Predictors of family communication of one’s organ donation intention in Switzerland

OBJECTIVES: Family members continue to play a prominent role in decisions to donate organs at the time of death. Prior knowledge of the deceased's intention to donate was identified as an important influential factor in the donation decision-making process. This study examined what factors lead to family communication of a person's wish regarding organ donation. METHODS: A population-based survey was used to identify the prevalence of people who had informed family members of their intention to donate. Associated factors were evaluated using bivariate and multivariate analyses. RESULTS: Multivariate analysis revealed that communication to a family member of the intention to donate organs was more likely if the respondent had a signed donor card (OR = 10.23, CI = 5.25-19.93), had a family discussion on organ donation or transplantation (OR = 7.12, CI = 4.91-10.34), had a partner and knew his or her attitude to organ donation (OR = 5.76, CI = 4.20-7.90), had previously personally had a good look at the issue of organ donation (OR = 2.59, CI = 1.79-3.75), was rather younger (OR = 0.98, CI = 0.97-0.99), was of Swiss nationality (OR = 2.21, CI = 1.25-3.91), felt that he or she was sufficiently informed (OR = 2.10, CI = 1.50-2.94), had the information necessary to come to an appropriate decision on organ donation and-although this relation may be weaker-were (rather) willing to become an organ donor after death (OR = 1.41, CI = 1.01-1.97). CONCLUSIONS: Our findings highlight the need for public education and community campaigns to promote the need to share with others, the intention to donate and to increase people's knowledge on this issue

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis

Breast cancer is the most common cancer in women worldwide and the solid tumor type for which the highest number of drugs have been approved to date. This study examines new drug approvals for breast cancer by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), based on an analysis of regulatory documents from both agencies for the period from 1995 to 2018. Of the 29 breast cancer drugs approved over this time span, 17 received positive decisions from both the FDA and EMA, including all drugs licensed after 2008. Nineteen of the 25 FDA-approved drugs, but none of the EMA approvals, benefited from special regulatory pathways (such as fast track, breakthrough therapy, or priority review). In the U.S.A., four accelerated approvals were granted (of which one, for bevacizumab, was later revoked), while only two drugs received provisional approvals following EMA review. New breast cancer drugs were approved approximately twelve months earlier in the United States than in Europe. These results suggest that a broader use of special regulatory pathways by EMA could help to accelerate access to novel drugs for European breast cancer patients

Direct medical costs of type 2 diabetes and its complications in Switzerland

Background: This paper analyses the direct medical costs of type 2 diabetes and its complications in Switzerland. Methods: Individual healthcare resource consumption related to type 2 diabetes and its complications was determined retrospectively in 1479 non-incident and non-dying patients over 12 months (1998-1999). Literature-derived attributable risks were used to correct for non-diabetes related macrovascular disease. Results: A total of 111 primary care physicians from 19 cantons throughout Switzerland participated. Their diabetic patients on average had 10.3 consultations per year related to this disease (95% CI: 10.0-10.7). Patients spent on average 2.7 days (95% CI: 2.2-3.3) per year in hospital due to diabetes and diabetes-related complications. Mean annual type 2 diabetes-related direct medical costs per patient amounted to CHF 3,508 / € 2,323 (95% CI: CHF 3,140-3,876 / € 2,080-2,567). They were particularly high in patients with insulin treatment or with complications. After application of attributable risks and a correction for the use of adjuvant materials, costs were CHF 3,324 / € 2,201. Assuming 250,000 patients with type 2 diabetes in Switzerland leads to an estimate of CHF 0.88 billion spent for this disease and its complications in 1998. This represents a share of about 2.2% of the country's total healthcare expenditures. Conclusion: These findings demonstrate the high economic importance of type 2 diabetes and its complications in Switzerlan

«Learning and Confirming» in Pharmaforschung und -entwicklung. Von Sackgassen und Durchbrüchen

Louis Shreiner prägte den Begriff «Learn and Confirm», um die Trennung von Früh- und Spätphase der Medikamentenentwicklung zu bezeichnen. Frühe oder «Lern»-Phasen dienen der Charakterisierung des Medikaments. Die Beschreibung der Dosis-Wirkung, das Testen von Biomarkern und die Patientenauswahl sind die Ziele der frühen Phasen. Die späten Phasen, für Wirksamkeit und Sicherheit, sind zur Bestätigung, weil sie teuer und langwierig sind. Tritt das Lernen von Arzneimitteleigenschaften noch in einer späten Phase auf, besteht ein hohes Risiko des Scheiterns. Typischerweise gibt es Budget- und Zeitdruck, um die klinische Entwicklung zu beschleunigen, indem Phasen kombiniert oder überlagert werden und Fragen auf diejenigen beschränkt werden, die für den Phasenübergang erforderlich sind. Etwa neun von zehn Medikamentenkandidaten erhalten keine Zulassung, was enorme Auswirkungen auf die Gesamtkosten der Medikamentenentwicklung hat. Doch was treibt diese Misserfolge an und wie kann die Forschung die Produktivität bei der Verlagerung von Medikamentenkandidaten aus dem Labor in die Klinik verbessern? Und besonders: Wie lernen wir aus Fehlern

Cost-effectiveness of 13-valent pneumococcal conjugate vaccine in Switzerland

The 7-valent pneumococcal conjugate vaccine (PCV7) has been shown to be highly cost-effective. The 13-valent pneumococcal conjugate vaccine (PCV13) offers seroprotection against six additional serotypes. A decision-analytic model was constructed to estimate direct medical costs and clinical effectiveness of PCV13 vaccination on invasive pneumococcal disease (IPD), pneumonia, and otitis media relative to PCV7 vaccination. The option with an one-dose catch-up vaccination in children of 15-59 months was also considered. Assuming 83% vaccination coverage and considering indirect effects, 1808 IPD, 5558 pneumonia and 74,136 otitis media cases could be eliminated from the entire population during a 10-year modelling period. The PCV13 vaccination programme would lead to additional costs (+€26.2 Mio), but saved medical costs of -€77.1 Mio due to cases averted and deaths avoided, overcompensate these costs (total cost savings -€50.9 Mio). The national immunisation programmes with PCV13 can be assumed cost saving when compared with the current vaccine PCV7 in Switzerland

Economic burden of symptomatic iron deficiency - a survey among Swiss women

BACKGROUND Symptomatic iron deficiency (ID) is a disorder affecting 10-20% of menstruating women. ID is diagnosed by measuring serum ferritin, a protein helping to store iron in the body. A deeper understanding of the association between ID and its societal and economic burden is relevant for patients, physicians, health care decision makers. METHODS An online household survey was carried out among Swiss women aged 18-50 years suffering from debilitating symptoms due to ID. The data was population-weighted for age and region. The costs of misdiagnosis and the ID-related economic burden (i.e. days of sick leave) from productivity losses on the labor market were determined and extrapolated to the Swiss population. Furthermore, the patient burden was assessed based on quality of life daily measurements. RESULTS The total sample included 1010 women who received an ID diagnosis with a blood test in the last 2 years (mean age: 33.5 years). Most named symptoms were "being tired or exhausted" (96.4%) and reduced physical energy level (41.0%). In total, 354 (35.0% of the total sample) patients received an initial diagnosis other than ID. Of those, 46.8% were treated prior to the ID diagnosis with a pharmacological medical therapy or psychotherapy. Extrapolating these numbers to the Swiss female population aged 18-50 years, the direct medical costs would be CHF 78 million (assuming an annual ID incidence of ID diagnosis of 9.5%). On average, 28.5% of participants in the work-force had to take sick leave due to ID symptoms within a period of 2 years (mean: 5.2 days, i.e. 2.6 days/year). The estimated annual indirect costs in Switzerland would be CHF 33 million (human capital approach) or CHF 26 million (friction cost method), respectively. Being exhausted and impaired concentration appear to be the most important factors negatively impacting daily living and hence quality of life. CONCLUSION The societal and economic burden among women due to debilitating symptoms of ID in Switzerland is substantial. Timely, correct diagnosis and treatment of ID may contribute to reducing this burden. Further studies are needed in this area to validate our results

Trends in influenza vaccination coverage rates in Germany over five seasons from 2001 to 2006

BACKGROUND: To assess influenza vaccination coverage from 2001 to 2006 in Germany, to understand drivers and barriers to vaccination and to identify vaccination intentions for season 2006/07. METHODS: 9,990 telephone-based household surveys from age 14 were conducted between 2001 and 2006. Essentially, the same questionnaire was used in all seasons. RESULTS: The influenza vaccination coverage rate reached 32.5% in 2005/06. In the elderly (> or years), the vaccination rate reached 58.9% in 2005/06. In those aged 65 years and older, it was 63.4%. Perceiving influenza as a serious illness was the most frequent reason for getting vaccinated. Thirteen percent of those vaccinated in 2005/06 indicated the threat of avian flu as a reason. The main reason for not getting vaccinated was thinking about it without putting it into practice. The major encouraging factor to vaccination was a recommendation by the family doctor. 49.6% of the respondents intend to get vaccinated against influenza in season 2006/07. CONCLUSION: Increasing vaccination rates were observed from 2001 to 2006 in Germany. The threat of avian influenza and the extended reimbursement programs may have contributed to the recent increase

Influenza vaccination coverage rates in five European countries during season 2006/07 and trends over six consecutive seasons

<p>Abstract</p> <p>Background</p> <p>The objectives of the survey were to identify the level of influenza vaccination coverage in five European countries between 2001 and 2007, to understand the drivers and barriers to vaccination, to assess vaccination intentions for the winter 2007/08 as well as major encouraging factors for vaccination.</p> <p>Methods</p> <p>Between 2001 and 2007, representative household surveys were performed with telephone or mailed (France) interviews of individuals aged 14 and above. The questionnaire used in the UK, Germany, Italy, France and Spain was essentially the same in all seasons. The data were subsequently pooled. Four target groups were defined for the analysis: 1) persons aged 65 years and over; 2) persons working in the medical field; 3) chronically ill persons and 4) combined target group composed of individuals belonging to one or more of the previous groups 1, 2 or 3.</p> <p>Results</p> <p>In 2006/07, vaccination coverage was, 25.0% in UK, 27.4% in Germany, 21.8% in Spain, 24.2% in France and 24.4% in Italy. During six influenza seasons (2001–2007), vaccination coverage showed a slight positive trend in the five countries (p ≤ 0.0001). In the elderly (≥ 65 years), across all countries, no significant trend was seen; the vaccination rate decreased non-significantly from a peak of 64.2% in season 2005/06 to 61.1% in season 2006/07. The most frequent reason for getting vaccinated was a recommendation by the family doctor or nurse (51%), and this was also perceived as the major encouraging factor for vaccination (61%). The main reason for not getting vaccinated was feeling unlikely to catch the flu (36%).</p> <p>Conclusion</p> <p>In the UK, Germany and Spain, influenza vaccination coverage rates in season 2006/07 dropped slightly compared to the previous season. However, a trend of increasing vaccination coverage was observed from 2001/02 to 2006/07 across Europe. The family doctor is the major source of encouragement for individuals getting vaccinated. Efforts to overcome the barriers to vaccination need to be put in place to reach the WHO objective of 75% coverage in the elderly by 2010. This is a major challenge to be faced by governments, healthcare workers and healthcare organisations.</p

Health economic assessment of ferric carboxymaltose in patients with iron deficiency and chronic heart failure based on the FAIR-HF trial: an analysis for the UK

AIMS: The purpose of this study was to evaluate the cost-effectiveness of iron repletion using intravenous (i.v.) ferric carboxymaltose (FCM) in chronic heart failure (CHF) patients with iron deficiency with or without anaemia. Cost-effectiveness was studied from the perspective of the National Health Service in the UK. METHODS AND RESULTS: A model-based cost-effectiveness analysis was used to compare iron repletion with FCM with no iron treatment. Using data from the FAIR-HF trial and publicly available sources and publications, per patient costs and clinical effectiveness of FCM were estimated compared with placebo. Cost assessment was based on study drug and administration costs, cost of CHF treatment, and hospital length of stay. The incremental cost-effectiveness ratio (ICER) of FCM use was expressed as cost per quality-adjusted life year (QALY) gained, and sensitivity analyses were performed on the base case. The time horizon of the analysis was 24 weeks. Mean QALYs were higher in the FCM arm (difference 0.037 QALYs; bootstrap-based 95% confidence interval 0.017-0.060). The ICER of FCM compared with placebo was €4414 per QALY gained for the FAIR-HF dosing regimen. Sensitivity analyses confirmed the base case result to be robust. CONCLUSION: From the UK payers' perspective, managing iron deficiency in CHF patients using i.v. FCM was cost-effective in this analysis. The base case ICER was clearly below the threshold of €22 200-€33 300/QALY gained (£20 000-£30 000) typically used by the UK National Institute for Health and Clinical Excellence and proved to be robust in sensitivity analysis. Improved symptoms and better quality of life contributed to this result