NeuroStar TMS Therapy Effective In Depression Treatment
Neuronetics, Inc. announced today 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 RatingScale (MADRS) symptom score change at 4 weeks, was statisticallysignificantly superior to placebo (p=0.0006), among NeuroStar-treatedpatients. Similar results were observed with the Hamilton DepressionRating Scale (HAMD).
-- NeuroStar TMS Therapy-treated patients had statistically significantresponse and remission rates, which were approximately twice the rate ofplacebo-treated patients. The response rate is the percentage ofpatients who had a greater than or equal to 50% improvement in symptoms,and the remission rate is the percentage of patients who achievedvirtually 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 achieveda 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 andrequired 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 ordiscomfort at the treatment area during active treatments, which wastransient and mild to moderate in severity. The incidence of this sideeffect 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 observationscompared 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.