Objectives: Hospital readmission has been an important issue in patients with chronic obstructive pulmonary disease (COPD), as it reflects exacerbation of the disease and quality of medical care, and incurs high medical expenditures. This study aimed to examine pattern and economic burden of readmission, and identify factors associated with risk of readmission in patients hospitalized for COPD in Taiwan. MethOds: The National Health Insurance claims database of a representative sample (two million subjects) of Taiwanese population in 2005 was adopted for this study. Adult individuals who were discharged from acute hospitals for COPD in 2005 were selected and their readmission pattern one-year after discharge were examined. Cox proportional hazards regression models were adopted to identify factors associated with risk of readmission. Results: The majority of the subjects was male and aged older than 65 years old. The 30-day, 3-month and one-year all-cause readmission rates were 28%, 46%, and 69%, respectively. The 30-day, 3-month and one-year COPD-specific readmission rates were 10%, 17%, and 31%, respectively. Approximately one-fourth of the subjects were readmitted more than twice during the follow-up. COPD, pneumonia, and respiratory failure/insufficiency/arrest were the top three most frequent causes for readmission during 30 days, 3 months, or one year after discharge. In the one-yar follow-up, hospital readmission accounted for 73% of total healthcare expenditures. Gender, previous hospitalization history, comorbidities, and length of stay and hospital accreditation level of the index hospitalization were associated with risk of allcause readmission. Gender, previous hospitalization history, and length of stay and hospital accreditation level of the index hospitalization were associated with risk of COPD-specific readmission. cOnclusiOns: This study identified patterns and causes of short-term and long-term readmission, and factors associated with risk of readmission in patients hospitalized for COPD. The information is of importance for planning interventions to reduce hospital readmission rate.
This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021. The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs.
OBJECTIVES: Review and investigate differences in side effects for the 1st and 2nd line treatments available for myasthenia gravis (MG) within the EU and compare their severity or frequency to those reported on patient leaflets (PIL). METHODS: Guidelines on MG were consulted to select the relevant treatments. Side effects of eleven treatments were extracted from EMA patient leaflets, additionally, a literature review was completed searching MEDLINE. Data was extracted on: side effects and frequency and then mapped against data found on the PIL. RESULTS: The literature review resulted in 50 papers, the extracted data compared to the PIL highlighted a higher frequency of some side effects, and additional side effects for a number of treatments. The comparison between the literature findings and the PIL suggested under-reporting of side effects and their prevalence. Notably, changes to blood and bone marrow levels were reported as rare on the PIL for Azathioprine but in literature 9-21% of MG patients were affected. Additionally, gastrointestinal disorders were reported on the Azathioprine PIL as rare for posttransplant patient, however literature suggests 35% of MG patients are affected. Less serious side effects were also under-reported; fever and chills on the IVIG PIL reports as very rare, while literature found 13.8-14.8% of patients affected. Current treatments reported side effects not mentioned on the patient leaflet, these additional side effects varied from tingling sensation in extremities to more serious side effects like elevated liver enzymes, nephrotoxicity and malignancies. CONCLUSIONS: There are limited studies focused on MG treatment side effects. Patients and clinicians rely on the PIL to inform on side effects. This report suggests the impact of side effects in the PIL is under-reported compared to real world evidence. Additional research into frequency, severity, and the consequences of these side effect differences between treatments of MG would be useful.
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