Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.
BACKGROUND
Implementation of a new therapy into clinical practice is a complex process. Various countries have different requirements for information but most often focus on economic evaluation, which often plays a stronger role in healthcare decision making than does clinical evidence.


METHODS
To identify all potential challenges in economic evaluation, the case of a new biological drug, rituximab, used to treat rheumatoid arthritis, has been taken as an example. We present methods and results of economic assessment, highlighting the specific issues that should be considered in countries with economic and health care conditions similar to those of Hungary.


RESULTS
In principle, economic evaluation requires data on characteristics of target population, disease progression, treatment impact, preferences, resource utilization and unit prices. Treatment effect/relative risk reduction and clinical practice patterns (resource use) may be more generalizable, whereas prices and baseline risk need to be jurisdiction specific. In order to address issues of transferability, investments need to be made in the collection of epidemiological and demographic data, plus data on clinical practice patterns, resource use, costs and health state valuation. In Hungary this problem has been solved through conducting a well designed 255 patient cross-sectional study.


CONCLUSIONS
The Hungarian example shows that there should be more investment in data collection for those parameters that are thought to differ most from place to place. Owing to the similarities between Central and Eastern Europe countries in health care systems, clinical practice patterns and economic indicators, they may be able to develop partnerships to develop relevant regional databases and registries.
Brodszky
Valentin
V
Health Economics and Technology Assessment Research Centre, Corvinus University of Budapest, Budapest, Hungary.
Orlewska
Ewa
E
Pentek
Martha
M
Karpati
Krisztian
K
Skoupa
Jana
J
Gulacsi
Laszlo
L
D000911:Antibodies, Monoclonal / Q000191:economics* / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents / Q000191:economics* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D003132:Commerce; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D003661:Decision Support Techniques; D004341:Drug Evaluation / Q000191:economics* / Q000331:legislation & jurisprudence; D006801:Humans; D006814:Hungary; D008390:Markov Chains; D000069283:Rituximab
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab