Table 2.
Summary of reimbursement aspects in Central Eastern European countries.
| Question | Bulgaria | Croatia | Czechia | Estonia | Hungary | Latvia | Lithuania | Poland | Romania | Slovakia |
|---|---|---|---|---|---|---|---|---|---|---|
| Are there any special laws /policies regarding orphan drugs different from the ones for non-orphan drugs? | No | Yes | No | No | Yes | No | Yes∗ | No | Yes | Yes |
| If yes, could you please describe in what way the special law/policy for orphan drugs differ from that for non-orphan drugs? | NA | Source of payment | NA | NA | e.g., acceptability of cost-effectiveness | NA | Positive decision of The Ultra-rare diseases reimbursement Committee | NA | Special therapeutic programs | No QALY thresholds |
| Who (or what entity) provides reimbursement decisions (decisions on the coverage of a part or whole cost of orphan drugs from public budget)? | The National Council for Pricing and Reimbursement of Medicinal Products | CHIF | SUKL | Ministry of Social Affairs, Health Insurance Fund | NIHIFM, Department of HTA, HTA Committee, Ministry of Human Capacities | The National Health Service of Latvia or Committee | Reimbursement committee or Ultra-rare diseases reimbursement Committee | MoH | Drug Agency evaluation, MoH, NHIH | MoH |
| Is the list of reimbursed drugs publicly available? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Who applies for reimbursement? Is it the MAH or a public decision-making body, e.g., the MoH? | MAH | MAH | MAH, importer, domestic manufacturer, health insurance company | MAH, doctors’ organizations | MAH | MAH, authorized representative, wholesaler | MAH, doctors’ or patients’ organizations, doctor application for an individual patient (ultra-rare disease) | MAH | MAH | MAH |
MAH, Marketing Authorization Holder; MoH, Ministry of Health; QALY, Quality-Adjusted Life Year; ICER, Incremental Cost-Effectiveness Ratio; GDP, Gross Domestic Product; CEA, Cost-Effectiveness Analysis; CUA, Cost-Utility Analysis; CMA, Cost-Minimization Analysis; BIA, Budget Impact Analysis; NA, Not Applicable; HTA, Health Technology Assessment; SUKL, State Institute for Drug Control in the Czechia; NHIH, National Health Insurance House in Romania; CHIF, Committee for Medicines in Croatia; NIHIFM, National Institute of Health Insurance Fund Management. “∗” indicates ultra-orphan (1:200,000) diseases.