OBJECTIVE: Clinical validation is considered a necessary component of any modeling in health economics (HE). Previously, we established a practical framework for the clinical validation of HE models (KOLVF) (Azimpour K. et al. 2019). The current research objective was to generate a case study to demonstrate the usefulness of the applying the KOLVF for the clinical validation of a budget impact model (BIM). We chose a new medical device developed to improve the management of osteoarthritis (OA) to present our findings.

METHODS: In concordance with KOLVF, three rounds of consultations were performed involving three clinical experts. The first occurred at the model conceptualization to gain insight on clinical situations, relevant target populations, treatment pathways, and feasible comparators. The second was conducted after initial input of real-world evidence and clinical trial data into the model, to solicit clinical advice on necessary model adjustments. The last consultation was performed after obtaining the results to detect if all the relevant questions were addressed transparently by the model.

RESULTS: Following the KOLVF protocol, the OA severity index used in the model was challenged, and the key opinion leaders (KOLs) helped to refine the segmentation of patients. Moreover, the outcomes of treatment were redefined as the adherence to current treatment and the need for total knee arthroplasty. Additional data gaps were validated, and some assumptions were also confirmed or slightly modified by the KOLs. In the final step of the process, the KOLs ensured the results were consistent with real-world practice.

CONCLUSION: The KOLVF provided a straightforward and thorough protocol for KOL involvement. Efficient use of time when clinically validating a model is key to achieving the full benefits of KOL advice. With proper application of the KOLVF, the process benefited from improved validation quality and reduced KOL time, yielding valuable input in a time- and budget-efficient manner.