What value do digital health solutions bring, what are the funding mechanisms and evaluations?

Digital health is currently booming, providing major innovations, particularly in terms of changing the practices of the stakeholders in the healthcare system as a whole. It allows our healthcare system to draw on new synergies between independent, hospital and medico-social professionals, as well as on high-performance digital tools for the benefit of all, users, patients and professionals. These tools, or digital solutions, have a strong potential to improve the healthcare system but also a strong potential for economic development. In this respect, the great diversity of existing and future digital solutions, as well as their vast fields of application, are prompting public and private stakeholders in the sector to question their integration into our healthcare system. The resulting challenges concern the identification of the targets they are intended for, the values they embody and, as a result, the methods of funding and evaluation. At a time when the first reimbursement terms for digital solutions are taking shape in the context of the Social Security Financing Bill for 2022, the roundtable wished to propose 8 recommendations to help structure exchanges between the various stakeholders and initiate avenues of work around the integration of digital solutions into the healthcare system. The main orientations are based on the proposal of a common and transparent reflection methodology around the technical scope of these solutions, the values they bring and the funding mechanisms. Other work will be necessary beyond the points addressed by the round table in order to go into greater depth on certain themes such as the adaptation of existing funding methods to the momentum and specificities of digital technology or the development of research work on the evaluation of the value claimed by these digital solutions.

Early patient access to health technologies: Is innovation needed for early management?

The question of early patient access to innovative health technologies arises from the assumption that, once a certain level of effectiveness or efficiency is achieved, waiting for mainstream coverage would represent a loss of opportunity for patients or for the community. This was the premise on which the round table based its dialogue. Early access is understood as the funding of a technology that comes within this field and is CE-marked but has not yet attained "mainstream" coverage. There are several early access schemes in France ("forfait innovation", early coverage, exceptional coverage, RIHN). This round table was an opportunity to establish mapping, extended to devices not dedicated to early access but which could nevertheless provide some patients with access to non-mainstreamed technologies (Article 51, ETAPES experiments, DGOS call for projects, local schemes). It is an initial step that would need to be further developed and complemented by the dissemination of common communication materials available to all, including patients. The existing schemes are in fact still poorly known. Consideration would also have to be given to the advisability of developing these schemes in order to adapt them to the new European requirements. More generally, early access schemes must be integrated into an ecosystem that is conducive for their relevance: consideration of procedures associated with medical devices benefiting from early access; short time frames of examination; patient information. Finally, the round table proposes the creation of a new early access scheme, complementary to those that exist and that would be positioned, after CE marking, between the "forfait innovation" and mainstreaming: PRESTO (Prise En charge Sécurisée et Temporaire de technologies innOvantes) (secure and temporary coverage for innovative technologies).

[INFORMATION ABOUT DRUGS]. / L'INFORMATION SUR LE MÉDICAMENT.

The disastrous nature of communication has a harmful effect on patients' confidence and consequences on the observance of their treatment. On the other hand, the European debate on the proposed directive on informing the public 'about drugs, although it has been somewhat slow, has clearly shown what is at stake and the complexity of the issue.