On 1 February, I had the opportunity to represent Roche at a panel event hosted by the Bavarian Representation: Improving patient access to oncology medicines and the role of the EU HTA Regulation: an urgent call to action. Co-hosted by EFPIA and Roche, the panel brought together representatives from the European Commission, patient groups, medical associations and industry.

In less than eleven months, EU HTA will be a reality. The intent of the panel was to identify the challenges and issues that impact the ongoing implementation, and identify collective actions that can be taken to mitigate these to ensure success. While I was reassured to hear the continued commitment of all parties present, there remain significant gaps in readiness that cannot be addressed by good intentions alone.

EU HTA is no longer a theoretical exercise for Roche. We have molecules that are in scope to go through a EUHTA Joint Clinical Assessment (JCA) in 2025. As such we are now making the necessary changes to our operating model to ensure we are ready. This includes employing new and adapting existing resources, establishing cross-functional and specialist teams, and anticipating internally the EU level PICOs to expect by also engaging our Roche colleagues in Member States. We are doing this, despite limited information about the actual rules, timelines and methods which will apply, in order to be best equipped to submit high quality JCA dossiers in a timely manner. We need to further keep in mind that there has been considerable investment in research and development to successfully bring these molecules to the market to serve patients’ needs. Putting these investments at risks with a suboptimal readiness for EU HTA for us is not an option. 

We are concerned that the EU HTA ecosystem won’t be prepared for application of the Regulation in 2025. While we are heartened at the overall commitment to the success of the EU HTAR implementation, and understand the challenges of a reform of this scale and nature, the lack of transparency and detail available about the JCA procedures and methodologies at this advanced stage of the implementation phase is concerning.

Based on our extensive experience with HTA globally and across Europe, we know what it takes to establish a functioning assessment process, especially when it must have relevance for decision makers across all Member States. Systematically involving Health Technology Developers (HTDs), patients and clinician experts in the scoping process has been shown to enhance the assessment process, for example through increasing the understanding of the lived experience of a disease.

We have learned from previous regulatory reforms that the absence of these details and the necessary resourcing required to establish it, is the difference between a successful implementation and one that causes complexity, confusion and ultimately delays. Adequate resourcing of all stakeholders, in particular the Secretariat of the EC and the HTA CG, therefore is crucial to success however this is currently not forthcoming for EUHTA. An experimental approach will jeopardise success before it has even commenced, and must be avoided if we are to enable timely, high quality and trusted EU HTA outputs right from the start.

There is less than one year to go before EU HTA is either a meaningful contributor to faster access for patients, and the foundation of a stronger and better Europe for life sciences, or becomes an additional hurdle and extra administrative process - the ‘27 plus one’ referred to by MEP Sokov during the panel. Slow or incomplete implementation will of course impact Member States and industry in terms of burden, but the true disadvantage will lie with patients. Access to medical innovation will at best continue to be inequitable across Europe and at worst current delays will be further increased.

Our vision for collaboration goes beyond shared interest and trust. On behalf of EFPIA and Roche, I reiterate the offer from the industry sector made during the panel: to exchange with the secretariat and the JCA Subgroup in detail over the implementation model. By sharing our expertise in HTA processes, experience in large scale reforms and our presence across and commitment to Europe, we believe we have a greater chance to ensure successful, seamless implementation of EUHTA and better outcomes for Europe and its people.

Background:

EU HTA foresees a new system of joint clinical assessment at EU level but maintains full autonomy for Member States to decide on pricing/reimbursement.