Table 7.
Aspect required | Bulgaria | Croatia | Czechia | Estonia | Hungary | Latvia | Lithuania | Poland | Romania | Slovakia |
---|---|---|---|---|---|---|---|---|---|---|
Is HTA dossier obligatory in pricing and reimbursement submission? | Yes | No but alternative assessment has to be submitted | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
In case if HTA is not obligatory it could be submitted with a reimbursement application as a additional facultative dossier? | It's obligatory | Yes | It's obligatory | It's obligatory | It's obligatory | It's obligatory | It's obligatory | It's obligatory | It's obligatory | It's obligatory |
Are HTA guidelines obligatory for submitted HTA dossier attached to the reimbursement application? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
What institutions are responsible for determining “benefit” and “value” of pharmaceuticals? | HTA Commission National Council Ministry of Health | The CHIF and their Expert council of the CHIF | State Institute for Drug Control (SUKL) | Ministry of Social Affairs Health Insurance Fund | The National Institute of Health Insurance Fund Management (since 2016) The HTA Office at the National Institute of Pharmacy and Nutrition The Medical Professional Colleges The Technology Assessment Committee | The National Health Service of Latvia | Ministry of Health The State Medicines Control Agency National Health Insurance Fund under the Ministry of Health | Polish HTA Agency (Agency for Health Technology Assessment and Tariff Systems; AOTMiT) | National Agency for Medicines and Medical Devices in Romania | Slovak Ministry of Health The Reimbursement Committee |