Approved and Commercialized Antidiabetic Medicines (Excluding Insulin) in Seven European Countries—A Cross-Sectional Comparison
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SUBMITTER: Atanasoie A
PROVIDER: S-EPMC11207096 | biostudies-literature | 2024 Jun
REPOSITORIES: biostudies-literature
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Project description:BackgroundSeveral new antidiabetic medicines (GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) have been approved by the European Medicines Agency since 2006. The aim of this study was to evaluate the uptake of new antidiabetic medicines in European countries over a 10-year period.MethodsThe study used IQVIA quarterly value and volume sales data January 2006-December 2016. The market uptake of new antidiabetic medicines together with intensity of prescribing policy for all antidiabetic medicines were estimated for Austria, Croatia, France, Germany, Hungary, Italy, Poland, Slovenia, Spain, Sweden, and the United Kingdom. The following measures were determined: number of available new active substances, median time to first continuous use, volume market share, and annual therapy cost.ResultsAll countries had at least one new antidiabetic medicine in continuous use and an increase in intensity of prescribing policy for all antidiabetic medicines was observed. A tenfold difference in median time to first continuous use (3-30 months) was found. The annual therapy cost in 2016 of new antidiabetic medicines ranged from EUR 363 to EUR 769. Among new antidiabetic medicines, the market share of DPP-4 inhibitors was the highest. Countries with a higher volume market share of incretin-based medicines (Spain, France, Austria, and Germany) in 2011 had a lower increase in intensity of prescribing policy. This kind of correlation was not found in the case of SGLT-2 inhibitors.ConclusionsThis study found important differences and variability in the uptake of new antidiabetic medicines in the included countries.
| S-EPMC8235847 | biostudies-literature
Project description:AimTo explore antidiabetic medicine prescribing to women before, during and after pregnancy in different regions of Europe.MethodsA common protocol was implemented across seven databases in Denmark, Norway, The Netherlands, Italy (Emilia Romagna/Tuscany), Wales and the rest of the UK. Women with a pregnancy starting and ending between 2004 and 2010, (Denmark, 2004-2009; Norway, 2005-2010; Emilia Romagna, 2008-2010), which ended in a live or stillbirth, were identified. Prescriptions for antidiabetic medicines issued (UK) or dispensed (non-UK) during pregnancy and/or the year before or year after pregnancy were identified. Prescribing patterns were compared across databases and over calendar time.Results1,082,673 live/stillbirths were identified. Pregestational insulin prescribing during the year before pregnancy ranged from 0.27% (CI95 0.25-0.30) in Tuscany to 0.45% (CI95 0.43-0.47) in Norway, and increased between 2004 and 2009 in all countries. During pregnancy, insulin prescribing peaked during the third trimester and increased over time; third trimester prescribing was highest in Tuscany (2.2%) and lowest in Denmark (0.5%). Of those prescribed an insulin during pregnancy, between 50.5% in Denmark and 88.8% in the Netherlands received an insulin analogue alone or in combination with human insulin, this proportion increasing over time. Oral products were mainly metformin and prescribing was highest in the 3 months before pregnancy. Metformin use during pregnancy increased in some countries.ConclusionPregestational diabetes is increasing in many areas of Europe. There is considerable variation between and within countries in the choice of medication for treating pregestational diabetes in pregnancy, including choice of insulin analogues and oral antidiabetics, and very large variation in the treatment of gestational diabetes despite international guidelines.
| S-EPMC4871589 | biostudies-literature
Project description:OBJECTIVES:The aim of this study was to adapt the Systemic Sclerosis Quality of Life Questionnaire (SScQoL) into six European cultures and validate it as a common measure of quality of life in systemic sclerosis (SSc). METHODS:This was a seven-country (Germany, France, Italy, Poland, Spain, Sweden and UK) cross-sectional study. A forward-backward translation process was used to adapt the English SScQoL into target languages. SScQoL was completed by patients with SSc, then data were validated against the Rasch model. To correct local response dependency, items were grouped into the following subscales: function, emotion, sleep, social and pain and reanalysed for fit to the model, unidimensionality and cross-cultural equivalence. RESULTS:The adaptation of the SScQoL was seamless in all countries except Germany. Cross-cultural validation included 1080 patients with a mean age 58.0 years (SD 13.9) and 87% were women. Local dependency was evident in individual country data. Grouping items into testlets corrected the local dependency in most country specific data. Fit to the model, reliability and unidimensionality was achieved in six-country data after cross-cultural adjustment for Italy in the social subscale. The SScQoL was then calibrated into an interval level scale. CONCLUSION:The individual SScQoL items have translated well into five languages and overall, the scale maintained its construct validity, working well as a five-subscale questionnaire. Measures of quality of life in SSc can be directly compared across five countries (France, Poland Spain, Sweden and UK). Data from Italy are also comparable with the other five countries although require an adjustment.
| S-EPMC6029637 | biostudies-other
Project description:The aim of the current study was to compare pricing methodologies at the manufacturer, wholesale, and retail levels, and to estimate the price differences of AT1-receptor blockers (sartans), Angiotensin-converting enzyme (ACE)-inhibitors, and their fixed-dose combinations (FDCs) in four countries using similar methodologies: Slovakia, Greece, Bulgaria, and Romania (SK, GR, BG, and RO, respectively). The methodologies for manufacturer, wholesale, and retail price establishment have been compared using nationally implemented rules. Overlapping trademarks were established retrospectively on the manufacturer and retail levels in November 2017. The average price per tablet, percentage of price deviation, and statistically significant differences were calculated. The selected countries apply external reference pricing at the manufacturer level. A wide variation in the number of referent countries was observed (from 12 to 27). Despite the use of a regressive scale for price calculation, large variations between margins and value-added tax (VAT) are established, thus leading to different final medicine prices. This study found that medicine prices were lower in RO than in other selected countries. It was caused by the fact that 15 products had the lowest manufacturer price and 14 products had the lowest retail price in RO. Results of Kruskal-Wallis test showed that there were no significant differences between prices per tablet on the manufacturer and retail levels. In the group of fixed-dose combinations, ramipril/hydrochlorothiazide, and irbesartan/hydrochlorothiazide showed more than 100% deviation. The prices of cardiovascular medicines differed within the observed countries. The differences in pricing methodologies (e.g., margins, VAT) at the national level did not significantly affect retail prices, as a low manufacturer price usually leads to a low retail price.
| S-EPMC7472524 | biostudies-literature
Project description:To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that manufacturers conduct additional studies during the postmarketing period. As a growing proportion of new cancer drugs are approved on the basis of limited evidence of clinical benefit, timely completion of postmarketing requirements is important. We used publicly available regulatory documents to evaluate key characteristics of pivotal studies supporting EMA-approved cancer drugs from 2004-2014 and assessed completion rates of postmarketing data collection requirements after a minimum of 5 years. From 2004-2014, 79% (45/57) of EMA-approved cancer drugs had to fulfill postmarketing requirements. Pivotal trials supporting the approval of cancer drugs with postmarketing requirements were less likely to have randomized designs (41/61, 67% vs. 11/11, 100%), include an active comparator (20/61, 33% vs. 10/11, 91%), or measure overall survival as the primary study end point (18/61, 30% vs. 6/11, 55%) compared with pivotal trials for drugs without postmarketing requirements. Among 200 postmarketing requirements, almost half were designed to assess drug safety. After a minimum of 5 years, 60% (121/200) of requirements were completed, 10% (19/200) were ongoing, and 30% (60/200) were delayed. About half (40/75, 53%) of postmarketing requirements for new clinical studies were completed on time. Delays in the completion of postmarketing requirements often did not impact the likelihood of drugs receiving permanent marketing authorization (87%, 39/45) after 5 years. Our findings highlight the need for EMA to better enforce its authority to require timely completion of postmarketing requirements and studies.
| S-EPMC9540185 | biostudies-literature
Project description:BackgroundIn this era of global health crises, public trust in scientists is a crucial determinant of adherence to public health recommendations. Studies of trust in scientists often link sociodemographic and other factors to such adherence but rely on assumptions about scientists and neglect scientific uncertainty. We undertook a cross-sectional mixed-methods study evaluating factors associated with public trust of scientists in Europe, investigating how and why respondents embraced certain claims in scientific debates.MethodsA survey was administered to 7000 participants across seven European countries in December 2020. Data concerning sociodemographic characteristics, trust in scientists, information source preferences, COVID-19 experiences and beliefs about pandemic origins were analysed using a multiple regression model. We employed thematic analysis to interpret open-text responses about pandemic origins and likely acceptance of treatments and vaccination.ResultsTrust in scientists was associated with multiple sociodemographic characteristics, including higher age and educational levels, left/centre political affiliation and use of certain information sources. Respondents claiming that COVID-19 was deliberately released and that 5G technology worsened COVID-19 symptoms had lower levels of trust in scientists. Explaining their positions in debates about pandemic origins, respondents trusting and not trusting scientists invoked scientific results and practices, arguing that scientists were not the most important actors in these debates.ConclusionsAlthough our quantitative analyses align with prior studies, our qualitative analyses of scientists, their practices and perceived roles are more varied than prior research presumed. Further investigation of these variations is needed to strengthen scientific literacy and trust in scientists.
| S-EPMC11812721 | biostudies-literature
Project description:BackgroundTobacco-control policies have been suggested to reduce smoking among adolescents. However, there is limited evidence on the real-world costs of implementation in different settings. In this study, we aimed at estimating the costs of school smoking bans, school prevention programmes and non-school bans (smoking bans in non-educational public settings, bans on sales to minors and bans on point-of-sale advertising), implemented in Finland, Ireland, the Netherlands, Belgium, Germany, Italy and Portugal, for 2016.MethodsWe retrospectively collected costs related to the inspection, monitoring and sanctioning activities related to bans and educational activities related to smoking prevention programmes. We used an 'ingredients-based' approach, identifying each resource used, quantity and unit value for one full year, under the state perspective. Costs were measured at national, regional, local and school-level and were informed by data on how these activities were performed in reality.ResultsPurchasing power parities adjusted-costs varied between €0.02 and €0.74 (average €0.24) per person (pp) for bans implemented outside schools. Mean costs of school smoking bans ranged from €3.31 to €34.76 (average €20.60), and mean costs of school educational programmes from €0.75 to €4.65 (average €2.92).ConclusionsIt is feasible to estimate costs of health policies as implemented in different settings. Costs of the tobacco control policies evaluated here depend mainly on the number of person-hours allocated to their implementation, and on the scale of intervention. Non-school bans presented the lowest costs, and the implementation of all policies cost up to €36 pp for 1 year.
| S-EPMC7183368 | biostudies-literature
Project description: Not available
| S-EPMC9857398 | biostudies-literature
Project description:Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification. Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection. Results: The results show that varying levels of detail are provided for the biomarker and the diagnostic test, including variability in where the information was presented. The overall results demonstrate transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR. Conclusions: With the introduction of the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices, medicines regulatory authorities' will be required to be consulted during the review of CDx conformity assessment and so, there is opportunity for more consistent and transparent information on CDx to be provided in the SmPC and EPAR.
| S-EPMC8591033 | biostudies-literature
Project description:IntroductionEconomic evaluations of tobacco control policies targeting adolescents are scarce. Few take into account real-world, large-scale implementation costs; few compare cost-effectiveness of different policies across different countries. We assessed the cost-effectiveness of five tobacco control policies (nonschool bans, including bans on sales to minors, bans on smoking in public places, bans on advertising at points-of-sale, school smoke-free bans, and school education programs), implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal.MethodsCost-effectiveness estimates were calculated per country and per policy, from the State perspective. Costs were collected by combining quantitative questionnaires with semi-structured interviews on how policies were implemented in each setting, in real practice. Short-term effectiveness was based on the literature, and long-term effectiveness was modeled using the DYNAMO-HIA tool. Discount rates of 3.5% were used for costs and effectiveness. Sensitivity analyses considered 1%-50% short-term effectiveness estimates, highest cost estimates, and undiscounted effectiveness.FindingsNonschool bans cost up to €253.23 per healthy life year, school smoking bans up to €91.87 per healthy life year, and school education programs up to €481.35 per healthy life year. Cost-effectiveness depended on the costs of implementation, short-term effectiveness, initial smoking rates, dimension of the target population, and weight of smoking in overall mortality and morbidity.ConclusionsAll five policies were highly cost-effective in all countries according to the World Health Organization thresholds for public health interventions. Cost-effectiveness was preserved even when using the highest costs and most conservative effectiveness estimates.ImplicationsEconomic evaluations using real-world data on tobacco control policies implemented at a large scale are scarce, especially considering nonschool bans targeting adolescents. We assessed the cost-effectiveness of five tobacco control policies implemented in 2016 in Finland, Ireland, the Netherlands, Belgium, Germany, Italy, and Portugal. This study shows that all five policies were highly cost-effective considering the World Health Organization threshold, even when considering the highest costs and most conservative effectiveness estimates.
| S-EPMC7291799 | biostudies-literature