J Hjelmgren1, F Berggren, F Andersson. 1. AstraZeneca R & D Lund, Clinical Science, Health Economics & Outcomes Research, SE-221 87 Lund, Sweden.
Abstract
OBJECTIVE: To classify, summarize, and compare the health economic guidelines (HE) issued in Europe, North America, and Australia to clarify similarities and differences between them. MATERIALS AND METHODS: In a literature review HE guidelines were classified according to whether they were 1) formalized, 2) informal, or 3) guidelines for health economic methods. All the guidelines were summarized in a table format according to 15 important methodological aspects. The aspects were compared both within and between the three groups. RESULTS: A total of 25 guidelines were identified, seven formalized, eight informal, and 10 guidelines for HE methods. The levels of agreement for methodological aspects within groups were 40% to 100%, 25% to 100% and 30% to 100% for the formalized, informal, and HE guidelines, respectively. The formal guidelines were slightly more homogenous than the other groups. The between-group comparison showed that the guidelines were in agreement for about 75% of methodological aspects. Disagreement between guidelines was found in choice of perspective, resources, and costs that should be included in the analysis, and in methods of evaluating resources used. CONCLUSION: A harmonization of methodological requirements and recommendations exists both within and between the guideline groups. This review provides information concerning the core of agreements that have been reached. A number of policy implications for various parties, mainly the pharmaceutical industry, were identified.
OBJECTIVE: To classify, summarize, and compare the health economic guidelines (HE) issued in Europe, North America, and Australia to clarify similarities and differences between them. MATERIALS AND METHODS: In a literature review HE guidelines were classified according to whether they were 1) formalized, 2) informal, or 3) guidelines for health economic methods. All the guidelines were summarized in a table format according to 15 important methodological aspects. The aspects were compared both within and between the three groups. RESULTS: A total of 25 guidelines were identified, seven formalized, eight informal, and 10 guidelines for HE methods. The levels of agreement for methodological aspects within groups were 40% to 100%, 25% to 100% and 30% to 100% for the formalized, informal, and HE guidelines, respectively. The formal guidelines were slightly more homogenous than the other groups. The between-group comparison showed that the guidelines were in agreement for about 75% of methodological aspects. Disagreement between guidelines was found in choice of perspective, resources, and costs that should be included in the analysis, and in methods of evaluating resources used. CONCLUSION: A harmonization of methodological requirements and recommendations exists both within and between the guideline groups. This review provides information concerning the core of agreements that have been reached. A number of policy implications for various parties, mainly the pharmaceutical industry, were identified.