Large international pharmaceutical companies are expecting the launch in Ukraine of a managed entry agreement mechanism (MEA), which will allow procuring innovative drugs using budget funds.
“We hope that MEA will start working this year,” Director of the health system development department at Roche Ukraine Maksym Proskurov told Interfax-Ukraine, recalling that the Cabinet of Ministers on January 27 of this year settled the procedure for conducting negotiations, concluding contracts and the MEA standard form.
Proskurov said that Roche is actively moving towards the conclusion of MEA. In particular, since April, the company has submitted four dossiers to the State Expert Center (SEC) for medical technology assessment, including three drugs for the treatment of cancer and one drug for the treatment of spinal muscular atrophy (SMA).
“An important basis for the MEA is passing the Health Technology Assessment (HTA) procedure, which actually scientifically substantiates the need to procure a drug based on the treatment effectiveness/price criterion. We expect that in September-October we will receive reports on the completion of the assessment,” he said.
At the same time, Proskurov drew attention to the fact that within the framework of the MEA “price discounts can be very different, but they will be significantly less than market discounts.” According to him, the key aspect when undergoing HTA is precisely the assessment of the impact on the budget, that is, the effective use of funds to provide as many patients as possible with innovative therapy within the rather limited Ukrainian budget.
“We hope that the first MEA will be concluded this year, since without this mechanism it is impossible to provide innovative medicines to patients with cancer and orphan diseases, such as SMA,” Proskurov said.
In turn, Head of the department for work with government bodies of Sanofi in Ukraine Natalia Baranovska said that in fact, the launch of the MEA mechanism is a long-awaited solution for many patients in Ukraine and the entire industry. “After all, MEA is a practice that has long been recognized all over the world and an effective tool for patients’ access to innovative drugs,” she said.
Baranovska said that Sanofi, as a world leader in the healthcare sector, has a wide practice of concluding such agreements with many countries in various therapeutic areas, including the treatment of orphan diseases.
At the same time, she said that it is for orphan diseases in Ukraine that “there are still several unresolved issues.” In particular, currently the legislation provides that for the feasibility of concluding a MEA, the HTA must be carried out. At the same time, the conduct of HTA of drugs intended for the treatment of orphan diseases “has many peculiarities.”
“Therefore, it is the issue of HTA for this group of diseases that has yet to be finalized by the Ministry of Health, and we, as a company, are ready to actively participate in its further discussion and refinement,” Baranovska said.
