<p>Cost-effectiveness model for a hypothetical monotherapy vs standard of care in adult patients with treatment-resistant depression</p>

Abstract

BackgroundPatients with treatment-resistant major depressive disorder (TRD) have limited treatment options. We developed an early stage cost-effectiveness model of TRD to explore the potential value of a hypothetical monotherapy relative to the standard of care (SOC). The relative impacts of the monotherapy’s three differentiating features over SOC are explored: efficacy advantage, tolerability advantage, and price premium.MethodsWe adapted an existing economic model of TRD to evaluate the cost-effectiveness of a hypothetical monotherapy for TRD with a 25% efficacy advantage, a 10% tolerability advantage, and a 50% price premium over SOC (selective serotonin reuptake inhibitor plus atypical antipsychotics [SSRI + AAP]). The model is a hybrid of a decision tree that captures patients’ outcomes after an 8-week acute treatment phase and a Markov model that simulates patients’ depression course through a 10-month maintenance phase. Sensitivity (deterministic and probabilistic) and scenario analyses were conducted to characterize the relative impacts of the monotherapy’s three differentiating features over SOC.ResultsOver the 12-month time horizon, the hypothetical monotherapy is shown to dominate SOC; it generates lower costs and higher quality-adjusted life years in comparison to SSRI + AAP. Sensitivity and scenario analyses showed that this dominance depends largely on the monotherapy’s efficacy and tolerability advantages over SOC. Specifically, a monotherapy with ≥ 12% efficacy or ≥70% tolerability advantage (and a 50% price premium) will always be superior to SSRI + AAP. Between these two extremes, most profiles, nonetheless, generate incremental cost-utility ratios for the monotherapy, which fall below common payer willingness-to-pay thresholds.ConclusionOur adaptation of an existing economic model of TRD provides a flexible platform for researchers to evaluate the efficacy/tolerability improvements required for a successful new TRD product and for decision-makers to assess the cost-effectiveness impact of uncertainties inherent in early stage product development in TRD.

Economic evaluation of interventions for treatment-resistant depression: A systematic review

“…Discontinuation might feasibly be rolled into the “non-response” health state, however, this was not explicitly stated in any evaluation that omitted a “discontinued” health state; these may consequently overestimate treatment benefits by failing to account for discontinued patients. Of those evaluations that did include discontinuation, four either did not distinguish between discontinuation related to AEs or lack of efficacy, or assumed discontinuation due to AEs to be embedded in loss of treatment effect ( 53 , 55 , 67 , 68 ). These four evaluations therefore considered AEs implicitly, but assumed no continued impact on quality of life beyond that of discontinuation due to lack of efficacy – an assumption that may not hold for severe or long-lasting AEs.…”