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Objectives: In the CheckMate 067 clinical trial NIVO+IPI regimen and NIVO monotherapy were shown to significantly improve progression-free survival (PFS) compared with IPI monotherapy (median PFS was 11.5, 6.9, and 2.9 months for NIVO+IPI, NIVO, and IPI respectively) in AM patients, but little is known regarding the healthcare costs of these newer therapies. The aim of this study was to compare the total melanoma-specific healthcare costs in CheckMate 067 with the standard of care (SOC) therapies in first-line AM treatment. MethOds: The Truven MarketScan database (MarketScan; April 2011-June 2013) was used to identify cost (in 2015 US$) of the current melanoma SOC. Patient-level data from CheckMate 067 were used to derive resource utilization for NIVO+IPI regimen and NIVO monotherapydue to the lack of real-world data at the time of analysis. Unit costs from MarketScan were applied to resources from CheckMate 067 to derive healthcare costs for NIVO+IPI regimen and NIVO monotherapy. All melanoma-specific healthcare costs (including drug, inpatient, outpatient, procedures, laboratory and emergency room costs) occurring during the first year of treatment were aggregated for each treatment and adjusted for censoring. A cost comparison analysis was then performed. Results: Ipilimumab (33%), vemurafenib (19%), temozolomide (16%), interleukin (11%) and interferon (6%) were the most widely prescribed drugs with 12-month total melanoma healthcare costs of $194k, $153k, $155k, $259k and $70k, respectively. The corresponding total melanoma healthcare costs for CheckMate 067 arms were $212k for IPI monotherapy, $234k for NIVO+IPI regimen and $172k for NIVO monotherapy. cOnclusiOns: These results suggests that NIVO+IPI regimen and NIVO monotherapy provide significant added clinical benefit at a marginally higher or even at a lower cost compared with IPI in previously untreated AM patients. Compared with IPI healthcare costs, NIVO+IPI regimen healthcare costs were only 10% higher, while NIVO monotherapy healthcare costs were 19% lower.

epidemiologic outlook and medical resources used in diagnosis, 1st/2nd/3rd and 4th lines of treatment, monitoring, palliative care and adverse events. Based on these results, diagnosis cost per patient was estimated as 723.39 TL and the annual costs of 1st/2nd/3rd and 4th lines of treatment per patient were estimated as 3,497.14 TL, 4,329.94 TL, 11,857.97 TL and 5,367.87 TL respectively. The annual monitoring costs of 1st/2nd/3rd and 4th lines of treatment per patient were estimated as 2,451.55 TL, 2,818.92 TL, 2,581.92 TL and 2,769.14 TL respectively. The annual costs of palliative care and adverse events per patient were estimated as 302.61 TL and 1,122.20 TL. Considering all these cost items, average annual cost per patient was found as 10,015.50 TL. ConClusions: The study revealed that there are different treatment approaches for HR+/HER2-post menopausal advanced/metastatic breast cancer treatment in Turkey. Total treatment costs to public payer have been calculated, taking into account all direct medical costs including adverse events, revealing differences between treatment lines.

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Background Coronavirus disease 2019 (Covid-19) active cases continue to demand the development of safe and effective treatments. This is the first clinical trial to evaluate the safety and efficacy of oral thymic peptides. Methods We conducted a nonrandomized phase 2 trial with a historic control group to evaluate the safety and efficacy of a daily 250-mg oral dose of thymic peptides in the treatment of hospitalized Covid-19 patients. Comparison based on standard care from registry data was performed after propensity score matching. The primary outcomes were survival, time to recovery and the number of participants with treatment-related adverse events or side effects by day 20. Results A total of 44 patients were analyzed in this study, 22 in the thymic peptides group and 22 in the standard care group. There were no deaths in the intervention group, compared to 24% mortality in standard care by day 20 (log-rank P=0.02). The Kaplan-Meier analysis showed a significantly shorter time to recovery by day 20 in the thymic peptides group as compared with standard care (median, 6 days vs. 12 days; hazard ratio for recovery, 2.75 [95% confidence interval, 1.34 to 5.62]; log-rank P=0.002). No side effects or adverse events were reported. Conclusion In patients hospitalized with Covid-19, the use of thymic peptides reported no side effects, adverse events, or deaths by day 20. When compared with registry data, a significantly shorter time to recovery and mortality reduction was measured. The Catholic University of Honduras Medical Research Group (GIMUNICAH) is working on a more extensive phase 3 trial. Trial registration: ClinicalTrials.gov NCT04771013. February 25, 2021.