Experts addressed different possible models for optimising data collection to support the adoption of cell and gene therapies in the UK. Barriers to digital integration, post-launch data collection and outcomes-based reimbursement were the primary focus of the day.

Advanced Therapy Medicinal Products (ATMPs) are continuing to show transformative potential across a wide range of disease areas, with a number of these therapies having secured world-first marketing authorisation, but barriers remain that prevent their widespread adoption. CGT Catapult hosted a workshop with key stakeholders to address how the existing data infrastructure in the UK could be developed and optimised to better support ATMP marketing authorisation, and how to establish real-world evidence to substantiate the long-term benefits of these innovative products.

Participants in the “ATTC Clinical Adoption Day: Data collection requirements for ATMP adoption into the NHS” workshop, which took place at One Whitehall Place on 7 November, included representatives from the NHS, industry and government organisations.

To help develop and deliver these potentially life changing therapies into the current healthcare setting, the Advanced Therapy Treatment Centres (ATTCs) network was established in early 2018. The network is funded by the Industrial Strategy Challenge Fund, under UK Research and Innovation, and aims to develop solutions for adoption of ATMPs by the NHS that can satisfy clinical, regulatory and reimbursement requirements. As coordinator of the ATTC Network, CGT Catapult hosted the workshop in partnership with the Association of the British Pharmaceutical Industry, BioIndustry Association, London Advanced Therapies and the Advanced Therapies Network.

Topics discussed at the workshop included the national healthcare digital landscape, post-launch ATMP data collection, value- and outcomes-based reimbursement, and barriers to implementing digital change in a healthcare setting. Models for optimising the digital infrastructure to support ATMP adoption were then discussed by attendees to reach a conclusion as to which would be the most appropriate. A summary of outputs from the discussions can be found here.

ATMPs are often faced with challenges such as small study sizes and difficulties in substantiating incremental benefits over existing therapies, which is a necessity for reimbursement. Bringing together key stakeholders and the ATTC network at the second annual Clinical Adoption Day workshop was important to once again collaborate and address these challenges.