An Access-Focused Patient-Centric Value Assessment Framework for Medication Formulary Decision-Making in Immune-Mediated Inflammatory Diseases.

The healthcare system in the United States (US) is complex and often fragmented across national and regional health plans which exhibit substantial variability in benefit design and formulary policies for accessing medications. We propose an access-focused value assessment framework for formulary decision-making for medications to manage immune-mediated inflammatory diseases (IMIDs), where patients are at the center of this framework. Formulary decision-making for IMID medications can be a challenging, even daunting, task with continuously evolving and enhanced treat-to-target goals. Given the complexity of the US healthcare system, patients and their caregivers need assurance from formulary decision-makers that rapid, predictable, and sustained access to both well-established treatments and innovative therapies will be a priority, with a particular emphasis on continuity of effective care. This access-focused patient-centric (APAC) value assessment approach encompasses three "value components"-higher therapeutic goals, better health-related quality of life, and improved work productivity-the monetization of which can be derived using data from clinical trials when real-world data are yet to become available. Measures and assessment approaches are outlined to serve as a pragmatic tool for decision-makers in the US to ensure timely delivery and sustained access of clinically indicated therapies aimed to improve patient outcomes, enhance equity, and increase efficiency.