Presentation (CTI)

OBJECTIVES: We propose the establishment of a Medicines Innovation Fund (MIF) in the context of Advanced Therapy Medicinal Products (ATMPs) and Priority Medicines (PRIMEs) in Greece to ensure a) early access to potentially innovative products and b) the value-for-money of these products and the long-term sustainability of the health care system.
METHODS: We reviewed EU best practices on medicines innovation funds, particularly for ATMPs and PRIMEs. We identified elements of their mechanisms that would be fit-for-purpose in the Greek setting. We detailed all processes, roles, digital tools and timelines relevant to the establishment of a MIF.
RESULTS: Following EMA approval, Marketing Authorization Holders (MAHs) of eligible products that want to enter the MIF should submit their products to the annual horizon scanning performed by the National Organization for the Provision of Healthcare Services. In their application to MIF, MAHs should submit evidence on expected number of patients, budget impact implications, and clinical outcome and economic indicators against which continuous data collection (including real-world data) will take place. Data collection indicators could fall under the following categories: effectiveness, safety and resource use, which should be agreed with the relevant HTA committee. At agreed timepoints, treating physicians will receive notifications to input data against these indicators in the Electronic Preauthorization System, required to keep patients on treatments. A preliminary assessment report will be produced at the midpoint of the plan, with a final assessment report produced at 3-6 months prior the product exit from the MIF. The report will be assessed by the HTA and Negotiation Committees, for their final opinion and reimbursement status.
CONCLUSIONS: A MIF is expected to incentivize MAHs to launch ATMPs and PRIMEs earlier in Greece as well as act as a transitional reimbursement mechanism to ensure value-for-money.