HTA experience in Ukraine, key achievements, and what will change in the new HTA Guideline – Oresta Piniazhko, Director of the Department of HTA and Rational Pharmacotherapy of the Center, shared the latest news during her speech at the industry conference “Pharmbudget 2024”, held recently in Kyiv.
The specialist reminded that HTA is one of the main tools for improving patients' access to clinically effective and cost-effective treatment in Ukraine. Over the period of 2021-2023, the Center, as the authorized body for state HTA, provided the relevant ministry with 88 conclusions with recommendations: about 36% of them concerned medicinal products for the treatment of oncological diseases, 21% – orphan, 10,4% – cardiovascular, 6% – for neonatal care, 4,5% – multiple sclerosis, 3% – diabetes mellitus.
About 50% of conclusions of the state HTA based on the expert evaluation of dossiers contain recommendations on implementing the HTA recommendations by considering the possibility of concluding managed access agreements (MAAs). The first 10 MAAs were concluded at the end of 2022.
Oresta Piniazhko also drew the attention of those present to the main updates to the draft Guideline “State Health Technology Assessment for Medicinal Products,” which were developed by specialists of the Department and which was under public discussion in August.
“The update of the guideline should help minimize methodological errors in the submission of applications and dossiers and, accordingly, improve their quality,” emphasized Oresta Piniazhko. “When updating the Guideline, the authorized body took into account the experience of analyzing the dossiers submitted by applicants. The new edition is also based on recommendations received during the participation of the Center's experts in international training programs – the HTA Capacity Building Program supported by the SAFEMed project and Radboud University Nijmegen (Radboud Universiteit Nijmegen, the Netherlands, 2023), and the comprehensive Knowledge Transfer and Capacity Development Program on the institutionalization and management of HTA processes for the MoH of Ukraine, at the invitation of NICE and the Department for Business and Trade of the United Kingdom (June, 2023).”
As a result, in the draft document:
- updated recommendations on determining the PICO scheme and analyzing the efficacy and safety of medicinal products;
- updated recommendations on pharmacoeconomic analysis and budget impact analysis;
- added HTA recommendations for vaccines;
- supplemented with sections on the identification and involvement of stakeholders, and assessment forms for conducting primary and professional expert evaluations, which guide experts during state HTA.
Also, the new edition of the Guideline for the first time includes prospects for expanding the scope of application of HTA, in particular regarding other medical technologies that are not medicinal products.
Oresta Pyniazhko reminded that the Center continues to work closely with applicants and conducts educational methodological trainings that will significantly improve the quality of applications and dossiers submitted for HTA. The next training will take place as early as October 25 this autumn, so we recommend registering to participate. https://www.dec.gov.ua/…/seminar-trening-omt…/
