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THE OUTCOMES OF MANAGED ENTRY AGREEMENTS IN ROMANIA FROM 2015 TO 2022

CIPRIAN PAUL RADU 1, LOREDANA DRĂGOI 2, MIHNEA A. UDROIU 3, BOGDAN C. PANĂ 1*, MIHAELA CATRINEL ILIESCU 4

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Managed Entry Agreements (MEA) are contracts between governments/payers and pharmaceutical companies done at a special discounted price, volumes and/or health outcomes to mitigate the uncertainty regarding a medicine’s relative effectiveness, cost-effectiveness, or budget impact. A contribution to the knowledge in the field is provided by this article’s analysis of eight years of implementation in Romania, which reveals data on the volumes, budgets and utilisation in various therapeutic areas. A descriptive analysis of the existing MEAs in Romania was performed, measuring the outcomes of MEA development in terms of the number of drugs reimbursed, the therapeutic areas covered, the treated patients and the resources allocated. In Romania, the MEAs are performed as Cost-Volume contracts (financial-based contracts) or Cost-Volume-Results contracts (outcome-based contracts). The number of drugs having MEA increased yearly in the period of 2015 and 2022, from 6 to 79 and from 2 to 12 therapeutic areas. The main drugs with Cost-Volume contracts, in 2022, were in the therapeutic areas of oncology, neurology and rare diseases. The Cost-Volume-Results contracts were used only in hepatitis C. The no. of patients treated with MEA drugs increased from 10 in 2015 to 250,726 patients in 2022. In Romania, the MEAs are, in 2022, a frequent pathway to the public reimbursement of new drugs, covering 16.82% of the total drug budget and representing 48.2% of the total innovative drugs entered to the market. MEAs proved to be a solid ground for the reimbursement of new drugs. The future steps for MEA are already envisaged in terms of new types of agreements that could bring additional benefits for the health care system and patients.