Fueled by high returns on its investments, the pharmaceutical industry in the United States has flourished for the past 50 years. The regulatory strategy of demanding stringent testing then allowing market-based pricing has allowed private companies to fund ambitious research and development activities with the assurance that these investments will be recovered. However, aggressive managed-care cost-containment strategies threaten the companies' ability to recoup research and development expenses and may affect their willingness to invest in future innovative research.

A complete and comprehensive search of the relevant evidence is an essential step in the preparation of a scientific systematic review. The Cochrane Pregnancy and Childbirth Database consists of some 600 systematic reviews, based on almost 6,000 randomized or quasi-randomized trials of care during pregnancy and childbirth. As ascertainment from electronic search of the National Library of Medicine MEDLINE database was not complete, the mainstay of our search strategy was a systematic hand search of some 60 journals, beginning with volumes published in 1950. Additional references were obtained from the list of references in primary research reports and conference reports. A major effort was made to identify unpublished trials and to obtain unpublished data from published trials.

We studied the role of economic incentives for private providers in explaining Spain's disproportionately large number of extracorporeal shock wave lithotripters (ESWLs) and low number of linear accelerators (linacs) per million population (pmp) in comparison to other countries of the Organization for Economic Cooperation and Development (OECD). We found that the reimbursement policy for 1990 allowed an average profit per private ESWL of $732,000, but no profit for linacs. Regional per-capita income was positively correlated with ESWLs pmp in Spain (R2 = 0.49; p =.001), but not with linacs. Sixty-nine percent of ESWLs were privately held versus only 16% of linacs. To avoid these types of distortions, financial incentives should be based on a reasonable relationship between cost and charges and should be associated with the appropriateness of medical care.

Biofeedback instrumentation has been a growing part of physical therapy practice for 20 years, and physical therapists have contributed to researching its efficacy in treating varying conditions. The application of biofeedback to the treatment of stroke was marked by some early difficulties with the quality of the electronics, but sophisticated contemporary equipment can do much more than was originally envisioned. The importance of relating quantified movement-based data to functional measures is projected as a high priority if appropriate reimbursement for physical therapy services with biofeedback is to continue in the future.

Rationale: Bayesian methods provide an interesting approach to assessing an implantable medical device (IMD) that has evolved through successive versions because they allow for explicit incorporation of prior knowledge into the analysis. However, the literature is sparse on the feasibility and reliability of elicitation in cases where expert beliefs are used to form priors.

Objectives: To develop an Internet-based method for eliciting experts’ beliefs about the success rate of an intracranial stenting procedure and to assess their impact on the estimated benefit of the latest version.

Study Design and Setting: The elicitation questionnaire was administered to a group of nineteen experts. Elicited experts’ beliefs were used to inform the prior distributions of a Bayesian hierarchical meta-analysis model, allowing for the estimation of the success rate of each version. RESULTS: Experts believed that the success rate of the latest version was slightly higher than that of the previous one (median: 80.8 percent versus 75.9 percent). When using noninformative priors in the model, the latest version was found to have a lower success rate (median: 83.1 percent versus 86.0 percent), while no difference between the two versions was detected with informative priors (median: 85.3 percent versus 85.6 percent).

Conclusions: We proposed a practical method to elicit experts’ beliefs on the success rates of successive IMD versions and to explicitly combine all available evidence in the evaluation of the latest one. Our results suggest that the experts were overoptimistic about this last version. Nevertheless, the proposed method should be simplified and assessed in larger, representative samples.

It has been suggested that health economists need to improve their methods in order to meet the challenges of evaluating genomic/genetic tests. In this article, we set out twelve challenges identified from a rapid review of the literature and suggest solutions to the challenges identified. Two challenges were common to all economic evaluations: choice of perspective and time-horizon. Five challenges were relevant for all diagnostic technologies: complexity of analysis; range of costs; under-developed evidence base; behavioral aspects; and choice of outcome metrics. The final five challenges were pertinent for genomic tests and only these may require methodological development: heterogeneity of tests and platforms, increasing stratification, capturing personal utility; incidental findings; and spillover effects. Current methods of economic evaluation are generally able to cope with genomic/genetic tests, although a renewed focus on specific decision-makers’ needs and a willingness to move away from cost-utility analysis may be required. Certain analysts may be constrained by reference cases developed primarily for the assessment of pharmaceuticals. The combined impact of multiple challenges may require analysts to be particularly careful in setting the scope of their analysis in order to ensure that feasibility is balanced with usefulness to the decision maker. A key issue is the under-developed evidence-base and it may be necessary to rethink translation processes to ensure sufficient, relevant evidence is available to support economic evaluation and adoption of genomic/genetic tests.

The profusion of clinical practice guidelines has been remarked on by many (3;6;8) and ascribed to a need to address the wide geographic differences in practice documented in the last quarter century (9;10), as well as to the increasing concern with the cost of health care. The idea is that guidelines, by outlining efficient care strategies, will enhance the quality of care and reduce unnecessary or unproductive expenditures. Others hold that guidelines are simply a means of transferring the results of research from the literature to clinicians (2;5). A darker view of guidelines sees them as instruments of control of medical practice by uncaring administrators concerned solely with cost reduction (4;7).

Osteoradionecrosis (ORN) is a known complication to radiation therapy for head and neck cancer with a prevalence of 5–7% among radiated patients. Treatment might include dental surgery and reconstruction of the jawbone as well as hyperbaric oxygen treatment (HBOT). HBOT takes place in a closed compartment where patients are breathing 100% oxygen under pressure for 90 minutes once a day every weekday for 6 weeks. In Denmark, HBOT is available at two facilities with very different organizational set-ups.

Objectives: The object of this study was to determine, taking into account uncertainty on cost and outcome parameters, the cost-effectiveness of high-dose chemotherapy (HDC) compared with conventional chemotherapy for advanced breast cancer patients.

Methods: An analysis was conducted for 300 patients included in a randomized clinical trial designed to evaluate the benefits, in terms of disease-free survival and overall survival, of adding a single course of HDC to a four-cycle conventional-dose chemotherapy for breast cancer patients with axillary lymph node invasion. Costs were estimated from a detailed observation of physical quantities consumed, and the Kaplan–Meier method was used to evaluate mean survival times. Incremental cost-effectiveness ratios were evaluated successively considering disease-free survival and overall survival outcomes. Handling of uncertainty consisted in construction of confidence intervals for these ratios, using the truncated Fieller method.

Results: The cost per disease-free life year gained was evaluated at 13,074€, a value that seems to be acceptable to society. However, handling uncertainty shows that the upper bound of the confidence interval is around 38,000€, which is nearly three times higher. Moreover, as no difference was demonstrated in overall survival between treatments, cost-effectiveness analysis, that is a cost minimization, indicated that the intensive treatment is a dominated strategy involving an extra cost of 7,400€, for no added benefit.

Conclusions: Adding a single course of HDC led to a clinical benefit in terms of disease-free survival for an additional cost that seems to be acceptable, considering the point estimate of the ratio. However, handling uncertainty indicates a maximum ratio for which conclusions have to be discussed.

Objectives: This study provides an overview of the Republic of Serbia healthcare system and describes the process of developing and conducting health technology assessment (HTA).

Methods: The authors performed pragmatic, nonsystematic literature review based on available statistical data, legislation, and studies.

Results: Healthcare law creates conditions that allow implementation of the principle “value for money.” The institutions directly vested in the implementation of HTA are the National Health Insurance Fund (NHIF) and the Ministry of Health (MoH). There are some reflections of the efforts by NHIF and MoH toward achieving this goal.

Conclusions: Despite the highly set objectives, there is still a lot of work to be done to build an adequate model to support decision-making processes to bridge the discrepancies between broadly defined rights to health care and limited resources in the country.

Objectives: The study question was whether dual-energy X-ray absorptiometry (DXA) alone is more cost-effective for identifying postmenopausal women with osteoporosis than a two-step procedure with quantitative ultrasound sonography (QUS) plus DXA. To answer this question, a systematic review was performed.

Methods: Electronic databases (PubMed, INAHTA, Health Evidence Network, NIHR, the Health Technology Assessment program, the NHS Economic Evaluation Database, Research Papers in Economics, Web of Science, Scopus, and EconLit) were searched for cost-effectiveness publications. Two independent reviewers selected eligible publications based on the inclusion/exclusion criteria. Quality assessment of economic evaluations was undertaken using the Drummond checklist.

Results: Seven journal articles and four reports were reviewed. The cost per true positive case diagnosed by DXA was found to be higher than that for diagnosis by QUS+DXA in two articles. In one article it was found to be lower. In three studies, the results were not conclusive. These articles were characterized by the differences in the types of devices, parameters and thresholds on the QUS and DXA tests and the unit costs of the DXA and QUS tests as well as by variability in the sensitivity and specificity of the techniques and the prevalence of osteoporosis.

Conclusions: The publications reviewed did not provide clear-cut evidence for drawing conclusions about which screening test may be more cost-effective for identifying postmenopausal women with osteoporosis.

“Key principles for the improved conduct of health technology assessment for resource allocation decisions.” The title says it all. I am amazed that such a summary is even possible and that it defines this field so well. Perhaps this report will be cited for years to come as the best and central definition of HTA. A field like this can be defined in other ways.

Objectives: The aim of cost-effectiveness analysis is to maximize health benefits from a given budget, taking a societal perspective. Consequently, the comparison of alternative treatments or technologies is solely based on their expected effectiveness and cost. However, the expectation, or mean, poses important limitations as it might be a poor summary of the underlying distribution, for instance when the effectiveness is a categorical variable, or when the distributions of either effectiveness or cost present a high degree of asymmetry. Clinical variables often present these characteristics.

Methods: In this study, we present a framework for cost-effectiveness analysis based on the whole posterior distribution of effectiveness and cost.

Results: An application with real data is included to illustrate the analysis. Decision-making measures such as the incremental cost-effectiveness ratio, incremental net-benefit, and cost-effectiveness acceptability curves, can also be defined under the new framework.

Conclusions: This framework overcomes limitations of the mean and offers complementary information for the decision maker.

The objective of the study was to ascertain the extent of utilization of medical technologies (defined as equipment) used in various health care institutions in Nigeria. The study also investigated the factors accounting for use of and under- and nonutilization of this equipment. Sixteen major and minor health care institutions were surveyed. The outcomes of the study indicate that not less than a third of the equipment was out of order at the time of the study. A number of factors are responsible for nonutilization of this equipment. They include lack of infrastructural facilities such as piped water, storage, and power supply; poor handling by badly trained staff; and the low priority that is accorded to maintenance. The study leads to the important conclusion that the local culture is unable to sustain the technologies that are procured.

Among alcohol and narcotics, alcohol is most comprehensively documented as a teratogen. However, for all other narcotics, data are continuously accumulating, convincingly displaying the teratogenic effects. The proportions between “somatic” teratogenicity and “behavioral” teratogenicity vary between the different agents. Preventive work in prenatal clinics and among social workers, as well as objective mass media attention to the problem, seems to have lowered the incidence of severe fetal alcohol syndrome where the above-mentioned activities have been practiced. The female alcohol consumption in Sweden decreased from 1976 to 1985; thereafter, a slow continuous increase is underway again, in Sweden the number of recruits to narcotic abuse peaked in the 1970s and early 1980s. Thereafter, the number of recruits among females decreased, but abuse has continued among the members of the older age groups.