Clinical Topics

VA Now Allows New Therapy Option for Treatment-Resistant Depression

by Brenda Mooney

May 23, 2019

Condition Significantly Increases Veterans’ Healthcare Costs

ORLANDO, FL—VA clinicians now will be able to prescribe a form of ketamine to help patients with treatment-resistant depression.

The condition is associated with healthcare resource utilization and costs at the VA nearly four times higher than for veterans without depression and 1.5 times higher for those with non-TRD depression.

A conference presentation late last year found those annual costs to be $5,906 higher than VA patients with depression responsive to treatment and $11,873 higher than those without depression.1

Furthermore, according to the study presented at Psych Congress 2018, veterans with TRD were 1.7 times more likely to have inpatient visits than those with non-TRD depression [95 percent CI: 1.57-1.83] and five times more likely than those without depression [95 percent CI: 4.51-5.63].

In March, the VA announced that healthcare providers will now be able to offer the newly approved esketamine nasal spray, marketed as Spravato, for TRD. The medication will be made available to veterans based on their individual medical needs combined with providers’ clinical assessments.

The decision followed approval of the product earlier that month by the Food and Drug Administration. Spravato was approved for use in conjunction with an oral antidepressant for the treatment of treatment-resistant depression in adults.

“We’re pleased to be able to expand options for veterans with depression who have not responded to other treatments,” said VA Secretary Robert Wilkie. “It reflects our commitment to seek new ways to provide the best healthcare available for our nation’s Veterans.”

The industry-sponsored research presented last year analyzed claims data from the VHA over a four-year period from April 2014 to March 2018.

“While approximately 13 percent of Americans will experience depression during their lifetime, nearly three times as many U.S. veterans will be affected by this illness, which may be due to exposure to traumatic experiences and separation from family during deployment or military trainings.1 Despite the higher prevalence, there has been limited research to date to understand the impact of treatment-resistant depression within this group,” explained co-author Onur Baser, PhD, adjunct professor of internal medicine, University of Michigan, and health economics research expert. “These findings add to the growing body of evidence showing the devastating personal and societal impact of TRD. More research and innovative therapies are urgently needed to help relieve the burden for this particularly vulnerable population.”

In the retrospective matched-cohort analysis, adults with depression who failed two or more antidepressant treatments of adequate dose and duration were defined as TRD, while patients not meeting that criterion made up the non-TRD depression cohort (index: first AD claim). $4,210 and $8,651 higher mental health-related healthcare costs each year than U.S. veterans with non-TRD depression or without depression, respectively.

Study authors pointed out that limited evidence is available regarding the economic burden associated with treatment-resistant depression among U.S. veterans, leading to their effort to compare the economic burden of major depressive disorder (MDD) patients with TRD to patients with non-TRD MDD and non-MDD.

Three cohorts were developed to help provide an answer:

  • Adults with MDD with TRD,
  • MDD patients without TRD, and
  • Patients without an MDD diagnosis.

Ultimately, each cohort included 10,449 matched patients, with a mean age of 48.9. Results indicated that, after baseline adjustment, TRD patients had higher per patient per year HRU than non-TRD MDD (all-cause inpatient visits: incidence rate ratio [IRR]: 1.70 [95% CI: 1.57-1.83]) and non-MDD patients (IRR: 5.04 [95% CI: 4.51-5.63]).

In addition, TRD patients incurred higher total all-cause healthcare costs PPPY than non-TRD MDD (mean difference: $5,906) and non-MDD patients (mean difference: $11,873) (all p<0.0001).

“These results add to the cost-of-illness literature by demonstrating an unmet need and the importance for novel treatment for U.S. veterans with TRD,” the study authors concluded.

“The more we learn about treatment-resistant depression, the more we realize how significant the unmet need is for people living with this debilitating illness, which is estimated to affect five million adults in the U.S,” added Holly Szukis, MPH, health economics and outcomes research specialist, Janssen Pharmaceuticals Inc. “This is an urgent public health crisis that demands a better understanding. Our Janssen Neuroscience team is committed to furthering our research on developing new treatment options for people with treatment-resistant depression.”

Restricted Distribution

The VA said Spravato will be available through a restricted distribution system under an FDA-approved Risk Evaluation and Mitigation Strategy. The purpose of the REMS is to mitigate the risks of serious adverse outcomes and the potential abuse and misuse of Spravato.

In the announcement, VA officials said healthcare providers will monitor veterans for serious adverse outcomes, such as sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, worsening of depression and suicidal thoughts and behaviors.

Veterans will self-administer Spravato nasal spray under the direct observation of a healthcare provider in a certified medical facility, and must be monitored by a clinician for at least two hours after receiving their dose.

The nasal spray cannot be dispensed directly to veterans for use at home.

A study published last year in the Journal of Clinical Psychiatry found that repeated ketamine infusions resulted in rapid and sustained improvement in both depression and post-traumatic stress disorder symptoms.2

“This report suggests that repeated ketamine treatments are safe and may represent an efficacious treatment for individuals with comorbid PTSD and TRD,” wrote authors from the Minneapolis VA Healthcare System, the Mayo Clinic and the University of Minnesota Medical School.

1 Benson C, Huang A, Amos T, Wang L. Economic Burden of Illness Among U.S. Veterans with Treatment-Resistant Depression. Presented at Pscyh Congress 2018 in Orlando, Florida.

2 Albott CS, Lim KO, Forbes MK, Erbes C, et. Al. Efficacy, Safety, and Durability of Repeated Ketamine Infusions for Comorbid Posttraumatic Stress Disorder and Treatment-Resistant Depression. J Clin Psychiatry. 2018 May/Jun;79(3). pii: 17m11634. doi: 10.4088/JCP.17m11634. PubMed PMID: 29727073.

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