Modified Delphi study of decision-making around treatment sequencing in relapsing-remitting multiple sclerosis.
Piena MA., Schoeman O., Palace J., Duddy M., Harty GT., Wong SL.
BACKGROUND: Existing effectiveness models of disease-modifying drugs (DMDs) for relapsing-remitting multiple sclerosis (RRMS) evaluate a single line of treatment; however, RRMS patients often receive more than one lifetime DMD. To develop treatment sequencing models grounded in clinical reality, a detailed understanding of the decision-making process regarding DMD switching is required. Using a modified Delphi approach, this study attempted to reach consensus on modelling assumptions. METHODS: A modified Delphi technique was conducted based on three rounds of discussion among an international group of 10 physicians with expertise in RRMS. RESULTS: The panel agreed that the expected time from disease onset to Expanded Disability Status Scale 6.0 is a proxy for disease severity as well as with classifying severity into three groups. A modelled clinical decision rule regarding the timing of switching should contain at least the time between relapses, magnetic resonance imaging outcomes, and the occurrence/risk of adverse events (AEs). The experts agreed that the assessment of AE risk for a DMD is dependent on disease severity, with more risks accepted when the patient's disease is more severe. The effectiveness of DMDs conditional on their position in a sequence and/or disease duration was discussed: there was consensus on some statements regarding this topic but these were accompanied by a high degree of uncertainty due to considerable knowledge gaps. CONCLUSION: Useful insights into the medical decision-making process regarding treatment sequencing in RRMS were obtained. The knowledge gained has been used to validate the main modeling concepts and to further generate clinically meaningful results.