The lag between effectiveness and cost-effectiveness evidence of new drugs

A new drug is approved for use if its efficacy and safety have been demonstrated. However, healthcare decision makers may also require data on the cost-effectiveness of new drugs if they are to make informed decisions about their place in therapy. Cost-effectiveness evidence may lag behind the effectiveness data in terms of its availability. We explored the timeliness of delivering cost-effectiveness information about new drugs with established effectiveness and significant financial impact. Drugs were identified, based on guidance documents and reports published by the UK National Institute for Clinical Excellence (NICE), and the following data were collected: dates of publication of first effectiveness and cost-effectiveness evidence, methodology of the cost-effectiveness analysis, quality scores of the clinical studies. Eighteen guidance documents on the use of new drugs/drug groups published by NICE by October 2001 covered 30 health technologies, which were included in the analysis. The analysis of the evidence showed that their effectiveness had been demonstrated in the last 12 years, with only two exceptions. However, cost-effectiveness evidence had been published for 21 (70%) of the technologies. The cost-effectiveness was estimated in 52.4% of cases using models. The good quality effectiveness evidence lagged behind the first effectiveness evidence by 1.40 years (95% CI 0.57–2.23), while the mean lag between the first effectiveness evidence and the first cost-effectiveness publications was estimated as 3.20 years (95% CI 1.76–4.65). Cost-effectiveness evidence thus often lags behind the effectiveness evidence. As a result healthcare decision makers are sometimes in a position of having to take decisions without having adequate cost-effectiveness data at their disposal.     

Germany’s decision rule for setting ceiling prices of drugs

In Germany, the Institute for Quality and Efficiency in Health Care (IQWiG) makes recommendations for ceiling prices of drugs based on an evaluation of the relationship between costs and effectiveness. To set ceiling prices, IQWiG uses the following decision rule: the incremental cost-effectiveness ratio (ICER) of a new drug compared with the next effective intervention should not be higher than that of the next effective intervention compared with its comparator. The purpose of this article is to analyse ethical implications of IQWiG's rule and compare them with those of two alternative decision rules, one that is based on an absolute cost-effectiveness threshold and one that falls in between. To this end, constrained optimization problems are defined that yield each decision rule. This article shows that IQWiG's rule accounts for severity of disease and past resource consumption. Potential problems and pitfalls are discussed.     

Comparative cost-minimisation of oral and intravenous chemotherapy for first-line treatment of non-small cell lung cancer in the UK NHS system

The National Institute for Health and Clinical Excellence recommends vinorelbine (VNB), paclitaxel, docetaxel, and gemcitabine in the treatment of non-small cell lung cancer. An economic model was prepared to determine the comparative cost of these agents, including the new oral formulation of VNB from a United Kingdom National Health System perspective. Clinical effectiveness was determined from published trials. Costs of drug acquisition, administration, toxicity management, and patient transportation costs were calculated from reference publications. A Markov model was used to estimate the cost per patient over 52 weeks. Intravenous VNB, gemcitabine, paclitaxel, and docetaxel incur annual follow-up costs of ￡3,746, ￡5,332, ￡5,977, and ￡6,766, respectively, while oral VNB with outpatient administration on d1, and self-administration at home on d8 every 21 days has a cost per patient per year of ￡2,888. Oral VNB allows further hospital resources savings.     

Bayesian cost-effectiveness analysis with two measures of effectiveness: the cost-effectiveness acceptability plane

Cost-effectiveness analysis (CEA) compares the costs and outcomes of two or more technologies. However, there is no consensus about which measure of effectiveness should be used in each analysis. Clinical researchers have to select an appropriate outcome for their purpose, and this choice can have dramatic consequences on the conclusions of their analysis. In this paper we present a Bayesian cost-effectiveness framework to carry out CEA when more than one measure is considered. In particular, we analyse the case in which two measures of effectiveness, one binary and the other continuous, are considered. Decision-making measures, such as the incremental cost-effectiveness ratio, incremental net-benefit and cost-effectiveness acceptability curves, are used to compare costs and one measure of outcome. We propose an extension of cost-acceptability curves, namely the cost-effectiveness acceptability plane, as a suitable measure for decision taking. The models were validated using data from two clinical trials. In the first one, we compared four highly active antiretroviral treatments applied to asymptomatic HIV patients. As measures of effectiveness, we considered the percentage of patients with undetectable levels of viral load, and changes in quality of life, measured according to EuroQol. In the second clinical trial we compared three methadone maintenance programmes for opioid-addicted patients. In this case, the measures of effectiveness considered were quality of life, according to the Nottingham Health Profile, and adherence to the treatment, measured as the percentage of patients who participated in the whole treatment programme.     

Informing the efficient use of health care and health care research resources - the case of screening for abdominal aortic aneurysm in Sweden

BACKGROUND: An analytical framework using Bayesian decision theory and value-of-information analysis has recently been advocated for the economic evaluation of health technologies. The purpose of this study was to apply this framework to screening for abdominal aortic aneurysm (AAA) in Sweden and to compare the conclusions from this study with the conclusions presented in an assessment performed by the Swedish Council of Technology Assessment (SBU). METHODS: A probabilistic decision-analytical model was developed to establish the cost-effectiveness of a screening programme for AAA relative to current clinical practice and to calculate the value-of-information. RESULTS: The cost per quality-adjusted life-year for screening was 9700 euro. The expected value of perfect information for the assessment of overall cost-effectiveness was low, suggesting little benefit in conducting further research. Expected value of perfect partial information indicated that rupture probabilities were associated with the highest uncertainty. By contrast, the SBU report concluded there was limited evidence of cost-effectiveness and proposed further research. CONCLUSION: The investigated screening programme for AAA is likely to be cost-effective and conducting another clinical trial is unlikely to add much valuable information to this decision problem. These recommendations contrast with the vaguer recommendations from SBU that more evidence is required of costs-effectiveness.     

Trabectedin for the treatment of relapsed ovarian cancer

The paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of trabectedin for the treatment of relapsed platinum-sensitive ovarian cancer, based upon a review of the manufacturer's submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submission addressed only part of the decision problem and did not provide evidence to compare trabectedin (Yondelis?, PharmaMar) and pegylated liposomal doxorubicin hydrochloride (PLDH) (Caelyx?, Schering-Plough) with key comparators. The submission's direct comparison evidence came from one reasonable-quality randomised controlled trial (RCT) of trabectedin and PLDH versus PLDH alone (ET743-OVA-301). The results of the RCT were subdivided into the entire platinum-sensitive population (> 6-month relapse after initial platinum-based chemotherapy) and partially platinum-sensitive (≥ 6- to 12-month relapse) and fully platinum-sensitive (> 12-month relapse) populations. The outcomes included were overall survival, progression-free survival measured by three types of assessor, response rates, adverse effects of treatment, health-related quality of life and cost per quality-adjusted-life-year (QALY) gained. A mixed treatment comparison (MTC) meta-analysis comparing trabectedin and PLDH with single-agent PLDH within the entire platinum-sensitive population, with paclitaxel or with topotecan also formed part of the submission. The RCT data showed that trabectedin plus PLDH compared with PLDH monotherapy had a significant effect on overall survival only within the partially platinum-sensitive subgroup. PFS results reported by the independent radiologists showed significant effects in favour of the trabectedin and PLDH arm for the entire and partially platinum-sensitive populations only. Rates of grade 3 and 4 adverse events were mostly higher in the trabectedin and PLDH arm than in the PLDH alone arm. There were several issues regarding the undertaking of the MTC, and thus the data were not considered robust. Furthermore, the ERG did not believe the MTC to be necessary to answer the decision problem. The manufacturer submitted a de novo cost-effectiveness model. The main analysis compared trabectedin in combination with PLDH versus paclitaxel, topotecan and PLDH (each as monotherapy) in the entire platinum-sensitive population, using results estimated from the MTC. Additional analyses were presented comparing trabectedin in combination with PLDH versus PLDH monotherapy using direct evidence from the OVA-301 trial for the fully, partially and entire platinum-sensitive populations. The cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was estimated to be ￡ 70,076 in the main analysis. In the additional analyses, the cost per QALY gained for trabectedin in combination with PLDH versus PLDH monotherapy was ￡ 94,832, ￡ 43,996 and ￡ 31,092 for the entire, partially and fully platinum-sensitive populations, respectively. Additional work was undertaken by the ERG using patient-level data and amending some assumptions to provide a better statistical fit to the Kaplan-Meier data than the exponential distribution assumed by the manufacturer. The ERG base-case estimate of the cost per QALY of trabectedin in combination with PLDH ranged from ￡46,503 to ￡54,607 in the partially platinum-sensitive population. At the time of writing, trabectedin in combination with PLDH for the treatment of women with relapsed platinum-sensitive ovarian cancer is not recommended by NICE in the final appraisal determination.     

Bevacizumab in combination with a taxane for the first-line treatment of HER2-negative metastatic breast cancer

This paper presents a summary of the evidence review group (ERG) report into the use of bevacizumab (Avastin?, Roche) in combination with a taxane for the treatment of untreated metastatic breast cancer (mBC). The main clinical effectiveness data were derived from a single, open-label randomised controlled trial (RCT) (E2100) that evaluated the addition of bevacizumab to weekly (q.w.) paclitaxel in patients with human epidermal growth factor receptor 2-negative mBC who had not previously received chemotherapy for advanced disease. This trial reported statistically significant increases in median progression-free survival (PFS) for the addition of bevacizumab (5.8-11.3 months). Median overall survival was not significantly different between the two groups; whether this is a true null finding or due to crossover between treatment arms cannot be established, as relevant data were not collected. The manufacturer reported that the addition of bevacizumab to paclitaxel q.w. therapy was associated with a significant improvement in quality of life, as measured by FACT-B (functional assessment of cancer therapy for breast cancer) scores. However, the ERG noted that these results were based on extreme imputed values, the removal of which led to non-significant differences in quality of life. The manufacturer conducted an indirect comparison. However, owing to methodological limitations and concerns about the validity and exchangeability of the included trials, the ERG did not consider the findings to be reliable. One additional relevant RCT [AVADO (Avastin and Docetaxel); BO17708] evaluating the addition of bevacizumab to docetaxel was excluded from the manufacturer's submission. This was summarised by the ERG. In terms of response rate and PFS, AVADO reported a markedly smaller benefit of adding bevacizumab to docetaxel than that reported for adding bevacizumab to q.w. paclitaxel in E2100. AVADO also reported no statistically significant effect of combination therapy versus docetaxel in terms of overall survival. The manufacturer developed a de novo economic model that considered patients with the same baseline characteristics as women in the E2100 trial. The model assessed BEV + PAC - bevacizumab 10 mg/kg every 2 weeks in combination with paclitaxel 90 mg/m2 weekly for 3 weeks followed by 1 week of rest; PAC q.w. - paclitaxel (monotherapy) 90 mg/m2 weekly for 3 weeks followed by 1 week of rest; DOC - docetaxel (monotherapy) 75 mg/m2 on day 1 every 21 days (considered current UK NHS clinical practice in the submission); and GEM + PAC - gemcitabine 1250 mg/m2 on days 1 and 8 plus paclitaxel 175 mg/m2 on day 1 every 21 days. Pairwise comparisons were made between BEV + PAC and PAC (using the E2100 trial), BEV + PAC and DOC, and BEV + PAC and GEM + PAC. Based on NHS list prices, the manufacturer's model estimated incremental cost-effectiveness ratios (ICERs) for BEV + PAC of ￡ 117,803, ￡ 115,059 and ￡ 105,777 per QALY gained, relative to PAC, DOC and GEM + PAC regimens, respectively. If the NHS Purchasing and Supply Agency prices for PAC with a 10-g cap on the cost per patient of BEV were used instead, the ICERs for BEV + PAC were estimated at ￡ 77,314, ￡ 57,753 and ￡ 60,101 per QALY, respectively. The submission suggested that the regimen of BEV + DOC is not cost-effective because it is considered less effective and more costly than BEV + PAC. Analysis by the ERG suggested that alternative assumptions can increase the ICERs further and, based on current prices, no plausible changes to the model assumptions will bring the ICERs for BEV + PAC lower.     

Evaluation of the National Institute for Health and Care Excellence Diagnostics Assessment Program Decisions: Incremental Cost-Effectiveness Ratio Thresholds and Decision-Modifying Factors

ObjectivesThe National Institute for Health and Care Excellence (NICE) Diagnostics Assessment Programme (DAP) evaluates the cost-effectiveness of diagnostic technologies. A decision-making process benchmarking the incremental cost-effectiveness ratio (ICER) against a threshold while considering decision-modifying factors is common to NICE evaluations. This study investigated whether DAP decisions are consistent with the ICER thresholds described in the DAP manual, and to assess the impact of decision-modifying factors.MethodsDAP evaluations published before March 2018 were reviewed, and the following items were extracted: diagnostic technologies evaluated, decision problems assessed, Diagnostics Advisory Committee (DAC) decisions, incremental quality-adjusted life years (QALYs), incremental costs, ICERs considered to be most plausible by the DAC, and decision justifications.ResultsAll 30 evaluations were reviewed; 8 were excluded because the DAC concluded there was “insufficient evidence” for decision making. In the remaining 22 evaluations, 91 decision problems were identified for further analysis, of which 52, 15, and 24 received “recommended,” “not recommended,” and “not recommended–only in research” guidance, respectively. The overall consistency rate of the DAC decisions with the £20 000/QALY threshold was 73.6%. Diagnostic technologies that were not recommended, despite an ICER less than £20 000/QALY, were associated with a larger number of decision-modifying factors favoring the comparator, versus recommended diagnostic technologies with ICERs less than £20 000/QALY. For technologies with ICERs greater than £20 000/QALY, the number of decision-modifying factors was comparable for positive and negative recommendations.ConclusionsMost DAP decisions were consistent with the ICER threshold. However, cost-effectiveness was not the only determining factor in decision making; recommendations also considered patient- and healthcare-centric factors and uncertainty.     

How should cost-effectiveness analysis be used in health technology coverage decisions? Evidence from the National Institute for Health and Clinical Excellence approach

BACKGROUND: In the National Health Service in England and Wales, technology coverage decisions are taken by the National Institute for Health and Clinical Excellence (NICE). The intention formally to apply cost-effectiveness analysis to the decision-making process distinguishes NICE from most other bodies making similar policy recommendations. We carried out a case study of the NICE Appraisals Committee to explore the influence and use of economic evaluation in the decision-making process. METHODS: Qualitative case study methodology. This involved analysis of all relevant secondary sources, observations of Appraisals Committee deliberations and interviews with a cross-section of Committee members. FINDINGS: Economic evaluation is integrated into the Committee's work. There are two main ways in which the use of economic analysis is understood by Committee members: an ordinal approach, whereby cost-effectiveness is only considered if the technology has passed a clinical effectiveness hurdle; and a framework approach, whereby the economic evaluation and model provide a structure for considering the decision problem and the evidence. These two approaches appear to operate simultaneously but are, in essence, inconsistent. CONCLUSIONS: The NICE 'experiment' has seen cost-effectiveness analysis move to the centre-ground of UK national policy deliberations regarding technology coverage. However, our case study implies that there may be room for further refinement of the appraisal process in order to resolve the observed tension between two different ways of incorporating cost-effectiveness analysis in NICE's decision-making.     

Adjuvant chemotherapy with taxoid-containing drugs in breast cancer: soon to be expected in the Netherlands

Taxanes such as paclitaxel and docetaxel are effective cytostatic agents in metastatic breast cancer. Until now, six randomised studies with taxanes as a component of adjuvant chemotherapy for non-metastasised mammary carcinoma have been reported: four with paclitaxel and two with docetaxel. The results were more favourable in the patients treated with paclitaxel than in the controls: the absolute difference in 5-year disease-free survival was 4-5% (to be added to the 65-72% following the standard treatment) and that in total 5-year survival was 0-3% (to be added to the 77-85% following the standard treatment). The benefits of the administration of paclitaxel were not accompanied by serious myelotoxicity. Treatment with docetaxel also resulted in more patients with disease-free 5-year survival (68 vs. 75%) and total 5-year survival (81 vs. 87%). The advantage of the combination with docetaxel was most pronounced in patients with 1-3 positive nodes and those with HER 2 overexpression in their tumour. Febrile neutropenia was more common in de docetaxel group but there was no increased mortality due to toxicity. In the near future, it is expected that taxanes will play an important role in the adjuvant chemotherapy of breast cancer.     

What Is the Evidence from Past National Institute of Health and Care Excellence Single-Technology Appraisals Regarding Company Submissions with Base-Case Incremental Cost-Effectiveness Ratios of Less Than £10,000/QALY?

Background

The National Institute for Health and Care Excellence has recently proposed that company submissions with a base-case incremental cost-effectiveness ratio (ICER) of less than £10,000/quality-adjusted life-year (QALY) might be eligible for a “fast-track” appraisal.

Searching for and use of conference abstracts in health technology assessments: policy and practice

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.     

Cost-effectiveness analysis and formulary decision making in England: findings from research

In a context of rapid technological advances in health care and increasing demand for expensive treatments, local formulary committees are key players in the management of scarce resources. However, little is known about the information and processes used when making decisions on the inclusion of new treatments. This paper reports research on the use of economic evaluations in technology coverage decisions in England, although the findings have a relevance to other health care systems with devolved responsibility for resource allocation. It reports a study of four local formulary committees in which both qualitative and quantitative data were collected. Our main research finding is that it is an exception for cost-effectiveness analysis to inform technology coverage decisions. Barriers to use include access and expertise levels, concerns relating to the independence of analyses and problems with implementation of study recommendations. Further barriers derive from the constraints on decision makers, a lack of clarity over functions and aims of local committees, and the challenge of disinvestment in medical technologies. The relative weakness of the research-practice dynamics in this context suggests the need for a rethinking of the role of both analysts and decision makers. Our research supports the view that in order to be useful, analysis needs to better reflect the constraints of the local decision-making environment. We also recommend that local decision-making committees and bodies in the National Health Service more clearly identify the 'problems' which they are charged with solving and how their outputs contribute to broader finance and commissioning functions. This would help to establish the ways in which the routine use of cost-effectiveness analysis might become a reality.     

Pre-assessment to assess the match between cost-effectiveness results and decision makers' information needs: an illustration using two cases in rehabilitation medicine in The Netherlands

OBJECTIVE: To determine if a pre-assessment can be used to establish whether cost-effectiveness results would meet the actual information needs of Dutch healthcare decision makers. METHODS: Two recent studies in rehabilitation medicine served as study material. Based on Wholey, a limited pre-assessment was performed in which the potential impact of cost-effectiveness analysis (CEA) results on intended users' decision making was assessed. Desk research and semi-structured interviews with several intended users of CEA results were performed. These included general practitioners, representatives of health insurance companies, the Health Care Insurance Board (CvZ), and medical guidelines committees. RESULTS: In day-to-day decision making of the interviewed decision makers, a cost-effectiveness criterion seemed to be of limited importance. Instead, results from clinical effectiveness studies and budget impact studies appeared to be sufficient. CvZ, however, preferred relative cost-effectiveness to be a criterion for inclusion in future reimbursement guidelines. In both cases the limited pre-assessments changed the expectations of the investigators regarding decision-making impact of an economic evaluation. CONCLUSION: This study revealed that the use of CEA results for Dutch micro- and meso-level healthcare decision making is not self-evident. The main purpose of CEA results is to support health policy making and planning at a macroeconomic level. Pre-assessment can be a valuable tool in designing a CEA to support the actual information needs of the decision makers.     

Introduction of emerging medical devices on the market: a new procedure in Belgium

When new medical technologies enter the market, there is often uncertainty about the added value for the patient and for society, hampering well-considered decision making about reimbursement. Current Belgian legislation already offered opportunities for the managed uptake of possibly innovative emerging implants. However, it has also some shortcomings such as the lack of a clear research design, rendering the scientific evaluation of clinical effectiveness, cost-effectiveness, and patient or organizational issues more difficult. Against this background, a new procedure was elaborated by the Belgian health insurance institute and the Belgian Health Care Knowledge Centre.     

10 Years of End-of-Life Criteria in the United Kingdom

ObjectivesIn January 2009, the National Institute for Health and Care Excellence introduced supplementary guidance for end-of-life (EoL) treatments, which allowed treatments with an incremental cost-effectiveness ratio over the regular threshold (£20 000-£30 000) to be recommended, if they satisfied the EoL criteria. The aims of this study were (1) to systematically review 10 years of EoL supplementary guidance implementation and explore how it could be improved, and (2) to create a framework for incorporating the uncertainty relating to EoL criteria satisfaction into model-based cost-effectiveness analyses for decision making.MethodsAll appraisals between January 2009 and 2019 were screened for EoL discussions. Data were extracted on the EoL criteria and cost-effectiveness assessment details. Additionally, a quantitative method was developed to include the EoL criteria satisfaction uncertainty into model-based cost-effectiveness analyses. A stylized example was created to provide a case study for the inclusion of EoL criteria satisfaction uncertainty.ResultsAn EoL discussion was identified in 35% of appraisals, 57% of which led to a positive EoL decision. Only 5.7% of technologies with positive EoL decisions were not recommended, versus 43.8% of technologies with negative EoL decisions. EoL criteria assessment was often reported insufficiently and evaluated inconsistently and nontransparently. A total of 54.9% of EoL decisions were made while at least 1 criterion was surrounded by considerable uncertainty. By applying the proposed quantitative method, this EoL criteria satisfaction uncertainty was accounted for in decision making. The stylized example demonstrated that the impact of EoL criteria satisfaction uncertainty can be substantial enough to reverse the reimbursement decision.ConclusionsTo improve consistency/transparency and correct reimbursement decisions’ likelihood, new guidelines on the implementation of the EoL criteria are needed.     

Reported Challenges in Health Technology Assessment of Complex Health Technologies

ObjectivesWith complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies.MethodsA survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination.ResultsA total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%).ConclusionsMost challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.     

Cost-effectiveness league tables: think of the fans

In a recent issue of Health Policy, Birch and Gafni argued against the use of cost-effectiveness league tables in health care decision making. They argued that league tables should be returned to where they are best used and understood--the sports pages. Recently the debate about the presentation and interpretation of cost-effectiveness data has been given an additional impetus in the UK through the publication, by the Department of Health, of the Register of Cost-Effectiveness Studies (RCES). During the production of the RCES, it became apparent that there were similarities between the decision makers' thirst for economic data and the sports fans' thirst for information about their team. In this paper we review the pros and cons of using published cost-effectiveness data in decision making, compared with the local team approach suggested by Birch and Gafni. We conclude that there are advantages from using published data, providing these are produced according to standardized methods and interpreted intelligently. Most importantly, cost-effectiveness data, whether published or generated locally, are unlikely to give decision makers a technical solution to the resource allocation problem. Rather, they should be viewed as a stimulus for local discussion and debate.     

The value of implementation and the value of information: combined and uneven development

AIM: In a budget-constrained health care system, the decision to invest in strategies to improve the implementation of cost-effective technologies must be made alongside decisions regarding investment in the technologies themselves and investment in further research. This article presents a single, unified framework that simultaneously addresses the problem of allocating funds between these separate but linked activities. METHODS: The framework presents a simple 4-state world where both information and implementation can be either at the current level or "perfect.' Through this framework, it is possible to determine the maximum return to further research and an upper bound on the value of adopting implementation strategies. The framework is illustrated through case studies of health care technologies selected from those previously considered by the UK National Institute for Health and Clinical Excellence (NICE). RESULTS: Through the case studies, several key factors that influence the expected values of perfect information and perfect implementation are identified. These factors include the maximum acceptable cost-effectiveness ratio, the level of uncertainty surrounding the adoption decision, the expected net benefits associated with the technologies, the current level of implementation, and the size of the eligible population. CONCLUSIONS: Previous methods for valuing implementation strategies have not distinguished the value of efficacy research and the value of strategies to change the level of implementation. This framework demonstrates that the value of information and the value of implementation can be examined separately but simultaneously in a single framework. This can usefully inform policy decisions about investment in health care services, further research, and adopting implementation strategies that are likely to differ between technologies.     

Cost-effectiveness analysis and diet quality index applied to the WHO Global Strategy

OBJECTIVE: To test the use of cost-effectiveness analysis as a decision making tool in the production of meals for the inclusion of the recommendations published in the World Health Organization's Global Strategy. METHODS: Five alternative options for breakfast menu were assessed previously to their adoption in a food service at a university in the state of Sao Paulo, Southeastern Brazil, in 2006. Costs of the different options were based on market prices of food items (direct cost). Health benefits were estimated based on adaptation of the Diet Quality Index (DQI). Cost-effectiveness ratios were estimated by dividing benefits by costs and incremental cost-effectiveness ratios were estimated as cost differential per unit of additional benefit. The meal choice was based on health benefit units associated to direct production cost as well as incremental effectiveness per unit of differential cost. RESULTS: The analysis showed the most simple option with the addition of a fruit (DQI = 64 / cost = R$ 1.58) as the best alternative. Higher effectiveness was seen in the options with a fruit portion (DQI1=64 / DQI3=58 / DQI5=72) compared to the others (DQI2=48 / DQI4=58). CONCLUSIONS: The estimate of cost-effectiveness ratio allowed to identifying the best breakfast option based on cost-effectiveness analysis and Diet Quality Index. These instruments allow easy application easiness and objective evaluation which are key to the process of inclusion of public or private institutions under the Global Strategy directives.