AVAILABILITY AND REIMBURSEMENT OF ORPHAN DRUGS IN THE CZECH REPUBLIC
Author(s)
Ornstová E1, Sebestianova M2, Paris M3, Mlcoch T2, Bartakova J2, Chadimova K2, Hajickova B2, Dolezal T2
1VALUE OUTCOMES, Prague 2, Czech Republic, 2VALUE OUTCOMES, Prague, Czech Republic, 3COGVIO, Prague, Czech Republic
OBJECTIVES: The objective was to analyse the Czech market with designated orphan medicinal products and evaluate their availability and patient access. The size of orphan market as well as the distribution among different reimbursement schemes were analysed. METHODS: Firstly, we identified drugs with valid orphan status by EMA between 2009-2016. Secondly, the presence of orphans in the Czech Republic was extracted from monthly mandatory distributor’s reports about drugs supplies. Orphans with standard reimbursement were acquired from the list of reimbursed medicinal products published by the responsible authority (SUKL) on monthly basis. Orphans marketed but not detected in SUKL’s listings were considered reimbursed through alternative schemes (mostly individually approved exceptional reimbursement). RESULTS: Since 2009, there were 58% of all EMA designated orphans available on the Czech market. The number of orphans distributed on the Czech market had a rising tendency (35 orphans in 2009 compared with 55 orphans in 2016). However, in December 2016 only 57% of all marketed orphans were listed as reimbursed drugs and therefore accessible to all eligible patients. The remaining 43% were financed by other means, which is turnover compared to proportions observed in December 2009, when only 21% of orphans were not listed among reimbursed drugs. The proportion of orphans entering the regular reimbursement system has been decreasing over the past seven years. Despite the fact, that large portion of orphans stays out of regular reimbursement system, it represents smaller market share (13%) compared to orphans listed as generally reimbursed products (87%). CONCLUSIONS: Availability of orphans on the Czech market is maintained but the volume suggests that it is harder for patients to obtain orphan treatment via individual reimbursement schemes, which places significant administrative burden on patients and officials involved in the individual approval process. Moreover, orphans with low patient potential are not incentivised adequately to access the regular reimbursement.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PSY147
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Prescribing Behavior, Reimbursement & Access Policy
Disease
Rare and Orphan Diseases