The new managed entry agreement (MEA) and health technology assessment (HTA) regulations adopted in Ukraine over the course of 2020 and 2021 present significant step forward in improving access to treatment in the country. These regulations aim to ensure that patients have access to safe, effective, and innovative medical products at fair prices, while also promoting transparency, accountability, and evidence-based decision-making.

Why were they implemented?

One of the primary goals of the new regulations is to increase access to new treatments and healthcare products. This is particularly important for patients with rare or complex diseases who may require specialized and expensive treatments that are not readily available or covered by insurance. The MEA mechanisms established under the new regulations enable the government to negotiate directly with pharmaceutical companies to procure these treatments at a reduced cost. This not only makes the treatments more accessible to patients but also saves the government money in the long term.

In addition to increasing access to treatments, the new regulations also aim to ensure the quality and safety of healthcare products. This is achieved through rigorous and evidence-based evaluation of products, as well as transparent decision-making and structured negotiations that ensure fair prices. The HTA agency established under the new regulations is responsible for conducting independent evaluations of healthcare products and services, and the regulatory body under the Ministry of Health has been authorized to perform HTA functions on a temporary basis. By ensuring that only safe and effective products are allowed to enter the market, the government is protecting public health and promoting trust in the healthcare system.

Another important goal of the new regulations is to incentivize innovation in medical technology by providing a clear framework for evaluation and reimbursement. By streamlining the approval process for new treatments and healthcare products, the government is encouraging pharmaceutical companies to invest in research and development, knowing that their products will be evaluated fairly and that they will receive a fair price for their innovations. This is particularly important in the context of rare or complex diseases, where there may be a limited market for new treatments and where incentives for innovation may be lower.

Implementation has been successful despite the geopolitical situation.

The new MEA and HTA regulations have already had a significant impact in Ukraine. As of March 2023, 11 items have been obtained through MEAs, including drugs for the treatment and prevention of angioedema attacks, haemophilia medication, Pompe disease, Gaucher disease, and spinal muscular atrophy. The MEAs have enabled patients to receive these treatments free of charge, and it is estimated that they will save approximately USD 10 million in 2022 alone. This demonstrates the effectiveness of the new regulations in increasing access to treatments and ensuring that patients receive the care they need.

To ensure the continued success of the new MEA and HTA regulations, the European Business Association (EBA) Healthcare Committee recommends implementing procurement within targeted regional programs and emphasizing the potential benefits of multi-year agreements. For instance, the Medical Procurement of Ukraine has established a 3-year MEA to provide treatment for Spinal Muscular Atrophy (SMA) with Evrysdi, which would normally cost around USD 6700 for one bottle. This approach not only provides stability for the pharmaceutical companies but also ensures that patients have access to treatments for an extended period of time.

In conclusion, the new MEA and HTA regulations in Ukraine represent a significant step forward in improving healthcare in the country. By increasing access to new treatments and healthcare products, ensuring quality and safety, promoting transparency and accountability, and incentivizing innovation, the government is working to build a healthcare system that meets the needs of all Ukrainians. As the program continues to evolve and expand, it is hoped that more patients will benefit from the benefits of these new regulations and that healthcare in Ukraine will continue to improve in the years to come.

Sources:

• Legal Alliance / Medicine procurement under Managed Entry Agreements (MEA): law passed https://www.legalalliance.com.ua/eng/news/medicine-procurementunder-managed-entry-agreements-mea-law-passed/

• Ukraine adopts MEAs for funding innovative medicines, biologicals and, vaccines and introduces HTA procedures https://cms-lawnow.com/en/ealerts/2021/02/ukraineadopts-meas-for-funding-innovative-medicines-biologicals-and-vaccines-and-introduces-hta-procedures

• Health Technology Assessment Implementation in Ukraine: Current Status and Future Perspectives https://www.researchgate.net/publication/336264423_Health_Technology_Assessment_Implementation_in_Ukraine_Current_Status_and_Future_Perspectives

• HTA207 Managed Entry Agreements in the Context of Health Technology Assessment Recommendations in Ukraine: Analysis on the Stage of Development https://www.valueinhealthjournal.com/article/S1098-3015(22)03870-0/fulltext

• EML Committee Ministry of Health of Ukraine https://www.ispor.org/docs/default-source/regional-chapters/ukraine/1oleshchuk-warsaw.pdf?sfvrsn=228eafb2_0

• Business welcomes the conclusion of the first 9 managed entry agreements for medicines https://eba.com.ua/en/biznes-vitaye-ukladennya-pershyh-9-dogovorivkerovanogo-dostupu-na-liky/

• Ukraine Finalizes 1st Batch of MEAs Including Roche’s Evrysdi https://www.navlindaily.com/article/15072/ukraine-finalizes-1st-batch-of-meas-including-roche-s-evrysdi

• Вперше в Україні пацієнтам будуть безоплатно доступні ліки проти спінальної м'язової атрофії https://moz.gov.ua/article/news/vpershe-v-ukraini-pacientambudut-bezoplatno-dostupni-liki-proti-spinalnoi-mjazovoi-atrofii

• Edem Adamanov, a representative of the Ministry of Health https://medzakupivli.com/en/pro-mzu-eng/novini-eng/31681-edem-adamanov-told-how-patients-withsma-can-get-treatment-for-free