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Abstract Backgrounds Limited information is available on the utility values of metastatic pancreatic cancer, focusing on different health statuses, selected chemotherapy, and related grades 1/2 and 3/4 adverse events (AEs). We evaluated Japanese societal-based health-related utility values for metastatic pancreatic cancer by considering different grade toxicities commonly associated with chemotherapy using the vignette-based method. Methods We developed health status scenarios for patients with metastatic pancreatic cancer undergoing chemotherapy and conducted utility research using the developed scenarios in four steps: ‘literature review,’ ‘exploratory interview,’ ‘content validation’, and ‘utility research’. In the development process, to consider the impact of AEs of chemotherapy for metastatic pancreatic cancer on health state utility values, we selected neutropenia, febrile neutropenia, diarrhea, nausea and vomiting, and neuropathy as representative AEs. Each AE was classified as either grade 1/2 or 3/4. We confirmed our created scenarios through cognitive interviews with the general population and clinical experts to validate the content. Finally, we developed 11 scenarios for using ‘utility research,’ evaluated in a societal-based valuation study using the face-to-face method. Participants for ‘utility research’ were the general population, and they evaluated these scenarios in the composite time trade-off (cTTO) and visual analog scale (VAS) of the European quality of life (EuroQol) valuation technology to derive health state utility scores. Results Of 220 responders who completed this survey, 201 were adapted into the analysis population. Stable disease with no AEs (reference state) had a mean utility value of 0.653 using cTTO. The lowest mean utility score in the stable state was 0.242 (stable disease + grade 3/4 vomiting). VAS results ranged from 0.189 to 0.468, depending on the various grades of AEs in stable disease. In addition, grade 3/4 AEs and grade 1/2 nausea/vomiting were associated with significantly greater disutility. Utility values were also strongly influenced by the direct impact of AE on physical symptoms, severity and their experience. In addition, 95.9% of the respondents agreed that they understood the questions in the post-response questionnaire. Conclusions We clarified the health state utility values of patients with metastatic pancreatic cancer based on the general population in Japan. The effect on utilities should be considered not only for serious AEs, but also for minor AEs.

We compared the cost-effectiveness of gemcitabine plus nab-paclitaxel (GnP) and modified FOLFIRINOX (mFFX)—standard first-line treatments for metastatic pancreatic cancer in Japan. This retrospective cohort study included patients with metastatic pancreatic cancer treated at the National Cancer Center Hospital East in Japan between December 2013 and February 2017. A partitioned survival model, featuring five mutually exclusive health states, was developed. A cost-effectiveness analysis was performed to obtain total costs and quality-adjusted life-years (QALYs). A 2% annual discount rate was applied to costs and outcomes. Parameter uncertainty effect was assessed using a one-way sensitivity analysis. mFFX treatment involved intravenous infusions of oxaliplatin, levofolinate, and irinotecan, whereas GnP treatment involved weekly intravenous administration of nab-paclitaxel and gemcitabine. Dosages were adjusted based on observed adverse events. The total costs of the mFFX and GnP arms were JPY 3,193,597 (USD 31,006) and JPY 3,913,171 (USD 37,992), respectively. Incremental total costs of JPY 719,574 (USD 6,986) were associated with GnP compared to mFFX. Total QALYs were 0.427 and 0.435 for mFFX and GnP, respectively. Therefore, GnP has slightly higher QALYs than mFFX in Japanese real-world clinical practice, suggesting it has a potentially better safety profile, although the impact on healthcare costs persists. [ABSTRACT FROM AUTHOR]

Background: Sodium–glucose cotransporter-2 inhibitors (SGLT2Is) have demonstrated effects beyond glucose-lowering, leading to their approval for treating chronic heart failure (HF) in Japan. This study examines prescription trends for SGLT2Is in patients with diabetes versus those without diabetes, focusing on their backgrounds and HF treatment status of patients without diabetes who received SGLT2I after an HF diagnosis. Methods: Using data from DeSC Healthcare Inc., we analyzed patients aged 65 and above who received their first SGLT2I prescription between October 2014 and February 2023. Patients were classified into SGLT2I-treated diabetic and non-diabetic groups. We analyzed the annual prescription trends and compared the characteristics of both groups who started SGLT2I between 2022 and 2023. Additionally, we assessed the timing of SGLT2I initiation and the use of concomitant HF treatment in patients without diabetes after HF diagnosis. Results: The proportion of patients without diabetes receiving their first SGLT2I prescription has increased since 2021. Patients without diabetes receiving SGLT2Is were older, likely owing to aging-related diseases. In patients without a confirmed diabetes diagnosis, SGLT2I was most frequently initiated at the time of HF diagnosis. Mineralocorticoid receptor antagonists (MRAs) are the most common concomitant HF medications. The increase in SGLT2I prescriptions for patients without diabetes receiving SGLT2I since 2021, particularly in older individuals, suggests that SGLT2I is being initiated either at the time of HF diagnosis or in a stepwise manner. Conclusion: In Japan, MRA is commonly used as a concomitant medication in patients without diabetes receiving SGLT2I. [ABSTRACT FROM AUTHOR]

There was no difference in the number of cases with >=3 prior treatment regimens between the azole prophylaxis and control groups, suggesting that antifungal prophylaxis is not a confounding variable for such treatment regimens. Ibrutinib, a first-generation inhibitor of Bruton's tyrosine kinase, is an important treatment option in chronic lymphocytic leukemia (CLL) [[1]]. For both the prophylaxis and control groups, data on ibrutinib treatment duration, prior CLL treatment regimens, oral azole prophylaxis, and corticosteroid treatments were collected at all relevant times during ibrutinib treatment. [Extracted from the article]