Since September 1, 2017, medicinal products authorized and included in the National List of Essential Medicines (hereinafter referred to as the National List) are subject to procurement by healthcare institutions fully or partially financed from the state and local budgets. These requirements do not apply to medicinal products purchased by the Ministry of Health based on Contracts with specialized procurement organizations.
To add a medicinal product to the National List, it is necessary to submit an Application and documents confirming the comparative efficacy, comparative safety and feasibility of the medicinal product to the State Expert Center of the Ministry of Health of Ukraine.
The Health Technology Assessment is carried out under the Resolution of the Cabinet of Ministers of Ukraine No. 1300 of 23 December 2020 "Procedure for Conducting Health Technology Assessment" and the Guidelines “Health Technology Assessment” ST-N MOZU 42-9.1:2021.
The Health Technology Assessment is carried out in the following cases:
- inclusion (exclusion) of medicinal products in (from) the National List of Essential Medicines;
- inclusion (exclusion) of medicinal products in (from) the nomenclature (lists, registers) purchased with budget funds for the implementation of programs and centralized health protection measures.
The Health Technology Assessment dossier consists of the following sections:
- General section.
- Clinical section.
- Pharmacoeconomic analysis section.
- Section of the analysis results.
The documentation is developed for a specific therapeutic indication of the medicinal product.
The clinical section includes the following subsections:
- Analysis of epidemiology in the world and Ukraine, social and economic burden.
- Diagnostics, prognosis.
- Modern treatment methods.
- Description of the health technology being assessed in Ukraine.
- Target population, treatment efficacy analysis.
- Competitive technology, justification of choice, efficacy analysis.
- Justification of the population and competitive technology, justification of the choice of the comparator.
- Outcomes assessed.
- Review of international and domestic guidelines, clinical treatment protocols.
- Clinical part conclusions.
The pharmacoeconomic section includes the following subsections:
- Medicinal product price in reference countries.
- Selection of the search strategy. Strategy for searching comparative clinical trials; strategy description and methodology.
- Assessment of the methodological quality of the selected studies.
- Clinical analysis of selected clinical trials.
- Safety assessment of compared technologies.
- Justification of the choice of the method of pharmacoeconomic analysis.
- Modelling. Pharmacoeconomic analysis.
- Sensitivity analysis.
- Analysis of the impact on the budget.
Justification of the feasibility of a medicinal product is a simulated pharmacoeconomic analysis using different types of analysis (analysis of the cost of the disease, cost-effectiveness, cost-utility, budget impact, cost minimization, etc.).
Since 2006 we support the pharmaceutical business in regulatory affairs, pharmacovigilance, and quality. We are a leading regulatory consultant in Ukraine and 11 countries of the CIS region. Our extensive team has the necessary knowledge, experience, and skills and is proficient in English.
We have provided regulatory services for more than 200 manufacturers of medicines, many of which recommend us as a regulatory partner.
- consultation, development of registration strategy;
- establishment of new registration, renewals, and variations;
- establishment and maintaining a pharmacovigilance system, outsourcing the functions of the local contact person;
- confirmation of manufacturing conditions with GMP requirements through recognition or inspection.
In addition to the main services, we also offer:
- translation of the scientific, medical, technical, and legal documentation;
- back-office operations: preparation of the registration dossier or any of its parts without submission;
- development and pre-printing verification of labeling artworks and instructions for use;
- medical writing of parts of the registration dossier;
- development of documentation and import licensing;
- writing of documentation for inclusion of the medicinal product in the National List (HTA).