PHP52 - Access To Innovative Medicines In The Czech Republic: Length Of Price And Reimbursement (P&R) Procedures

Abstract

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. 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 2016. At the time of data collection closure, 40 procedures had at least appraisal report issued, out of which 28 had also decision issued. The average time until the first appraisal report was 9.2 (± 3.9) months. The average procedure length, i.e. until decision publication, was 12.9 (± 4.8) months. No correspondence or relation was observed between the procedure length and drug-related properties of the dossier, such as budget impact size or medicine therapeutic area. Combination of the very formal administrative character and rigorous scientific evaluation, together with parallel complex negotiations between the proceeding’s stakeholders, apparently leads to delays in P&R decisions, i.e. patients’ access. The key question for the regulators possibly remains how to increase SUKL’s throughput, i.e. reduce delays, without stepping down on the recently acquired high-quality scientific assessment and rigour.