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Technology assessment in Catalonia: Integrating economic appraisal
Sm. Sci. Med. Vol. 38, No. 12, pp. 1643-1646, I994 Copyright 0 1994 Elsevier Science Ltd Printed in Great Britain. All rights reserved
Pergamon
02779536194 $7.00 + 0.00
TECHNOLOGY ASSESSMENT IN CATALONIA: INTEGRATING ECONOMIC APPRAISAL ALICIA GRANADOS Oficina d’Avaluaci6
and JOSEP M. BORRAS
de Tecnologies Mediques, Department of Health, Pave116 Ave Maria, les Corts 131-159, 08028-Barcelona, Spain
Travessera
de
Abstract-A
brief description of the evolution and role of the Catalan Office for Health Technology Assessment (COHTA) into the framework of the Catalan Health Care Service are presented. Methodological approaches used by COHTA range from synthesis of scientific evidence to the collection of primary data. Regarding the integration of economic appraisal into technology assessment, the main approaches are the following: integration into clinical trials funded by the COHTA and in the reimbursement policies of the Catalan Health Service. COHTA participates in the process of purchasing medical technologies, especially expensive ones, and in the establishment of reimbursement policies of medical technologies. The particular characteristics of COHTA as a regional agency for Technology Assessment and its position into the framework of the Department of Health are discussed. Among the advantages of this position are the knowledge of the relevant questions for policy makers and the potential influence in the process. Among the disadvantages are the possibility of losing autonomy. Regional agencies that are closely related to the regional health services could provide a better understanding of the real problems in clinical practice and in the utilization of health technologies. Key words-technology
assessment,
economic
appraisal,
1. INTRODUCTION
The rational introduction of medical technologies (encompassing both equipment and procedures) requires the demonstration of their efficacy and safety. Further, their diffusion and utilization must be accompanied by the assessment of their effectiveness, and that the reimbursement systems used provide incentives intended to promote appropriate clinical practices. The Catalan Office for Health Technology Assessment (COHTA) was created as a part of Department of Health in Catalonia, Spain, on the basis of this considerations. Catalonia is an autonomous region of Spain, and since the adoption of the new Spanish Constitution in 1979, the Catalan Government has the power to legislate in certain areas and is responsible for providing health care in Catalonia. The Catalan Department of Health instituted the Catalan Health Service as the public body responsible for the management, financing, and provision of health care in the region. The health care system provides universal coverage as mandated by law. In Catalonia, the first initiative taken to promote a rational introduction and diffusion of medical technologies dates from 1984, when the Advisory Board on ‘high technology’ was funded. All of its members were clinicians with different specialties. At that time, the Advisory Board was deemed to be an appropriate mechanism for deciding the usefulness of a given technology. However, it is currently considered insufficient for the following reasons: decision
reimbursement
policies
makers ought to base their decisions on the most objective data available, it is necessary to have data on the cost-effectiveness of a given technology and comparative assessments must be made of the different technologies available. As a result of these considerations COHTA was created in early 1991 as the agency responsible for carrying out medical technology assessment in the Catalan health care system. It is the first agency created in Spain specifically for these activities. The function of the COHTA is to provide decision makers with relevant data on health technologies, knowledge about the consequences of their utilization, trends of existing technologies and cost-effectiveness of technologies when available. In order to carrying this out the organization, the financing system and the evolution of the Catalan Health Service have to be taken into account. In developing its objectives, COHTA works in cooperation with scientific and medical associations, universities and research institutes. COHTA is involved in the decision making process regarding the financing and the diffusion of new technologies in Catalan hospitals that are financed by the public budget. Its main tasks are as follows: -To participate in cal technologies, special payment technologies are -To participate in ment policies of 1643
the process of purchasing mediespecially expensive ones. The procedures employed for these managed at regional level. the establishment of reimbursemedical technologies.
ALICIA GRANADOSand JOSEPM. BornAs
1644
It has to be emphasized, however, that the reports made by COHTA represent only one of the many elements of the decision making process, since COHTA’s approach main contribution is to offer, on the basis of scientific evidence, relevant data. When making their decisions, policy makers must take into account other kinds of data in addition to scientific evidence. To carry out its task, the COHTA combines several methodological approaches depending on the specific topic, the context and the timing of the decision. Among the different projects developed by the COHTA in its still short history are two ongoing randomized clinical trials, the development of systems intended to collect specific data such as the evaluation of patterns of utilization of cardiovascular surgery, percutaneous transluminal angioplasty, and long-term domiciliary oxygen-therapy; and the consequences of newly implemented reimbursement systems, such as those for radiotherapy. Other approaches include the synthesis of information from medical literature so as to provide critical data in the decision making process regarding the introduction and the diffusion of medical technology. Consequently these methodological approaches range from the synthesis of scientific evidence to the collection of primary data. One problem that COHTA faces is how to translate scientific evidence into the Catalan health care system. This implies the ascertainment of the effectiveness of a given technology of proven efficacy in the Catalan setting. ECONOMIC APPRAISAL INTO THE RESEARCH PROJECTS
public funds until the results of the trial were available, it did decide to fund a research project. This project is being carried out in cooperation with two university hospitals, a health economics advisory group and an university research institute. The end points of the trial include the estimation of symptom and complication rates, the assessment of health status by means of the Nottingham health profile and the assessment of costs. The trial is still in progress because patient recruitment has been slower than expected. This is due to the almost parallel development of the laparoscopic cholecystectomy, which is being diffused in Catalonia as quickly as in the rest of Europe. The decision to carry out a trial has had some effects on the number of devices available in Catalonia. The market has been somewhat self-regulating, as can be seen by the fact that only two of the four original devices are stiil being used. No public hospital will buy any such a device until the results of the trial are known and the decision of the Catalan Department of Health is made. This approach has also established a precedent in linking a research project to the introduction in the public Catalan health care system of technologies which has not shown its effectiveness. When a research project is either proposed to or developed by COHTA, COHTA tries to perform an economic evaluation as a component of the project in connection with clinical researchers. There are other projects in which primary data are not collected, but published results are used as a reference for an economic appraisal.
2. INTEGRATING
Economic appraisal has been integrated into a variety of projects as a part of the research design e.g. randomized clinical trials (RCT). In other cases, economic estimates have been made to improve the reimbursement system of some technologies so as to influence their diffusion. A few years ago, one of the more fashionable technologies was biliary lithotripsy. Its potential as a treatment of biliary stones was a matter of great discussion. Due to the competitive position of the private health care sector in Catalonia four such devices were operative, though none of them were in public hospitals. A contract to treat patients from the public sector was offered to the Health Department. The traditional response would have been to contract some predetermined number of treatments that would be paid for on a per treatment basis. However, in this case the response was different. The Department decided, following the proposal from the Program of High Technology (the predecessor of COHTA) to carry out a RCT to demonstrate the effectiveness of the procedure as compared to that of open cholecystectomy. While the Department of Health decided not to reimburse lithotripsy from
3. REIMBURSEMENT POLICIES
The general reimbursement policy in Catalonia is based on per diem hospital stay adjusted for length of stay. The per diem fees vary with the hospital level (county, intermediate and university hospitals) and are supposed to include all technologies of the hospital. However, certain ‘big ticket’ technologies such as MRI, CT-scanner, cardiovascular surgery or organ transplantation are not included in this general reimbursement scheme. There is not an explicit scheme that allows one to determine which technologies ought to be included in the general contract of the hospital or what should be paid under a special agreement. This reimbursement policy induced demand as shown by the increasing number of MRIs or CTscanner being used in the Catalan health service. In practice, the number of such procedures that were paid for was limited and they were established prospectively each year. Nevertheless, the demand produced long waiting lists for diagnosis or treatment and increased the pressure on the system to buy new devices. Once this situation was recognized, what could be done? COHTA proposed two different approaches.
Technology assessment in Catalonia The first one is being implemented for MRI, and consists of an information system created to detect a pattern of utilization that takes into account a variety of parameters (access, results of the procedure in terms of additional diagnosis information obtained, previous tests performed) and detects outliers. An economic analysis aimed at establishing the real cost of the procedures in the Catalan setting has also been developed. It is intended to adapt the fees of the procedure to its real costs. Apart from the intrinsic value of having objective information regarding patterns of utilization of MRI, this approach could facilitate the dialogue with clinicians with the aim of readdressing those patterns. Without these data it is extremely difficult to have real grounds for discussion with policy makers about a technology in its diffusion stage. The only available data would, then, be those concerning the fees paid for reimbursement. Consequently, COHTA might be left in a position of passively observing an increase in the total cost of the services rendered for MRI without knowing whether this increase matches their rational use in terms of clinical practice and research standards. Even in the absence of material for carrying out the analysis of clinical outcomes, this information system brings solid evidence before the clinicians and specially before policy makers for their consideration. The second approach implies a modification in reimbursement, such as that used for radiotherapy. For this technology, the reimbursement policy was based on a very low fee per fraction of radiotherapy treatment. This gave rise, first, to low incentives for the purchase of radiotherapy equipment, and, second, to high incentives for highly fractionated treatments. It made it impossible to determine the number of patients being treated, and favored low quality services. A deficit of radiotherapy equipment existed in Catalonia and consequently waiting lists were significant. From COHTA’s standpoint, the goal was to help to develope a new reimbursement system that could achieve the following: 1. Gather information about the numbers of treatments performed. 2. Promote the diffusion of the technology 3. Established fees according to real costs adjusted for the complexity of the treatment A new reimbursement system was proposed that included a reimbursement fee per patient treated (controlled for the number of fractions of treatment), and a differential fee that is adapted both to the complexity of the treatment and the number of patients treated. Due to the capital investment needed to purchase new equipment, the Department of Health is supporting the investments but also requires the collection of information for evaluation purposes. The challenge for the future is to improve the information about the clinical effectiveness of radiotherapy.
1645
One conclusion from this experience is that reimbursement policies should include a comprehensive economic appraisal that help to promote a rational diffusion and utilization of technologies. This is probably the best way to integrate the economic evaluations into health policy in Catalonia.
4. FINAL COMMENTS
An analysis of the role played by COHTA as a governmental agency allows one to make some points specifically related to technology assessment and the integration of economic appraisal. In the context of Catalan Health Service, technology assessment is becoming an important component of the policy making process, but it is not the only component. The position of COHTA within the framework of the Department of Health, and the fact that it is a regional agency differentiates it from other technology assessment offices. Our general approach tend toward positioning COHTA close enough to the decision makers in order to ascertain what relevant questions are, but also to close the clinicians and researchers so as to understand their problems in daily practice and the methodological approach that best fits their situation. This approach has advantages and disadvantages. Among the former, the knowledge of the real issues that could be tackled effectively by COHTA, better understanding through the use of a shared language, and its potential influence in the policy making process should be emphasized. Among the disadvantages are the possibility of losing autonomy in the assessment process and the consequent threat to COHTA’s credibility, and the push for timely results. The balance, however, is clearly on the positive side. Other technology assessment approaches have different problems, such as the difficulty in identifying the relevant questions that should be posed by policy makers. The problems that usually interest policy makers are related to ‘big ticket’ technologies. Despite this fact, COHTA tries to include as priorities for assessment other technologies that do not need major capital investment, such as long-term domiciliary oxygen-therapy or other ‘small ticket’ technologies that are widely diffused in the health care system. A basic strategy in technology assessment should be to involve clinicians in the assessment process. Economic appraisal needs to be a component of the assessment process, and play a role when dealing with clinicians. When an evaluation is based on actual clinical data collected in conjunction with appropriate clinical physicians, an economic appraisal is more meaningful and likely to be integrated in the policy making process. Further, clinicians should be involved in the discussions of technology assessment reports and the tendency to discuss these reports only with managers or policy makers should be avoided.
1646
ALICIAGRANALWSand JOSEP M. Boards
Finally, regional agencies that are closely related to regional health services could provide a better understanding of the specific problems in clinical practice and in the utilization of health technologies. The regional approach could also be in a good position to
participate in the policy making process by providing data drawn on the analysis of scientific evidence available regarding technologies or, in the absence of enough scientific evidence by funding research projects with the goal of answering relevant questions.
Pergamon
02779536194 $7.00 + 0.00
TECHNOLOGY ASSESSMENT IN CATALONIA: INTEGRATING ECONOMIC APPRAISAL ALICIA GRANADOS Oficina d’Avaluaci6
and JOSEP M. BORRAS
de Tecnologies Mediques, Department of Health, Pave116 Ave Maria, les Corts 131-159, 08028-Barcelona, Spain
Travessera
de
Abstract-A
brief description of the evolution and role of the Catalan Office for Health Technology Assessment (COHTA) into the framework of the Catalan Health Care Service are presented. Methodological approaches used by COHTA range from synthesis of scientific evidence to the collection of primary data. Regarding the integration of economic appraisal into technology assessment, the main approaches are the following: integration into clinical trials funded by the COHTA and in the reimbursement policies of the Catalan Health Service. COHTA participates in the process of purchasing medical technologies, especially expensive ones, and in the establishment of reimbursement policies of medical technologies. The particular characteristics of COHTA as a regional agency for Technology Assessment and its position into the framework of the Department of Health are discussed. Among the advantages of this position are the knowledge of the relevant questions for policy makers and the potential influence in the process. Among the disadvantages are the possibility of losing autonomy. Regional agencies that are closely related to the regional health services could provide a better understanding of the real problems in clinical practice and in the utilization of health technologies. Key words-technology
assessment,
economic
appraisal,
1. INTRODUCTION
The rational introduction of medical technologies (encompassing both equipment and procedures) requires the demonstration of their efficacy and safety. Further, their diffusion and utilization must be accompanied by the assessment of their effectiveness, and that the reimbursement systems used provide incentives intended to promote appropriate clinical practices. The Catalan Office for Health Technology Assessment (COHTA) was created as a part of Department of Health in Catalonia, Spain, on the basis of this considerations. Catalonia is an autonomous region of Spain, and since the adoption of the new Spanish Constitution in 1979, the Catalan Government has the power to legislate in certain areas and is responsible for providing health care in Catalonia. The Catalan Department of Health instituted the Catalan Health Service as the public body responsible for the management, financing, and provision of health care in the region. The health care system provides universal coverage as mandated by law. In Catalonia, the first initiative taken to promote a rational introduction and diffusion of medical technologies dates from 1984, when the Advisory Board on ‘high technology’ was funded. All of its members were clinicians with different specialties. At that time, the Advisory Board was deemed to be an appropriate mechanism for deciding the usefulness of a given technology. However, it is currently considered insufficient for the following reasons: decision
reimbursement
policies
makers ought to base their decisions on the most objective data available, it is necessary to have data on the cost-effectiveness of a given technology and comparative assessments must be made of the different technologies available. As a result of these considerations COHTA was created in early 1991 as the agency responsible for carrying out medical technology assessment in the Catalan health care system. It is the first agency created in Spain specifically for these activities. The function of the COHTA is to provide decision makers with relevant data on health technologies, knowledge about the consequences of their utilization, trends of existing technologies and cost-effectiveness of technologies when available. In order to carrying this out the organization, the financing system and the evolution of the Catalan Health Service have to be taken into account. In developing its objectives, COHTA works in cooperation with scientific and medical associations, universities and research institutes. COHTA is involved in the decision making process regarding the financing and the diffusion of new technologies in Catalan hospitals that are financed by the public budget. Its main tasks are as follows: -To participate in cal technologies, special payment technologies are -To participate in ment policies of 1643
the process of purchasing mediespecially expensive ones. The procedures employed for these managed at regional level. the establishment of reimbursemedical technologies.
ALICIA GRANADOSand JOSEPM. BornAs
1644
It has to be emphasized, however, that the reports made by COHTA represent only one of the many elements of the decision making process, since COHTA’s approach main contribution is to offer, on the basis of scientific evidence, relevant data. When making their decisions, policy makers must take into account other kinds of data in addition to scientific evidence. To carry out its task, the COHTA combines several methodological approaches depending on the specific topic, the context and the timing of the decision. Among the different projects developed by the COHTA in its still short history are two ongoing randomized clinical trials, the development of systems intended to collect specific data such as the evaluation of patterns of utilization of cardiovascular surgery, percutaneous transluminal angioplasty, and long-term domiciliary oxygen-therapy; and the consequences of newly implemented reimbursement systems, such as those for radiotherapy. Other approaches include the synthesis of information from medical literature so as to provide critical data in the decision making process regarding the introduction and the diffusion of medical technology. Consequently these methodological approaches range from the synthesis of scientific evidence to the collection of primary data. One problem that COHTA faces is how to translate scientific evidence into the Catalan health care system. This implies the ascertainment of the effectiveness of a given technology of proven efficacy in the Catalan setting. ECONOMIC APPRAISAL INTO THE RESEARCH PROJECTS
public funds until the results of the trial were available, it did decide to fund a research project. This project is being carried out in cooperation with two university hospitals, a health economics advisory group and an university research institute. The end points of the trial include the estimation of symptom and complication rates, the assessment of health status by means of the Nottingham health profile and the assessment of costs. The trial is still in progress because patient recruitment has been slower than expected. This is due to the almost parallel development of the laparoscopic cholecystectomy, which is being diffused in Catalonia as quickly as in the rest of Europe. The decision to carry out a trial has had some effects on the number of devices available in Catalonia. The market has been somewhat self-regulating, as can be seen by the fact that only two of the four original devices are stiil being used. No public hospital will buy any such a device until the results of the trial are known and the decision of the Catalan Department of Health is made. This approach has also established a precedent in linking a research project to the introduction in the public Catalan health care system of technologies which has not shown its effectiveness. When a research project is either proposed to or developed by COHTA, COHTA tries to perform an economic evaluation as a component of the project in connection with clinical researchers. There are other projects in which primary data are not collected, but published results are used as a reference for an economic appraisal.
2. INTEGRATING
Economic appraisal has been integrated into a variety of projects as a part of the research design e.g. randomized clinical trials (RCT). In other cases, economic estimates have been made to improve the reimbursement system of some technologies so as to influence their diffusion. A few years ago, one of the more fashionable technologies was biliary lithotripsy. Its potential as a treatment of biliary stones was a matter of great discussion. Due to the competitive position of the private health care sector in Catalonia four such devices were operative, though none of them were in public hospitals. A contract to treat patients from the public sector was offered to the Health Department. The traditional response would have been to contract some predetermined number of treatments that would be paid for on a per treatment basis. However, in this case the response was different. The Department decided, following the proposal from the Program of High Technology (the predecessor of COHTA) to carry out a RCT to demonstrate the effectiveness of the procedure as compared to that of open cholecystectomy. While the Department of Health decided not to reimburse lithotripsy from
3. REIMBURSEMENT POLICIES
The general reimbursement policy in Catalonia is based on per diem hospital stay adjusted for length of stay. The per diem fees vary with the hospital level (county, intermediate and university hospitals) and are supposed to include all technologies of the hospital. However, certain ‘big ticket’ technologies such as MRI, CT-scanner, cardiovascular surgery or organ transplantation are not included in this general reimbursement scheme. There is not an explicit scheme that allows one to determine which technologies ought to be included in the general contract of the hospital or what should be paid under a special agreement. This reimbursement policy induced demand as shown by the increasing number of MRIs or CTscanner being used in the Catalan health service. In practice, the number of such procedures that were paid for was limited and they were established prospectively each year. Nevertheless, the demand produced long waiting lists for diagnosis or treatment and increased the pressure on the system to buy new devices. Once this situation was recognized, what could be done? COHTA proposed two different approaches.
Technology assessment in Catalonia The first one is being implemented for MRI, and consists of an information system created to detect a pattern of utilization that takes into account a variety of parameters (access, results of the procedure in terms of additional diagnosis information obtained, previous tests performed) and detects outliers. An economic analysis aimed at establishing the real cost of the procedures in the Catalan setting has also been developed. It is intended to adapt the fees of the procedure to its real costs. Apart from the intrinsic value of having objective information regarding patterns of utilization of MRI, this approach could facilitate the dialogue with clinicians with the aim of readdressing those patterns. Without these data it is extremely difficult to have real grounds for discussion with policy makers about a technology in its diffusion stage. The only available data would, then, be those concerning the fees paid for reimbursement. Consequently, COHTA might be left in a position of passively observing an increase in the total cost of the services rendered for MRI without knowing whether this increase matches their rational use in terms of clinical practice and research standards. Even in the absence of material for carrying out the analysis of clinical outcomes, this information system brings solid evidence before the clinicians and specially before policy makers for their consideration. The second approach implies a modification in reimbursement, such as that used for radiotherapy. For this technology, the reimbursement policy was based on a very low fee per fraction of radiotherapy treatment. This gave rise, first, to low incentives for the purchase of radiotherapy equipment, and, second, to high incentives for highly fractionated treatments. It made it impossible to determine the number of patients being treated, and favored low quality services. A deficit of radiotherapy equipment existed in Catalonia and consequently waiting lists were significant. From COHTA’s standpoint, the goal was to help to develope a new reimbursement system that could achieve the following: 1. Gather information about the numbers of treatments performed. 2. Promote the diffusion of the technology 3. Established fees according to real costs adjusted for the complexity of the treatment A new reimbursement system was proposed that included a reimbursement fee per patient treated (controlled for the number of fractions of treatment), and a differential fee that is adapted both to the complexity of the treatment and the number of patients treated. Due to the capital investment needed to purchase new equipment, the Department of Health is supporting the investments but also requires the collection of information for evaluation purposes. The challenge for the future is to improve the information about the clinical effectiveness of radiotherapy.
1645
One conclusion from this experience is that reimbursement policies should include a comprehensive economic appraisal that help to promote a rational diffusion and utilization of technologies. This is probably the best way to integrate the economic evaluations into health policy in Catalonia.
4. FINAL COMMENTS
An analysis of the role played by COHTA as a governmental agency allows one to make some points specifically related to technology assessment and the integration of economic appraisal. In the context of Catalan Health Service, technology assessment is becoming an important component of the policy making process, but it is not the only component. The position of COHTA within the framework of the Department of Health, and the fact that it is a regional agency differentiates it from other technology assessment offices. Our general approach tend toward positioning COHTA close enough to the decision makers in order to ascertain what relevant questions are, but also to close the clinicians and researchers so as to understand their problems in daily practice and the methodological approach that best fits their situation. This approach has advantages and disadvantages. Among the former, the knowledge of the real issues that could be tackled effectively by COHTA, better understanding through the use of a shared language, and its potential influence in the policy making process should be emphasized. Among the disadvantages are the possibility of losing autonomy in the assessment process and the consequent threat to COHTA’s credibility, and the push for timely results. The balance, however, is clearly on the positive side. Other technology assessment approaches have different problems, such as the difficulty in identifying the relevant questions that should be posed by policy makers. The problems that usually interest policy makers are related to ‘big ticket’ technologies. Despite this fact, COHTA tries to include as priorities for assessment other technologies that do not need major capital investment, such as long-term domiciliary oxygen-therapy or other ‘small ticket’ technologies that are widely diffused in the health care system. A basic strategy in technology assessment should be to involve clinicians in the assessment process. Economic appraisal needs to be a component of the assessment process, and play a role when dealing with clinicians. When an evaluation is based on actual clinical data collected in conjunction with appropriate clinical physicians, an economic appraisal is more meaningful and likely to be integrated in the policy making process. Further, clinicians should be involved in the discussions of technology assessment reports and the tendency to discuss these reports only with managers or policy makers should be avoided.
1646
ALICIAGRANALWSand JOSEP M. Boards
Finally, regional agencies that are closely related to regional health services could provide a better understanding of the specific problems in clinical practice and in the utilization of health technologies. The regional approach could also be in a good position to
participate in the policy making process by providing data drawn on the analysis of scientific evidence available regarding technologies or, in the absence of enough scientific evidence by funding research projects with the goal of answering relevant questions.