International lessons in new methods for grading and integrating cost effectiveness evidence into clinical practice guidelines.

Economic evidence is influential in health technology assessment world-wide. Clinical Practice Guidelines (CPG) can enable economists to include economic information on health care provision. Application of economic evidence in CPGs, and its integration into clinical practice and national decision making is hampered by objections from professions, paucity of economic evidence or lack of policy commitment. The use of state-of-art economic methodologies will improve this. Economic evidence can be graded by 'checklists' to establish the best evidence for decision making given methodological rigor. New economic evaluation checklists, Multi-Criteria Decision Analyses (MCDA) and other decision criteria enable health economists to impact on decision making world-wide. We analyse the methodologies for integrating economic evidence into CPG agencies globally, including the Agency of Health Research and Quality (AHRQ) in the USA, National Health and Medical Research Council (NHMRC) and Australian political reforms. The Guidelines and Economists Network International (GENI) Board members from Australia, UK, Canada and Denmark presented the findings at the conference of the International Health Economists Association (IHEA) and we report conclusions and developments since. The Consolidated Guidelines for the Reporting of Economic Evaluations (CHEERS) 24 item check list can be used by AHRQ, NHMRC, other CPG and health organisations, in conjunction with the Drummond ten-point check list and a questionnaire that scores that checklist for grading studies, when assessing economic evidence. Cost-effectiveness Analysis (CEA) thresholds, opportunity cost and willingness-to-pay (WTP) are crucial issues for decision rules in CEA generally, including end-of-life therapies. Limitations of inter-rater reliability in checklists can be addressed by including more than one assessor to reach a consensus, especially when impacting on treatment decisions. We identify priority areas to generate economic evidence for CPGs by NHMRC, AHRQ, and other agencies. The evidence may cover demand for care issues such as involved time, logistics, innovation price, price sensitivity, substitutes and complements, WTP, absenteeism and presentism. Supply issues may include economies of scale, efficiency changes, and return on investment. Involved equity and efficiency measures may include cost-of-illness, disease burden, quality-of-life, budget impact, cost-effective ratios, net benefits and disparities in access and outcomes. Priority setting remains essential and trade-off decisions between policy criteria can be based on MCDA, both in evidence based clinical medicine and in health planning.

A cohort study following up on a randomised controlled trial of a telemedicine application in COPD patients.

INTRODUCTION: The studies that constitute the knowledge base of evidence based medicine represent only 5%-50% of patients seen in routine clinical practice. Therefore, whether the available evidence applies to the implementation of a particular service often remains unclear. Chronic obstructive pulmonary disease (COPD) is no exception. METHODS: In this article, the effects of implementing a telemedicine intervention for COPD patients were analysed using data collected before, during, and after a randomised controlled trial (RCT).More specifically, regression techniques using robust variance estimators were used to analyse whether the use of telemedicine, patient age, and gender could explain the risk of readmission, length of hospital admission, and death during a five-year observation period. RESULTS: Increased risk of readmission was significantly related to both use of telemedicine and increased age in three sub-periods of the study, whereas women showed a more pronounced risk of readmission than men only during and after the RCT period. The number of days admitted to hospital was higher for patients using telemedicine and being of older age. Risk of death during the observation period was decreased for patients using telemedicine and for female patients and increased for elderly patients. No interaction between intervention and time period was observed.Statistically significant relationships were identified between use of telemedicine and risk of readmission, days admitted to hospital, and death. DISCUSSION: Research on effect modification in telemedicine is essential in designing future implementation of interventions as it cannot be taken for granted that effectiveness follows from efficacy.

Checklists for external validity: a systematic review.

RATIONALE, AIMS AND OBJECTIVES: The quality of the current literature on external validity varies considerably. An improved checklist with validated items on external validity would aid decision-makers in judging similarities among circumstances when transferring evidence from a study setting to an implementation setting. In this paper, currently available checklists on external validity are identified, assessed and used as a basis for proposing a new improved instrument. METHOD: A systematic literature review was carried out in Pubmed, Embase and Cinahl on English-language papers without time restrictions. The retrieved checklist items were assessed for (i) the methodology used in primary literature, justifying inclusion of each item; and (ii) the number of times each item appeared in checklists. RESULTS: Fifteen papers were identified, presenting a total of 21 checklists for external validity, yielding a total of 38 checklist items. Empirical support was considered the most valid methodology for item inclusion. Assessment of methodological justification showed that none of the items were supported empirically. Other kinds of literature justified the inclusion of 22 of the items, and 17 items were included on the basis of consensus. On 36 occasions, the items were presented without methodological justification for inclusion. Assessment of frequency/occurrence showed that items were mentioned in one to at most 17 checklists. CONCLUSION: This paper provides building blocks for the development of a new checklist for external validity. The next step is provision of empirical evidence for the checklist items to be selected, and finally, development and validation of a checklist on external validity.

Is the planned and ongoing project (POP) database a suitable tool to reduce duplication in the process of assessing new health technologies in the European Union? Preliminary experience in the context of the EUnetHTA Joint Action Project Framework (2010-2012).

OBJECTIVES: The European Network for Health Technology Assessment (EUnetHTA) Joint Action Project Framework, 2010-12, Work Package 7B (WP 7B), was aimed at facilitating collaboration between HTA agencies to avoid duplication of assessment efforts. A major task of WP 7B was to collect information on planned and ongoing (POP) projects by EUnetHTA agencies and to incorporate this information in a POP Database. We analyzed whether the Database served its intended purpose. METHODS: A survey was sent to all fifty-seven EUnetHTA partners, complemented by telephone interviews with the Ludwig Boltzmann Institute of HTA in Austria (lead institution). Furthermore, detailed documentation on the activities of the POP Database was provided to the research team at CAST (University of Southern Denmark) by the lead institution. RESULTS: Forty-two of fifty-seven agencies (74 percent) responded to the survey. Eleven collaborations initiated by agencies themselves were reported. The scope of these collaborative activities was usually limited to information exchange on for example literature search protocols. A slight reduction of duplication of effort was documented. In addition, twelve collaborations at the full report level were initiated by the lead institution. CONCLUSION: While the POP Database has the potential to reduce duplication of effort, this has not been realized during the 3-year period of the EUnetHTA Joint Action Project Framework, 2010-12. Further evidence needs to be gathered to determine whether the POP Database is effective and whether the benefits outweigh the resources required to maintain it.

Mapping of health technology assessment in selected countries.

OBJECTIVES: The aim of this study was to develop and apply an instrument to map the level of health technology assessment (HTA) development at country level in selected countries. We examined middle-income countries (Argentina, Brazil, India, Indonesia, Malaysia, Mexico, and Russia) and countries well-known for their comprehensive HTA programs (Australia, Canada, and United Kingdom). METHODS: A review of relevant key documents regarding the HTA process was performed to develop the instrument which was then reviewed by selected HTAi members and revised. We identified and collected relevant information to map the level of HTA in the selected countries. This was supplemented by information from a structured survey among HTA experts in the selected countries (response rate: 65/385). RESULTS: Mapping of HTA in a country can be done by focusing on the level of institutionalization and the HTA process (identification, priority setting, assessment, appraisal, reporting, dissemination, and implementation in policy and practice). Although HTA is most advanced in industrialized countries, there is a growing community in middle-income countries that uses HTA. For example, Brazil is rapidly developing effective HTA programs. India and Russia are at the very beginning of introducing HTA. The other middle-income countries show intermediate levels of HTA development compared with the reference countries. CONCLUSIONS: This study presents a set of indicators for documenting the current level and trends in HTA at country level. The findings can be used as a baseline measurement for future monitoring and evaluation. This will allow a variety of stakeholders to assess the development of HTA in their country, help inform strategies, and justify expenditure for HTA.

Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

OBJECTIVES: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. METHODS: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. RESULTS: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. CONCLUSIONS: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Systems to support health technology assessment (HTA) in member states of the European union with limited institutionalization of HTA.

OBJECTIVES: The aim of this study was to support health technology assessment (HTA) capacity building in Member States of the European Union with limited experience or without institutionalized HTA. The main output is a Handbook on HTA Capacity Building. METHODS: The methods used were worldwide surveys of (i) HTA organizations, (ii) information management units, and (iii) HTA educational programs. The results of two surveys (i & ii) were combined with expert opinion to produce the Handbook on HTA Capacity Building. RESULTS: Survey of HTA organizations (n = 41, response rate 35 percent). Most of the organizations were established by the government (61 percent), and all were not-for-profit. Working on HTA (80.5 percent) and doing research (63.4 percent) were the main lines of activity. Survey on information management units (n = 23, response rate 23 percent). Most (74.2 percent) of the responding HTA agencies reported having personnel dedicated to HTA information services. Survey on HTA educational programs (n = 48, response rate 60 percent). In total, nine Master of Science (MSc) programs were identified (three MSc in HTA and six MSc in HTA-related areas). Handbook on HTA Capacity Building. A group of twenty experts from thirteen countries developed the handbook. It consists of nine chapters focusing on HTA institutional development (structural setup, work processes, and visibility). CONCLUSIONS: Setting up organizational structures and establishing effective HTA programs that guide key policy decisions is a challenging task. There are no standard models or pathways. "One size fits all" is not a useful principle because of the wide systemic and cultural differences between countries. The Handbook on HTA Capacity Building includes approaches for overall institutional development, especially in formulating objectives, setting up structures, and defining work processes.

Why did some Danish counties introduce breast cancer screening and others not? An exploratory study of four selected counties.

OBJECTIVES: Of the fourteen counties and two municipalities that until recently were responsible for healthcare provision in Denmark, five introduced mammography screening (MS) programs. The objective of this research is to explain this decision-making variation and to gain insight into priority setting processes in health-care provision at the county level in Denmark. METHODS: Literature on priority setting in health care was used to derive seven explanatory factors for comparing decision making on MS between four selected counties, of which two had implemented MS. The relative importance of each explanatory factor in each county was determined by analyzing policy documents, supplemented with interviews of selected stakeholders. The results were combined and compared at the county level. RESULTS: Evidence of effectiveness of MS was considered satisfactory and ethical issues related to MS were perceived relatively unproblematic only in those counties that introduced MS. Lack of resources, that is, radiologists, was an additional important factor for counties not implementing MS. Local opinion leaders have played a stimulating role, whereas advisory policy documents at the central government level and even legislation have had a minor impact. CONCLUSIONS: The four counties have based their decision making on the introduction of MS on different combinations of a limited number of factors that have been differentially weighted. The pattern of relevant factors in both counties not introducing MS is rather similar. The study elucidates the role of complementary factors to evidence in decision making. Of interest, recent public sector reforms have resulted in the decision to have MS implemented nationwide.

Cost-utility analysis of intensive blood glucose control with metformin versus usual care in overweight type 2 diabetes mellitus patients in Beijing, P.R. China.

OBJECTIVE: The UKPDS 34 and 51 showed that intensive blood glucose control with metformin is cost-saving and increases life expectancy in overweight type 2 diabetic patients in the United Kingdom. Diabetes is becoming an important health problem in urban China. This study addresses the effects and costs of intensive blood glucose control in this setting, aimed at supporting decision-making on the allocation of scarce resources. METHODS: A decision analytic model was developed to estimate the costs and effectiveness of intensive blood glucose control in overweight type 2 diabetes patients in Beijing, compared with usual care in accordance with clinical practice. The analysis was carried out from a health-care perspective. RESULTS: The base-case analysis (3% discount rate) shows that the average incremental costs of 11 years of intensive treatment with metformin are 126.6 K RMB (16.4 K US$) per quality-adjusted life year (QALY) gained. The incremental cost-effectiveness ratio (ICER) is sensitive to the costs of medication alternatives for metformin in the intensive treatment group and to the discount rate used (0%: 105.6 K RMB (13.7 K US$) per QALY gained; 5%: 171.0 K RMB (22.2 K US$) per QALY gained). After 20 and 30 years (lifetime) follow-up, the ICERs become increasingly favorable, 90.1 K RMB (11.7 K US$) and 74.3 K RMB (9.6 K US$), respectively. The ICER is most sensitive to the costs of medication alternatives for metformin in the intensive treatment group, and to the discount rate. CONCLUSIONS: Interpretation of the findings depends on the maximum willingness to pay for a QALY in China, which has not officially been defined. If this would be three times the gross domestic product per capita, a value that has been suggested in the literature, lifetime intensive blood glucose control is likely to be cost-effective. Our findings differ from the UKPDS studies and emphasize that generalizing the results of studies across countries requires considerable adaptation to the local context.

Does the National Institute for Health and Clinical Excellence only appraise new pharmaceuticals?

OBJECTIVES: To determine the relative extent to which the National Institute for Health and Clinical Excellence (NICE) appraises new versus existing technologies, and pharmaceutical versus nonpharmaceutical health technologies. METHODS: We categorized technologies within NICE appraisals published between March 2000 and June 2006 by type and classified them as new or existing using the timeline between launch in the United Kingdom and referral to NICE. We used a 3-year postlaunch cutoff to determine whether a technology was new, with a sensitivity analysis of 1 and 5 years. RESULTS: We reviewed 159 technologies from 88 appraisals. Of these, 84 (53 percent) were new (sensitivity analysis 36 to 67 percent) and 75 (47 percent) were existing technologies. A total of 119 (75 percent) were pharmaceuticals, 22 (14 percent) were devices, 14 (9 percent) were procedures, and 4 (3 percent) were categorized as miscellaneous. Classification according to newness and technology type showed that 62 percent (42 to 75 percent) of the pharmaceuticals appraised were new. CONCLUSIONS: By developing and applying a definition of new, we have found that the criticism of the bias toward new technologies is unfounded when applied to the appraisal program overall. At the same time, new pharmaceuticals are over-represented in the program compared with devices and procedures. This domination may cause inflationary pressures on the health service, but any wholesale move away from the technological frontier may be more costly.

[Development of an Internet search strategy to identify new medical technologies in prostate cancer]. / Udvikling af en internetsøgestrategi til identifikation af ny medicinsk teknologi inden for prostatacancer.

INTRODUCTION: Technological change is rapid in medicine. The Internet is becoming more and more important as a source of keeping abreast of technological change, but tools to aid clinicians in finding relevant information on the Internet are lacking. The objective of this project was to develop an Internet search strategy to identify new technologies for the treatment of localised prostate cancer. MATERIALS AND METHODS: Web sites were found by means of a literature search and by searching specific Internet sources. Inclusion and exclusion criteria were developed based on literature and applied to a variety of potentially relevant sites. An initial strategy was developed, technologies identified, and the novelty and relevance were assessed by urologists in the team. This information was used to adjust the strategy. 6 general urologists assessed the efficiency of the strategy. Their input was used to define a final listing of sites. RESULTS: The strategy consists of 10 sites which should be visited in the following order: YahooHealth, DoctorsGuide, The National Electronic Library for Medicines, CancerPage, Medscape, MedlinePlus, HealthAndAge, CancerConsultants, EurekAlert, Oncolink. Links to the exact sites are provided at www.ugeskriftet.dk. CONCLUSION: This study resulted in an Internet search strategy to identify new medical technologies for a well-defined indication. The methods used may be useful in order to develop similar strategies in other clinical areas in urology or other specialties.

Selecting new health technologies for evaluation: can clinical experts predict which new anticancer drugs will impact Danish health care?

Several countries have systems in place to support the managed entry of new health technologies. The big challenge for these so-called horizon-scanning systems is to select those technologies that require decision support by means of an early evaluation. Clinical experts are considered a valuable source of information on new health technologies, but research on the relevance of their input is scarce. In 2000, we asked six Danish expert oncologists to predict whether a sample of 19 new anticancer drugs would impact Danish health care over the next 5 years. In 2005, we assessed the accuracy of these predictions in a delayed type cross-sectional study. The specificity of the Danish experts' prediction was 1 (95% confidence interval 0.74-1.00) and the sensitivity was 0.63 (0.31-0.86). The negative predictive value was 0.79 (0.52-0.92) and the positive predictive value was 1 (0.57-1.00). This indicates that clinical experts have the ability to predict which new anticancer drugs are unlikely to have an impact. This information can be used to increase the efficiency of selecting new technologies for evaluation. As the experts missed 37% of drugs that are in need of guidance, they should not be relied upon to select drugs relevant for evaluation.

Does persistent involvement by the GP improve palliative care at home for end-stage cancer patients?

OBJECTIVE: To analyse the effect of GP home visits on the granting of a terminal declaration (TD) and on place of death. PARTICIPANTS AND DESIGN: A total of 2025 patients with cancer as the primary cause of death in the period 1997-1998, were investigated in a mortality follow-back design using the Danish Cancer Register and four administrative registers. The Danish TD can be issued by a physician for patients with an estimated prognosis of six months or less. The TD gives the right to economic benefits and increased care for the dying patient. SETTING: The island of Funen/Denmark. MAIN OUTCOME MEASURES: Main outcome--hospital death. Intermediate outcome--TD. RESULTS: A total of 38% of patients received a TD and 56% died in hospital. GP home visits in the week before TD (odds ratio (OR): 16.8; 95% CI: 8.2-34.4), as well as four weeks before TD (OR: 6.4; 95% CI: 4.5-9.2) were associated with an increased likelihood of receiving a TD. GP home visits in the group with TD (OR: 0.18; 95% CI: 0.11-0.29) and the group without TD (OR: 0.08; 95% CI: 0.05-0.13) was inversely associated with hospital death. A dose-response relationship was found in both groups. CONCLUSION: Persistent involvement by the GP is associated with improved end-of-life care for cancer patients. Provided that temporal relations are taken into account, the mortality follow-back design can be a suitable and ethical research method to highlight and monitor end-of-life cancer care.

Selection of new health technologies for assessment aimed at informing decision making: A survey among horizon scanning systems.

OBJECTIVES: Uncertainty is pervasive in decision making on new health technologies; therefore, some countries have put systems in place to support decision makers with timely information. An important, but as yet undocumented, determinant of the potential value for decision making of these so-called horizon scanning systems (HSSs) is how the most significant health technologies are selected. METHODS: All thirteen member organizations of EuroScan, a collaborative network for HSSs, were surveyed and interviewed on how they prioritize technologies for assessment. RESULTS: The majority of HSSs directly serves a customer. Some customers actively request early assessments of new health technologies, thereby diminishing the need for priority setting for the HSSs. All systems express a concern to miss an important technology and/or to select an unimportant technology. Almost all HSSs use explicit selection criteria, but these criteria hardly ever are operationalized. The number of criteria used varies, but costs and health benefit of the technology are always taken into account. The process of reaching a final decision is implicit, undocumented in all but one system, and is based on agreement by consensus. CONCLUSIONS: The process of making the final decision on which technologies to assess can be improved by applying existing criteria more consistently and transparently. Current practice does not safeguard against missing an important technology. This finding is probably most important to act upon for systems with customers that do not actively request assessment of specific technologies.

[Prostate-specific antigen in the diagnosis of prostate cancer in Denmark]. / Prostataspecifikt antigen i diagnostikken af prostatacancer i Danmark.

INTRODUCTION: The incidence of prostate cancer is increasing. Potentially curative treatment can be attempted in clinically localised disease, emphasising the role of early diagnosis. Prostate-specific antigen (PSA) is used as a biological marker for prostate cancer, but its value as a diagnostic test is associated with some degree of uncertainty. In 1999 the Danish Uro-Oncological Committee recommended measurement of the ratio of free to total PSA (f/tPSA) as a complementary analysis to total PSA (tPSA) in patients in whom the tPSA level is below 10 ng/mL. To assess whether the recommendation of the Danish Uro-Oncological Committee has been implemented in daily clinical practice, we carried out a survey of a pre-selected sample of hospital laboratories. MATERIALS AND METHODS: Fifteen laboratories in Denmark, all associated with a university hospital, were surveyed in April 2004. Questions focused on current laboratory practice with regard to tPSA and f/t PSA. RESULTS: Within or outside their own facilities, the hospital laboratories all had tPSA analysed, and 64 percent had f/t PSA analysed. All the laboratories used the same critical value for tPSA (<4 ng/mL), while there was considerable variation in the critical value applied for f/tPSA. Forty-four percent of laboratories partially complied with the recommendation of the Danish Uro-Oncological Committee to analyse f/t PSA in addition to tPSA in patients in whom the total PSA level is below 10 ng/mL. DISCUSSION: Despite the recommendation of the Danish Uro-Oncological Committee, measurement of f/tPSA is not fully implemented in laboratories associated with university hospitals in Denmark. There is considerable practice variation in the analysis of f/t PSA as well.

Priority setting for horizon scanning of new health technologies in Denmark: views of health care stakeholders and health economists.

In the context of the establishment of a Danish Horizon Scanning System (HSS) the views of health care stakeholders and health economists were solicited by means of postal surveys on the need for adaptation of a priority setting instrument for health technology assessment (HTA). The aim was to investigate if the instrument needed adaptation for priority setting in the context of a Danish HSS and, if so, how the instrument should be changed. A literature study served to enhance interpretation of the findings of the surveys and to formulate changes in the instrument that synthesize or bridge any differing views between the two groups. The results show that the instrument should apply a health care perspective, and that technologies should be prioritised on the basis of the criteria: marginal benefits, marginal costs, budget impact, impact on access to care, and additional criteria with an impact on health policy, such as the educational needs and organisational changes associated with the new technology. The proposed changes are regarded as an intermediate step in the process of producing a fully adapted instrument that can serve as a formal support for priority setting of new health technologies for assessment in the Danish HSS.

Population-based study of place of death of patients with cancer: implications for GPs.

BACKGROUND: A majority of patients with cancer who are seriously ill have a preference of dying at home. However, only a minority of patients actually die at home in most Western countries. AIM: To explore factors associated with place of death in an unselected population of patients with cancer. DESIGN OF STUDY: Case-control study. SETTING: County of Funen, Denmark. METHOD: Register linkage from six Danish healthcare registers. RESULTS: The GP's home visit during the last 3 months before death was inversely associated with dying in hospital (adjusted odds ratio [OR] = 0.08, 95% confidence interval [CI] = 0.06 to 0.12) and so were community nurses visiting the home (OR = 0.36, 95% CI = 0.26 to 0.48). Furthermore, being married (OR = 0.68, 95% CI = 0.56 to 0.85), and age at death of 40-65 years (OR = 0.70, 95% CI = 0.56 to 0.90) seemed to have an effect. Hospital death was associated with survival time of less than 1 month (OR = 2.27, 95% CI = 1.69 to 3.13). Type of cancer, sex, or residence (urban versus rural) were not associated with a hospital death in this multivariate analysis. CONCLUSIONS: Dying at home was, to a higher extent, associated with GP visit and, to a lesser extent, community nurse visit than with clinical and sociodemographic characteristics of patients with cancer. In our view, these findings indicate the importance of the GP in particular. To increase the opportunity to die at home, more research is needed on the role of the GP and the interface between GPs and other providers of health care at home for patients who are terminally ill with cancer.

"The future should not take us by surprise": preparation of an early warning system in Denmark.

OBJECTIVES: To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue. METHODS: On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study. RESULTS: Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred. CONCLUSIONS: The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.

Economic evaluation of integrated care: an introduction.

BACKGROUND: Integrated care has emerged in a variety of forms in industrialised countries during the past decade. It is generally assumed that these new arrangements result in increased effectiveness and quality of care, while being cost-effective or even cost-saving at the same time. However, systematic evaluation, including an evaluation of the relative costs and benefits of these arrangements, has largely been lacking. OBJECTIVES: To stimulate fruitful dialogue and debate about the need for economic evaluation in integrated care, and to outline possibilities for undertaking economic appraisal studies in this relatively new field. THEORY: Key concepts, including e.g. scarcity and opportunity costs, are introduced, followed by a brief overview of the most common methods used in economic evaluation of health care programmes. Then a number of issues that seem particularly relevant for economic evaluation of integrated care arrangements are addressed in more detail, illustrated with examples from the literature. CONCLUSION AND DISCUSSION: There is a need for well-designed economic evaluation studies of integrated care arrangements, in particular in order to support decision making on the long-term financing of these programmes. Although relatively few studies have been done to date, the field is challenging from a methodological point of view, offering analysts a wealth of opportunities. Guidance to realise these opportunities is provided by the general principles for economic evaluation, which can be tailored to the requirements of this particular field.

Reimbursement of glitazones in treatment of type 2 diabetes patients in Denmark in the context of a voluntary system for submitting pharmacoeconomic studies.

In 1998, guidelines for pharmacoeconomic evaluation were issued in Denmark. It was left to the discretion of the industry for which products to submit a pharmacoeconomic study. The impact of this voluntary system is illustrated by a case study on reimbursement of two types of glitazones. A review is presented of the evidence on safety, effectiveness and cost-effectiveness of glitazones that was available in the public domain at the time of reimbursement decision making, which was matched to the Danish criteria for general reimbursement of new pharmaceuticals. The study concludes that the voluntary system has not supported the inclusion of efficiency considerations in reimbursement decision making on glitazones. The decision-making process may be improved by mandatory pharmacoeconomic evaluations for selected products such as glitazones, which potentially represent a benefit to patients and potentially improve the cost-effectiveness of care, while at the same time having a considerable budget impact.