Integrating Healthcare System Value Into New Medicine Evaluations for Timely and Full Patient Access

OBJECTIVES: National payers assess the value of a new medicine for specific patient groups, focusing on comparative and cost effectiveness. Subnational payers, however, consider value in terms of practical implementation for the entire local population and all diseases. To ensure timely patient access, healthcare system value drivers such as strategic planning for service capacity, healthcare system risk, and the patient pathway must be planned and evaluated. How could early planning amongst stakeholders and national payer value assessments guide subnational payers in evaluating a medicine’s holistic value and enabling timely patient access?

METHODS: A targeted gray literature search of Health Technology Assessment (HTA) reports and relevant publications examined value drivers in national assessments, focusing on frameworks used by HTA bodies. CAR T therapies were examined as a case study, recognizing the unique challenges in healthcare system readiness for patient access that these medicines bring.

RESULTS: Advanced therapy medicinal products like CAR Ts rely on complex requirements in the care pathway and clinical infrastructure for successful patient access. The literature search revealed that national value assessment focused narrowly on the theoretical patient value of these new technologies, characterized by unmet need, clinical or comparative efficacy, and economic budget impact, but overlooked the extent to which these drivers could influence the realization of these benefits in the healthcare system

CONCLUSIONS: Value assessment frameworks are a hotly debated topic as healthcare decision makers seek to quantify value and guide decisions amid escalating healthcare costs. Despite calls to integrate patient and broader societal perspectives, we found little evidence in national assessments to guide factors affecting how fully value can be achieved within the healthcare system. The fragmented nature of healthcare systems causes inconsistent adoption and delays of new medicines, highlighting the need to integrate healthcare system value drivers to fully enable patient access to innovative therapies.