CMS Issues Decision for Definition of Treatment-Resistant Depression
February 2018 ~
CMS has issued a notice detailing its finalized definition of treatment-resistant depression (TRD), such as major depressive disorder (MDD) or bipolar disorder, in the Medicare population.
Treatment for MDD can be inadequate because patients either do not seek it or the care received is substandard, according to the agency, and for patients receiving adequate treatment, only 30% (3% of patients with MDD) reach the treatment goal of full recovery or remission and the remaining 70% will either respond without remission (about 20%) or not respond at all (50%).
The finalized definition is intended to inform future discussions and decisions about how to define TRD and specify the important outcomes measured in research studies, as well as clarify how trials or observational studies might best be designed and conducted to inform clinical practice and health policy.
To assess how closely current TRD treatment studies fit the most common definition, and to suggest how to improve TRD treatment research, CMS requested a review the current definitions of TRD from the Agency for Healthcare Research and Quality (AHRQ). The report was conducted by RTI-University of North Carolina at Chapel Hill (RTI-UNC) Evidence-based Practice Center (EPCs under contract to the AHRQ.
The Technical Assessment Report on the Definition of Treatment-Resistant Depression in the Medicare Population states while no consensus definition existed for TRD, however, the majority of systematic reviews and guidelines or consensus statements reported that the commonly used definitions were based on treatment of patients whose depression failed to respond (a decrease in depressive severity of at least half) or did not go into remission (complete recovery as measured by a score on a depressive severity instrument below a threshold) following two or more treatment attempts of an adequate dose and duration.
According to their report, available definitions are anchored primarily by consideration of three key variables: number of prior treatment failures (the primary consideration), adequacy of prior treatment doses, and adequacy of prior treatment duration. Although experts may converge on two as the best number of prior treatment failures, they do not agree on definitions for adequacy of either dose or duration or outcomes measures.
The researchers conclude that there are two key steps that are critical to advancing TRD research: (1) developing a consensus definition of TRD that addresses how best to specify the number of prior treatment failures and the adequacy of dose and duration; and (2) identifying a core package of outcome measures that can be applied in a standardized manner.