Optune (NovoTTF-200A)

What Is the Indication Under Review? The indication under review is for the treatment of adults with newly diagnosed glioblastoma multiforme (ndGBM) following maximal debulking surgery and completion of radiotherapy together with and after standard of care maintenance chemotherapy. Glioblastoma is the development of cancer among glial cells in the central nervous system and is the most common form of brain cancer in Canada. What Is Optune? Optune is a medical device that produces alternating electrical fields called tumour-treating fields to target the growth of cancerous cells in addition to chemotherapy. Current treatment for glioblastoma consists of a combination of surgery, radiotherapy, and chemotherapy. How Did CADTH Evaluate This Device? To examine the value of Optune for the treatment of ndGBM, CADTH: reviewed and critically appraised the clinical and economic evidence submitted by the sponsor reviewed the literature to identify and describe ethical considerations relevant to the use of Optune, as well as to assess the validity of the sponsor’s modelling approaches, assumptions, and estimates regarding Optune sought input from patient and clinician groups and consulted an expert panel. What Did CADTH Find? Clinical Evidence This review included the EF-14 trial, a pivotal, multicentre, open-label randomized controlled trial that assessed the efficacy and safety of Optune plus temozolomide in adults with ndGBM following maximal debulking surgery and completion of radiotherapy, together with and after standard of care maintenance chemotherapy. Based on the single trial, there is evidence of low to moderate certainty that Optune plus temozolomide likely increases progression-free survival at 6 months of treatment and overall survival at 24 months of treatment compared to temozolomide alone. The treatment effect of Optune plus temozolomide on progression-free survival and overall survival may be dose-dependent, with at least 18 hours of daily use required for the most benefit. Overall, the evidence was of very low to moderate certainty due to concerns regarding selection bias and low generalizability of the results to real-world settings. Economic Evidence The submitted fee for Optune is $27,000 per month, which is added to the cost of temozolomide based on its public list price. The incremental cost-effectiveness ratio for Optune plus temozolomide versus temozolomide alone was $899,470 per quality-adjusted life-year (QALY) gained (incremental costs = $336,902; incremental QALYs = 0.37). Optune plus temozolomide was not considered cost-effective relative to temozolomide alone at conventional willingness-to pay thresholds (i.e., $50,000 per QALY gained and $100,000 per QALY gained). Consequently, a price reduction of between 91% and 97% would be required for Optune plus temozolomide to be considered cost-effective at a willingness-to-pay threshold between $50,000 and $100,000 per QALY gained. The budget impact of reimbursing Optune through the federal, provincial, and territorial public drug plans (excluding Quebec) is estimated to be $75,795,323 to cover 232 patients over the initial 3 years of funding. Ethical Considerations The extent to which Optune meets patients’ needs for an effective, accessible, and easily usable treatment may depend on an individual patient’s values and caregiver support network, especially as Optune requires managing an additional treatment modality and may require additional caregiver support. Further study on how — or if — factors such as functional status, race, sex, age, socioeconomic status, and availability of caregiver support have implications for device uptake and ability to adhere to treatment would be helpful to inform patient-centred and equitable use, given the diverse patient population in Canada. Careful attention must be paid to the quality of clinical consent conversations, including considerations of disease progression potentially impairing capacity to consent and requiring a substitute decision-maker. Equity-enhancing strategies for implementation will need to be explored to ensure that Optune is accessible in an equitable and effective manner for all eligible patients in Canada.