Pharmaceutical regulation and policies in Austria

Abstract

Austria is a middle-sized, high-income country in Central Europe with universal health coverage and a highly fragmented health care system. Medicines for outpatient use that are reimbursed by the social health insurance are price-regulated, whereas medicines for inpatient use are neither subject to price regulation nor to health technology assessment (HTA). These medicines are procured by hospitals, hospital groups and provinces which are the main owner of public hospitals. The major pricing policy for new medicines in the outpatient sector is external price referencing. Austria refers to all other 26 European Union (EU) Member States; the determined benchmark price must not exceed the EU average price. External price referencing is based on list prices, but the statutory manufacturer discounts applicable in some reference countries are considered. Regular price reviews with subsequent price adjustments are in place. For generic and biosimilar medicines to be included in the outpatient positive list, a price link policy is applied with different reduction rates for generics and biosimilars. In the supply chain, prices of all medicines are regulated through regressive mark-up schemes for wholesale and community pharmacies. The inclusion in the outpatient positive list is based on an HTA process which comprises pharmacological, medical-therapeutic and economic evaluations, followed by price negotiations about the reimbursement price. For medicines with high financial burden for the public payers, the Austrian Social Insurance (for the outpatient sector) and procurers for hospitals tend to conclude managed-entry agreements with confidential discounts. For outpatient medicines, patients are charged a fixed prescription fee per prescribed item; no further co-payments apply for outpatient or inpatient medicines. Studies have shown that the current pricing and reimbursement policies in Austria have contributed to keep prices of outpatient medicines stable (high-cost medicines tend to range above EU average), whereas the unregulated prices of medicines used in hospitals are frequently the highest in European comparison. Pharmacy mark-ups are also high in comparison to other European countries.