Early patient access to health technologies: Is innovation needed for early management? - 03/03/20
the participants of Giens XXXV Round Table 'Health technologies'
Sandrine Bourguignon d, Nathalie Chabin e, Pierre-Yves Chambrin f, Dominique Costagliola g, Laure Huot h, Anne-Sophie Joly i, Guirec Le Lous j, Nicolas Martelli k, David Orlikowski l, Vincent Petit m, Cyril Puc n, Christophe Roussel o, Fanny Wilquin-Bequet ppages | 13 |
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Summary |
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).
Le texte complet de cet article est disponible en PDF.Keywords : Early access, Innovation, Technology assessment, Medical device, Health technology, Funding
Plan
☆ | The articles, analyses and proposals resulting from the Ateliers de Giens are those of the authors and do not pre-empt the proposals of their organisation. |
Vol 75 - N° 1
P. 71-83 - janvier 2020 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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