Abstract
BackgroundAn antiemetic triplet regimen of 5-hydrotryptamine-3 receptor antagonist, dexamethasone, and aprepitant is the standard prophylaxis with highly emetogenic chemotherapy (HEC). A randomized phase III trial comparing palonosetron (PALO) versus granisetron (GRA) in the triplet antiemetic regimen (The TRIPLE study) showed the superiority of PALO over GRA for delayed-phase vomiting in patients receiving cisplatin-based HEC. However, economic efficiency evaluations including quality of life have not been done. The present study was a cost-utility analysis of PALO within the Japanese medical insurance system.MethodsThe data source was the results of the TRIPLE study. A decision tree was constructed to assess the incremental cost-effectiveness ratio (ICER) using quality-adjusted life years (QALYs) and the medical service fees and the drug price for 2018 from the perspective of the payer. A one-way sensitivity analysis and a probabilistic sensitivity analysis (PSA) were performed to assess the robustness of the model. A threshold analysis was performed to determine the cost-effective price of PALO.ResultsIn the base case, the estimated incremental effect of PALO addition was 0.000645 QALYs, the estimated incremental cost was 10,455 JPY (93.21 USD), and the ICER was 16,204,591 JPY QALY (144,465 USD/QALY). In the PSA, the probability of superior cost-effectiveness was 3.64%. In the threshold analysis, the acceptable price of PALO was estimated to be 7,743 JPY (69.03 USD).ConclusionsIf willingness-to-pay is taken as 5,000,000 JPY/QALY (44,575 USD/QALY), the antiemetic regimen using PALO for cisplatin-containing HEC was not cost-effective at this time. The cost of drugs, with the arrival of inexpensive generic drugs, will make a major contribution to its cost-effectiveness.
Highlights
An antiemetic triplet regimen of 5-hydrotryptamine-3 receptor antagonist, dexamethasone, and aprepitant is the standard prophylaxis with highly emetogenic chemotherapy (HEC)
Regimens that include cisplatin, which is widely used in the treatment of Kashiwa and Matsushita BMC Health Services Research (2019) 19:438 lung, stomach, and head and neck cancers, meet the criteria for highly emetogenic chemotherapy (HEC), and the JapanSociety of Clinical Oncology (JSCO) Clinical Practice Guidelines for Antiemesis In Oncology recommend an antiemetic triplet regimen of 5-hydroxytryptamine3 receptor antagonist (5-HT3RA), neurokinin 1 receptor antagonist, and dexamethasone (DEX) during HEC
This is the first report in which the incremental cost-effectiveness ratio (ICER) was calculated with quality-adjusted life years (QALYs) of the antiemetic triplet regimen of PALO in combination with APR and DEX compared to that of GRA with APR and DEX for cisplatin-containing HEC
Summary
An antiemetic triplet regimen of 5-hydrotryptamine-3 receptor antagonist, dexamethasone, and aprepitant is the standard prophylaxis with highly emetogenic chemotherapy (HEC). Regimens that include cisplatin, which is widely used in the treatment of Kashiwa and Matsushita BMC Health Services Research (2019) 19:438 lung, stomach, and head and neck cancers, meet the criteria for highly emetogenic chemotherapy (HEC), and the JSCO Clinical Practice Guidelines for Antiemesis In Oncology recommend an antiemetic triplet regimen of 5-HT3RA, neurokinin 1 receptor antagonist, and dexamethasone (DEX) during HEC. Of these three agents, the 5-HT3RA palonosetron (PALO) was approved by the US Food and Drug Administration in addition to existing agents in 2003, and it was approved for use in Japan in 2010. The increased economic burden is a concern for PALO, which is a more expensive antiemetic than other 5HT3RAs
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