No abstract

direct and indirect costs of patients with AF-related stroke in China, producing an average cost per patient per year and the economic burden of the whole AFrelated stroke Chinese population. METHODS: A cost-of-illness analyses was performed. Prevalence data on AF-related stroke for the Chinese population was collected from literatures. An observational retrospective study was conducted to collect the economic data. We recruited 156 patients diagnosed with AF and stroke in Beijing, Shanghai and Guangzhou between October 2012 and December 2012. Patients or their carers were interviewed about resource utilization and absenteeism from work in the past year. Direct medical costs included outpatient visit, hospitalization, ambulatory, drug, diagnostic tests, and physiotherapy costs. Indirect costs were estimated using a human capital approach. All costs referred to 2011. RESULTS: Among 156 patients with AFrelated stroke, 59.35% were male and the mean age was 67.9±30.2 years. 98.0% patients have at least one kind of health insurance. From the societal perspective, total costs per patient over 1 year amounted to Chinese Yuan (CNY) 25538 (median: CNY13342, IQR: CNY7662-CNY 38714), with direct costs accounting for 94.2% and indirect costs for 5.8% of the total. And for the direct costs, the informal care costs were CNY9162. The drug costs were CNY6293. Based on the prevalence of AF and AF-related stroke in China from literatures, there was about 0.968 million patients of AF-related stroke. Costs for the nation are estimated at CNY24.7 billion per year. CONCLUSIONS: The economic burden of AF-related stroke in China is considerable. The primary burden on patients was due to informal care and drugs.

ADR reporting systems can be tools for assessing economic burden. A large proportion of ADRs included symptom clusters, requiring methods to improve cost-estimation. Results will be used to help inform medication safety policies and initiatives.

Ipilimumab+Nivolumab-Chemotherapies is 806,340V per QALY gained compared with Ipilimumab-Anti-PD1. Conclusions: For patients with BRAF wild-type MM, for thresholds between 0 and 800,000V, only Chemotherapies-Immunotherapies sequences has more than 55% chance of being efficient in France based on observational data.

mobility cup (DMC) to allow their reimbursement under a commercial name. The aim of this study was to highlight regulatory changes brought by the new regulation as suggested by the assessment of DMCs by the CNEDiMTS. Methods: A retrospective analysis of the clinical data described in the opinions issued by the CNEDiMTS was carried out from the beginning of the individual evaluation of DMCs in 2014 until the first quarter of 2019. These data were compared with the clinical requirements of the EU MDR. Results: The CNEDiMTS supported the reimbursement of 42/71 DMCs (59%), 38 of them were based on specific clinical studies, all of which were observational. Of this 38 DMCs, 53% reported published and retrospective studies, 79% were cohorts, 71% multicentre, 74% non-comparative and the median follow-up time for patients was 40 months (mean: 45 6 30 months). Four files of DMCs didn't include specific clinical studies. Instead, two included a technical equivalence rationale comparing them to other DMCs. The CNEDiMTS has requested the implementation of a post-registration follow-up study for all DMCs eligible for reimbursement to confirm their in preventing dislocations and long-term survival. Conclusions: The CNEDiMTS formulated requirements on the specific clinical data expected. This assessment suggests that the EU MDR might require clinical studies for IMDs, with a significant restriction for equivalence. Real life monitoring studies could be designed to meet both the requirements of CE marking under the EU MDR and those of post-registration monitoring studies required for reimbursement.