Neuronetics, Inc. announced
that a new health economic study evaluating the cost effectiveness of its
NeuroStar TMS Therapy system in the treatment of depression was presented
at the U.S. Psychiatric and Mental Health Congress in San Diego last week.
This study is the largest and most comprehensive cost effectiveness study
to date of TMS Therapy in patients with major depression who have failed to
achieve benefit from prior antidepressant treatment, also called
treatment-resistant depression (TRD).
Compared to antidepressant medication treatment as usual, NeuroStar TMS
Therapy was demonstrated to be cost effective if reimbursed by third-party
payers at rates up to $400 per treatment session, when only health gains
were evaluated. When productivity gains due to clinical improvement and
reduced caregiver costs were also included, the cost effectiveness was
substantially greater. These results were found when comparing open-label
NeuroStar TMS Therapy health outcomes in the FDA-indicated patient
population to the health outcomes from the antidepressant medications used
in the open-label, NIMH-sponsored STAR*D (Sequenced Treatment Alternatives
to Relieve Depression) study. In these open-label conditions, which are
most like real-world clinical practice, NeuroStar TMS Therapy provided a
net cost savings during a year of follow up when compared to antidepressant
medication treatment as usual.
"Even under the most conservative modeling assumptions that we tested,
TMS Therapy demonstrated an incremental cost effectiveness ratio that did
not exceed the most stringent willingness to pay benchmark in the U.S. for
a new treatment," said Kit N. Simpson, Dr.PH, health economist at the
Medical University of South Carolina and an author of the study. "NeuroStar
TMS Therapy appears to be a cost effective treatment option for depressed
patients who failed to benefit from prior antidepressant medications, at
expected reimbursement rates," Simpson said.
The Economic Burden of Depression
In 2000, the economic burden of depression was estimated to be $83.1
billion in the U.S. Patients with treatment-resistant depression (TRD) had
significantly more inpatient hospitalizations, had more outpatient office
visits, and used substantially more psychotropic medications. Average
annual costs for TRD patients as compared to non-TRD patients ranged from
between two times greater and six times greater. TRD patients had
significantly greater work loss costs (disability and absenteeism) than
either non-TRD patients or average non-depressed beneficiaries. Increased
costs for depressed patient care are not limited to the cost of treating
their depression, but also include increased health care utilization for
non-psychiatric conditions.
About NeuroStar TMS Therapy
The NeuroStar TMS Therapy system is the first and only TMS Therapy
device cleared by the FDA for the treatment of depressed patients who
failed to benefit from prior antidepressant treatment. NeuroStar TMS
Therapy is a non-systemic (does not circulate in the bloodstream throughout
the body) and non-invasive (does not involve surgery) form of
neuromodulation. It stimulates nerve cells in an area of the brain that is
linked to depression, by delivering highly focused MRI-strength magnetic
pulses. Patients being treated by NeuroStar TMS Therapy do not require
anesthesia or sedation and remain awake and alert. It is a 40-minute
outpatient procedure that is prescribed by a psychiatrist and performed in
a psychiatrist's office. The treatment is typically administered daily for
4-6 weeks.
NeuroStar TMS Therapy is indicated for the treatment of Major
Depressive Disorder in adult patients who have failed to achieve
satisfactory improvement from one prior antidepressant medication at or
above the minimal effective dose and duration in the current episode. In
clinical trials, the patient population upon which the FDA indication is
based was comprised of 164 patients with unipolar, non-psychotic major
depressive disorder. Almost all of them (97%) had suffered previous
depression episodes. These patients also had an extensive treatment history
without a satisfactory improvement. They had received a median of 4 total
prior antidepressant treatment attempts in the current episode, one of
which achieved treatment adequacy at or above the minimal effective dose
and duration. Forty-eight percent were unemployed due to their depression,
35% had a co-morbid anxiety disorder, and all had moderate to severe
depressive symptoms.
NeuroStar TMS Therapy has not been studied in patients who have not
received prior antidepressant treatment. Efficacy has not been established
in patients who have failed to receive benefit from two or more prior
antidepressant treatments at minimal effective dose and duration in the
current episode.
In the indicated patient population, the following efficacy results
were observed in the randomized, controlled study:
-- The primary efficacy measure, the Montgomery-Asberg Depression Rating
Scale (MADRS) symptom score change at 4 weeks, was statistically
significantly superior to placebo (p=0.0006), among NeuroStar-treated
patients. Similar results were observed with the Hamilton Depression
Rating Scale (HAMD).
-- NeuroStar TMS Therapy-treated patients had statistically significant
response and remission rates, which were approximately twice the rate of
placebo-treated patients. The response rate is the percentage of
patients who had a greater than or equal to 50% improvement in symptoms,
and the remission rate is the percentage of patients who achieved
virtually complete symptom resolution.
Patients who did not respond in the randomized, controlled study
entered into a 6-week, open-label treatment study. In the open-label study,
which is most like real-world clinical practice, the following was
observed:
-- Patients treated for the first time with NeuroStar TMS Therapy achieved
a 54% response rate and a 33% remission rate on the HAMD 24-item scale,
at the end of 6 weeks.
Patients who benefited from NeuroStar TMS Therapy in either the
randomized, controlled study or the open-label study were placed on
antidepressant medication monotherapy and entered into a six-month
maintenance of effect study. In this study, the following results were
observed:
-- Patients previously treated with NeuroStar TMS Therapy had less than 10%
relapse rate at the end of six months.
-- Approximately half of patients experienced symptom breakthrough and
required TMS Therapy re-treatment.
Throughout the NeuroStar TMS Therapy studies, more than 10,000 active
TMS treatments were safely performed. The following were the safety results
observed:
-- No systemic side effects, such as weight gain, sexual dysfunction,
sedation, nausea, or dry mouth
-- No adverse effects on concentration or memory
-- No seizures
-- No device-drug interactions
-- The most common adverse event related to treatment was scalp pain or
discomfort at the treatment area during active treatments, which was
transient and mild to moderate in severity. The incidence of this side
effect declined markedly after the first week of treatment.
-- There was a less than 5% discontinuation rate due to adverse events.
-- During a 6-month follow-up period, there were no new safety observations
compared to those seen during acute treatment.
NeuroStar TMS Therapy is contraindicated in patients with implanted
metallic devices or non-removable metallic objects in or around the head.
As with any antidepressant treatment, patients should be monitored for
symptoms of worsening depression.
About the Health Economic Analysis of NeuroStar TMS Therapy
Health care resource utilization data related to depression care only
were collected during a multi-center study of NeuroStar TMS Therapy
(N=301). These data were collected at the beginning of the study for each
patient for the three months prior to start of treatment in order to
establish a baseline. Health care resource utilization data were then
collected again six months after the completion of acute treatment with
NeuroStar TMS Therapy. An analysis was performed using the actual data
collected to stratify the acute treatment outcomes. A commonly-used health
economic model was then used to estimate the illness course over a full
year of treatment follow up.
The cost effectiveness of NeuroStar TMS Therapy is described by an
incremental cost-effectiveness ratio (ICER) per quality adjusted life year
(QALY) gained, a widely-accepted health economic measure. The incremental
cost effectiveness ratio (ICER) is defined as the ratio of the change in
costs of a therapeutic intervention compared to an alternative treatment
option or to a treatment control condition. A quality adjusted life year
(QALY) is a way of measuring disease burden, including both the quality and
the quantity of life lived, as a means of quantifying the benefit of a
medical intervention. Cost effectiveness was also assessed on a direct cost
per patient basis across a range of per treatment reimbursement rates from
$250 to $500 per treatment session. The impact of costs due to losses in
work productivity and to caregiver time was also examined.
When NeuroStar TMS Therapy was compared to sham treatment, the
third-party payer reimbursement rate would need to exceed $400 per
treatment session before the ICER exceeded the most stringent willingness
to pay threshold for a new treatment. When productivity gains due to
clinical recovery and reduced caregiver costs were included, the ICER was
substantially improved. In open-label conditions comparing NeuroStar TMS
Therapy (at a mid level reimbursement rate of $350 per treatment session)
to antidepressant medications used in the NIMH-sponsored STAR*D study,
NeuroStar provided a net cost savings of $1,141 per patient per year. At
this reimbursement rate, treating only 10,000 patients annually would save
the health care system over $11M compared to current pharmaceutical
standard of care. The cost savings increased to $9,251 per patient per year
when the costs for productivity gains were included. The analysis included
2 hours of lost productivity per treatment session for the patient to leave
work to receive the 40 minute treatment.
Availability of NeuroStar TMS Therapy
Initially, NeuroStar TMS Therapy will only be available in a limited
number of treatment centers around the country.
About Neuronetics
Neuronetics, Inc. is a privately-held medical device company focused on
developing non-invasive therapies for psychiatric and neurological
disorders using MRI-strength magnetic field pulses. Based in Malvern, PA.,
Neuronetics is the leader in the development of TMS Therapy, a non-invasive
form of neuromodulation. For more information, please visit
neuronetics.
Neuronetics, Inc.
neuronetics
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