On 23 December 2020, the Cabinet of Ministers of Ukraine approved the procedure ("Procedure") for state health technology assessment ("HTA"). State HTA is intended to provide Ukrainian policymakers with data and evidence to support their decisions on how to efficiently direct limited health budget and select from the range of health technologies available.
Medicinal products shall be subject to state HTA in the following cases:
1) Inclusion into, or exclusion from, the National Essential Medicines List ("NEML");
2) Inclusion into, or exclusion from, the lists of medicines subject to centralized public procurement on national level.
3) Conclusion and extension of managed entry agreements ("MEA");
4) Regional procurements by local healthcare authorities outside of the NEML.
N.B.: based on previously released drafts of the Procedure, it was intended to postpone the HTA requirement for regional procurements till 1 January 2022. The approved version does not reflect that. Unless it is modified, in 2021 regional procurements outside the NEML shall be possible subject to the state HTA.
Specially designated state agency to be established by 1 January 2022. Until that, State Enterprise "State Expert Center of the Ministry of Health of Ukraine" ("SEC").
N.B.: In the approved version of the Procedure, the delegation of state HTA function to SEC was delayed till 1 January 2022. This may be a technical mishap, which hopefully will be fixed by the Government. If not, it may significantly hurdle the overall implementation of state HTA.
Pharmaceutical companies are advised to pay attention to these changes and start / continue preparations for state HTA of their medicinal products, particularly those that could further potentially be subject to MEA or considered for inclusion into lists for public procurement.
For further information, please contact Asters' Counsel Viktoriya Podvorchanska