Canadian Coordinating Office For Health Technology Assessment Research Articles

"The future should not take us by surprise": preparation of an early warning system in Denmark.

To explore and test methods for the operation of a national Early Warning System (EWS) in Denmark and to support decision making by the Danish Centre for Evaluation and Health Technology Assessment on this issue. On the basis of literature reviews, information from members of EuroScan, and supported by clinical experts and stakeholders, existing methods were adapted and new methods were developed as part of a feasibility study. Approximately 200 technologies in 30 specialties were identified on the basis of information by EuroScan. A new instrument was developed to distinguish between important and unimportant technologies (filtering). Clinical experts in six specialties applied the instrument to sixty-two technologies in their respective fields, of which nine (15%) were judged potentially important for the Danish health care system. For priority setting, adapting a Dutch instrument to the Danish context was discussed. In principle, the instrument was acceptable, but several changes were proposed, for example, relating to the decentralized structure of the Danish health care system. For early assessment, the format and methods applied by SBU and Canadian Coordinating Office for Health Technology Assessment (CCOHTA) were compared and applied to pharmaceuticals (glitazones in treatment of type 2 diabetes mellitus) and a procedure (embolization of uterine fibromas). Given the main target group of the Danish EWS, local decision makers, the CCOHTA format was preferred. The findings of the study have laid the foundation for an EWS using appropriate methods adapted to local circumstances. On the basis of the findings, a decision was made to start an EWS.

Challenges, choices, and Canada.

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was established by the Federal, Provincial, and Territorial Ministers of Health in 1989 for a 3-year trial period. In 1993 CCOHTA was made a permanent organization and in 1999 the Deputy Ministers of Health renewed CCOHTA's mandate and increased its funding. CCOHTA's role is to coordinate health technology assessment (HTA) priorities across jurisdictions, foster and undertake assessment activity, and function as a clearinghouse for technology assessment results while increasing healthcare system stakeholder awareness of HTA findings. The coordinated and collaborated approach adopted by CCOHTA minimizes duplication with other national and provincial organizations and contributes to the ability of the Canadian healthcare system to continue to deliver high-quality health care to its constituents.

Funding the New Biologics – CCOHTA Report on the Cost Effectiveness of Infliximab for Crohn’s Disease: Pearls and Pitfalls

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) published an economic analysis, using a Markov model, of infliximab therapy for Crohn’s disease that is refractory to other treatments. This was the first fully published economic analysis that addresses this treatment option. Health state transitions were based on data from Olmsted County, Minnesota, health state resource profiles were created using expert opinion and a number of assumptions were made when designing the model. The analysis was rigorous, the best available efficacy and safety data were used, state-of-the art sensitivity analyses were undertaken and an ‘acceptability curve‘ was constructed. The model found that infliximab was effective in increasing quality-adjusted life years when offered in a variety of protocols, but it was associated with high incremental cost utility ratios compared with usual care. The results should be interpreted, however, in view of a number of limitations. The time horizon for the analysis was short (one year), because of a lack of longer-term efficacy data, and might have led to an underestimation of the benefits from averting surgery. Because the analysis was performed from the perspective of a Canadian provincial ministry of health, only direct medical costs were considered. Patients with active Crohn’s disease are likely to incur significant indirect costs, which could be mitigated by this medication. The analysis should be updated as new data become available. Moreover, small changes in the cost of the medication could make the treatment cost effective, according to this model. Economic analyses, such as the one undertaken by the CCOHTA, cannot by themselves solve dilemmas in the allocation of limited health care resources, and other considerations must be included when formulating policy. This is especially important for patients with severe Crohn’s disease, who have significant disability and for whom few therapeutic options exist.

Funding the new biologics--what can we learn from infliximab? The CCOHTA report: a gastroenterologist's viewpoint.

The treatment of severe Crohn's disease is difficult, and approximately 20% of patients do not respond to conventional therapy, including corticosteroids and immunosuppressives. Infliximab is one of the only treatments of proven efficacy in this group. Awareness of its benefits and risks is incomplete, because the drug has only recently been introduced and published research data are relatively sparse. Economic analyses help to evaluate the value of interventions that are both effective and expensive, but their validity is compromised by input data that involve questionable assumptions. They should not, therefore, be the only basis for funding decisions. Patients with severe Crohn's disease are frequently unable to be gainfully employed and thus incur significant indirect costs. In a recent study by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), infliximab was deemed to not meet commonly accepted standards of cost effectiveness. This economic analysis did not incorporate indirect costs, and thus was inherently flawed and likely underestimated infliximab's value. The CCOHTA report also used population data from a period of time during which treatment of Crohn's disease was undergoing major transition. The study population was based in Minnesota and thus might not be applicable to Canada. Although they are routinely used in cost effectiveness models, quality-adjusted life-years gained are difficult to translate into practice, and the health care resources required to induce remission (or some other clinically meaningful result) might be a preferable measure. The CCOHTA report also did not include concomitant therapy with immunosuppressives, despite growing evidence for its benefit. Instead, it considered 'usual care', but, given the lack of effective treatment for many patients with Crohn's disease, such an option constitutes 'no care' and continued suffering. Economic analyses should not be the only basis on which decisions regarding the funding of infliximab, or other new agents, are made.

Funding the new biologics--a health economic critique of the CCOHTA report: infliximab for the treatment of Crohn's disease.

The report of the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) on the use of infliximab in the treatment of refractory Crohn's disease stated that the medication did not meet 'conventional standards of cost-effectiveness'. It had several methodological weaknesses, however, including the derivation of the quality-adjusted life-years (QALYs) gained and the interpretation of the incremental cost utility ratios (ICURs). The validity of economic analyses is highly dependent on the underlying assumptions that are made about the implications of health care states and treatments. The authors of the report mapped utilities from three health states, taken from an American study, onto the nine health states that were considered in their economic analysis. The QALYs that were derived might not have been sensitive to small changes in health outcomes. Moreover, the indirect costs of Crohn's disease and its complications were ignored. Therefore, it is possible that the benefits of infliximab therapy were underestimated. The high ICURs that were quoted in the report do not necessarily mean that infliximab is not valuable, because opportunity costs were not considered. Instead of calculating the ICUR, a preferable approach would be to determine the benefit of this therapy, compared with that which could be derived from alternative uses of the same amount of health care resources. A 'balance sheet' approach would allow decision-makers to determine whether the additional cost of infliximab therapy would be justified by the health care gains that it produces. It is inappropriate to assign an arbitrary cut-off point to cost effectiveness, as defined by ICURs, especially when considering new and expensive treatments for severely ill patients who have few other therapeutic alternatives. Because only a small number of patients would require infliximab, the overall expenditure that would be required to make it available may be manageable.

The revised Canadian Guidelines for the Economic Evaluation of Pharmaceuticals.

The first edition of the Guidelines for Economic Evaluation of Pharmaceuticals: Canada was published in November 1994. At that time, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was assigned the task of maintaining and regularly updating the Canadian Guidelines. Since their introduction, a great deal of experience has been gained with the practical application of the guidelines. Their role has also evolved over time, from being a framework for pharmacoeconomic research to the point where a wide variety of decision-makers use economic evaluations based on the principles set out in the guidelines as a means of facilitating their formulary decisions. In addition, methodologies in certain areas (and the body of related research literature in general) have developed considerably over time. Given these changes in the science and the experience gained, CCOHTA convened a multi-disciplinary committee to address the need for revisions to the guidelines. The underlying principles of the review process were to keep the guidance nature of the document, to focus on the needs of 'doers' (so as to meet the information needs of 'users') and to provide information and advice in areas of controversy, with sound direction in areas of general agreement. The purpose of this review is three-fold: (i) to outline the process which lead to the revision of the Canadian Guidelines; (ii) to describe the major changes made to the second edition of this document; and (iii) to consider the 'next steps' as they relate to the impact of such guidelines and the measurement of outcomes related to economic assessments of pharmaceuticals in general.

A Canadian Perspective

Although the healthcare program in Canada is in many ways universal, there are several differences between the provinces. Two key federal bodies (the Health Protection Branch of Health Canada and the Patented Medicine Prices Review Board) are involved in the drug review process. In addition, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA), an organization funded jointly by provinces and the federal government, reviews new or existing drugs at the request of provinces. Each province or territory and the federal government has its own drug plan or plans. The 10 Canadian provinces require a notice of compliance, information on pricing, and clinical and comparative information for submission of a new drug. Over the last 3 years, 8 of the 10 provinces have required pharmacoeconomic analyses to be added to the submissions. Four of the eight provinces requiring pharmacoeconomic evaluations have specified that these evaluations should be made according to the Canadian Coordinating Office for Health Technology Assessment guidelines. A review of the utilization patterns of lipid-lowering therapies is presented in this Canadian context. Statins comprised 80% of the lipid-lowering drug market in 1995. Prescribers use statins available in Canada interchangeably for all approved and nonapproved indications. The newest statin, atorvastatin, has attained a market share for new prescriptions equivalent to simvastatin and pravastatin, despite the lack of clinical outcome studies. CCOHTA reviewed the evidence of efficacy and effectiveness of statins, evaluated whether significant differences existed between statins, and analyzed published economic evaluations. It found that treatment of higher-risk patients with statins is more cost-effective than that of lower-risk subjects. The evaluation also concluded that the statins, as a class, probably act in reducing LDL and raising HDL, resulting in beneficial clinical outcomes.

MGA6 Survey Strategies in the Revision of the Guidelines for Economic Evaluation: Canada

In 1994 the Guidelines for Economic Evaluations of Pharmaceuticals: Canada (1st ed) was published, and the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was assigned with its maintenance. In 1996, CCOHTA struck a Committee of experienced stakeholders to review the Guidelines. METHODS: The Committee distributed an initial survey (n = 1,500), directed specifically to those in economic evaluation research (“doers”), and to those who use the results for decision-making (“users”). Results from this survey guided the creation of the 2nd edition of the Guidelines. The survey process was repeated with a draft of the 2nd edition, and focused on the degree to which changes to the Guidelines met their objectives and were an improvement over the 1st edition. RESULTS: Respondents to both surveys were comparable in proportion and composition, with the majority of respondents being Canadian in origin (75–78%) and representing the doers (45–46%). Responses to the initial survey (10% response rate) suggested a need to clarify the Guidelines' audience. With this in mind, the Committee confirmed that the document should provide guidance for “doers” of evaluations but that this was for the purposes of providing a clear, comprehensive and scientifically satisfactory report for “users”. The initial survey also identified key areas of concern, which determined the changes introduced to the 2nd edition. This encompassed the following areas: format changes, cost issues, portability/generalizability, sensitivity analysis and statistics, HRQOL/QALYs, WTP/CBA, equity, limitations/assumptions, subgroup analysis, and meta-analysis. The responses to the follow-up survey (50% response rate) indicated that the goals of the revision process were achieved and provided an improvement over the 1st edition (70–80% agreement rating). Academics and users felt that the Guidelines were realistic, while less enthusiastic support came from governments and doers. CONCLUSIONS: Survey methodologies are an effective means of focusing efforts in the Guideline review process.

Risperidone and clozapine were more cost effective than haloperidol and chlorpromazine in patients with schizophrenia

. Glennie J. Technology overview: pharmaceuticals: pharmacoeconomic evaluations of clozapine in treatment-resistant schizophrenia and risperidone in chronic schizophrenia. Ottawa (ON): Canadian Coordinating Office for Health Technology Assessment (CCOHTA); 1997 Jul....

Review: Tacrine has limited efficacy for Alzheimer disease

Source Citation Glennie J, for the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). The efficacy of tacrine and the measurement of outcomes in Alzheimer's Disease. CCOHTA Tec...

Internet information sources for the identification of emerging health technologies. A starting point.

The basis of an early warning system for new and emerging health technologies is information, and in particular, information that has been selectively extracted from the huge quantity of data in the fields of medicine, science, and biobusiness. The information will be useful only if presented in a format suitable to the needs of health care decision makers and produced at the time most likely to influence the introduction or diffusion of new technologies. In 1997 the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) began a one-year pilot project to identify and provide information on developments in medical technologies that may have a significant impact on health care in Canada. We began by examining the information available to us through the Internet, based on the assumption that electronic sources can offer more timely access to a greater range of information, often with little or no cost involved. It was important to identify the sites that offered the most relevant information in the least amount of time.

Reports from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective serotonin reuptake inhibitors for major depression.

Reports from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective serotonin reuptake inhibitors for major depression.

Outcome measurement in economic evaluation

Outcome measurement in economic evaluation

Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA)

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Evaluation of the Canadian Coordinating Office for Health Technology Assessment

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was recently evaluated. We summarize the evaluation process, report, and 17 recommendations for enhancing CCOHTA's effectiveness. This paper may be useful for evaluators of agencies for technology assessment.

Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA).

Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA).

Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Photodynamic therapy.

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Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA)

Report from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA)

Reports from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Magnetic field strength issues in magnetic resonance imaging (MRI).

Reports from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Magnetic field strength issues in magnetic resonance imaging (MRI).

Reports from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA)

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