QUALITY ASSURANCE OF FOURTH HURDLE IN HUNGARY – A METHODOLOGICAL APPROACH

Author(s)

Kalo Z1, Pekli M2, Inotai A31Eotvos Lorand University, Budapest, Hungary, 2National Institute for Strategic Health Research, Budapest, Hungary, 3Semmelweis University, Budapest, Hungary

OBJECTIVES: Despite the availability of Hungarian methodological guidelines the quality of economic evaluations submitted in pharmaceutical reimbursement dossiers are rather heterogeneous. The 10-12 point international critical appraisal checklists are not detailed enough to filter the problems occurring in Hungarian studies, therefore they are not widely used. As a consequence only small proportion of economic evaluations are published in medical journals, which limits the development of health economic skills and the broad utilisation of economic rationale in medical decision-making. The aim of our study was to develop a relevant Hungarian checklist for the critical appraisal of economic evaluations. METHODS: Fifty economic evaluations submitted for reimbursement of pharmaceuticals in 2007-8 were scrutinized by two independent reviewers to identify the most common methodological problems. Reviewers had no intention to revise previous reimbursement decisions. Based upon the assessment of 10 studies, a draft checklist was developed. After assessing 25 reports, an extended workshop was settled to reconcile the opinion of reviewers and to improve the checklist. The reviewers scrutinized the second 25 economic evaluations according to the checklist. The checklist was finalized at a second workshop. RESULTS: The final checklist consists of 3-8 dichotomised questions in several major topics concerning comparator selection, effectiveness, costs, sensitivity analysis, methodological approach and interpretation of results. When the checklist is used for critical appraisal, reviewers may exclude non-relevant question items. CONCLUSIONS: Our checklist is based on current Hungarian practice. As the published checklist will be officially used for the appraisal of economic evaluations in reimbursement dossiers, submitters can assure the quality of their economic evaluations and predict outcomes of the health technology assessment process. The transparent method of single technology assessment may improve the consistency of pharmaceutical reimbursement decisions and the utilization of economic evaluations in other fields of health care decision-making.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PHP10

Topic

Health Policy & Regulatory

Topic Subcategory

Pricing Policy & Schemes

Disease

Multiple Diseases

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