Original Title: Avis - Dispositif Optune pour le traitement des patients adultes atteints d’un glioblastome nouvellement diagnostiqué

Authors' objectives: L’Institut national d’excellence en santé et en services sociaux (INESSS) was mandated by the Bureau de l'innovation to assess the value of Optune technology and the relevance of its coverage by the public plan as a treatment device for adult patients with newly diagnosed glioblastoma with and after standard temozolomide maintenance chemotherapy.

Authors' results and conclusions: RESULTS: (#1 SOCIO-CULTURAL DIMENSION): Despite the media visibility of the Optune device and the enthusiasm for new therapeutic options, the acceptability of the device by Quebec patients is difficult to predict, as several factors need to be taken into consideration - e.g., aesthetic considerations, portability of the device and usage requirements. According to advisory committee members, the maximum acceptability rate could be as high as 50% of eligible patients offered the treatment. Some health technology assessment agencies have assessed Optune and issued divergent recommendations, some favourable from the Haute Autorité de Santé (HAS, France), other unfavourable from the National Institute for Health and Care Excellence (NICE, UK). For their part, publications by listed oncology learned societies have chosen to recommend the Optune device as a complementary treatment option to temozolomide in patients under 70 years of age. (#2 POPULATION DIMENSION): Glioblastoma is a heterogeneous cancer, with some subtypes more aggressive than others, affecting an estimated 150 new patient/year in Quebec. Median survival is around 8 months, with a 1-year survival rate of 25%. The disease is both cognitively and physically disabling, and family caregivers play an important role in its management. Current management is mainly based on diagnosis with magnetic resonance imaging (MRI), followed by tumour resection, when possible, combined radiotherapy with temozolomide, and maintenance chemotherapy with temozolomide (Stupp protocol). Despite treatment, 90% of patients will experience a recurrence of their cancer within 7 months. At this stage, there is no recognized standard of care. Glioblastoma is therefore an incurable pathology with limited treatment options, and with high unmet medical needs related to the development of new treatment options to prolong life and reduce the risk of recurrence.(#3 CLINICAL DIMENSION): The efficacy of the Optune device is supported by the EF-14 study, an open-label, multicenter, randomized Phase 3 clinical trial conducted in 14 countries, including Canada. This study compared the efficacy of the Optune device / temozolomide combination versus temozolomide alone in adult patients with supratentorial glioblastoma. The EF-14 study is judged to be of good methodological quality, despite the presence of a selection bias favouring the inclusion of individuals with a better prognosis. Moreover, the study population is also younger, has a higher performance index and contains a higher proportion of individuals with MGMT (6-O-Methylguanine-DNA methyltransferase) promoter methylation than the Quebec glioblastoma patient population. The main results of the study showed clinically significant gains in progression-free survival of 2.7 months and overall survival of 4.9 months. A dose-response effect was also observed according to patients' level of adherence to treatment, with a minimum use threshold of 50% to obtain a benefit, i.e., 12 hours per day. Secondary analyses failed to identify a sub-population that might benefit more from treatment and showed that all subgroups treated with the Optune device benefited. The main adverse events attributable to this device were skin reactions and irritations. (#4 ORGANIZATIONAL DIMENSION): The Optune device does not replace current care, but it is added to the standard maintenance treatment. GBM patients’ diagnosis MRI images are transmitted to the manufacturer for array creation. Once the healthcare professional has assessed the patient's eligibility and transmitted the prescription to the manufacturer, the latter charges a monthly fee for unlimited array replacement, equipment delivery, patient service (technical assistance and training), and healthcare professional service, which includes training and reporting on patient compliance. This rental model is not common in Quebec, and the real involvement of healthcare network professionals and resources in monitoring patient use of the device is also uncertain, for example regarding skin effects, array repositioning and technical problems. However, Quebec centres participated in the EF-14 study and therefore have some experience with the device and the manufacturer. (#5 ECONOMIC DIMENSION): The use of the Optune device to treat patients with newly diagnosed glioblastoma concomitantly with temozolomide versus temozolomide alone is not cost-effective. The real costs of adding the Optune device, particularly those associated with its implementation in the health and social services network and with the involvement of healthcare personnel in patient follow-up, are uncertain. Market share for the OptuneTM device is also uncertain, since it depends on the quality of the manufacturer's service offering in Quebec, the organizational capacity of the Quebec healthcare network, and real patient acceptability.

Authors' recommendations: Based on the information available to date, and given the importance of the uncertainties raised, INESSS considers that it would not be fair and equitable to provide public coverage for the Optune device for the treatment of adult patients with newly diagnosed supratentorial glioblastoma following maximal reduction surgery and completion of radiotherapy with and after standard maintenance chemotherapy. INESSS may reassess the Optune device, at the request of the ministère de la Santé et des Services sociaux (MSSS), when more information becomes available, including data in reallife settings that will better reduce uncertainties and mitigate associated risks.

Authors' methods: A review of data from the literature and those provided by the manufacturer was carried out to assess the scientific evidence regarding the application of tumour treating fields provided by Novocure's Optune device for the treatment of newly diagnosed glioblastoma. Contextual and experiential stakeholder data were also collected through an expert advisory committee and one-on-one interviews with caregivers and patients who have used the Optune device.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dispositif-optunemc-pour-le-traitement-des-patients-adultes-atteints-dun-glioblastome-nouvellement-diagnostique.html

Year Published: 2023

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/dispositif-optunemc-pour-le-traitement-des-patients-adultes-atteints-dun-glioblastome-nouvellement-diagnostique.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)