GENERAL ESSAYS
Expanding the scientific basis of health technology assessment: A research agenda for the next decade
- Renaldo N. Battista
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 275-280
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Objectives: The complexity of health technology assessment (HTA) has increased, in part because of its evolution through three distinct phases: the machine, the clinical outcomes, and the delivery models. However, the theoretical foundation for the field remains underdeveloped.
Methods: It is high time for HTA to bring together aspects of conceptual and theoretical works from other fields to strengthen the foundation of HTA.
Results: Many challenges await the further development of HTA. They can be captured around three research themes: adapting HTA to an evolving analysis object; translating HTA results into policy, management, and practice decisions; and evaluating organizational models of HTA.
Conclusions: Consolidating the scientific basis of HTA is essential if we are to succeed in increasing the relevance of HTA in some of the most challenging health-related decisions that we will make as individuals and societies.
Commentary
- H. David Banta, Egon Jonsson
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 280-282
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Battista has written a thoughtful and timely challenge to the field of health technology assessment (HTA). As the author points out, HTA is changing and evolving. One of the greatest challenges is that HTA now seems firmly established in a number of countries, and is being looked to more and more for the “answers.” We accept and endorse Battista's central thesis, and essentially all of his critical questions, including his ideas about future research topics. We hope to evoke further thoughts in the reader and perhaps stimulate other responses, either private and public.
Searching for and use of conference abstracts in health technology assessments: Policy and practice
- Yenal Dundar, Susanna Dodd, Paula Williamson, Tom Walley, Rumona Dickson
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 283-287
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Objectives: Current policy and practice regarding identification of and extent of use of data from conference abstracts in health technology assessment reviews (TARs) are examined.
Methods: The methods used were (i) survey of TAR groups to identify general policy and experience related to use of abstract data, and (ii) audit of TARs commissioned by the National Institute for Health and Clinical Excellence (NICE) and published between January 2000 and October 2004.
Results: Five of seven TAR groups reported a general policy that included searching for and including studies available as conference abstracts and presentations. A total of sixty-three published HTA reports for NICE were identified. Of these reports, thirty-eight identified at least one randomized controlled trial available as an abstract/presentation. Twenty-six (68 percent) of these thirty-eight TARs included studies available as abstracts.
Conclusions: There are variations in policy and practice across TAR groups regarding the searching for and inclusion of studies available as conference abstracts. There is a need for clarity and transparency for review teams regarding how abstract data are managed. If conference abstracts are to be included, reviewers need to allocate additional time for searching and managing data from these sources. Review teams should also be encouraged to state explicitly their search strategies for identifying conference abstracts, their methods for assessing these abstracts for inclusion and, where appropriate, how the data were used and their effect on the results.
Case study of the comparison of data from conference abstracts and full-text articles in health technology assessment of rapidly evolving technologies: Does it make a difference?
- Yenal Dundar, Susanna Dodd, Paula Williamson, Rumona Dickson, Tom Walley
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 288-294
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Objectives: The aim of this study was to examine (i) the consistency of reporting research findings presented in conference abstracts and presentations and subsequent full publications, (ii) the ability to judge methodological quality of trials from conference abstracts and presentations, and (iii) the effect of inclusion or exclusion of data from these sources on the pooled effect estimates in a meta-analysis.
Methods: This report is a case study of a selected health technology assessment review (TAR) of a rapidly evolving technology that had identified and included a meta-analysis of trial data from conference abstracts and presentations.
Results: The overall quality of reporting in abstracts and presentations was poor, especially in abstracts. There was incomplete or inconsistent reporting of data in the abstract/presentations. Most often inconsistencies were between conference slide presentations and data reported in published full-text articles. Sensitivity analyses indicated that using data only from published papers would not have altered the direction of any of the results when compared with those using published and abstract data. However, the statistical significance of three of ten results would have changed. If conference abstracts and presentations were excluded from the early analysis, the direction of effect and statistical significance would have changed in one result. The overall conclusions of the original analysis would not have been altered.
Conclusions: There are inconsistencies in data presented as conference abstracts/presentations and those reported in subsequent published reports. These inconsistencies could impact the final assessment results. Data discrepancies identified across sources included in TARs should be highlighted and their impact assessed and discussed. Sensitivity analyses should be carried out with and without abstract/presentation data included in the analysis. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials.
Doing mini–health technology assessments in hospitals: A new concept of decision support in health care?
- Lars Ehlers, Malene Vestergaard, Kristian Kidholm, Birgitte Bonnevie, Poul Holt Pedersen, Torben Jørgensen, Malene Fabricius Jensen, Finn Børlum Kristensen, Mette Kjølby
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 295-301
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Objectives: The purpose of this project was to evaluate local decision support tools used in the Danish hospital sector from a theoretical and an empirical point of view.
Methods: The use of local decision support was evaluated through questionnaires sent to all county health directors, all hospital managers, and all heads of clinical departments in cardiology, orthopedic surgery, and intensive care. In addition, respondents were asked to submit whatever decision support tools they were using (including mini-HTAs, other forms or checklists, and special procedures for decision making concerning new health technologies). A theoretical analysis of the decision support tools (decision theory) was performed as well as a comparison with the business case method used in private companies. Finally, the Danish mini-HTA was compared with foreign production and use of HTA and HTA-like assessments as local decision support.
Results: The response rate was high (87 percent, 94 percent, 85 percent, respectively). We collected sixty different forms (of which forty-nine were mini-HTAs) and twenty variants of written procedures. We found theoretical and empirical evidence that local involvement in the process of making the HTA could be important for the use of the results from the HTA and for the process of implementing the new technology.
Conclusions: Doing mini-HTA in hospitals seems to balance the need for quality and depth with the limited time and resources for assessment.
Technology assessment and knowledge brokering: The case of assisted reproduction in The Netherlands
- Jessika van Kammen, Carin W. Jansen, Gouke J. Bonsel, Jan A. M. Kremer, Johannes L. H. Evers, Juriy W. Wladimiroff
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 302-306
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Objectives: Even when policy makers show interest and evidence-informed and convincing HTA studies are available, use of assessment products is not guaranteed. In this article, we report our experience with knowledge brokering to foster evidence-informed policy making on cost-effective treatment and reimbursement of assisted reproduction in The Netherlands.
Methods: From earlier work in the field of knowledge brokering, we foresaw the need for a deliberative strategy to manage the inherent tension between scientific rigor demanded by researchers and responsiveness to real-time needs demanded by policy makers. Therefore, we structured the process in three distinct steps: (i) agreement about the main messages from the research, (ii) analysis of the policy context and of the meaning of the main messages for the actors involved, and (iii) an invitational meeting to make recommendations for action.
Results: One of the recommendations that would require changes in ministerial policy was followed up instantly, whereas the other recommendation is still under debate. The Dutch Society of Obstetrics and Gynecology activated the revision of two guidelines. The patient organization uses the new scientific insights in informing members and the public. Closing the loop, The Netherlands Organisation for Health Research and Development (ZonMw) funded research to close knowledge gaps that became apparent in the process.
Conclusions: Knowledge brokering is a promising approach to bring HTA into practice. We conclude that the methodologies to feed research results into the policy process are still in an incipient stage and need further development.
Ethics and health technology assessment: Handmaiden and/or critic?
- Annette J. Braunack-Mayer
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 307-312
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Objectives: This study examines the content and role of ethical analysis in health technology assessment (HTA) and horizon scanning publications. It proposes that ethical analysis in HTA is of at least two different types: an ethics of HTA and an ethics in HTA.
Methods: I examine the critical differences between these approaches through the examples of the analysis of genetic screening for breast cancer and home blood glucose testing in diabetes. I then argue that, although both approaches subscribe to similar views concerning HTA and ethics, they use different theoretical and methodological traditions to interpret and explain them.
Results and Conclusions: I conclude by suggesting that we need the interpretive insights of both these approaches, taken together, to explain why ethics has not been able yet to contribute fully to HTA and to demonstrate the scope and complexity of ethical work in this domain.
Early home-supported discharge of stroke patients: A health technology assessment
- Torben Larsen, Tom S. Olsen, Jan Sorensen
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 313-320
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Objectives: A comprehensive and systematic assessment (HTA) of early home-supported discharge by a multidisciplinary team that plans, coordinates, and delivers care at home (EHSD) was undertaken and the results were compared with that of conventional rehabilitation at stroke units.
Methods: A systematic literature search for randomized trials (RCTs) on “early supported discharge” was closed in April 2005. RCTs on EHSD without information on (i) death or institution at follow-up, (ii) change in Barthél Index, (iii) length of hospital stay, (iv) intensity of home rehabilitation, or (v) baseline data are excluded. Seven RCTs on EHSD with 1,108 patients followed 3–12 months after discharge are selected for statistical meta-analysis of outcomes. The costs are calculated as a function of the average number of home training sessions. Economic evaluation is organized as a test of dominance (both better outcomes and lower costs).
Results: The odds ratio (OR) for “Death or institution” is reduced significantly by EHSD: OR = .75 (confidence interval [CI], .46–.95), and number needed to treat (NNT) = 14. Referrals to institution have OR = .45 (CI, .31–.96) and NNT = 20. The reduction of the rate of death is not significant. Length of stay is significantly reduced by 10 days (CI, 2.6–18 days). All outcomes have a nonsignificant positive covariance. The median number of home sessions is eleven, and the average cost per EHSD is 1,340 USD. The “action mechanism” and financial barriers to EHSD are discussed.
Conclusions: EHSD is evidenced as a dominant health intervention. However, financial barriers between municipalities and health authorities have to be overcome. For qualitative reasons, a learning path of implementation is recommended where one stroke unit in a region initiates EHSD for dissemination of new experience to the other stroke units.
Economics of tandem mass spectrometry screening of neonatal inherited disorders
- Abdullah Pandor, Joe Eastham, James Chilcott, Suzy Paisley, Catherine Beverley
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- 09 August 2006, pp. 321-326
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Objectives: The aim of this study was to evaluate the cost-effectiveness of neonatal screening for phenylketonuria (PKU) and medium-chain acyl-coA dehydrogenase (MCAD) deficiency using tandem mass spectrometry (tandem MS).
Methods: A systematic review of clinical efficacy evidence and cost-effectiveness modeling of screening in newborn infants within a UK National Health Service perspective was performed. Marginal costs, life-years gained, and cost-effectiveness acceptability curves are presented.
Results: Substituting the use of tandem MS for existing technologies for the screening of PKU increases costs with no increase in health outcomes. However, the addition of screening for MCAD deficiency as part of a neonatal screening program for PKU using tandem MS, with an operational range of 50,000 to 60,000 specimens per system per year, would result in a mean incremental cost of −£17,298 (−£129,174, £66,434) for each cohort of 100,000 neonates screened. This cost saving is associated with a mean incremental gain of 57.3 (28.0, 91.4) life-years.
Conclusions: Cost-effectiveness analysis using economic modeling indicates that substituting the use of tandem MS for existing technologies for the screening of PKU alone is not economically justified. However, the addition of screening for MCAD deficiency as part of a neonatal screening program for PKU using tandem MS would be economically attractive.
Genetic screening by DNA technology: A systematic review of health economic evidence
- Wolf Rogowski
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 327-337
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Objectives: The Human Genome Project has led to a multitude of new potential screening targets on the level of human DNA. The aim of this systematic review is to critically summarize the evidence from health economic evaluations of genetic screening in the literature.
Methods: Based on an extensive explorative search, an appropriate algorithm for a systematic database search was developed. Twenty-one health economic evaluations were identified and appraised using published quality criteria.
Results: Genetic screening for eight conditions has been found to be investigated by health economic evaluation: hereditary breast and ovarian cancer, familial adenomatous polyposis (FAP) colorectal cancer, hereditary nonpolyposis colorectal carcinoma (HNPCC), retinoblastoma, familial hypercholesterolemia, hereditary hemochromatosis, insulin-dependent diabetes mellitus, and cystic fibrosis. Results range from dominated to cost-saving. Population-wide genetic screening may be considered cost-effective with limited quality of evidence only for three conditions. The methodology of the studies was of varying quality. Cost-effectiveness was primarily influenced by mutation prevalence, genetic test costs, mortality risk, effectiveness of treatment, age at screening, and discount rate.
Conclusions: Health economic evidence on genetic screening is limited: Only few conditions have properly been evaluated. Based on the existing evidence, healthcare decision makers should consider the introduction of selective genetic screening for FAP and HNPCC. As genetic test costs are declining, the existing evaluations may warrant updating. Especially in the case of hereditary hemochromatosis, genetic population screening may be about to turn from a dominated to a cost-effective or even cost-saving intervention.
The economics of blood: Gift of life or a commodity?
- Panos Kanavos, John Yfantopoulos, Christina Vandoros, Costantina Politis
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 338-343
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Objectives: To calculate the costs of blood collection, testing, storage, and transfusion in Greece.
Methods: Costing information was collected from two large public hospitals, in Athens and Crete, that also act as blood banks. Given that private health care accounts for 40 percent of total health spending, the same costs were also considered in a private setting by collecting key reagent cost data from a leading private hospital in Athens. Mainly direct costs were considered (advertising campaigns, personnel, storage and maintenance, reagent costs, transportation costs from blood bank to end-use hospitals, and cross-matching and transfusion costs in receiving hospitals) and some indirect costs (opportunity cost of blood donorship).
Results: Captive donorship accounts for over 50 percent of the national blood supply. A unit of blood transfused would cost between €294.83 and €339.83 in public hospitals and could reach €413.93 in a private facility. This figure may be an underestimate, as it excludes opportunity costs of blood transfusion for patients and the healthcare system.
Conclusions: Blood has a significant cost to the health system. Policy makers and practitioners should encourage its rational use, build on current policies to further improve collection and distribution, encourage further volunteer donorship in Greece, and also consider alternatives to blood where the possibility exists.
Women's preferences for cervical cancer screening: A study using a discrete choice experiment
- Sarah Wordsworth, Mandy Ryan, Diane Skåtun, Norman Waugh
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 344-350
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Objectives: Recent policy recommendations for cervical screening include liquid-based cytology. This new approach could improve laboratory throughput, reducing the waiting time for test results. New guidelines also standardize the interval for screening, with women aged 25–50 offered screening every 3 years and women aged 50–64 every 5 years. Quantitative evidence on the preferences of women for alternative screening programs is limited; this study, therefore, elicits such preferences.
Methods: A postal questionnaire using a discrete choice experiment was mailed to 2,000 women in the Tayside Health Board region of Scotland.
Results: A response rate of 44 percent from those women who had previously had a smear was achieved. Women had a significant positive preference for reductions in recall rates and waiting time for results. Women preferred more frequent screening, particularly those aged 50+. Expected reductions in the chance of recall from the conventional Pap smear to the new liquid-based cytology were associated with a willingness to pay of £41. Women aged 50+ would be willing to pay £42 to increase the frequency of screening from every 5 to every 3 years. Service characteristics did not influence screening participation.
Conclusions: Guidance to move to liquid-based cytology will meet women's preferences for fewer repeat cervical smears and should reduce waiting time for results. However, proposals to increase screening intervals for those aged 50+ are inconsistent with the preferences for this age group. From a policy perspective, our study results suggest that the changes in attributes of the service such as unsatisfactory smear rates and frequency of screening, will improve service efficiency without affecting participation rates.
Decision makers' and scientists' opinion about contingent valuation and choice experiments for measuring willingness to pay in health care: Results from a survey in Germany
- Oliver H. Günther, Hans-Helmut König
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 351-361
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Objectives: Assessment of willingness to pay (WTP) by contingent valuation (CV) and choice experiments (CE) is increasingly performed in economic evaluation of health care. However, the question of whether the methods for measuring WTP are acceptable to decision makers and scientists has remained largely unacknowledged. The aim of this study was to learn more about decision makers' and scientists' opinion concerning these methods.
Methods: An expert group developed a questionnaire consisting of key items that may influence the opinion about CV and CE according to the constructs “attitude toward behavior,” “subjective norm,” and “behavioral intention” as defined by the Theory of Reasoned Action by Ajzen and Fishbein. In a survey, seventy-seven decision makers representing key institutions in the German healthcare system and forty-two scientists in health economics completed the questionnaire.
Results: Scientists and decision makers in particular did not show a high intention to use methods for measuring WTP. Skepticism regarding precision of the methods and subjects' capability to imagine paying an amount of money for a certain health commodity were stated along with the assertion that the hypothetical decision-making scenario was rather a distant reality. Nevertheless, the majority of scientists and decision makers did not state rejection of the methods.
Conclusions: Increasing the probability of using methods for measuring WTP in health care, the hypothetical scenarios should be made more realistic and payment vehicles should be used to help patients relate payment to a real health benefit. Moreover, an intensive discussion on the potential usefulness of CV/CE without excluding ethical concerns in comparison to existing alternatives has to be resumed.
Economic evaluation of empirical antisecretory therapy versus Helicobacter pylori for management of dyspepsia: A randomized trial in primary care
- Dorte Ejg Jarbol, Mickael Bech, Jakob Kragstrup, Troels Havelund, Ove B. Schaffalitzky de Muckadell
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- 09 August 2006, pp. 362-371
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Objectives: An economic evaluation was performed of empirical antisecretory therapy versus test for Helicobacter pylori in the management of dyspepsia patients presenting in primary care.
Methods: A randomized trial in 106 general practices in the County of Funen, Denmark, was designed to include prospective collection of clinical outcome measures and resource utilization data. Dyspepsia patients (n=722) presenting in general practice with more than 2 weeks of epigastric pain or discomfort were managed according to one of three initial management strategies: (i) empirical antisecretory therapy, (ii) testing for Helicobacter pylori, or (iii) empirical antisecretory therapy, followed by Helicobacter pylori testing if symptoms improved. Cost-effectiveness and incremental cost-effectiveness ratios of the strategies were determined.
Results: The mean proportion of days without dyspeptic symptoms during the 1-year follow-up was 0.59 in the group treated with empirical antisecretory therapy, 0.57 in the H. pylori test-and-eradicate group, and 0.53 in the combination group. After 1 year, 23 percent, 26 percent, and 22 percent, respectively, were symptom-free. Applying the proportion of days without dyspeptic symptoms, the cost-effectiveness for empirical treatment, H. pylori test and the combination were 12,131 Danish kroner (DKK), 9,576 DKK, and 7,301 DKK, respectively. The incremental cost-effectiveness going from the combination strategy to empirical antisecretory treatment or H. pylori test alone was 54,783 DKK and 39,700 DKK per additional proportion of days without dyspeptic symptoms.
Conclusions: Empirical antisecretory therapy confers a small insignificant benefit but costs more than strategies based on test for H. pylori and is probably not a cost-effective strategy for the management of dyspepsia in primary care.
Measuring quality of life: The development and initial validation of the Patient-Reported Erectile Function Assessment instrument
- George W. Torrance, Margaret-Anne Keresteci, Richard Casey, Nancy C. Ryan, Jean-Eric Tarride
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- 09 August 2006, pp. 372-378
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Objectives: Erectile dysfunction (ED) is a complex condition, which is variously influenced by physical, emotional, societal, and relationship factors. ED has serious implications for the quality of life (QoL) enjoyed by an affected male and his partner. It is very important, therefore, to understand the impact of ED on the QoL of those affected by it. Our objective was to determine if the eight-question Patient Reported Erectile Function Assessment (PREFA) could act as an independent, comprehensive disease-specific instrument in the assessment of QoL as it is impacted by ED.
Methods: During the development and validation of the Erectile Function–Visual Analog Scale (EF-VAS) (14), a new ED-specific preference-based instrument, a series of questions were included at the beginning of the assessment that would act as a way to encourage respondents to focus on their own experience with ED. Upon analysis of the EF-VAS data, it became apparent that the eight-question “warm up” section might act as a stand-alone assessment. Accordingly, the eight questions were named PREFA, and a validation analysis was undertaken to determine their consistency, feasibility, reliability, validity, and responsiveness.
Results: The PREFA questionnaire was found to be feasible and simple to complete, reliable, and valid, with excellent responsiveness. Overall, the PREFA has demonstrated that it can perform as a stand alone, validated assessment of the impact of ED on QoL, assessing areas of QoL not previously captured in existing instruments.
Conclusions: The PREFA is suitable for use in clinical and research settings as a disease-specific QoL assessment tool.
Priority setting for research in health care: An application of value of information analysis to glycoprotein IIb/IIIa antagonists in non-ST elevation acute coronary syndrome
- Zoë Philips, Karl Philip Claxton, Stephen Palmer, Laura Bojke, Mark John Sculpher
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- 09 August 2006, pp. 379-387
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Abstract: The purpose of this study is to explain the rationale for the value of information approach to priority setting for research and to describe the methods intuitively for those familiar with basic decision analytical modeling. A policy-relevant case study is used to show the feasibility of the method and to illustrate the type of output that is generated and how these might be used to frame research recommendations. The case study relates to the use of glycoprotein IIb/IIIa antagonists for the treatment of patients with non-ST elevation acute coronary syndrome. This is an area that recently has been appraised by the National Institute for Health and Clinical Excellence.
RESEARCH REPORTS
Health economic evaluation in Greece
- Dimitrios Rovithis
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- 09 August 2006, pp. 388-395
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Objectives: There is a growing volume of literature on health economic evaluation, with this form of analysis becoming increasingly influential at the decision-making level worldwide. The purpose of this study was to review the current state of health economic evaluation in Greece, with a view to uncovering reasons why its use in this country is limited.
Methods: A search of the NHS Economic Evaluation Database was undertaken. The search included cost, cost-of-illness, cost-minimization, cost-effectiveness, cost-consequences, cost-utility, and cost-benefit analyses and was narrowed only to Greek authors undertaking solo or joint health economic evaluation in Greece.
Results: The search revealed that, in Greece, very little health economic evaluation has been undertaken. The main reason for the lack of interest is that the current chaotic healthcare system structure and financing does not provide the appropriate incentives to stimulate a powerful interest in this type of research. This condition is a result of the lack of a long-term national health policy and the hesitation of the present and past Greek governments to date to proceed to large-scale reforms because of political considerations. The Greek governments have also been content with the good health indicators being achieved.
Conclusions: Even if it is accepted that good health prevails in Greece, slower economic growth rates, an ageing population, and the continuous immigration will place increasing pressure on healthcare resources and will necessitate a more rational use of these resources. Health economic evaluation, by weighing benefits against costs, therefore, has an important role to play.
Cost-effectiveness analysis of strategies for HER2 testing of breast cancer patients in France
- Magali Morelle, Elodie Haslé, Isabelle Treilleux, Jean-Philippe Michot, Thomas Bachelot, Frédérique Penault-Llorca, Marie-Odile Carrère
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- Published online by Cambridge University Press:
- 09 August 2006, pp. 396-401
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Objectives: A cost-effectiveness analysis was conducted comparing diagnostic strategies for determining the HER2 status of invasive breast carcinomas, as an indication for trastuzumab at metastatic relapse.
Methods: A decision tree compared five strategies distinguished by (i) the use of immunohistochemical (IHC) and/or fluorescent in situ hybridization (FISH) techniques, and (ii) the test schedule (at initial diagnosis or metastatic relapse). Most cost and effectiveness data came from a French multicentric study of 2,045 patients from eight hospitals. We were not able to select final criteria for trastuzumab effectiveness, because published data rely on IHC techniques not used in France (i.e., HercepTest). We, therefore, selected two intermediate criteria for inappropriate treatment at relapse, that is, patients with HER2-amplified tumors not receiving trastuzumab (Criterion 1) and HER2-nonamplified tumors improperly treated with trastuzumab (Criterion 2). Sensitivity analyses were then performed to assess the robustness of the results to (i) discount rate, (ii) cost of FISH, and (iii) tissue fixation technique.
Results: The strategy using IHC at diagnosis was dominated by the four other strategies. Among these approaches, the only efficient strategy for both criteria was IHC used alone at metastatic relapse; strategies using FISH, or IHC followed by FISH on IHC2+ cases were efficient for Criterion 1, whereas IHC followed by FISH on IHC2+ and 3+ cases was efficient for Criterion 2.
Conclusions: Determining HER2 status at diagnosis, as an indication for trastuzumab at metastatic relapse, incurs substantial incremental costs, which do not appear to be justified. No other strategy can be excluded at first.