CMS Panel to Discuss Tx-Resistant Depression

BALTIMORE -- An advisory panel to the Centers for Medicare & Medicaid Services will be discussing the definition of treatment resistant depression at a meeting here next Wednesday.

The Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a panel of experts that offers CMS advice about clinical topics, has been tasked by the agency with offering recommendations regarding "the use of the definition of [treatment-resistant depression (TRD)] in the context of clinical studies, coverage with evidence development, and treatment outcomes."

MEDCAC advisors do not have authority to make coverage decisions; however, the committee can offer guidance to the agency about how to make evidence-based coverage determinations.

The committee will vote on whether a standard definition of TRD can be applied to Medicare beneficiaries in clinical trials for various treatments and what specific characteristics should be included in that definition.

For example, panelists will vote on whether the following traits should be considered "defining characteristics."

• The number, dose, and classification of antidepressants used and for how long
• The type of depressive episode (i.e., unipolar, bipolar, psychotic, atypical, etc.)
• The use of combination pharmacological therapies or augmentation therapies
• The use of other nonpharmacological therapies (i.e., electroconvulsive therapy)
• Suicidal ideation and attempts at suicide
• Changes in the results of standard depression rating scales

Most depression medications usually require 3 to 8 weeks before anyone can determine their efficacy, John VanDenBerg, PhD, CEO and president of VanDenBerg Consulting, which provides technical assistance for arranging wraparound services for families with complex mental and behavioral health issues, told MedPage Today in an email.

"So, each trial requires the person to go through 3-8 weeks of hoping for help, dealing with side effects such as not being able to sleep, not being able to work, not being able to function normally. Then, at the end of that time, the [medication] is discontinued and even deeper depression sets in," he said.

VanDenBerg, who said he is not an expert in depression, witnessed these ordeals with his late mother, who suffered from depression for 40 years.

He stressed that "[A]ny definition of treatment-resistant depression must take into account the hopelessness that results from multiple trials ... which results in even deeper depression."

At 73 years old, VanDenBerg's mother found a medication that worked. "Her next 15 years were relatively depression-free."

CMS offered no comment about the reason for convening the meeting and no further explanation of the debate around defining treatment-resistant depression.

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CMS Panel to Discuss Tx-Resistant Depression