During the 26th year of the International Journal of Technology Assessment in Health Care (IJTAHC), 154 original manuscripts were evaluated. Of these, 70 percent were from Europe and 14 percent from North America, as judged by the address of the first author. At the end of September 2010, sixty-four papers (42 percent of submissions) had been accepted for publication, seventy-two (47 percent) had been rejected, fourteen (9 percent) had been invited to submit a new version, and four (3 percent) were still in review.

Objectives: The aim of this study was to assess the test performance and clinical effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC) in people suspected of new or recurrent bladder cancer.

Methods: A systematic review was conducted of randomized controlled trials (RCTs), nonrandomized comparative studies, or diagnostic cross-sectional studies comparing PDD with WLC. Fifteen electronic databases and Web sites were searched (last searches April 2008). For clinical effectiveness, only RCTs were considered.

Results: Twenty-seven studies (2,949 participants) assessed test performance. PDD had higher sensitivity than WLC (92 percent, 95 percent confidence interval [CI], 80–100 percent versus 71 percent, 95 percent CI, 49–93 percent) but lower specificity (57 percent, 95 percent CI, 36–79 percent versus 72 percent, 95 percent CI, 47–96 percent). For detecting higher risk tumors, median range sensitivity of PDD (89 percent [6–100 percent]) was higher than WLC (56 percent [0–100 percent]) whereas for lower risk tumors it was broadly similar (92 percent [20–95 percent] versus 95 percent [8–100 percent]). Four RCTs (709 participants) using 5-aminolaevulinic acid (5-ALA) as the photosensitising agent reported clinical effectiveness. Using PDD at transurethral resection of bladder tumor (TURBT) resulted in fewer residual tumors at check cystoscopy (relative risk [RR], 0.37, 95 percent CI, 0.20–0.69) and longer recurrence-free survival (RR, 1.37, 95 percent CI, 1.18–1.59), compared with WLC.

Conclusions: PDD detects more bladder tumors than WLC, including more high-risk tumors. Based on four RCTs reporting clinical effectiveness, 5-aminolaevulinic acid–mediated PDD at TURBT facilitates a more complete resection and prolongs recurrence-free survival.

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

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

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

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

Background: Using multiples of India's per capita gross domestic product (GDP) as the threshold for economic value as suggested by the World Health Organization (WHO), decision analysis modeling was used to estimate a more affordable monthly cost in India for a hypothetical new cancer drug that provides a 3-month survival benefit to Indian patients with metastatic colorectal cancer (mCRC).

Methods: A decision model was developed to simulate progression-free and overall survival in mCRC patients receiving chemotherapy with and without the new drug. Costs for chemotherapy and side-effects management were obtained from both public and private hospitals in India. Utility estimates measured as quality-adjusted life-years (QALY) were determined by interviewing twenty-four oncology nurses using the Time Trade-Off technique. The monthly cost of the new drug was then estimated using a target threshold of US$9,300 per QALY gained, which is three times the Indian per capita GDP.

Results: The base-case analysis suggested that a price of US$98.00 per dose would be considered cost-effective from the Indian public healthcare perspective. If the drug were able to improve patient quality of life above the standard of care or survival from 3 to 6 months, the price per dose could increase to US$170 and US$253 and offer the same value.

Conclusions: The use of the WHO criteria for estimating the cost of a new drug based on economic value for a developing country like India is feasible and can be used to estimate a more affordable cost based on societal value thresholds.

Objectives: The aim of this study was to review international experiences of patient or public involvement in the field of health technology assessment (HTA).

Methods: A systematic review of the scientific literature was conducted. A literature search was performed across nine databases. Other literature was identified through citation tracking, government websites (HTA agencies), and Internet search engines. Characteristics of the studies, description of the activities related to patient or public involvement, impact of these activities on the HTA process, and factors facilitating or limiting involvement were abstracted independently by two reviewers.

Results: A total of 1,441 potentially relevant papers were identified by the main search strategy. Among these, seventeen papers met the inclusion criteria; other search strategies identified seven additional documents. The findings reveal that patient or public involvement in HTA activities was reported in two domains, research and HTA process. In the research domain, patients are consulted to gather evidence about their perspectives, experiences, or preferences about a health technology. These perspectives could add key dimensions to the evaluation of health technologies that might otherwise be overlooked. In the domain of the HTA process, patients or public representatives participate in different stages of this process: prioritization, evidence assessment, or dissemination of findings.

Conclusions: There are few published examples of experiences involving patients and the public in HTA. These examples show that patients' or the public's perspectives could add important dimensions to the evaluation of health technologies. However, there is a need to develop more systematic approaches to considering patients' and the public's perspectives in HTA.

Objectives: This study explores the factors that enhance or reduce the prospects for public involvement in the activities of health technology assessment (HTA) agencies.

Methods: The analytical framework for this study is based on the work of John W. Kingdon, which provides a comprehensive synthesis of the factors influencing governments and public organizations' agenda. The study draws insights from forty-two semistructured telephone interviews with informants involved in international HTA networks and/or in HTA agencies in Canada, Denmark, and the United Kingdom.

Results: This exploratory study suggests that the HTA community is moving toward greater public involvement. However, the HTA community remains cautious and ambivalent about the technical feasibility of public involvement, its acceptability to policy makers and practitioners, and its impacts on HTA agencies' resources and procedures.

Conclusions: The study stresses the importance of conducting rigorous and compelling evaluations to inform HTA agencies' decision to adopt, or reject, public involvement practices.

Objectives: The objective of this exploratory study was to survey international health technology assessment (HTA) professionals to determine attitudes toward ethics in HTA.

Methods: An exploratory, quantitative, cross-sectional study design was developed. The sample population (n = 636) was selected from authors of the 206 articles published in the International Journal of Technology Assessment in Health Care between 2005 and 2007. A survey instrument was piloted and e-mailed.

Results: The response rate was low (n = 104; 16.4 percent). Respondents were primarily middle-aged (46 ± 11 years) male (62 percent) health professionals from Western countries (n = 92; 88.5 percent), with a mean of 10 (± 6 years) years of HTA experience. Although at least 90 percent of respondents agreed that healthcare decisions involved value judgments and that ethical analysis was important to HTA, respondents were divided as to whether normative (n = 45; 44.6 percent) or descriptive (n = 38; 37.6 percent) ethical recommendations were necessary. Most respondents (n = 83; 81.4 percent) believed that HTA should include citizen participation, but two thirds (n = 67; 67.0 percent) agreed that the final decision should be restricted to decision makers. A majority of respondents thought that ethical analysis could be discussed anywhere within the HTA process, either by an expert trained in ethics (n = 62; 60.8 percent) or by an external consultant (n = 80; 78.4 percent).

Conclusions: This study showed that ethical discourse in HTA is constrained by practical considerations, which serves to limit moral inquiry. To increase ethical analysis, a positive attitude toward ethics needs to be fostered within the HTA community.

Objectives: The aim of this study was to analyze the motives, enablers, and barriers to promote or initiate health technology assessment (HTA) in different contexts.

Methods: An observational study design was used to address the above question that included a survey questionnaire and a two-phase study. The respondents for the questionnaire and first round of the study were from HTA agencies of high income countries and those low and middle income countries that have managed to establish HTA agencies (n = 50), that are members of International Network of Agencies for Health Technology Assessment (INAHTA), EuroScan, or European network for Health Technology Assessment (EUnetHTA). The second round of the study was exclusively with respondents from low and middle income countries that were manly affiliated to Health Technology Assessment International (HTAi) interest subgroup for low and middle income countries and aimed to initiate HTA activities (n = 34).

Results: Forty-one of fifty HTA agencies answered the survey questionnaire. Thirty-three of fifty individuals belonging to HTA agencies from high income countries and sixteen of thirty-four individuals from low and middle income countries answered in the first and second phases of the study, respectively. In the promotion and/or initiation of HTA, the top three motives were the same for both high income and low and middle income countries. The top three enablers were also similar but the prioritization varies. The top three barriers were more context specific.

Conclusions: HTA promotion or initiation is influenced by the following: (i) key players that affect the time taken to establish HTA agencies; (ii) three models for HTA promotion and initiation: top-down (political interest), bottom-up (academic/research interest), and converging (political and academic/research interests); and (iii) motives, enablers, and barriers at the local context.

Objectives: The aim of this study was to critically examine the current guidance for conducting ethics analysis in health technology assessment (HTA) and to offer recommendations for how to improve this practice.

Methods: MEDLINE, Philosopher's Index, and Google Scholar were searched for articles and reports using the keywords “ethics” and “health technology assessment” and related terms. Bibliographies of all relevant articles were also examined for additional references. A philosophical analysis of the existing guidance was conducted.

Results: We offer three recommendations for improving ethics analysis in HTA. First, ethical and legal issues must be clearly separated so that all policy-relevant questions that the technology raises can be considered clearly and systematically. Second, analysts must make better use of ethics theory and discuss better how particular theoretical approaches and associated analytic tools are selected to make transparent which alternative approaches were considered and why they were rejected. Third, the necessity for philosophical expertise to adequately conduct ethics analysis needs to be acknowledged.

Conclusions: To act on these recommendations for ethics analysis, we offer these three steps forward: acknowledge and use relevant expertise, further develop models for conducting and reporting ethics analyses, and make use of untapped resources in the literature.

Background: In many countries, the incremental cost-effectiveness ratio (ICER) is used to assess whether an intervention is worth its costs. At the same time, policy makers often feel uncomfortable with refusing reimbursement of any intervention purely on the basis of the fact that the ICER exceeds a specific threshold value. Reluctance to define a single threshold value for the ICER seems to have been stronger in social security systems than in national healthcare services systems. This study explores how basic differences between healthcare systems impact upon the potential usefulness of an ICER threshold value.

Methods: This study is a narrative review of literature about the theoretical foundations of the ICER threshold value approach and its practical relevance in different types of healthcare systems.

Results: A single ICER threshold value cannot be maintained, defined, or measured and should not be used as a policy-making tool. None of the solutions presented up until now to make the ICER threshold approach a valuable policy-making tool overcome the important weaknesses of the approach.

Conclusions: ICERs and ICER threshold values are insufficient for assessing interventions' value for money. Rather, they should be considered as one element in the decision-making process. Complete rationalization of the decision-making process by means of quantitative decision criteria is undesirable and not feasible. Increasing transparency in the criteria used for a decision and explicitness about the relative importance of each criterion should, therefore, be the major goal.

Background: To ensure rapid access to new potentially beneficial health technologies, obtain best value for money, and ensure affordability, healthcare payers are adopting a range of innovative reimbursement approaches that may be called Managed Entry Agreements (MEAs).

Methods: The Health Technology Assessment International (HTAi) Policy Forum sought to identify why MEAs might be used, issues associated with implementation and develop principles for their use. A 2-day deliberative workshop discussed key papers, members' experiences, and collectively addressed four policy questions that resulted in this study.

Results: MEAs are used to give access to new technologies where traditional reimbursement is deemed inappropriate. Three different forms of MEAs have been identified: management of budget impact, management of uncertainty relating to clinical and/or cost-effectiveness, and management of utilization to optimize performance. The rationale for using these approaches and their advantages and disadvantages differ. However, all forms of MEA should take the form of a formal written agreement among stakeholders, clearly identifying the rationale for the agreement, aspects to be assessed, methods of data collection and review, and the criteria for ending the agreement.

Conclusions: MEAs should only be used when HTA identifies issues or concerns about key outcomes and/or costs and/or organizational/budget impacts that are material to a reimbursement decision. They provide patient access and can be useful to manage technology diffusion and optimize use. However, they are administratively complex and may be difficult to negotiate and their effectiveness has yet to be evaluated.

Objectives: The primary objective of this study was to determine the extent to which international standards on transparency and quality are met by the health technology assessment (HTA) process in Poland. A secondary objective is to describe the outcomes of the HTA process and their associated factors.

Methods: All published online HTA appraisal and meeting proceedings on pharmaceutical products in 2008 were reviewed using a score card developed from international checklists recommended by INAHTA and ECHTA.

Results: The sixty-nine reports reviewed showed that five of nine transparency standards and six of eight quality standards were usually met by the HTA reports. Areas for improvement for transparency include inputs from external stakeholders, availability of English summaries, conclusions, implications of results, and suggested program of action. Areas of improvement for quality include appropriateness of target population and comparator/s, sufficiency of evidence on efficacy and safety, methodological rigor, economic model assumptions, and adaptation to the Polish setting. A consideration of the ethical and social consequences to the healthcare system must also be strengthened.

Conclusions: The study demonstrates that the incorporation and implementation of the HTA appraisal process in Poland has been successful. HTA appraisal reports in Poland have considered most of the international standards of transparency and quality. Recommendations for both HTA users and doers are forwarded for the improvement of the HTA process in the Polish setting.

The article by O'Malley and Jordan (2009) contains fundamental errors and misunderstands the process it claims to describe (4).

The premise of the paper is that the Australian and New Zealand Horizon Scanning Network (ANZHSN) “was set up to scan the introduction of new and emerging medical technologies into the public sector, with consideration to the private sector.” However, the terms of reference of the policy body (HealthPACT) directing the ANZHSN's activities state that its role is to “provide a forum for monitoring, reviewing, and sharing information regarding health technology to inform service planning and policy development in the public sector” (1). HealthPACT is largely a jurisdictional committee, with representation from the Australian Government, each of its seven states and territories, the New Zealand Health Ministry and district health boards.

Thank you for the opportunity to reply to the letter by Mundy, Hiller, and Merlin “The true role of horizon scanning in Australia: Who it informs and why”. This letter states that our paper (1) “Horizon scanning of new and emerging medical technology in Australia: Its relevance to Medical Services Advisory Committee health technology assessments and public funding,” published in July 2009, contains fundamental errors and misunderstands the process it claims to describe.

Cleemput et al. make a point that the incremental cost-effectiveness ratio (ICER) alone is not a sufficient criterion to guide decision making in health care, and needs many other supplementary inputs. This is nothing new, it has been well known for years to researchers and decision makers alike. ICER serves as an important ingredient to guide decision making, at least in some healthcare systems.