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Table 4 Summary of aspects related to health technology assessment (HTA)

From: Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe

Question Bulgaria Croatia Czechia Estonia Hungary Latvia Lithuania Poland Romania Slovakia
Are there any advisory bodies (e.g. HTA agencies) that make recommendations whether or not to reimburse a specific orphan drug? Yes Yes Yes No Yes Yes N/A Yes Yes Yes
Does a positive recommendation mean the orphan drug will definitely be reimbursed? No Yes Yes No No No Yes No Yes No
Are the reimbursement recommendations publicly available? Yes No Yes Yes No Yes No Yes Yes Yes
Does the orphan drug need to show cost-effectiveness to be reimbursed? No Yes Yes Yes Yes Yes Yes* Yes No Yes
Does the orphan drug need to show an acceptable safety profile to be reimbursed? Yes Yes Yes Yes Yes Yes Yes Yes No Yes
Does the orphan drug need to show acceptable efficacy to be reimbursed? Yes Yes Yes Yes Yes Yes Yes Yes No Yes
Are there any HTA requirements for orphan drugs to be reimbursed? Yes Yes Yes Yes Yes No N/A Yes N/A Yes
  1. *Not required for ultra-rare diseases; N/A – not applicable