for patients aged 65 and 56, respectively. It has been estimated that treating relevant glioblastoma patients with Optune (approximately 30-50 patients annually) will result in a total annual budget impact of approximately NOK xxxxxx. The budget calculations are uncertain and simplified. The additional cost per QALY gained, associated with treatment of glioblastoma with Optune in combination with TMZ compared to TMZ monotherapy, is significantly higher than what can be considered cost-effective treatment, given the severity of the current patient group and the uncertainties in the analyses. The model’s time horizon and quality of life weights constitute the greatest uncertainties and have a significant impact on the results

Project Status: Completed

Year Published: 2025

URL for published report: https://www.nyemetoder.no/metoder/elektrisk-feltterapi-optune-tumor-treating-fields-indikasjon-ii/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Norway

Organisation Name: Norwegian Medical Products Agency

Contact Address: PO Box 240 Skøyen, N-0213 Skøyen

Contact Name: Elisabet Hafstad

Contact Email: post@noma.no