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Ukrainian Government Approves the Procedure for State Health Technology Assessment

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.

SCOPE

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.

Exceptions:

  • medicines included into the centralized procurement lists as at 24 December 2020;
  • medicines on the NEML;
  • emergency procurements required to address epidemics, natural disasters etc.;

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.

AUTHORITY

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.

PROCESS


TIMELINE
 

  • The Procedure becomes effective from (i) 24 December 2020 for medicinal products, and (ii) 1 January 2022 for other health technologies;
  • 6 months for the MOH to approve a guideline for state HTA of medicinal products;
  • 1 January 2023 – deadline for completing state HTA of medicinal products that (i) are subject to public procurement on national level outside of the NEML, and (ii) are on the NEML, but not included into the WHO Model List of Essential Medicines.

KEY TAKEAWAY

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 

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