[Relevance of pharmacoeconomic analyses to price and reimbursement decisions in Austria].
Since the social sick funds have only limited amounts of money at their disposal, whereas the pharmaceutical market is constantly growing, thorough evaluations have to be undertaken how contributions are to be spent to get adequate value for money and especially to gain utmost benefit for the patients. When deciding on whether a pharmaceutical is listed in the Code of Reimbursement or not, pharmacoeconomic studies are obligatory in two cases: for real innovations with substantial therapeutic benefit and for applications for inclusion in the Yellow Box, when there are no alternatives listed in the Yellow Box. On the basis of the pharmacoeconomic study a comprehensible and justifiable cost/use relation of the pharmaceutical applied for should be proven in comparison with therapeutic alternatives in Austria. However, a pharmacoeconomic study is always only one aspect among others deciding on reimbursement and price. Even though the pharmaceutical applied for is not included in the Code of Reimbursement, reimbursement is possible in special cases if there is no adequate pharmaceutical listed in the Code of Reimbursement and the pharmaceutical is absolutely needed for therapeutic reasons. In these cases prior approval from a chief medical officer is required. Pharmacoeconomic studies for the purpose of section sign 25 of the Rules of Procedure for publishing the Code of Reimbursement (VO-EKO) must meet the following requirements: From a methodical point of view both cost-effectiveness analyses and--in justified cases--cost-utility analyses may be used. Due to required accuracy and traceability incremental analyses are preferred. Medical and economic data underlying the pharmacoeconomic study have to show a high degree of validity and evidence. The perspective to be taken is that of the Austrian Health Insurance. When determining the therapeutic alternatives, the most frequent indication, the most purposeful medical dosage and the main group of affected patients have to be considered. Hereby the order "Green Box-Yellow Box-Red Box" has to be taken into account. The direct costs of the obligatory benefits of the social insurance institutions of medical treatment (medical assistance, drugs, substitute assistance), institutional care (based on LKF points) and the medical measures of rehabilitation are to be set. Due to required transparency and traceability quantity and cost structure have to be listed separately. Prices of single items and resource usage in form of units of measurement have to be stated. Studies performed in other countries than Austria may be subject to different health care systems, general conditions, therapeutic alternatives and costs and have therefore to be adapted to Austrian conditions. It must not be disregarded that pharmacoeconomics as any other science comprises different opinions and basic approaches and that pharmacoeconomics is making progress all the time. However, considering their limitations with regard to the interpretation of the results, pharmacoeconomic studies are a key factor for assessing new pharmaceuticals and represent an important contribution to reimbursement and price decisions in Austria.
Führlinger
Susanne
S
Hauptverband der Osterreichischen Sozialversicherungsträger, Wien, Osterreich. vertragspartnermedikamente@hvb.sozvers.at
D000328:Adult; D001317:Austria; D002648:Child; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D016527:Drug Costs; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D017850:Economics, Pharmaceutical / Q000331:legislation & jurisprudence; D019317:Evidence-Based Medicine; D005252:Fees, Pharmaceutical; D006801:Humans; D007348:Insurance, Health / Q000191:economics; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D008483:Medical Assistance / Q000191:economics; D015201:Meta-Analysis as Topic; D008962:Models, Theoretical; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic