Cost Savings for the Health Care System May Be Expected With NeuroStar Relative to Standard Care in Patients With Inadequate Benefit to Prior Antidepressant Treatment
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
"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
The Economic Burden of Depression
In 2000, the economic burden of depression was estimated to be
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
When NeuroStar TMS Therapy was compared to sham treatment, the third-party payer reimbursement rate would need to exceed
Availability of NeuroStar TMS Therapy
Initially, NeuroStar TMS Therapy will only be available in a limited number of treatment centers around the country. For specific information on treatment locations offering NeuroStar TMS Therapy, please visit www.NeuroStarTMS.com or call the Neuronetics Customer Service Center at (877) 600-7555.
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
SOURCE Neuronetics, Inc.