Guidelines for economic evaluation of pharmaceuticals: Canada 2nd edition
Cite as:
Guidelines for economic
evaluation of pharmaceuticals: Canada. 2nd. edition. Ottawa:
The Canadian Coordinating Office for Health Technology Assessment; 1997.
Pharmacoeconomics is the application of the methods of economic evaluation of health care programs to interventions involving pharmaceutical products. The techniques and these Guidelines are, on the whole, transferable to the evaluation of any health technology; and the Committee encourages the use of these Guidelines for other health care interventions.
In contrast to the first edition, the focus of the second edition of these Guidelines is to provide assistance to the 'doer' of the analysis or study, for the purposes of providing standardized and reliable information for the target audience - the 'user'. To this end, changes to the Guidelines have focused on key areas where there have been significant developments in theory and/or methodology. At times, these developments have been considerable and/or controversial, in which case the Committee has tried to address all sides of the issue. Any expansion of a given topic should not be interpreted as implying a preference on the part of the Guidelines towards that methodology. Investigators should be assured that emphasis on evolving methodologies is purely for purposes of explanation and clarification.
These Guidelines attempt to be as prescriptive and helpful as possible, and to provide opportunities for creativity and innovation. There is reference to a partner document, A Guidance Document for the Costing Process (CCOHTA, 1996), which provides more details on costing methodology. The second edition should be useful for directing study design, as well as providing a template for the final reports of evaluations. However, investigators should note that, first, each study is unique and considerable thought is required just to implement the Guidelines intelligently. Second, creativity can be exercised to justify particular deviations, or omissions, from the recommended set of methods. Third, there is unlimited scope in adding additional analyses to those suggested in the Guidelines. Finally, creative exploration in methodological research is required to investigate alternative pharmacoeconomic methods for use in updating the Guidelines themselves. To this end, it is suggested that users should be flexible in terms of taking into account deviations from the methodologies suggested herein, provided that these deviations are appropriately justified by the doers.
The second edition of the Guidelines for Economic Evaluation of Pharmaceuticals: Canada has undergone extensive revisions both in format and content. Like the first edition, a great many individuals representing academia, government, private industry and the health care professions have provided insight and suggestions for change. There were three major reasons for revising the first edition of the Guidelines. First, one of the commitments made by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was to review and update the Guidelines. Second, many individuals and organizations have used the Guidelines, thus providing a wealth of experience and development in this field of study. Third, consensus has developed in some areas which were previously controversial.
The first task of the Guidelines Review Committee was to survey all individuals who had received the first edition of the Guidelines since its publication. From the analysis the Committee identified key concerns regarding methodology, organization and comprehensiveness. Although the Guidelines provide further clarification regarding some issues, they are neither a textbook on pharmacoeconomics nor are they intended to be rigid, since many methodologic issues remain unresolved.
The major changes to this edition are as follows:
As with any project, there are many individuals who have been instrumental in developing the final product. The Committee worked diligently in the development of these Guidelines. In particular, Dr. George Torrance, who was the principal writer of the first edition of the Guidelines, and Dr. Judith Glennie, who has been editor and contributing author for this second edition, deserve special credit for their efforts. The Committee is also indebted to the following individuals who provided their expertise in the development of these Guidelines: Dr. Bernie O'Brien, Dr. Peter Tugwell, Dr. Lawrence Joseph, Mr. John Hoar, Dr. Jayanti Mukherjee and Mr. David Moher, as well as the many individuals around the globe who responded to our surveys and provided constructive comments and suggestions. This document incorporates most of their comments; however, CCOHTA and the editor take responsibility for its form, content and any errors or omissions.
Pharmacoeconomics is the application of the methods of economic evaluation of health care programs to interventions involving pharmaceutical products. The techniques and these Guidelines are, on the whole, transferable to the evaluation of any health technology; and the Committee encourages the use of these Guidelines for other health care interventions.
In contrast to the first edition, the focus of the second edition of these Guidelines is to provide assistance to the 'doer' of the analysis or study, for the purposes of providing standardized and reliable information for the target audience - the 'user'. To this end, changes to the Guidelines have focused on key areas where there have been significant developments in theory and/or methodology. At times, these developments have been considerable and/or controversial, in which case the Committee has tried to address all sides of the issue. Any expansion of a given topic should not be interpreted as implying a preference on the part of the Guidelines towards that methodology. Investigators should be assured that emphasis on evolving methodologies is purely for purposes of explanation and clarification.
These Guidelines attempt to be as prescriptive and helpful as possible, and to provide opportunities for creativity and innovation. There is reference to a partner document, A Guidance Document for the Costing Process (CCOHTA, 1996), which provides more details on costing methodology. The second edition should be useful for directing study design, as well as providing a template for the final reports of evaluations. However, investigators should note that, first, each study is unique and considerable thought is required just to implement the Guidelines intelligently. Second, creativity can be exercised to justify particular deviations, or omissions, from the recommended set of methods. Third, there is unlimited scope in adding additional analyses to those suggested in the Guidelines. Finally, creative exploration in methodological research is required to investigate alternative pharmacoeconomic methods for use in updating the Guidelines themselves. To this end, it is suggested that users should be flexible in terms of taking into account deviations from the methodologies suggested herein, provided that these deviations are appropriately justified by the doers.
The second edition of the Guidelines for Economic Evaluation of Pharmaceuticals: Canada has undergone extensive revisions both in format and content. Like the first edition, a great many individuals representing academia, government, private industry and the health care professions have provided insight and suggestions for change. There were three major reasons for revising the first edition of the Guidelines. First, one of the commitments made by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was to review and update the Guidelines. Second, many individuals and organizations have used the Guidelines, thus providing a wealth of experience and development in this field of study. Third, consensus has developed in some areas which were previously controversial.
The first task of the Guidelines Review Committee was to survey all individuals who had received the first edition of the Guidelines since its publication. From the analysis the Committee identified key concerns regarding methodology, organization and comprehensiveness. Although the Guidelines provide further clarification regarding some issues, they are neither a textbook on pharmacoeconomics nor are they intended to be rigid, since many methodologic issues remain unresolved.
The major changes to this edition are as follows:
-
Major rewrites have been done in the following sections: cost-benefit analysis, equity, utilities, treatment comparators, effectiveness, preferences, costing, uncertainty, and portability.
-
Several sections have an annotated bibliography which recommends representative readings on the subject area. The sections to which this feature was added were those where the Committee felt major controversies existed. These references are subject to change over time, and future editions of these Guidelines will include additional sections with bibliographies provided.
-
The references have been expanded and updated.
- A new reporting structure format has been developed to address the needs of users.
As with any project, there are many individuals who have been instrumental in developing the final product. The Committee worked diligently in the development of these Guidelines. In particular, Dr. George Torrance, who was the principal writer of the first edition of the Guidelines, and Dr. Judith Glennie, who has been editor and contributing author for this second edition, deserve special credit for their efforts. The Committee is also indebted to the following individuals who provided their expertise in the development of these Guidelines: Dr. Bernie O'Brien, Dr. Peter Tugwell, Dr. Lawrence Joseph, Mr. John Hoar, Dr. Jayanti Mukherjee and Mr. David Moher, as well as the many individuals around the globe who responded to our surveys and provided constructive comments and suggestions. This document incorporates most of their comments; however, CCOHTA and the editor take responsibility for its form, content and any errors or omissions.