morphology and another for proposed referral pathway using flow cytometry were developed in Microsoft Excel. Budget impact analysis was conducted comparing cost outcomes of the two decision trees. Due to the lack of publicly available data, local oncology and pathology experts were interviewed for proportion of patients going through the referral pathway, diagnosis accuracy of morphology (78%) and flow cytometry (95%), treatment response rates (60-80%), test cost (morphology: Rp450,000; flow cytometry: Rp933,300) and treatment cost (acute myeloid leukemia: Rp100 million; acute lymphocytic leukemia: Rp60 million). Global peerreviewed data were used for classification accuracy of both tests. Outcomes estimated and compared include patients accurately diagnosed, average time to diagnosis, average prognosis and costs. Results: With the adoption of flow cytometry, for 100,000 symptomatic patients, the model estimated 25,000 more patients receiving accurate diagnosis; average time to diagnosis can be shortened by one week and average probability of death can be reduced by 9%. Total diagnostics and treatment cost is estimated to be Rp25 billion lower. Rp17 million can be avoided from unnecessary treatment due to morphological inaccuracies. On average, additional Rp453,000 may be required for each patient's diagnosis but Rp439,000 can be saved from treatment. Conclusions: With flow cytometry, more patients can be diagnosed accurately and treated appropriately earlier, thus improving acute leukemia survival. Cost savings can be expected due to reduction of unnecessary treatment.
Objectives: Regulatory science (RS) grounds its value on enhancing regulatory capacity through developing and adopting scientific disciplines applicable to the evaluation of health-related products. While drug regulatory authorities (DRAs) are increasingly engaged with RS, their approaches have not been systemically examined. This research aimed to analyze the experiences of RS development based on a cross-country comparison guided by the logic modeling. Methods: DRAs in China (National Medical Products Administration, NMPA), the United States (Food and Drug Administration, FDA), the European Union (European Medicines Agency, EMA) and Japan (Pharmaceuticals and Medical Devices Agency, PMDA) were the study targets as they had officially launched RA initiatives. Documentary analysis of government documents and scoping literature review were conducted for data collection.
statistics were used to assess the outcomes. Results: The mean (range) age of patients was 56.6 (29 -83) years. Among the 118 patients, the most common first line systemic therapy group after diagnosis of ABC was endocrine-based therapy (39.0%) or endocrine therapy+chemotherapy (ChT) combinations (38.1%). In MONARCH 3 characteristic patients (n=56), endocrine based therapy was most common (44.6%).Oncologist visits, at annual rate of 9.20 (95% CI: 8.81, 9.60), and hospitalizations, at annual rate of 1.08 (95% CI: 0.96, 1.22), and mean (SD) length of stay of 6.95 (6.71) days, were key drivers of health resource utilization. Of the 118 patients, the 72 with at least one chemotherapy agent in their first-line regimen had annual hospitalization rate of 1.4 vs. 0.45 admissions; annual hospital days of 8.5 vs. 5.1; and rate of at least 1 severe adverse (grade 3 or higher) events of 66.7% vs 28.3%, compared to the 46 patients on first-line endocrine based therapy. Conclusions: These findings on real world HRU reflected clinical guidelines and severity of ABC. Current treatment pathways suggest an unmet need for new medications that lead to reduction in high rate of chemotherapy use. Results can inform future evaluations of new ABC treatments that estimate the health economic impact of their adoption in Taiwan.
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