Background: There is a need for innovative methodologies to identify and prioritize topics for health technology assessment (HTA). A pilot project to evaluate the methodology for specialty mapping was undertaken in the area of child and adolescent health. Two case studies are presented, in the area of sexually transmitted infections and acute pain.

Methods: The methodology comprised sequential stages, based on principles of systematic review. A “stakeholder model” encouraged wider participation. Key stages included identifying the topic area and setting the scope; developing a care pathway; searching for clinical guidelines/guidance, and evaluation literature; synthesis and mapping of literature to the “nodes” of the care pathway to highlight gaps; prioritizing the topics with stakeholders; and referring priorities to the appropriate agencies.

Results: A total of thirty guidelines/guidance documents and sixteen evaluation studies were mapped across the two case studies. In some nodes of the care pathway, more literature was mapped than others, suggesting important gaps in research and policy guidance. Sixty-two policy questions were identified and were rated by stakeholders in prioritization workshops. The highest priorities have been considered by senior committees for likely commissioning as research or guidelines/guidance.

Conclusions: This is one of the few published examples of innovative methodology to identify and prioritize topics for HTA. Specialty mapping can make a positive contribution to the policy agenda, with several research and policy gaps being fed into existing prioritization channels. Adequate time, resources, and capacity is required particularly in engaging stakeholders and developing a care pathway. Implementation of specialty mapping in other topic areas with on-going evaluation is recommended.

Objectives: The aim of the study is to make an international comparison of Health Technology Assessment (HTA) Agencies, to show their similarities and differences.

Methods: An e-mail questionnaire was sent to thirty HTA agencies internationally. Questions related to the structure of the agency, the relationship with health-related institutions, the prescriptiveness of the decisions taken, the main core and the modalities to spread the assessment, and the type of funding.

Results: Twenty-four HTA Agencies answered the questionnaire: 25 percent in America, 4.2 percent in Australia, and 70.8 percent in Europe. Fifty-four percent of HTA Agencies are governmental institutions (83.3 percent have central government funding), while 62.5 percent have relationships with health-related governmental institutions. Of the agencies, 87 percent reported that their decisions are not prescriptive, while for 20.8 percent and 8.3 percent of them stated that this was the case totally or partially, respectively, especially for the governmental and American Agencies. Seventeen agencies (70.8 percent) declared their work on multiannual programs (77 percent of the governmental HTA Agencies and 100 percent of the American ones). The assessments mainly addressed diagnostic procedures (85.7 percent) and pharmaceuticals (25 percent). The most common way to disseminate results is by means of paper report (91.7 percent), followed by the Internet (16.7 percent), and seminars to expert audiences (12.5 percent).

Conclusions: The comparative analysis of HTA Agencies showed that governmental and American Agencies have a profound impact on the prescriptiveness of their assessment, and this could be linked to the fact that these types of Agencies work on multiannual programs. European and American HTA Agencies have many similarities in terms of type of assessment, funding, and dissemination of results.

The application of conditionality to coverage decisions for healthcare technologies is increasing. Coverage with Evidence Development (CED) represents a specific approach to coverage for promising technologies for which the evidence remains uncertain. CED demands that additional evidence is generated to address the sources of uncertainty and secure ongoing coverage. This study explores the conceptual and policy issues relating to CED and discusses issues involved in operationalizing CED in practice, including presenting criteria for which technologies may be most suitable for CED. This study is intended to further the debate on the use of CED as well as highlight areas that warrant further research.

The study by Hutton, Trueman, and Henshall provides a thoughtful and helpful set of observations about the potential benefits of linking reimbursement to requirements for further clinical research (coverage with evidence development—CED), as well as the likely challenges and obstacles to implementation. In this commentary, we will expand upon several of the key points made in their study and offer some additional suggestions for moving this policy discussion forward

Objectives: Previously in Finland, each municipality selected which methods to use in screening for fetal abnormalities. This resulted in practice variation and inequity. The national health technology assessment (HTA) office Finohta compared the methods and time frames available when screening for chromosomal and structural abnormalities. The assessment identified a need to discuss several value-laden questions before policy decisions could be taken.

Methods: The National Screening Committee (NSC) at the Ministry of Health and Social Affairs (MOH) formulated a statement based on the HTA report to inform policy makers. This article describes the steps in the policy process.

Results: The national screening committee organized an open forum to discuss the ethically relevant aspects of fetal screening, and a lengthy public discussion highlighted the viewpoints of various stakeholders. Based on the assessment, public discussion, and several committee meetings that heard further experts, the NSC formulated a conclusion based on equity of access. This also offered options for families unwilling to terminate a pregnancy due to fetal abnormality. The MOH sent the conclusion to a comment round, and the proposal was accepted with minor adjustments. The Ministry decided to unify the regulation of all public screening programs by one statute. The policy process lasted three years, and the methods to screen for fetal abnormalities will be unified after a further 3 years.

Conclusions: The assessment of screening programs for fetal abnormalities reached beyond its original mandate. The process of examining values behind screening resulted in a program that respects the differing objectives and ethical values of pregnant families, and to national legislation on screening programs.

Objectives: The aim of this study was to estimate the impact of new medical technologies on public healthcare expenditures in Israel over the period 2000–07.

Methods: For each year, government estimates for the costs of new technologies recommended as high-priority for public funding were summarized. The ratio of projected costs of these technologies to total public healthcare expenditures was calculated and compared with actual governmental budget allocations for new technologies.

Results: Funding all new high-priority medical technologies would have increased healthcare expenditures by 2.1 percent per year. Government allocations for new technologies raised expenditures by 1.0 percent per year.

Conclusions: New medical technologies significantly increase healthcare expenditures in Israel. Budgetary constraints have reduced their actual impact by 52 percent. This study indicates the need for an annual addition of 2 percent to public healthcare budget for funding new high-priority technologies.

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.

Objectives: U.S. expenditures on medical devices ($70 billion in 2003) are one of the fastest growing components of hospital costs. Physicians’ selection of medical devices lacks an evidence base on the comparative clinical effectiveness of these products. Comparative studies (e.g., vendor 1 versus vendor 2, technology A versus technology B) are increasingly promoted in the public sector as a means of cost containment, value-based purchasing, and quality improvement. This study illustrates how hospitals and physicians can conduct comparative technology assessments of product performance.

Methods: Surgeons evaluated comparable medical devices manufactured by eight different vendors in standardized surgical procedures. Devices included sutures and endomechanical products, which account for $2.5 billion of total device spending. Evaluations covered multiple performance dimensions, including ergonomics, functionality, clinical acceptability, and vendor preference.

Results: One vendor's products garnered consistently high ratings from surgeons, while two other vendors garnered consistently low ratings. Differences in ratings were statistically significant and persist when controlling for physician background characteristics and prior experience. Study results were used by a large hospital group purchasing organization to select which vendors to contract with for these products.

Conclusions: Comparative technology evaluations assist physicians and hospitals in making cost-effective purchases of devices. These evaluations provide robust information on the performance of products routinely used by clinicians. Such evaluations can be carefully designed to have scientific rigor and clinical credibility.

Objectives: The aim of this study was to assess the cost-effectiveness of laparoscopic surgery compared with open surgery for the treatment of colorectal cancer.

Methods: A Markov model was developed to model cost-effectiveness over 25 years. Data on the clinical effectiveness of laparoscopic and open surgery for colorectal cancer were obtained from a systematic review of the literature. Data on costs came from a systematic review of economic evaluations and from published sources. The outcomes of the model were presented as the incremental cost per life-year gained and using cost-effectiveness acceptability curves to illustrate the likelihood that a treatment was cost-effective at various threshold values for society's willingness to pay for an additional life-year.

Results: Laparoscopic surgery was on average £300 more costly and slightly less effective than open surgery and had a 30 percent chance of being cost-effective if society is willing to pay £30,000 for a life-year. One interpretation of the available data suggests equal survival and disease-free survival. Making this assumption, laparoscopic surgery had a greater chance of being considered cost-effective. Presenting the results as incremental cost per quality-adjusted life-year (QALY) made no difference to the results, as utility data were poor. Evidence suggests short-term benefits after laparoscopic repair. This benefit would have to be at least 0.01 of a QALY for laparoscopic surgery to be considered cost-effective.

Conclusions: Laparoscopic surgery is likely to be associated with short-term quality of life benefits, similar long-term outcomes, and an additional £300 per patient. A judgment is required as to whether the short-term benefits are worth this extra cost.

Objectives: The aim of this study was to systematically review economic analyses comparing drug-eluting stents (DES) to bare metal stents (BMS) in patients who undergo percutaneous coronary intervention to form an overall view about cost-effectiveness of DES and to construct a simple decision analysis model to evaluate the cost–utility of DES.

Methods: Electronic databases searched from January 2004 to January 2006 were Cochrane Database of Systematic Reviews; DARE, HTA, EED (NHS CRD); MEDLINE(R) In-Process, Other Non-Indexed Citations, MEDLINE(R). References of the papers identified were checked. We included randomized controlled trials (RCT) or model-based cost-effectiveness analyses comparing DES to BMS in patients with coronary artery disease. The methodological quality of the papers was assessed by Drummond's criteria. Baseline characteristics and results of the studies were extracted and data synthesized descriptively. A decision tree model was constructed to evaluate the cost–utility of DES in comparison to BMS, where health-related quality of life was measured by the 15D.

Results: We identified thirteen good-quality economic evaluations. In two of these based on RCTs, DES was found cost-effective. In six studies, it was concluded that DES might probably be a cost-effective strategy in some circumstances, but not as a single strategy, and four studies concluded that DES is not cost-effective. One study did not draw a clear conclusion. In our analysis, the overall incremental cost-effectiveness ratio was €98,827 per quality-adjusted life-years gained. Avoiding one revascularization with DES would cost €4,794, when revascularization with BMS costs €3,260.

Conclusions: The evidence is inconsistent of whether DES would be a cost-effective treatment compared with BMS in any healthcare system where evaluated. A marked restenosis risk reduction should be achieved before use of DES is justifiable at present prices. When considering adoption of a new health technology with a high incremental cost within a fixed budget, opportunity cost in terms of untreated patients should be seriously considered as a question of collective ethics.

Objectives: Major depression is common in elderly patients. Interpersonal psychotherapy (IPT) is a potentially effective treatment for depressed elderly patients. The objective of this study was to evaluate the cost-effectiveness of IPT delivered by mental health workers in primary care practices, for depressed patients 55 years of age and older identified by screening, in comparison with care as usual (CAU).

Methods: We conducted a full economic evaluation alongside a randomized controlled trial comparing IPT with CAU. Outcome measures were depressive symptoms, presence of major depression, and quality of life. Resource use was measured from a societal perspective over a 12-month period by cost diaries. Multiple imputation and bootstrapping were used to analyze the data.

Results: At 6 and 12 months, the differences in clinical outcomes between IPT and CAU were small and nonsignificant. Total costs at 12 months were €5,753 in the IPT group and €4,984 in the CAU group (mean difference, €769; 95 percent confidence interval, −2,459 – 3,433). Cost-effectiveness planes indicated that there was much uncertainty around the cost-effectiveness ratios.

Conclusions: Based on these results, provision of IPT in primary care to elderly depressed patients was not cost-effective in comparison to CAU. Future research should focus on improvement of patient selection and treatments that have more robust effects in the acute and maintenance phase of treatment.

Objectives: Stereotactic radiosurgery (SRS) is used to treat intracranial lesions and vascular malformations as an addition or replacement to whole brain radiotherapy and microsurgery. SRS can be delivered by hardware and software appended to standard linear accelerators (Linacs) or by dedicated systems such as Gamma Knife, which has been proposed as a more accurate and user friendly technology. Internationally, dedicated systems have been funded, despite limitations in evidence. However, some countries including Australia have not recommended additional reimbursement for dedicated systems. This study compares the costs of Linac radiosurgery with Gamma Knife radiosurgery.

Methods: Due to limited evidence on comparative effects, the economic analysis was restricted to a cost evaluation. The base-case analysis assumed a modified Linac was used only to treat SRS patients. However, because a modified Linac could be used to treat other radiotherapy patients, a second analysis assumed spare time was used to meet other radiotherapy needs, and Linac capital costs were apportioned according to SRS use.

Results: The incremental cost of Gamma Knife versus a modified Linac was estimated as AU$209 per patient. This result is sensitive to variations in assumptions. A second analysis proportioning capital costs according to SRS use showed that Gamma Knife may cost up to AU$1673 more per patient.

Conclusions: Gamma Knife may be cost competitive only if demand for SRS services is high enough to fully use equipment working time. However, given low patient demand and competing radiotherapy needs, Gamma Knife appears more costly and further evidence of survival or quality of life advantages may be required to justify reimbursement.

Objectives: The aim of this study was to identify research and development on genetic testing to find out if research addresses important disease areas, how far it is from potential clinical use, and what consequences might arise for the prioritization of health technology assessment (HTA) activities. Also a horizon scanning methodology developed in Germany is demonstrated.

Methods: A systematic search on genetic testing was conducted in an innovation database (ZIM database). Based on a daily monitoring of literature and Internet sources, reports from 2003 up to 2005 were classified related to the type of innovation, the addressed disease categories, and the developmental phase of the technology. More detailed analyses for the most frequently addressed groups of diseases were conducted.

Results: From 239 relevant reports, 41 percent referred to neoplasms; 10 percent to diseases of the cardiovascular system; 9 percent to diseases of the nervous system; 7 percent to mental and behavioral disorders; and 5 percent to endocrine, nutritional, and metabolic diseases. A total of 69 percent of research is situated in basic preclinical research, 22 percent in clinical/experimental research, and 6 percent are genetic tests being used. Diagnostic applications were most frequently reported (28 percent), followed by therapeutic prediction (22 percent), preventive prediction (18 percent), pharmacogenetics (16 percent), and screening (16 percent).

Conclusions: Widespread diseases are frequently addressed in research. HTA on genetic testing might focus on innovations addressing neoplastic diseases (in particular breast, colon, and prostate cancers) and pharmacogenetic applications for therapeutic prediction. The horizon scanning approach seems useful in the early steps of HTA processes to identify emerging new technologies that might have significant impact on future health care.

All of the panelists who participated in this conference and contributed to the writing of this statement were identified as having no financial or scientific conflict of interest, and all signed forms attesting to this fact. Unlike the expert speakers who present scientific data at the conference, the individuals invited to participate on the consensus panel are reviewed prior to selection to ensure they are not proponents of an advocacy position with regard to the topic.

The email address provided for Hussein Z. Noorani in the “Contact Information” section of the above article is incorrect. The correct email address is [email protected].