Adenot Isabelle, Camus Dorothée, Épis de Fleurian Anne-Aurélie, Tassy Diane, Bourguignon Sandrine, Chabin Nathalie, Chambrin Pierre-Yves, Costagliola Dominique, Huot Laure, Joly Anne-Sophie, Le Lous Guirec, Martelli Nicolas, Orlikowski David, Petit Vincent, Puc Cyril, Roussel Christophe, Wilquin-Bequet Fanny
HAS, 93210 Saint-Denis, France.
SNITEM, 92400 Courbevoie, France.
Therapie. 2020 Jan-Feb;75(1):71-83. doi: 10.1016/j.therap.2019.11.008. Epub 2019 Dec 16.
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).
早期让患者获得创新医疗技术这一问题源于这样一种假设,即一旦达到一定的有效性或效率水平,等待主流医保覆盖将意味着患者或社区失去机会。这是本次圆桌会议对话的前提。早期获得被理解为对该领域内已获得CE认证但尚未获得“主流”医保覆盖的技术提供资金支持。法国有几种早期获得计划(“创新套餐”、早期覆盖、特殊覆盖、RIHN)。本次圆桌会议提供了一个机会来进行梳理,范围扩大到并非专门用于早期获得但仍可为一些患者提供使用非主流技术机会的设备(第51条、ETAPES实验、DGOS项目征集、地方计划)。这是需要进一步发展并通过向包括患者在内的所有人提供通用宣传材料来加以补充的初步步骤。实际上,现有计划仍然鲜为人知。还必须考虑是否宜于发展这些计划,以便使其适应新的欧洲要求。更普遍地说,早期获得计划必须融入一个有利于其发挥作用的生态系统:考虑与受益于早期获得的医疗器械相关的程序;审查时间短;患者信息。最后,圆桌会议提议创建一种新的早期获得计划,作为对现有计划的补充,在获得CE认证后,该计划将介于“创新套餐”和主流医保覆盖之间:PRESTO(创新技术的安全临时覆盖)。