Annual direct and indirect costs attributable to nocturia in Germany,Sweden, and the UK

Objective

Our aim was to estimate the prevalence-based cost of illness imposed by nocturia (≥2 nocturnal voids per night) in Germany, Sweden, and the UK in an average year.

Methods

Information obtained from a systematic review of published literature and clinicians was used to construct an algorithm depicting the management of nocturia in these three countries. This enabled an estimation of (1) annual levels of healthcare resource use, (2) annual cost of healthcare resource use, and (3) annual societal cost arising from presenteeism and absenteeism attributable to nocturia in each country.

Results

In an average year, there are an estimated 12.5, 1.2, and 8.6 million patients ≥20 years of age with nocturia in Germany, Sweden, and the UK, respectively. In an average year in each country, respectively, these patients were estimated to have 13.8, 1.4, and 10.0 million visits to a family practitioner or specialist, ~91,000, 9000, and 63,000 hospital admissions attributable to nocturia and 216,000, 19,000, and 130,000 subjects were estimated to incur a fracture resulting from nocturia. The annual direct cost of healthcare resource use attributable to managing nocturia was estimated to be approximately €2.32 billion in Germany, 5.11 billion kr (€0.54 billion) in Sweden, and £1.35 billion (€1.77 billion) in the UK. The annual indirect societal cost arising from both presenteeism and absenteeism was estimated to be approximately €20.76 billion in Germany and 19.65 billion kr (€2.10 billion) in Sweden. In addition, in the UK, the annual indirect cost due to absenteeism was an estimated £4.32 billion (€5.64 billion).

Conclusions

Nocturia appears to impose a substantial socioeconomic burden in all three countries. Clinical and economic benefits could accrue from an increased awareness of the impact that nocturia imposes on patients, health services, and society as a whole.

     

An evaluation of managed entry agreements in Belgium: A system with threats and (high) potential if properly applied

ObjectiveTo evaluate the strengths and weaknesses of managed entry agreements (MEAs) in Belgium.MethodsAll Belgian MEAs signed between 2010 and 2015 (n = 71) were studied, including the re-evaluations of 16 reimbursement requests for which the initial MEA had ended. The analysis was supported by the findings from a systematic literature review and structured interviews with Belgian stakeholders.ResultsThe current application of MEAs provides the short-term advantage of getting a positive reimbursement decision with lower confidential prices. However, it is not clear whether the negotiated prices are in line with the added value of the interventions. Furthermore, the contracts do not provide incentives for manufacturers to gather evidence or to set public prices at an acceptable level.ConclusionsBased on our analysis of the Belgian MEAs and discussions with Belgian stakeholders, an overview of various issues and pitfalls related to the current application of the system is given. Recommendations are made related to providing correct incentives to deliver good evidence, establishing a correct link between identified uncertainties/problems and the type and content of the MEA, reducing the risk of making the system non-transparent, the importance of international collaboration, etc. in order to optimize the potential of this system. These recommendations are addressed to both the Belgian policymakers and stakeholders in other countries making use of MEAs.     

The role of general practitioners in the initial management of women with urinary incontinence in France,Germany, Spain and the UK

Objective: To describe the role of general practitioners (GPs) in the initial management of women with urinary incontinence (UI) in four European countries with different healthcare systems. Methods: Cross-sectional community postal survey of 2953 women with UI in France, Germany, Spain and the UK. Results: Forty-eight per cent of community-dwelling women with UI had discussed their UI with a doctor. More women discussed UI in France and Germany than in the UK and Spain. The patient usually raised the issue during consultations for some other reason. Fear of or actual deterioration in UI was the most important reason for discussing UI. Overall, 52% of incontinent women first discussed their UI with a GP, and almost a third of women reported having all their UI discussions in a GP setting. Twenty-nine per cent of women reported that GPs had either recommended treatment or monitoring of their condition before beginning treatment, and 24% reported that the GP had referred them to another doctor for evaluation and treatment. Most women in the UK first discussed UI with a GP, whereas in Germany most discussed UI with a specialist. In Spain and France, about half the women first discussed their UI with a GP.

Conclusion: GPs are involved to varying degrees in the initial management of UI in France, Germany, Spain and the UK. Even in countries where women have a choice of whether to see a GP or specialist about UI, many choose to have their first contact with a GP.     

Global spending on orphan drugs in France, Germany, the UK, Italy and Spain during 2007

Background

Orphan drugs are indicated for the treatment of rare diseases which, in the EU, are defined as those with a prevalence of <5 per 10 000 inhabitants. Characteristically, these diseases negatively affect health-related quality of life and may be life threatening. The EU has passed legislation to encourage pharmaceutical companies to invest in research programmes into rare diseases, with the aim of developing new, safe and effective orphan drugs.

Objectives

To describe the status of orphan drugs in five countries in the EU (France, Germany, the UK, Italy and Spain), estimate the mean annual cost per patient and indication of these orphan drugs, and determine the associated cost of these drugs in comparison with overall spending on drugs in each country (year 2007 values).

Methods

The analysis was limited solely to costs of orphan drugs with sales data available for 2007. The mean annual cost per patient was estimated using recommended regimens for maintenance dose and duration from the summary of product characteristics. Likewise, the ratio between annual costs per patient for treatment of each disease and its prevalence was calculated. Sales data were available for at least one of the countries studied for 38 of the 44 orphan drugs authorized by the European Medicines Agency. Only 21 products had data available for all five countries studied.

Results

Germany was the country with access to the largest number of orphan drugs (36), followed by the UK (34), Spain (28), France (27) and Italy (25). The mean annual cost per patient and indication of the 38 orphan drugs on the market ranged widely from €331 to €337 501. It appears that orphan drugs indicated to treat diseases with a prevalence of <2 per 10 000 inhabitants have higher annual per-patient costs than those indicated to treat diseases with a higher prevalence. The percentage of total drug spending accounted for by orphan drugs in 2007 was 1.7% in France, 2.1% in Germany, 1.0% in the UK, 1.5% in Italy and 2.0% in Spain, with an average overall percentage of 1.7% for these five countries.

Conclusions

In 2007, spending on orphan drugs in five European countries was acceptable in terms of the percentage of these countries’ overall drug expenditure. Mean annual costs per patient of orphan drugs varied widely, with costs being related to the prevalence of the disease for which the product is indicated.     

Homicide, suicide, motor vehicle crash, and fall mortality: United States'' experience in comparative perspective.

US mortality data on motor vehicle crashes, falls, suicide, and homicide for 1980 are compared with corresponding data for France, Japan, West Germany, and the United Kingdom. Unadjusted and age-specific death rates are presented, together with age-adjusted rates of years of life lost (YLL). A large male excess in rates is typical outside the fall category. Motor vehicle crashes are the predominant cause of YLL, and the United States manifests the highest YLL rates for each sex. US fall death rates at the older ages are exceeded by those of France and West Germany. The elderly generally manifest the greatest risk of suicide; American females exhibit a unique rate decline after ages 45-54 years, however. Beyond early adulthood, US suicide rates are lower than those of France, Japan, and West Germany. US homicide rates dwarf those of the comparison countries with 16- to 29-fold differentials separating prime-risk American males aged 25-34 years from their foreign counterparts.     

Achieving higher performing primary care through patient registration: A review of twelve high-income countries

BackgroundPatient registration with a primary care providers supports continuity in the patient-provider relationship. This paper develops a framework for analysing the characteristics of patient registration across countries; applies this framework to a selection of countries; and identifies challenges and ongoing reform efforts.Methods12 jurisdictions (Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Ontario [Canada], Sweden, Switzerland, United Kingdom) were selected for analysis. Information was collected by national researchers who reviewed relevant literature and policy documents to report on the establishment and evolution of patient registration, the requirements and benefits for patients, providers and payers, and its connection to primary care reforms.ResultsPatient registration emerged as part of major macro-level health reforms linked to the introduction of universal health coverage. Recent reforms introduced registration with the aim of improving quality through better coordination and efficiency through reductions in unnecessary referrals. Patient registration is mandatory only in three countries. Several countries achieve high levels of registration by using strong incentives for patients and physicians (capitation payments).ConclusionPatient registration means different things in different countries and policy-makers and researchers need to take into consideration: the history and characteristics of the registration system; the use of incentives for patients and providers; and the potential for more explicit use of patient-provider agreements as a policy to achieve more timely, appropriate, continuous and integrated care.     

Recent vaccine mandates in the United States,Europe and Australia: A comparative study

BackgroundIn response to recent outbreaks of vaccine-preventable diseases and concerns around vaccine refusal, several high-income countries have adopted or reformed vaccine mandate policies. While all make it more difficult for parents to refuse vaccines, the nature and scope of ‘mandatory vaccination’ is heterogeneous, and there has been no attempt to develop a detailed, comparative systematic account of the possible forms mandates can take.MethodsWe compare the construction, introduction/amendment, and operation of six new high profile vaccine mandates in Australia, France, Germany, Italy, California, and Washington. We rank these policies in order of their relative restrictiveness and analyze other differences between them.ResultsNew mandate instruments differ in their effects on behavior, and with regard to their structure, exemptions, target populations, consequences and enforcement. We identify diverse means by which vaccine mandates can restrict behaviors, various degrees of severity, and different gradations of intensity in enforcement.ConclusionWe suggest that politico-cultural context and vaccine policy history are centrally important factors for vaccine mandate policymakers to consider. It matters whether citizens trust their governments to limit individual freedom in the name of public health, and whether citizens have previously been subjected to vaccine mandates. Furthermore, political communities must consider the diverse mechanisms by which they may construct vaccine mandate policies; whether through emergency decrees or ordinary statutes, and how (or whether) to involve various stakeholder groups in developing and implementing new vaccine mandate policies.     

Crossing Borders: Factors Affecting Differences in Cost-Effectiveness of Smoking Cessation Interventions between European Countries

ObjectivesMany different factors affect the transferability of cost-effectiveness results between countries. The objective is to quantify the impact of nine potential causes of variation in cost-effectiveness of pharmacological smoking cessation therapies (SCTs) between The Netherlands (reference case), Germany, Sweden, UK, Belgium, and France.MethodsThe life-time benefits of smoking cessation were calculated using the Benefits of Smoking Cessation on Outcomes model, following a cohort of smokers making an unaided quit attempt, or using nicotine replacement therapy (NRT), bupropion, or varenicline. We investigated the impact of between-country differences in nine factors—demography, smoking prevalence, mortality, epidemiology and costs of smoking-related diseases, resource use and unit costs of SCTs, utility weights and discount rates—on the incremental net monetary benefit (INMB), using a willingness-to-pay (WTP) of €20,000 per quality adjusted life year (QALY).ResultsThe INMB of 1000 quit attempts with NRT versus unaided, varies from €0.39 million (Germany) to €1.47 million (France). The differences between the countries were primarily due to differences in discount rates, causing the INMB to change between ?65% to +62%, incidence and mortality rates (epidemiology) of smoking-related diseases (?43% to +35%) and utility weights. Impact also depended on the WTP for a QALY and time horizon: at a low WTP or a short time horizon, the resource use and unit costs of SCTs had the highest impact on INMB.ConclusionsAlthough all INMBs were positive, there were significant differences across countries. These were primarily related to choice of discount rate and epidemiology of diseases.     

Social/economic costs and health-related quality of life in patients with histiocytosis in Europe

Objective

The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with histiocytosis in Europe.

Methods

We conducted a cross-sectional study of patients with histiocytosis from France, Germany, Italy, Spain, Bulgaria, the UK, and Sweden. Data on demographic characteristics, health resource utilisation, informal care, loss of labour productivity and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire.

Results

A total of 134 patients (35 France, 32 Germany, 30 Italy, 24 Spain, 7 Bulgaria, 4 UK and 2 Sweden) completed the questionnaire. The average annual costs ranged from € 6832 to € 33,283 between countries, the year of reference being 2012. Estimated direct healthcare costs ranged from € 1698 to € 18,213; direct nonhealthcare costs ranged from € 2936 to € 17,622 and labour productivity losses ranged from € 1 to € 8855. The mean EQ-5D score for adult histiocytosis patients was estimated at between 0.32 and 0.85, and the mean EQ-5D visual analogue scale score was estimated at between 50.00 and 66.50.

Conclusion

The main strengths of this study lie in our bottom-up approach to costing and in the evaluation of histiocytosis patients from a broad perspective (societal costs). This type of analysis is very scarce in international literature for rare diseases in comparison with other illnesses. We conclude that histiocytosis patients incur considerable societal costs and experience substantial deterioration in HRQOL.

     

What can lifespan variation reveal that life expectancy hides? Comparison of five high-income countries

ObjectivesIn most countries, life expectancy at birth (e0) has improved for many decades. Recently, however, progress has stalled in the UK and Canada, and reversed in the USA. Lifespan variation, a complementary measure of mortality, increased a few years before the reversal in the USA. To assess whether this measure offers additional meaningful insights, we examine what happened in four other high-income countries with differing life expectancy trends.DesignWe calculated life disparity (a specific measure of lifespan variation) in five countries -- USA, UK, France, Japan and Canada -- using sex- and age specific mortality rates from the Human Mortality Database from 1975 to 2017 for ages 0--100 years. We then examined trends in age-specific mortality to identify the age groups contributing to these changes.SettingUSA, UK, France, Japan and CanadaParticipantsaggregate population data of the above nations.Main Outcome MeasuresLife expectancy at birth, life disparity and age-specific mortality.ResultsThe stalls and falls in life expectancy, for both males and females, seen in the UK, USA and Canada coincided with rising life disparity. These changes may be driven by worsening mortality in middle-age (such as at age 40). France and Japan, in contrast, continue on previous trajectories.ConclusionsLife disparity is an additional summary measure of population health providing information beyond that signalled by life expectancy at birth alone.     

Reconciling a “pleasant exchange” with evidence of information bias: A three-country study on pharmaceutical sales visits in primary care

ObjectivesTo examine and compare the experiences and attitudes of primary care physicians in three different regulatory environments (United States, Canada, and France) towards interactions with pharmaceutical sales representatives, particularly their perspectives on safety information provision and self-reported influences on prescribing.MethodsWe recruited primary care physicians for 12 focus groups in Montreal, Sacramento, Toulouse and Vancouver. A thematic analysis of the interview data followed a five-stage framework analysis approach.ResultsFifty-seven family physicians (19 women, 38 men) participated. Physicians expected a commercial bias and generally considered themselves to be immune from influence. They also appreciated the exchange and the information on new drugs. Across all sites, physicians expressed concern about missing harm information; however, attitudes to increased regulation of sales visits in France and the US were generally negative. A common solution to inadequate harm information was to seek further commercially sourced information. Physicians at all sites also expressed sensitivity to critiques from medical students and residents about promotional interactions.ConclusionsPhysicians have contradictory views on the inadequate harm information received from sales representatives, linked to their lack of awareness of the drugs’ safety profiles. Commonly used strategies to mitigate information bias are unlikely to be effective. Alternate information sources to inform prescribing decisions, and changes in the way that physicians and sales representatives interact are needed.     

以英、德、美为参照评析中国医疗卫生服务模式与诉讼制度

通过英、德、美医疗卫生服务模式与诉讼制度异同,评析我国相关体制现状与新医改对其影响。     

Social/economic costs and quality of life in patients with haemophilia in Europe

Objective

The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with haemophilia in Europe.

Methods

We conducted a cross-sectional study of patients with haemophilia from Bulgaria, France, Germany, Hungary, Italy, Spain Sweden and the UK. Data on demographic characteristics, health resource utilisation, informal care, loss of labour productivity and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D) questionnaire. The costs have been estimated from a societal perspective adopting a bottom-up approach.

Results

A total of 401 questionnaires were included in the study, of which 339 were collected from patients with haemophilia and 62 from caregivers. The lowest average annual cost per person was reported in Bulgaria (€6,660) and the highest in Germany (€194,490). Our results demonstrate both a large difference from country to country in the average annual cost per patient in 2012 and the driving role of drugs in costs. Drugs represent nearly 90 % of direct healthcare costs in a majority of the countries analysed (Hungary, Italy, Spain and Germany). In Bulgaria, France and Sweden, however, healthcare services (visits, tests and hospitalisations) prevail. Costs are also shown to differ between children and adults. The mean EQ-5D index score for adult patients was 0.69 and mean EQ-5D VAS was 66.6. The mean EQ-5D index score for carers was 0.87 and mean EQ-5D VAS was 75.5. In the disability score, 60 % showed no disability and measuring caregiver burden with the Zarit Index produced an overall mean score of 25.3.

Conclusion

We have shown that haemophilia is associated with a substantial economic burden and impaired HRQOL. Studies on cost of illness and HRQOL are important for haemophilia as the future of this disease is likely to change with the development of new innovative treatments. The introduction of these treatments will most likely impact future costs related to haemophilia.

     

The clinical impact of multiple prevention strategies for respiratory syncytial virus infections in infants and high-risk toddlers in the United States

BackgroundRespiratory syncytial virus (RSV) remains a leading cause of medically-attended acute respiratory infection in infants and children. With multiple preventative interventions under development, accurate estimates of health care resource utilization are essential for policy decision making.MethodsWe developed a literature-based decision-tree model that estimated annual medically-attended RSV (MA-RSV) lower respiratory tract infection (LRTI) and non-LRTI episodes in the US for all infants and for high-risk toddlers. The model accounted for the gestational age and birth-month of infants, and the seasonal variation in RSV incidence. The impact of no prophylaxis, palivizumab, maternal vaccine, and long-acting monoclonal antibody (mAb) interventions was estimated.ResultsWe estimated 1.23 million (range: 0.96 million–1.40 million) annual MA-RSV LRTI/non-LRTI episodes comprised of 1.19 million (range: 0.93 million–1.36 million) emergency department (ED) and outpatient visits, and 39,040 (range: 32,726–45,851) hospitalizations. Outpatient and ED visits were comprised of 586,034 (range: 430,595–718,868) LRTIs and 608,733 (range: 495,705–644,658) non-LRTIs. The long-acting mAb intervention resulted in the greatest number of averted outpatient and ED episodes (310,997 [53%] LRTIs; 284,305 [47%] non-LRTIs) and hospitalizations (21,845 [56%]). Full-term infants constitute the highest proportion of episodes across all interventions.ConclusionsMA-RSV disease is substantial in infants and high-risk toddlers. Long-acting mAbs are most effective at reducing the number of MA-RSV LRTI/non-LRTI episodes, and the only intervention that prevents disease in older infants (≥6 months old).     

A multi-national European cross-sectional study of feline calicivirus epidemiology,diversity and vaccine cross-reactivity

BackgroundFeline calicivirus (FCV) is an important pathogen of cats for which vaccination is regularly practised. Long-term use of established vaccine antigens raises the theoretical possibility that field viruses could become resistant. This study aimed to assess the current ability of the FCV-F9 vaccine strain to neutralise a randomly collected contemporary panel of FCV field strains collected prospectively in six European countries.MethodsVeterinary practices (64) were randomly selected from six countries (UK, Sweden, Netherlands, Germany, France and Italy). Oropharyngeal swabs were requested from 30 (UK) and 40 (other countries) cats attending each practice. Presence of FCV was determined by virus isolation, and risk factors for FCV shedding assessed by multivariable logistic regression. Phylogenetic analyses were used to describe the FCV population structure. In vitro virus neutralisation assays were performed to evaluate FCV-F9 cross-reactivity using plasma from four vaccinated cats.ResultsThe overall prevalence of FCV was 9.2%. Risk factors positively associated with FCV shedding included multi-cat households, chronic gingivostomatitis, younger age, not being neutered, as well as residing in certain countries. Phylogenetic analysis showed extensive variability and no countrywide clusters. Despite being first isolated in the 1950s, FCV-F9 clustered with contemporary field isolates. Plasma raised to FCV-F9 neutralized 97% of tested isolates (titres 1:4 to 1:5792), with 26.5%, 35.7% and 50% of isolates being neutralized by 5, 10 and 20 antibody units respectively.ConclusionsThis study represents the largest prospective analysis of FCV diversity and antigenic cross-reactivity at a European level. The scale and random nature of sampling used gives confidence that the FCV isolates used are broadly representative of FCVs that cats are exposed to in these countries. The in vitro neutralisation results suggest that antibodies raised to FCV-F9 remain broadly cross-reactive to contemporary FCV isolates across the European countries sampled.