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.
Indian pharmaceutical companies are ready to provide Ukrainians with antiviral drugs, the Indian Pharmaceutical Manufacturers Association (IPMA) has said.
“The leading Indian pharmaceutical companies represented by IPMA in Ukraine are ready to assist Ukraine in providing it with high-quality and effective medicines, including antiviral drugs, which have recently been used in the fight against the coronavirus disease COVID-19 in the world,” the association said.
IPMA also reported that Indian doctors have noted some success in treating COVID-19 with drugs such as LPV/r, Oseltamivir, Ribavirin and Chloroquine.
“At the same time, it is probably still necessary to observe patients in order to reach a final conclusion,” the IPMA said.
At the same time, the association said that Indian family companies, which are one of the world leaders in the production of drugs for the treatment of HIV/AIDS, will be ready for a possible increase in supplies to Ukraine if the country makes such a decision.
“So far, such negotiations are not conducted, but we are ready for them,” the IPMA said.
At the same time, the association said that Indian pharmaceutical companies have sufficient capacity to meet increasing demand.
“Like any state, in connection with the current situation in the world – the COVID-19 pandemic, India should protect its citizens first of all. But for now, our manufacturers have enough capacities to provide other countries [with drugs] as well,” the IPMA said.
The association said that currently, due to the lack of air traffic, there are some difficulties with the delivery of goods from India, including drugs, while there are no delays in customs and interruptions in logistics.
The range of orders that come from pharmacies and medical institutions as a whole has not changed, but, in addition to ordinary orders, there is a demand for masks and disinfectants.
