Large intl pharmaceutical companies expect launch of MEA in Ukraine

(Text after paragraph 10 has been added in news item issued on Sept 21)

KYIV. Sept 22 (Interfax-Ukraine) – 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.

For his part, Director General of AstraZeneca for Ukraine and Eurasia Yevhen Haidukov said that the company also welcomes the adoption of the law, which should launch the MEA mechanism.

"The final adoption of the law indicates that support for innovation is a priority for the state," he said.

Haidukov said that innovation is at the heart of AstraZeneca’s activities.

"The number of MEAs concluded by different states with AstraZeneca is growing every year. We are glad that the new MEA mechanism, for which the necessary regulatory framework has now been created, can be used to significantly expand the access of Ukrainian patients to innovative therapy," he said.

According to Haidukov, under MEA AstraZeneca is ready to offer effective treatment for patients with cancer, cardiovascular diseases, and diseases associated with metabolic disorders – a treatment that can provide effective results, improving the quality of life of patients, increasing their survival rate.

At the same time, the expert said that "the MEA mechanism is new for Ukraine, and it will require a significant mobilization of efforts from all parties so that the first MEA can take place already in 2022."

"At present, the AstraZeneca is at the stage of preparing several dossiers for submission to the SEC for undergoing the HTA," he said.

Haidukov said that based on the results of the HTA, AstraZeneca will be ready to make every effort to quickly go from the beginning of the negotiation procedure on the MEA to the conclusion of the agreement.

"I think that during the negotiations with the aim of concluding a MEA, AstraZeneca will also be able to propose solutions that may further interest government agencies to develop one or another therapeutic area in Ukraine," he said.

Haidukov expressed hope that in the near future the adopted law will be signed by the President of Ukraine and come into force. He said that the company hopes that the term of the MEA will be increased to two or three years.

"This would allow all participants in the MEA mechanism to ensure more long-term planning and expand the access of Ukrainian patients to effective innovative therapy," the expert said.