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

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

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

ISSN: 1750-1172