AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
social insurance institutions in order to avoid the social insurance institutions requesting a cost estimate in advance regarding devices if no con- tract between the social insurance institutions
this period, the costs are covered only if there is approval from the chief medical office of the social insurance institutions. Finally, even the so-called “no-box” medicinal products – ie, products for which no application has been made to be included in the EKO – can be reimbursed if the individual prescription has been approved by the chief medical office. As this option is usually chosen for very expensive medicines, the Austrian legislator has introduced a requirement that the EU average price be rel- evant to these products if turnover exceeds EUR 750,000 (see 8.1 Price Control for Pharmaceu- ticals and Medical Devices ). Changes within the boxes and deletions from the EKO are possible at the request of both the company authorised to distribute the product and the DVB (supported by the HEK’s recom- mendations). If the social insurance institution refuses reim- bursement in an individual case, the patient can file an action before the civil courts. In these pro- ceedings, typically, the court reviews the social insurance institution’s decision with the help of a specific expert, who is entitled to decide on the reimbursement. The court’s decision may be challenged before the Higher Regional Court and, eventually, before the Supreme Court. No system comparable to the EKO exists for medical devices and IVD devices. For reim- bursement of medical devices and IVD, see 8.3 Pharmaceuticals and Medical Devices: Reim- bursement From Public Funds . 8.5 Regulation of Prescriptions and Dispensing by Pharmacies Essentially, retailing of medicinal products (whether available only upon prescription or
and the manufacturer is in place. 8.4 Cost-Benefit Analyses for
Pharmaceuticals and Medical Devices Any entity authorised to distribute a medicinal product approved and available in Austria may apply for inclusion in the EKO. The medicinal products undergo a pharmacological, medical- therapeutic, and health-economic evaluation regarding their eligibility for reimbursement. In this process, the DVB is supported by the Medi- cines Evaluation Commission ( Heilmittel-Evalu- ierungs-Kommission , or HEK), an independent advisory body that is not bound by instructions. The HEK’s recommendations form the basis of the DVB’s decisions. The EKO is divided into three areas (known as “boxes”), which are outlined below. • The Green Box contains medicines that the health insurance institutions reimburse to the socially insured without special authorisation. These are freely prescribable. • The Yellow Box includes medicinal products that social insurance institutions consider to have a significant additional therapeutic ben- efit for patients but which were not included in the Green Box for medical or economic reasons. For these medicines, health insur- ers reimburse the insured if the prescription has been approved by their chief medical office (dark yellow area RE1). In some cases, a retrospective control is also accepted (light yellow area RE2). • The Red Box contains medicinal products for a limited time while the company’s request for inclusion in the EKO is being reviewed. During
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