Introduction: Although there is a significant utilization gap of biologic medicines in the EU, many studies estimate equity in patient access to biopharmaceuticals only based on their availability on the national list of reimbursed medicines. Hidden access barriers may facilitate financial sustainability of pharmaceuticals in less affluent EU countries; however, they have rarely been documented in scientific publications. Our objective was to explore these access barriers for tumor necrosis factor (TNF) alpha inhibitors in rheumatoid arthritis (RA) in five Central and Eastern European countries. Methods: A detailed interview guide was developed based on multi-stakeholder workshops and a targeted literature review. In each participant country 3-3-3-3 interviews with payers, rheumatologists, patients/patient representatives, and industry representatives were conducted. Responses were aggregated at a country level and validated by primary investigators in each country. Results: Limited number of RA centers and consequently significant travelling time and cost for patients in distant geographical areas, uneven budget allocation among centers, limited capacity of nurses, narrowed patient population in national financial protocols compared to international clinical guidelines in initiating or continuing biologics, high administrative burden in prescribing biologics and limited health literacy of patients were the most relevant barriers to timely patient access in at least three participant countries. Conclusion: Assessing only the availability of TNF alpha inhibitors on the national list of reimbursed medicines provides limited information about real-world patient access to these medicines. Revealing hidden access barriers may contribute to initiate policy actions which could reduce inequity in patient access.
- Publikační typ
- časopisecké články MeSH
OBJECTIVE: Complications contribute largely to the economic gravity of diabetes mellitus (DM). How they arise and are treated differs substantially between countries. This paper assesses the total annual, direct, and indirect cost of severe hypoglycemia events (SHEs) in nine European countries: Bulgaria, Croatia, the Czech Republic, Greece, Hungary, Macedonia/the former Yugoslav Republic of Macedonia (MK), Poland, Slovenia, and Spain. METHODS: Data was collected on epidemiology, treatment structure, SHE-driven resource consumption, and unit costs. Two systematic reviews-on the SHE rates and the resources used for treatment-and data on the days-of-work lost due to SHE along with salaries and employment rates were used. The total SHE cost in each country was calculated and how the differences are driven by individual parameters was analysed. RESULTS: The annual costs of SHEs varied in absolute terms from €379,951.25 in MK up to €58,429,684.40 in Spain, or-when expressed per one drug-treated DM patient-from €5.47 in Bulgaria up to €17.74 in Spain. Indirect cost constituted between 6.01% (MK) and 26.49% (Hungary) of the total cost. The differences between countries are driven mostly by the cost of treating a single event, and this is related to general differences in prices. LIMITATIONS: The main limitation is the lack of good quality data in some parts, and the necessity to use mean-value imputations, experts' opinions, etc. Additionally, we only considered DM treatment as the SHE driver, while other elements, e.g. style of living, may contribute substantially. CONCLUSIONS: A common framework can be applied to estimate the economic burden of SHE in various countries, allowing one to identify the drivers of differences in cost. Treating DM is complex, and so no resolute conclusions ought to be drawn as to whether SHE management is better in one country than another.
- MeSH
- hypoglykemie ekonomika patologie MeSH
- lidé MeSH
- náklady a analýza nákladů * MeSH
- náklady na zdravotní péči trendy MeSH
- osobní újma zaviněná nemocí * MeSH
- stupeň závažnosti nemoci MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa MeSH
