Systems approach to biomedical innovation enables improved access for patients.

FoCUS’s Precision Financing Solutions for durable cell and gene therapies and the LEAPS’s learning ecosystem to optimize therapeutic regimens for chronic diseases share core principles. First, they both demonstrate MIT NEWDIGS’s commitment to ensuring appropriate and timely patient access to biomedical innovations. Second, they both capitalize on our unique multi-stakeholder collaboration methods in order to create sustainable system change. Third, and importantly, they both address high impact needs first elucidated in the NEWDIGS Adaptive Licensing Project that concluded in 2013. These needs relate to two critical success drivers for implementing Adaptive Licensing: (1) the ability to progressively reduce uncertainty about the safety and effectiveness of therapeutics in the real world setting by using evidence generated in that setting, coupled with (2) more adaptive mechanisms for coverage and reimbursement, where prices adjust (up and down) as pre-planned evidence is generated.

Adaptive Reimbursement is core to both the LEAPS and FoCUS projects. The LEAPS Plan/Produce/Use learning lifecycle is exploring how adaptive reimbursement could fuel the adoption of anticipated findings from the LEAPS evidence generation platforms into patient-centered decision making. Examples include outcomes-based agreements for sub-populations with a greater likelihood of responding to a therapy, or improving the timing and selection of therapies associated with switching from one therapeutic to another over a given patient’s journey. LEAPS may also extend this concept to the data providers, varying their benefits based on the contribution of their data to the evidence. The FoCUS Precision Financing Solutions employ multiple adaptive reimbursement approaches from short-term milestone-based contracts to multi-year performance-based annuities.

Adaptive Reimbursement relies on continuous evidence development, especially from real world sources, to both design the reimbursement approaches and adjudicate the results. Both LEAPS and FoCUS are moving beyond presentations to design and catalyze demonstration of the needed fit-for-purpose systems.

Adaptive Reimbursement is an essential component of MIT NEWDIGS’s systems approach to biomedical innovation that enables improved access for patients to appropriate therapies by harnessing the power of continuous real world learning. We look forward to advancing our use of this approach as we explore additional solutions going forward.