Costs of tuberculosis disease in the European Union--论文代写范文精选

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Abstract
Without better vaccines it is unlikely that tuberculosis (TB) will ever be eliminated. An investment of ∼€560 million is considered necessary to develop a new, effective vaccine in the European Union (EU). However, less is known about the costs of TB disease in the EU. We performed a systematic review of literature and institutional websites addressing the 27 EU members to summarise cost data. We searched MEDLINE, EMBASE and Cochrane bibliographies for relevant articles.

Combining direct and indirect costs, we arrived at an average per-TB case costs in the original EU-15 states plus Cyprus, Malta and Slovenia of €10 282 for drug-susceptible TB, €57 213 for multidrug resistant (MDR)-TB and €170 744 for extensively drug resistant (XDR)-TB. In the remaining new EU states, costs amounted to €3427 for drug-susceptible TB and €24 166 for MDR-TB/XDR-TB. For the 70 340 susceptible TB cases, 1488 MDR-TB and 136 XDR-TB cases notified in 2011 costs of €536 890 315 accumulated in 2012. In the same year, the 103 104 disability-adjusted life years caused by these cases, when stated in monetary terms, amounted to a total of €5 361 408 000.Thus, the resulting economic burden of TB in the EU clearly outweighs the cost of investing in more efficient vaccines against TB.

Introduction
Although vaccination with bacille Calmette–Guérin (BCG), the only available vaccine against tuberculosis (TB), has been shown to decrease the risk of severe forms of TB in young children (disseminated TB and TB meningitis) [1], it is ineffective in preventing infectious pulmonary TB, which occurs mainly in adults and remains the primary source of TB transmission. Currently, 12 vaccines have been taken into phase I or II clinical trials, with the aim of replacing the present BCG vaccine or at enhancing immunity induced by BCG [2, 3], and with the hope of licensing at least one new vaccine by 2018 [4].

An investment of ∼€560 million is considered necessary to achieve this result in the European Union (EU) [5]. As part of its efforts for funding, the Tuberculosis Vaccine Initiative (TBVI) has proposed an investment model to close the financial gap and speed up the development of those new TB vaccines [6]. The economic calculation that follows shows how the annual cost of TB in the EU clearly outweighs the total cost of developing new vaccines.

Confusion may arise as to the definition of the region when looking at the cost of TB in Europe. A much used estimation of TB-related costs in Europe, the European Academies Science Advisory Council study [7], comes from the European Lung White Book, which placed these in 2003 at €2.1 billion in the European region as defined by the World Health Organization (WHO), i.e. comprising 53 member states including the EU, EU-associated and former Soviet Union (FSU) countries [8]. However, some details of that cost calculation have not been provided and thus it is challenging to provide a more explicit, reasonable cost calculation of TB disease focusing on the current 27 member states of the EU (EU-27).

Numerous publications stress the dramatic increase of multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB in the world [9, 10]. According to estimates by the WHO, of the total 8.7 million new cases in 2011 an estimated 3.7% had MDR-TB [11], defined as resistance to at least the two most powerful first-line anti-TB drugs, isoniazid and rifampicin, and ∼58 000 cases involved XDR-TB, defined as resistance to any fluoroquinolone and at least one of the three injectable anti-TB drugs (amikacin, capreomycin or kanamycin) in addition to MDR.

Of the 22 countries considered “MDR-TB high burden”, 15 are in the WHO Europe region [12]. In 2011 the number of cases tested for MDR-TB in Europe was 84 140, of which 68% delivered a positive bacteriological result [13].

The highest rates of MDR-TB, up to 26% among new cases and up to 65% among previously treated cases, are seen in the countries of the FSU [14, 15], which together had an estimated 31 000 cases in total in 2010 [16].

According to a recent document of the WHO Regional Office for Europe [17] the total number of notified XDR-TB patients in the WHO European region almost tripled, from 132 in 2008 to 344 in 2009.

For 2011, the European Centre for Disease Prevention and Control (ECDC) and WHO Regional Office for Europe surveillance report [18] mentions 1518 MDR-TB cases and 136 XDR-TB cases. This confirms that drug-resistant TB is an important problem, especially because it is well known to be associated with a relatively low treatment success rate [19, 20] and, as shown in our calculations later on, a significant increase in treatment cost. Accordingly, in every economic analysis the increasing cost of MDR-TB has to be included according to its proportion among all TB cases arising in the EU.

The historical summary of the Wolfheze workshops and their consensus documents with recommendations on TB control activities in the EU [21] highlights the ultimate target of TB elimination, defined as a TB incidence of less than one case per million population [22]. As it must be recognised, following current trends, Europe is unlikely to achieve elimination of the disease by the target date of 2050 [23, 24], we urgently need new vaccines, as well as improved diagnostics [25, 26] and new drugs [27–29]. With respect to economic considerations, the aim of the present study was to evaluate the costs associated with TB disease in order to determine whether they outweigh the investment needed to generate a new vaccine.

Calculation of disability-adjusted life years and conversion to monetary terms
Disability-adjusted life years (DALYs) represent the loss equivalent to 1 year of full health due to a specific disease, in this case TB. In brief, they are the sum of life years lost (YLL) due to premature mortality, i.e. the number of deaths due to TB multiplied by the standard life expectancy at the age at which death occurs, and of the years lived with the disability (YLD), the latter gained by multiplying incident TB cases by treatment duration and disability weight for the condition: DALY=YLL+YLD.

The basic formula for calculation of YLL and YLD on a population basis are as follows: YLL=[n/r] (1-1-e-rL), where n is the number of deaths, L is the life expectancy at age of death (years) and r is the discount rate; and YLD=[I×DW×L (1-e-rL)]/r, where I is the number of incident cases, DW is the disability weight and L is the duration of disability (years).

For practical purposes we calculated the difference between life expectancy and average age at death from TB, summed across the EU-27 population and incorporated a 3% discount rate as well as a non-uniform age weighting (full equations are shown in the online supplementary material) [31]. In line with the Global Burden of Disease (GDB) study [32] we used an average disability weight for TB disease of 0.271. YLDs were calculated separately for drug-susceptible TB (L=0.5 years) and MDR-TB (L=2 years).

Finally, the resulting DALYs were multiplied by the long-established estimate of the European Commission of €52 000 as value of 1 life-year lost (VOLY) [33], derived from citizens’ responses to willingness-to-pay questionnaires on the topic of air pollution mortality, which remains unadjusted in consideration of the fact that the TB burden weighs more heavily on the poorer EU member states than it does on the former EU core members [34].

Discussion
Our objective was to review and summarise the available evidence on cost and the cost components of TB and MDR-TB/XDR-TB in the EU. However, despite of a growing flood of epidemiological publications on TB and MDR-TB, aggregated TB costs in the individual EU member countries are sparse and information on the attributable cost components that may act as cost drivers is often incomplete.

Due to different health systems in the EU, there are considerable differences in refunding expenditures of diagnostics and treatment, and what makes the assessment of TB costs even more complicated methodologically is the fact that every country has its own way of monitoring and registering costs. Furthermore, the countries clearly depend on the generally differing pricing of pharmaceutical companies for identical drugs and the degree of eventual sponsoring by nonprofit organisations such as the GDF. Thus, with respect to the target cost components listed earlier, the data provided are quite heterogeneous. Indeed, there are only two studies providing weighted cost data both for drug-susceptible TB and for MDR-/XDR-TB [41, 44] in which the cost components had been comprehensively deduced from all the country-specific economic sources. For the majority of countries there were no data available at all, making extrapolation necessary.

Nevertheless, despite the limitations of our review, the best available cost data are part of the evidence needed for budgeting for and financing the expansion of TB services, especially with respect to scaling-up MDR-TB treatment. The increase of the number of cases of MDR- and XDR-TB is a real health threat but also raises an important concern about the rise of the cost of TB globally as well as in the EU. TB represents a high cost for the EU; summing nearly €537 million each year according to our conservative cost calculations and based on the ECDC/WHO Regional Office for Europe number of cases in the year 2011. Although TB rates are decreasing slightly, drug-resistant strains are on the rise, bringing an increase in treatment costs. No mention is made of MDR-TB and XDR-TB for 2011 in either Malta or Slovenia, and XDR-TB cases are reported in only 12 out of the 27 EU countries, although we can assume that such cost-driving cases were present in at least some of those countries.

We are aware that our calculations underestimate the real overall cost of TB in the EU. The study of DE VRIES et al. [44], the only one fully assessing costs due to TB cases as well as general costs, demonstrates that the costs due to TB of €29.49 million in 2009 in the Netherlands are mainly (61%) due to surrounding costs such as surveillance, screening of high-risk groups, follow-up and treating of contacts and BCG vaccination. The “net” cost in the UK only for detecting and treating latent TB infection and BCG vaccination in 2006 were estimated to be GBP 10.405 million (€15.264 million adjusted to 2012) by the calculations of the National Institute for Health and Clinical Excellence [56], indicating that costs directly linked to TB disease are meaningful but represent only a fraction of its whole financial impact.

Without new tools to control the disease, it is unlikely that the cost of TB will go down. With respect to the development of new vaccines, TBVI’s funding model proposes an investment of €560 million spread over 10 years. This cost is only slightly higher than the current cost of TB disease in the EU for 1 year based on 2011 cases, but, using a minimal discount rate of 3%, the net present value of an investment of €537 million at the end of 10 years would be ∼€722 million.

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