Investigating Potential Problems in Comparator Drug Selection for Cost-Effectiveness Assessment of Newly Approved Drugs for Reimbursement Decision
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Objectives: Since cost-effectiveness (CE) is a relative concept in which the incremental costs of a new drug versus comparator treatment are compared with the incremental effects, the choice of a com- parator heavily influences the incremental CE ratio. It has been argued that the selection criteria of comparator treatments suggested by CE guidelines are not well constructed to produce a valid CE as- sessment of drugs. The present study investigated types of potential problems in comparator selection in complying with the Korean CE guideline. Methods: We conducted focus group interviews (FGIs) with experts from drug companies charged with generating and/or submitting CE evidence of their products for reimbursement decisions. To investigate the frequency of the potential problems in the field, we conducted an online survey among those working in drug companies, using a questionnaire developed from the FGI results. Results: Among the six problems identified by the FGIs, the highest proportion of survey respondents experienced “difficulty in obtaining reliable market share data nec- essary to choose comparator treatment” (94%), followed by “drugs widely used for a long time select- ed as comparators because they were recognized as standard treatments” (88%) and “therapeutically nonequivalent drugs selected as comparators” (72%). Conclusion: The results of our investigation would contribute to improving the quality of CE guidelines and the true value assessment of pharma- ceutical interventions.
Abstract
Objectives: Since cost-effectiveness (CE) is a relative concept in which the incremental costs of a new drug versus comparator treatment are compared with the incremental effects, the choice of a com- parator heavily influences the incremental CE ratio. It has been argued that the selection criteria of comparator treatments suggested by CE guidelines are not well constructed to produce a valid CE as- sessment of drugs. The present study investigated types of potential problems in comparator selection in complying with the Korean CE guideline. Methods: We conducted focus group interviews (FGIs) with experts from drug companies charged with generating and/or submitting CE evidence of their products for reimbursement decisions. To investigate the frequency of the potential problems in the field, we conducted an online survey among those working in drug companies, using a questionnaire developed from the FGI results. Results: Among the six problems identified by the FGIs, the highest proportion of survey respondents experienced “difficulty in obtaining reliable market share data nec- essary to choose comparator treatment” (94%), followed by “drugs widely used for a long time select- ed as comparators because they were recognized as standard treatments” (88%) and “therapeutically nonequivalent drugs selected as comparators” (72%). Conclusion: The results of our investigation would contribute to improving the quality of CE guidelines and the true value assessment of pharma- ceutical interventions.
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