DEVELOPMENT OF A CHECK LIST FOR QUALITY ASSESSMENT OF PHARMACOECONOMIC EVALUATIONS SUBMITTED FOR REIMBURSEMENT IN TAIWAN
Author(s)
Wu GHM1, Liao CH1, Shau WY1, Lo PC1, Pwu RF21Center for Drug Evaluation, Taipei, Taiwan, 2Taipei Medical University, Taipei, Taipei, Taiwan
Presentation Documents
OBJECTIVES: It is not mandatory for pharmaceutical manufacturers to submit cost-effectiveness evidence yet in Taiwan, but an incentive of a maximum 10% mark-up for conducting local cost-effectiveness analysis has been announced since 2010. HTA/CDE (Division of Health Technology Assessment, Center for Drug Evaluation) assists the assessment on the strength of evidence of local cost-effectiveness evaluation, and a checklist was therefore developed to ensure the consistency and to improve the transparency. This study presents the impact of local pharmacoeconomic incentive and the development of the checklist. METHODS: By reviewing other international checklists for quality assessment of pharmacoeconomic evidence and adding items for local adaptation and transferability, a checklist consisting of four dimensions including PICOS, cost-effectiveness analysis design, source of parameters, and overall quality was developed with a four-level-grading for evidence strength. The local pharmacoeconomic evidence was identified from the dossiers submitted by the manufacturers during 2008-2011, and was independently assessed by the four reviewers in the economic evaluation team of HTA/CDE as reference cases. Discrepancies between reviewers were discussed until consensus was reached. RESULTS: There were 83 and 67 dossiers submitted for reimbursement before and after the incentive was announced, respectively. However, no local pharmacoeconomic evidence has been submitted until eight months after the incentive was announceed. Another four dossiers consist of five local pharmacoeconomic evaluation (one with multiple indications) were submitted in 2011. The strengths of evidence were graded as strong, medium, low, and very low for 0, 1, 2, and 3 cases according to the checklist. CONCLUSIONS: A pragmatic strategy was used to incorporate cost-effectiveness evidence into the drug reimbursement decisions in Taiwan. Local pharmacoeconomic evidence submissions increase slowly after the incentive was announced. A quality assessment checklist was proposed. Further experience will be cumulated and discussed among the submitting bodies, the appraisal committee members, and HTA/CDE.
Conference/Value in Health Info
2012-09, ISPOR Asia Pacific 2012, Taipei, Taiwan
Value in Health, Vol. 15, No. 7 (November 2012)
Code
HT3
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Multiple Diseases