OBJECTIVES: Validate an iterative and multi-disciplinary Lean Assessment Process (LAP) methodology for identifying clinical needs, assessing technology acceptance, a precursor for early economic evaluation and adoption strategies

METHODS: The LAP methodology investigates initial concepts for medical technologies, directing product development of early-stage technologies and to validate the clinical pathway and utility for later-stage technologies. The methodology specializes in human factors, health economics and market access engaging with key stakeholders in the care pathway. LAP is used as an early Health Technology Assessment tool and informs on the preliminary assessment of the product design, value, and evidence requirements and provides input to early economic evaluation. Thereby reducing market uncertainties and informing the optimum route to market and adoption strategies.

To validate the use of LAP methodology as a precursor for early economic evaluation, a cost consequence analysis was conducted to evaluate the impact of introducing multiparametric magnetic resonance (mpMR) as an alternative to liver biopsy for autoimmune hepatitis (AIH). LAP study was used to align evidence for exploring the clinical needs and assessing the stakeholder’s acceptance of introducing mpMR in the AIH care pathway to replace liver biopsy. Key insights from the stakeholders were thematically analyzed, forming the basis for decision-analytic model to compare the cost consequences of introducing an mpMR scan in place of liver biopsy.

RESULTS: LAP methodology was able to provide the required information to form the basis of the early economic analysis, thereby LAP can be used as a precursor for early economic evaluation. Additionally, the report also provides information on the adoption strategy including key elements needed to be considered when designing a clinical trial or a real-world cost-effectiveness analysis in future.

CONCLUSIONS: The LAP methodology can be used as a rapid tool to evaluate the initial value proposition and as a precursor for early economic evaluation and adoption strategies.