The French National Authority for Health defines early access as a system that enables patients who have reached a therapeutic impasse to benefit, on an exceptional and temporary basis, from certain drugs that are not authorized for a specific therapeutic indication.
To this end, a certain amount of data (patient characteristics, treatment efficacy, quality of life, etc.) must be collected by prescribers and patients. This data is collected under the responsibility of the laboratory marketing the treatment and is financed by the latter.
However, this high-value-added data is only collected for the duration of early access.
At the same time, medico-administrative data from the SNDS (the French National Health Data System) of the French National Cancer Institute, enables us to track the consumption of care by patients at high risk of cancer, whether diagnosed, treated or monitored, throughout the course of their treatment.
Our mission? To support industry-led projects aimed at proving the concept of matching these two databases. Is it possible? Is it of high quality? Does it provide access to progression-free cancer survival? Can adverse effects be detected?
Our challenge? Better tracking of early-access patients over time, but also estimating the use of healthcare resources and their costs, optimizing acceptance of innovation, ensuring equitable access, and engaging patients in translating their quality of life into actionable data.
The Association is supporting two projects aimed at standardizing database matching methodologies to offer better monitoring of early-access patients.
– A project led by AstraZeneca, evaluating the possibility of long-term follow-up in the SNDS of patients with inoperable stage III non-small-cell lung cancer treated with Durvalumab under a cohort ATU (temporary authorization for use).
– A project supported by AMGEN, studying the long-term follow-up of patients with advanced non-small-cell lung cancer treated with Sotorasib.
Click here to see all the projects supported by the sector.