ACCESS TO INNOVATIVE MEDICINES IN THE CZECH REPUBLIC- LENGTH OF PRICE AND REIMBURSEMENT (P&R) PROCEDURES

Author(s)

Klimes J, Fuksa L, Vocelka M
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Králové, Czech Republic

OBJECTIVES: Since January 2008, the Czech Republic (CZ) regulation on P&R processes in drugs follows both specific assessment and formal proceeding rules including timelines based on EU Transparency Directive. But only much later (2012/2013), specific methodologies for mandatory budget impact and cost-effectiveness analyses were issued by Czech P&R decision body (State Institute for Drug Control; SUKL) formalizing the SUKL’s position as a national HTA agency for appraisal of medicines. The aim of the present study was to describe how the current status quo affects the actual length of the procedures concerning innovations. METHODS: Lists of administrative proceedings and individual proceeding files, were both accessed via public SUKL web page. First, all proceedings initiated between January 2013 and February 2016 were identified (N = 4,153). Consequently, only P&R proceedings on innovative medicines were selected: the inclusion criteria were strictly limited to first-in-class drugs at their 1st submission. The selected proceedings (N = 65) were then analysed and followed up to May 10th

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP52

Topic

Health Policy & Regulatory, Health Service Delivery & Process of Care

Topic Subcategory

Approval & Labeling, Hospital and Clinical Practices, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Multiple Diseases

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