Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Major depressive disorder, treatment refractory depression.
Treatment: Vagus Nerve Stimulation (Pre-Service).
The insurer denied the Vagus Nerve Stimulation (Pre-Service).
The denial is overturned.

The patient is a male with history of medically refractory depression. He has failed
treatment with multiple medications, electroconvulsive therapy (ECT),
psychotherapy, and repetitive transcranial magnetic stimulation (rTMS), but still has
severe unremitting depression. The patient was recommended for vagus nerve
stimulator placement for severe medically refractory depression.

Yes, the health plan should cover the proposed vagus nerve stimulation.
The patient has failed all gold standard treatments for severe depression. The use
of vagus nerve stimulation has been shown to provide benefit for this patient
population and it is Food and Drug Administration (FDA) approved for this
indication. In addition, the literature does support its use. Therefore, the health plan
should cover this treatment as the patient has failed an adequate trial of treatments
and this is within the standard of care and medically appropriate. Some of the
pertinent points of relevant literature are summarized below.

"The mood effects of VNS (vagus nerve stimulation) were discovered from clinical
trials investigating the use of VNS (vagus nerve stimulation) for reducing seizures in
epileptic patients. Since then, VNS (vagus nerve stimulation) has gone on to be
FDA (Food and Drug Administration) approved for depression. The field of VNS
(vagus nerve stimulation) is growing, and as noninvasive VNS (vagus nerve
stimulation) quickly advances, it is important to consider a historical perspective to
develop future brain stimulation therapies." (Austelle et al.)

"ECT (Electroconvulsive therapy), TMS (Transcranial magnetic stimulation) and
VNS (vagus nerve stimulation) are effective treatment for late-life depression, and
research has continued to refine the techniques. Investigative neuromodulation
techniques are promising, but evidence for the safety and efficacy of these devices
in the geriatric population is needed." (van Rooij et al.)

"Stimulation of the left vagus nerve is a novel antidepressive therapy that relies
upon the vagal projections to the brain stem to modulate brain circuits involved in
mood regulation. There is cumulative evidence from prospective and long-term
studies that has demonstrated tolerability and effectiveness of vagus nerve
stimulation (VNS) in major depressive episodes (MDE). VNS (vagus nerve
stimulation) in MDE (major depressive episodes) has the following advantages:
symptomatic response (defined as at least a 50% improvement in MDE (major
depressive episodes) severity) occurs in at least 15-17% of patients after 10 weeks
of VNS (vagus nerve stimulation) treatment and in at least 22-37% of patients after
12 months of VNS (vagus nerve stimulation) treatment, remissions are observed in
at least 15-17% of patients after 12 months of treatment, there is a sustained
response in 13-27% of patients during 12 months of VNS (vagus nerve stimulation),
and successful maintenance of the initial improvement is observed in a high
percentage of patients (73-77% of patients who had meaningful or greater benefit
after 3 months of treatment maintained at least meaningful benefit after 12 months
of treatment)." (Eljamel)

Yes, the requested vagus nerve stimulation is more beneficial than any standard
treatment for the insured's condition or disease.
There is currently limited options available to this patient who has failed all gold
standard treatments. Vagus nerve stimulation is within the standard of care and
would be considered the next most appropriate management option.