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Life Sciences Bulletin: The managed entry agreements race in Slovakia

As 2023 drew to a close, the pharmaceutical sector in Slovakia saw a notably busy period due to a looming deadline for the conclusion of Managed Entry Agreements (MEAs). 

All medicinal products previously subject to conditional reimbursement were required to undergo resubmission, culminating in the conclusion of MEAs with the Ministry of Health by the 31st of December. Failure to comply would not only result in the delisting of these products, but also controversially, necessitate that Marketing Authorisation Holders (MAHs) bear the cost of treatment until patients could transition to a comparable therapy, although for a period no longer than 24 months.

The deadline for finalising these MEAs proved to be a formidable challenge. During the course of the year, the Ministry of Health was overwhelmed not only with resubmissions but also concurrent negotiations stemming from new pricing and reimbursement applications that mandated MEAs.

As a result of the unwavering efforts of the market access teams from pharmaceutical companies, and the dedication of the hardworking, albeit thinly-stretched, team at the Ministry of Health, the situation was effectively resolved. The majority of negotiations and agreements were successfully concluded just before the festive Christmas period.

Consequently, patients in Slovakia will continue to have access to a variety of innovative treatments, with the prospect of new ones being introduced in the near future.