Thank you so much, Anand Jha! This was an extremely valuable discussion, and we are incredibly thankful to have hosted you and our panelists!
Market Access | Oncology | Emerging Markets | General Manager | Strategy | Entrepreneurship
I was finally able to summarize a very important panel discussion on the adoption of EU HTAR and Joint Clinical Assessment (JCA) that will be adopted from January 2025 across the EU, starting with Cancer and ATMPs. While the article provides more details, below are some key tips / insights that the panel shared for being better prepared. Thanks Stephanie Dr. med. Rosenfeld Inka Heikkinen Thomas Grub Sandeep Kiri and also Anastasia Trubnikova for making it happen. 1. PICO simulation exercises need to happen early, to be able to get the EU JCA dossier ready in time with the needed data. These could be done as early as when finalizing the pivotal trials design 2. Internal communication will be key. Get cross functional teams - regulatory, clinical development, commercial on-board to know exactly what is happening. Important to raise awareness across the organization about the process and ensure enough resources are available and teams are giving the right priority for the JCA preparation. If possible, get a Center of Excellence (CoE) within the company to avoid everyone getting panicked. 3. For mid-size companies it is more about the central coordination vs creating new positions or change to org structure. Regardless of whether a new structure is created, it will be important to assign accountability and be ready to respond to queries 4. Start working with medical societies early, as they will play a big role at the country levels - especially in defining the PICOs for the member state 5. Engage other stakeholders, including patient groups as early as possible. At the EU level around 30 different groups are involved, not only medical societies but also patients and academicians, so do not wait till last minute to engage the different stakeholders 6. While the corporate market access strategy may not be immediately impacted, step back and look at the broader context of how EU JCA Assessment will have global implications on product access as the report will be available globally. This will likely impact EU as well as Global Launch Sequences. #JCA #EUHTA #europeancommission #patientaccess #healthpolicy