Objective: To estimate the cost-effectiveness (CE) of interferon beta-1b (IFNβ-1b) in slowing disability progression in persons with relapsing-remitting multiple sclerosis (RRMS).

Methods: Treatment program costs and health outcomes are modeled for cohorts of 1,000 females and 1,000 males followed 40 years from onset. Fifteen scenarios model MS natural history progression, treatment efficacy, direct treatment costs, and MS healthcare costs. A single randomized placebo-controlled trial of IFNβ-1b found reduced disease activity by MRI, reduced frequency and severity of exacerbations, and a tendency toward slower disability progression.

Disability years avoided are modeled as the primary health outcome analyzed. A ministry of health (MOH) perspective is adopted, using Nova Scotia population-based data. Annual IFNβ-1b direct treatment costs (Can $16,685) are high relative to both MOH healthcare costs per person with MS (Can $2,000) and estimated MOH costs avoided.

Results: Given “reference case” assumptions for women with RRMS, treatment reduces lifetime disability years by 10%. Cost per disability year avoided before discounting is Can $189,230 (US $124,892), and Can $274,842 (US $181,395) after discounting at 5%. Estimates for alternative scenarios vary greatly, leaving main findings unchanged.

Conclusions: Using the Expanded Disability Status Scale, cost per disability year avoided due to interferon beta-1b treatment in RRMS is quite high. Comparable CE estimates, using MS-specific or generic health-related quality-of-life outcome measures, are even higher. Further research is required to better measure treatment effects, modification of MS natural history, and net societal costs of IFNβ-1b in RRMS.

Objectives: To report on a workshop, and subsequent discussions, that reviewed the achievements and progress of the EuroScan collaboration since its establishment in 1999 to share information on the methods and results of early identification and assessment of new and emerging health technologies; considered challenges to the collaboration; and discussed its possible future direction.

Methods: A workshop was held in Stockholm in September 2006, with thirty-two participants from ten countries and representatives from EuroScan member agencies, policy makers involved in policy or decision making relating to new technologies, and invited external commentators from international HTA networks. The workshop used a mix of presentations, panel and audience discussions, and small group work to consider the achievements and challenges put forward.

Results: EuroScan has developed as a sustainable network, and has made progress on all tasks in its initial action plan, with the EuroScan information sharing database on new and emerging technologies being one of the collaboration's key achievements. Identified immediate concerns for the network included consideration of the impact of its current name and membership model; acknowledgement and publication of the full range of benefits of membership; contribution to and development of the database to encourage increased information sharing; and EuroScan's ongoing interaction with the wider HTA world.

Conclusions: The workshop was a useful mechanism for reviewing the work of EuroScan and for creating a platform to take the collaboration forward. The workshop affirmed the benefits of the network to individual members; posed some significant challenges to the network to consider; and acted as a stimulus for an interim name change to better represent the global membership, and a major review of the EuroScan database of identified and assessed emerging health technologies.

Introduction: HTA agencies, especially in developing countries, are under resourced and unable to conduct the desired amount of assessments. Adapting HTA reports (HTAs) from other jurisdictions is an alternative for saving resources.

Objectives: To explore HTA transferability experiences in Latin-America and Caribbean (LAC): are decision makers (DMs) using HTAs from other jurisdictions? Are researchers adapting HTAs when developing local reports? How useful is the information found in HTAs from other jurisdictions?

Methods: Web-based survey sent to 13031 HTA researchers and DMs.

Results: We received 671 responses from 19 countries. DMs reported using HTAs from other jurisdictions to guide decisions in the majority of the situations: 52.6 percent HTAs from outside LAC (e.g., Europe), 23.1 percent from other LAC countries, and only 24.3 percent HTAs from their own countries. 63 percent of researchers reported using HTAs from other jurisdictions. Usefulness scored significantly higher for HTAs from other jurisdictions as compared to local HTAs (7.1 versus 6.0 in a 1–10 scale; p < .01). Both DMs and researchers considered the information regarding safety and effectiveness more applicable than the information on social aspects, or economic evaluation. Barriers that limit transferability had significantly different scores for HTAs from other LAC countries as compared to those from regions outside LAC (i.e., poor methodological quality 6.7 versus 5.3, different epidemiological context 6.0 versus 7.4; all p < .01).

Conclusions: HTAs from outside the region are commonly used. However, DMs and researchers agreed that HTAs from LAC had the greatest potential for transferability, provided that barriers such as poor methodological quality could be overcome.

Objectives: The aim of this study was to summarize and assess economic evaluations of poison centers (PCs) from the perspectives of society, the payer, and the healthcare system.

Methods: A systematic review was performed to identify complete economic evaluations regardless of the language or publication status. Two reviewers evaluated the abstracts for eligibility, extracted the data, and assessed the study quality using a standardized tool.

Results: In total, 422 non-duplicated studies were retrieved, but only nine met the eligibility criteria. Five of the eligible studies were published in the 1990s, and four were published in the 2000s. Six studies met at least seven of ten quality criteria. In all studies, the presence of PCs was compared with a scenario of their absence. Eight studies used cost–benefit analyses and one used a cost-effectiveness approach. The cost–benefit ratios ranged from 0.76 to 7.67, which indicates that each United States dollar (USD) spent on poison centers can save almost 8 USD on medical spending. A cost-effectiveness analysis showed that each successful outcome achieved by a PC avoids a minimum of 12,000 USD to 56,000 USD in other healthcare spending.

Conclusions: The data in our review show that PCs are economically viable. PCs improve the efficiency of healthcare expenditure and contribute to the sustainability of the healthcare system. An investment in PCs is a rational public health policy approach that contrasts the current trend of reducing spending on PCs.

Objectives: Order sets are widely used in hospitals to enter diagnosis and treatment orders. To determine the effectiveness of order sets in improving guideline adherence, treatment outcomes, processes of care, efficiency, and cost, we conducted a systematic review of the literature.

Methods: A comprehensive literature search was performed in various databases for studies published between January 1, 1990, and April 18, 2009. A total of eighteen studies met inclusion criteria. No randomized controlled trials were found.

Results: Outcomes of the included studies were summarized qualitatively due to variations in study population, intervention type, and outcome measures. There were no important inconsistencies between the results reported by studies involving different types of order sets. While the studies generally suggested positive outcomes, they were typically of low quality, with simple before-after designs and other methodological limitations.

Conclusions: The benefits of order sets remain eminently plausible, but given the paucity of high quality evidence, further investigations to formally evaluate the effectiveness of order sets would be highly valuable.

This paper presents the results of a contingent valuation study measuring willingness to pay (WTP) for treatment of patients with von Willebrand's disease. Median WTP for treatment of this disorder was $1,500 or $3,500, depending on how the initial bid was structured. Regression analysis shows that income, education, and a category rating scale for health status were significant in predicting WTP. The adjusted annual WTP was $2,178. WTP surveys may increasingly be useful for health technology assessment. Starting point bias in how the bids are structured must be recognized.

Objective: Health technology assessment (HTA) can be used both to promote access to safe, efficacious, and cost-effective technologies, and to discourage access to undesirable ones. Yet HTA has had less success than might be hoped in pursuing the latter goal. This paper examines the scope of HTA as currently practiced to contribute to regulation of access to undesirable technologies.

Design: The study design is a critical analysis of HTA's methods, based on an exposition of the normative issues involved in restriction of access to health technologies. The paper classifies technologies that might figure as potential candidates for exclusion into five categories and underscores the key social and ethical dilemmas associated with limiting their use.

Results: For four of the five categories of technology outlined, limitation of access necessarily involves denial of benefit. Limitation of access thus inevitably raises difficult normative issues. We show that these are ill-addressed by the range of “evidence” typically considered in technology assessments, which centers predominantly on clinical and technical features such as efficacy, safety, and costs.

Conclusions: If HTA is to enhance our ability to make reasonable decisions concerning the use and diffusion of health technologies, it must better integrate consideration of the social, political, and ethical dimensions of health technologies into the process of technology assessment. We suggest a framework within which to approach this goal.

In Hungary, the history of the health technology assessment (HTA) dates back to 1993 when HTA and related activities started by professional initiatives. The legal background, institutionalization, and training capacities were created between 1998 and 2004. The main challenges for HTA in Hungary are partly similar to the ones in countries with a developed economy; no question it is time for cost-effectiveness. However, there are very important differences as well, that is why transferability and adaptability issues have to be considered. This article describes the characteristic features of the Hungarian healthcare system, the history and the current role of HTA, and the most important challenges.

Background and Purpose: Outcome in patients hospitalized for acute stroke varies considerably between populations. Within the framework of the GAIN International trial, a large multicenter trial of a neuroprotective agent (gavestinel, glycine antagonist), stroke outcome in relation to health care resource use has been compared in a large number of countries, allowing for differences in case mix.

Methods: This substudy includes 1,422 patients in 19 countries grouped into 10 regions. Data on prognostic variables on admission to hospital, resource use, and outcome were analyzed by regression models.

Results: All results were adjusted for differences in prognostic factors on admission (NIH Stroke Scale, age, comorbidity). There were threefold variations in the average number of days in hospital/institutional care (from 20 to 60 days). The proportion of patients who met with professional rehabilitation staff also varied greatly. Three-month case fatality ranged from 11% to 28%, and mean Barthel ADL score at three months varied between 64 and 73. There was no relationship between health care resource use and outcome in terms of survival and ADL function at three months. The proportion of patients living at home at three months did not show any relationship to ADL function across countries.

Conclusions: There are wide variations in health care resource use between countries, unexplained by differences in case mix. Across countries, there is no obvious relationship between resource use and clinical outcome after stroke. Differences in health care traditions (treatment pathways) and social context seem to be major determinants of resource use. In making comparisons between countries, great care should be exercised in using outcome variables as indicators of quality of stroke care.

Objectives: Although the clinical benefits of endovenous thermal ablation are widely recognized, few studies have evaluated the health economic implications of different treatments. This study compares 6-month clinical outcomes and cost-effectiveness of endovenous laser ablation (EVLA) compared with radiofrequency ablation (RFA) in the setting of a randomized clinical trial.

Methods: Patients with symptomatic primary varicose veins were randomized to EVLA or RFA and followed up for 6 months to evaluate clinical improvements, health related quality of life (HRQOL) and cost-effectiveness.

Results: A total of 131 patients were randomized, of which 110 attended 6-month follow-up (EVLA n = 54; RFA n = 56). Improvements in quality of life (AVVQ and SF-12v2) and Venous Clinical Severity Scores (VCSS) achieved at 6 weeks were maintained at 6 months, with no significant difference detected between treatment groups. There were no differences in treatment failure rates. There were small differences in favor of EVLA in terms of costs and 6-month HRQOL but these were not statistically significant. However, RFA is associated with less pain at up to 10 days.

Conclusions: EVLA and RFA result in comparable and significant gains in quality of life and clinical improvements at 6 months, compared with baseline values. EVLA is more likely to be cost-effective than RFA but absolute differences in costs and HRQOL are small.

Objectives: Recent concerns have been raised for the safety after drug-eluting stents (DES) implantation compared with the use of bare-metal stents (BMS) in patients with ST-elevation acute myocardial infarction (STEMI). The objective of this study was to estimate the relative impact of DES versus BMS on mortality, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) in STEMI patients by performing comprehensive meta-analyses of randomized controlled trials (RCTs) and observational studies.

Methods: We performed an electronic search and manual search of studies presented through September 2009, without language restrictions. An approach of “using systematic reviews” was used. Two independent reviewers extracted prespecified data from each study. A random-effects model was used to combine trials and to perform stratified analyses based on study designs and the duration of follow-up.

Results: Fourteen RCTs were identified (N = 7,654). Compared with BMS, DES significantly reduced TVR (risk ratio [RR], 0.48; 95 percent confidence interval [CI], 0.41–0.56) and MI (RR, 0.77; 95 percent CI, 0.61–0.97), without increasing mortality (RR, 0.88; 95 percent CI, 0.70–1.10) and ST (RR, 0.93; 95 percent CI, 0.72–1.21). Among 35 observational studies (N = 44,849), the use of DES was associated with a significant reduction in mortality (RR, 0.85; 95 percent CI, 0.79–0.91) and TVR (RR, 0.61; 95 percent CI, 0.48–0.77). MI and ST were significantly lower in the DES group within 1-year follow-up, but there were no differences within 2 years of follow-up. There was no evidence of statistical heterogeneity and publication bias.

Conclusions: These data in aggregate suggest that using DES in STEMI patients is safe and efficacious, but there are differences between RCT and observational data comparing DES and BMS.

Throughout the history of the development and use of medical technologies (phar-maceuticals, laboratory tests, invasive and noninvasive procedures, and medical devices), physicians and their patients have been the primary assessors of a technology's worth. If a drug, test, or procedure produces consistent beneficial effects, with little or no risk, then such a technology is commonly added to the clinician's arsenal of weapons against illness and disease. Academic researchers, however, with their keen desires to find new and better ways to diagnose, treat, and cure, are relied upon to produce evidence documenting a technology's efficacy. Others engaged in technology assessment activities—from their own perspectives—include manufacturers, who produce data showing the value of the products they hope to sell; hospitals that wish to make cost-effective purchases; and government agencies, with mandates to protect the public and to spend public dollars wisely. Still, it is the practicing physician who ultimately judges a technology's value based upon its use in individual clinical situations. Until very recently, with the apparent adequacy of these evaluative methods, medical professional societies were not required to enter the technology assessment arena.

In an effort to control ambulatory care costs, regulatory practice guidelines (références médicales opposables or RMOs) were introduced by law in France in 1993. RMOs are short sentences, negatively formulated (“it is inappropriate to \ldots”), covering medical and surgical topics, diagnosis, and treatment. Since their introduction, physicians who do not comply with RMOs can be fined. The fine is determined by a weighted combination of indices of harm, cost, and the number of violations.

The impact of the RMO policy on physician practice has been questioned, but so far few evaluations had been performed. At the end of 1997, only 121 physicians had been fined (0.1% of French private physicians). The difficulty of controlling physicians, the large number of RMOs, and the lack of a relevant information system limit the credibility of this policy.

The simultaneous development of a clinical guideline program to improve the quality of care and of a program to control medical practice can lead to a misunderstanding among clinicians and health policy makers. Financial incentives or disincentives could be used to change physician behavior, in addition to other measures such as education and organizational changes, if they are simple, well explained, and do not raise any ethical conflict. But these measures are dependent on the structure and financing of the healthcare system and on the socioeconomic and cultural context. More research is needed to assess the impact of interventions using financial incentives and disincentives on physician behavior.

Objectives: Ethical evaluation has become an important part of health technology assessment (HTA), but so far no generally accepted method for doing this exists. This article explains the eclectic approach developed at the Finnish HTA office.

Methods: Each HTA report is produced in cooperation with the methodological and clinical experts from various levels of healthcare organizations. An open framework for ethical evaluation when assessing different types of interventions is used to identify all possible stakeholders for each particular intervention. The ethical consequences for each party are identified during the entire process of the HTA project.

Results: The results of an ethical evaluation in four different HTA projects (two on screening, one on surgical intervention, and one in rehabilitation) show that an open framework is useful for opening discussion and understanding the scope of each ethical evaluation. Both content and methodological experts have found the process to be useful in capturing the broad consequences of implementing a new method.

Conclusions: Ethical evaluation is a continuous process that considers the prevalent morals, values, and behavioral models of the society. An in-depth ethical evaluation helps the decision-makers to realize the consequences that implementing a new method has on individual citizens, the healthcare system, and society.

Objectives. In a democratic system, decision makers are accountable for the reasonableness of their decisions. This presumes (i) transparency, (ii) relevance of the decision criteria, (iii) revisability of decisions, and (iv) enforcement/regulation. We aim to (i) evaluate the extent to which drug reimbursement decision-making processes in different contexts meet these conditions and (ii) develop, starting from these findings, a framework for improving the transparency and the relevance of used decision criteria.

Methods. We evaluated the Austrian, Belgian, French, Dutch, and Swedish drug reimbursement systems. Based on this evaluation, we developed a framework for improving the transparency of drug reimbursement decision-making processes. It makes explicit the questions often addressed implicitly during decision-making processes as well as criteria for answering each question.

Results. Transparency of appraisal processes varies across systems. Justification with explicit criteria is generally limited. Although relevant criteria are similar across systems, their operationalization varies and their role in the appraisal process is not always clear. All systems seem to implicitly address five key questions, relating to (i) the medical, therapeutic, and societal need for treatment; (ii) preparedness to pay for treating the condition as a principle and (iii) for using the treatment under consideration; (iv) preparedness to pay more compared with alternatives; and (v) actual willingness to pay from public resources.

Conclusions. Transparency of the appraisal process can be improved by using an explicit decision framework. Systematic use of such a framework enhances consistency across decisions, allows justification of value judgments, and thus enhances legitimacy of societal decision making.

The collective experience of health technology assessment (HTA) in different countries delineates a pattern of development, a “natural history,” of HTA in three phases: emergence, consolidation, and expansion. This study examines the rationale for HTA, definitions of its scope and breadth, its methods and organizational models, and its knowledge translation strategies, as HTA moves from one phase to the next. The study then identifies factors that facilitate or delay the transitions.

Background: Generation of additional evidence may be necessary to access new promising technologies (marketing approval or coverage). Access with evidence generation (AEG) is a more recent concept with regard to coverage than to marketing approval.

Objectives: One aim of Work Package 7 (WP7) Strand A of the European network for Health Technology Assessment (EUnetHTA) was to provide an overview of national AEG mechanisms associated with marketing approvals and funding or coverage decisions.

Methods: A systematic literature review, surveys of WP7 Partners, and consultation of key people were used to obtain information on the AEG mechanisms used by twenty-three countries (twenty European countries, United States, Canada [Ontario], and Australia).

Results: Interest in the implementation of AEG policies, particularly at the coverage decision stage, is growing. An overview of national experiences was used to draw up a generally applicable five-step policy framework for AEG mechanisms that comprised (i) a first assessment identifying knowledge gaps; (ii) a decision conditional to evidence generation; (iii) generation of the evidence requested; (iv) re-assessment integrating the new evidence; (v) a revised decision. The critical factors for success that were identified were coordination, methodological guidance, funding, and a regulatory framework. Countries were categorized on the basis of current implementation of the proposed policy framework.

Conclusions: International collaboration is necessary to gather a critical mass of high-quality data quickly and to ensure timely access to new promising technologies. The overview produced by WP7A has led to development of tools to facilitate collaboration on evidence generation.

Objectives and Methods: Health technology assessment (HTA) often requires the identification and review of economic evaluations and models. This study surveys the available specific and general resources to search to identify economic evaluations. It also provides information on efficient searching of those resources and comments on the current evidence-base.

Results: Published checklists recommend searching for economic evaluations in specific information resources which collect economic evaluations such as NHS EED and HEED, followed by top-up searches of large biomedical bibliographic databases (such as MEDLINE and EMBASE). Other resources such as the HTA and DARE databases can yield reports of economic evaluations. Searches within NHS EED and HEED can be made more efficient by using database-specific search options. Searches within large biomedical databases such as MEDLINE and EMBASE require the use of economic search terms called search filters. Search filters are highly sensitive, retrieving most economic evaluations, but suffer from low precision returning many irrelevant records which need to be assessed.

Conclusions: It is relatively easy to identify rapidly a high proportion of economic evaluations but more research is required to improve the efficiency of this process. There are key high yield resources to search but more evidence is required on their overlap and unique contribution to searches. The value of other resources, particularly those providing access to gray literature, should be explored. Research into efficient retrieval requires clear definitions of economic evaluations to allow comparison across studies.

Five “big ticket” medical technologies (BTTs) in 1990 were compared in the 24 OECD countries in relation to population, the number of physicians, gross domestic product (GDP), and health care expenditures (HCE). Wide variations were observed between and within countries for all measures. Regression analysis revealed that HCE explains part of the variation in the distribution of computed tomography scanners (excluding Japan), magnetic resonance imaging units, and radiation therapy units (R2 between 0.40 and 0.69), but not extracorporeal shock wave lithotripters. To a lesser extent, GDP was also found to correlate with the distribution of these technologies, but no correlation was found with number of physicians. Other factors affecting the diffusion of these technologies are proposed for study.