Financial Outcomes of Managed Entry Agreements for Pharmaceuticals in Italy.

Importance: Most countries in the Organisation for Economic Co-operation and Development apply managed entry agreements (MEAs), reimbursement arrangements between manufacturers and payers, to pharmaceuticals. Few data exist regarding their ability to lower expenditures. Objective: To analyze the financial outcomes of MEAs for pharmaceuticals from 2019 to 2021 in Italy. Design, Setting, and Participants: In this observational study of MEAs and pharmaceutical spending in Italy, medications that were monitored through individually collected data and generated paybacks from manufacturers during the 2019 to 2021 study period were included in the analysis. Payback data were collected through pharmaceutical spending monitoring activities conducted by the Agenzia Italiana del Farmaco (Italian Medicines Agency). Expenditure data were collected through the Italian Drug Traceability System. Products were categorized by type of MEA: financial-based, outcome-based, or mixed. Main Outcomes and Measures: The main outcome was median payback as a proportion of expenditure by category of MEA. Results were also provided by subtype: cost sharing or capping models for financial-based MEAs and risk-sharing or payment-by-result models for outcome-based MEAs. Mixed MEAs were considered when medications had multiple indications with different MEA types. Results: A total of 73 medications with MEAs generated a payback by manufacturers during the study period. Six were either not reimbursable or delivered within the Italian National Health Service, and 5 had incomplete data. Of the 62 medications analyzed, 24 (38.7%) had financial-based MEAs, 30 (48.4%) had outcome-based MEAs, and 8 (12.9%) had mixed MEAs. A total payback amount of €327.5 million was calculated during the 3 years, corresponding to 0.9% of the €41.1 billion of total expenditures for medications purchased by public health facilities in Italy. Financial-based MEAs returned the highest payback revenues, €158.1 million; the outcome-based MEAs and mixed MEAs generated smaller paybacks of €74.5 million and €94.9 million, respectively. Overall, the median proportion of payback to expenditure on the medications analyzed was 3.8%. For mixed MEAs, the payback-to-expenditure proportion was 6.7%; for outcome-based MEAs, 3.3%; and for financial-based MEAs, 3.7%. Conclusions and Relevance: This observational study found limited evidence that MEAs lower pharmaceutical expenditures. Determining criteria for prioritizing MEA use, identifying potential design changes, and improving implementation may be needed in the future.