The implementation of outcomes-based reimbursement (OBR) for cell and gene therapies can expedite patient access and alleviate decision uncertainty. However, OBR is not widely implemented in England. Most cell and gene therapies in late-stage development target oncology, and two data collection infrastructures: the Systemic Anti-Cancer Therapy (SACT) dataset, and The European Society for Blood and Marrow Transplantation (EBMT) registry, could help facilitate the implementation OBR in cancer treatment in England.This study aimed to conduct a gap analysis to identify the requirements for upgrading the SACT and EBMT databases to enable OBR, and estimate the cost of the upgrade using a manual or part automation approach. Secondary research was conducted to analyze current data capture and identify gaps, while primary research with experts in healthcare IT systems integration and platform development, as well as experts in SACT and EBMT, informed the assumptions and data used to identify the top-level cost estimates. The study found that the SACT dataset in its current form is insufficient for enabling OBR in oncology; the EBMT registry has a higher potential but is limited to key clinical outcomes only. Part automation requires a higher upfront investment than the manual workaround but is more cost-effective in the long term. It was determined that an automated and scalable data collection infrastructure should be implemented, integrating clinical, economic, and humanistic outcomes with healthcare cost data and payment systems, to enable OBR in cancer and other therapy areas. |