In December 2021, the EU-regulation on HTA (HTAr) was passed. Among other things, HTAr mandates joint EU-level assessment of all new medicines in parallel with the EMA regulatory review, based on a dossier submitted by the manufacturer. Having a joint assessment covering the needs of all 27 EU member states and tied to EMA timelines, is a completely new paradigm that will have major implications for how companies set up and align HTA and regulatory and statistical work.
What is a Joint Clinical Assessment and what requirements are outlined in the HTAR. Furthermore, insights are provided on the scoping process and relevance of the PICO for a JCA.
One of the most discussed issues around the upcoming HTA legislation (HTAR) is the fear of being confronted with an unreasonable number of PICO's at the time of a joined clinical assessment (JCA). Surprisingly this issue is rarely, if ever, discussed by the applicants during the JSC's. The assumption must be that the PICO can't be predicted early in the process and will likely be only determined at the very last moment by the HTAB's. While there is a scoping process taking place immediately before the start of the JCA it is worth understanding that these PICOs do not arbitrarily change and that they are predictable.
Anja will discuss the theory behind the PICO and how it is supposed to be interpreted by applicants.
Dima will present lessons learned from previously conducted pan-EU assessments under JA3 with a forward looking view on what an additive PICO approach embedding evidence requirements of all Member States could look like.
The EU pharmaceutical industry is keen act as a partner in the development of a fit-for-purpose future system of JCA at EU level. As such, EFPIA is working with its members across a matrix of topics ranging from EU JCA process and implementation at national level, methods, JSC and overall advocacy with an underlying legal support as well. The purpose is to ensure that EFPIA speaks with one voice at EU level but also to ensure that companies are prepared from day 1 to meaningfully participate in the future system and to leverage these efforts into better evidence generation and overall clinical assessment of their innovation.
The new paradigm for EU HTA Joint Clinical Assessments will rely heavily on statistical analysis. How can the statistical community prepare for this development? When, where, and how should statisticians be involved? What new capacities and systems needs to be developed? How can academic, government, and industry statisticians effectively collaborate to achieve the EU HTA regulation goals of patient access? In this panel discussion, we will talk with a number of key leaders in the area on these questions and more.