OBJECTIVES: To determine the therapeutic value classification of isatuximab + pomalidomide + dexamethasone (IsaPd) in the treatment of adults with Relapsing or Refractory Multiple Myeloma (RRMM) with at least 2 previous lines of treatment including lenalidomide and a proteosome inhibitor, using the Colombian HTA agency methodology.

METHODS: Classification was performed following the modified Delphi technique with a panel of experts composed of three haemato-oncologists, two methodological experts, a pharmaceutical chemist, and a patient group representative. Efficacy and safety results were obtained through a literature systematic review, and a GRADE evaluation for the evidence quality was performed. The panel participated in an early dialogue to define the research question, classification of outcomes importance and therapeutic value classification.

RESULTS: 23 study reports were included in the evidence body for analysis and 10 efficacy and safety results were submitted for the classification process. Available evidence only allowed the comparison versus daratumumab + pomalidomide + dexamethasone (DaraPd), with a matched-adjusted indirect comparison (MAIC) as the only source reducing heterogeneity amongst clinical trials to allow the comparison. According to the evidence evaluated by the panel, given the results of superior overall survival, similar progression free survival and similar safety, the suggested therapeutic value classification of IsaPd was category 2: greater efficacy (moderate certainty) and similar safety.

CONCLUSIONS: The lack of head-to-head studies to compare IsaPd against other third-line treatments and the heterogeneity amongst the populations included in clinical studies make difficult objective comparisons against alternatives. However, available evidence allowed the panel to conclude that the use of IsaPd is superior to DaraPd in the treatment of adults with RRMM with at least 2 previous lines of treatment including lenalidomide and a proteosome inhibitor, since it showed clinical benefits in critical outcomes for decision making with no difference in safety.