A device developed by Israel’s Brainsway is available for tens of millions of customers of UnitedHealth Group, a healthcare provider which now offers the system for the treatment of major depressive disorder via its Optum Health Services Platform. The treatment is covered for patients who have not responded to other antidepressant treatments for depressive episodes that have lasted at least two months, Optum said in its latest coverage guidelines.
Brainsway’s device is based on transcranial magnetic stimulation (TMS), a noninvasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil, or “H-coil,” placed adjacent to a patient’s scalp. The pulses cause small electrical currents that stimulate nerve cells in the targeted region, affecting the neurons to alleviate depression by modulating cortical excitability.
Studies have shown TMS can be effective in a number of neurological, psychiatric and medical conditions such as Alzheimer’s disease, autism, Asperger’s disorder, substance addiction, alcoholism, tinnitus, bipolar depression, post-traumatic stress disorder, migraine, cognitive deficits, Parkinson’s disease, multiple sclerosis, neuropathic pain and schizophrenia.
Other than therapy, TMS is the only physically noninvasive treatment for these and other conditions. Patients wear the Brainsway device in the form of a helmet for about 20 minutes, with the H-coil placed on the spot on the head where the brain cells that a therapist wants to manipulate are located. EMG recording electrodes connected to the hand muscles demonstrate the effectiveness of the “dose” — how intense the TMS pulses need to be — with the electrodes gauging the response to the treatment. The treatment has no side effects, with “the most prominent sensation felt by the patient during treatment a small vibration of the coil elements over the head,” according to the company.
The FDA approved the Brainsway system in January 2013 for the treatment of depression in patients who have failed to respond to antidepressant medications. Since then, it has been installed in numerous hospitals in the US and Europe, the latest being Harvard University’s McLean Hospital, one of the world’s top psychiatric hospitals. The system is being tested for its effectiveness in treating additional conditions, including schizophrenia, obsessive-compulsive disorder and addiction to smoking.
FDA approval paved the way for coverage by Optum, which will bring Brainsway therapy to millions of Americans. In its February 2014 Coverage Determination Guidelines, Optum states that Brainsway’s system is “considered an Emerging Treatment, and is typically excluded from coverage,” but is being covered specifically for its effectiveness in treating depression when other therapies fail. Optum plan members who have an extended depressive condition that “has not responded to at least one but no more than four antidepressant treatments in the current episode, or has not tolerated two antidepressant medications at or above the minimal effective dose and duration in the current episode” are eligible for the treatment, the company said.
The H-coil at the heart of the Brainsway system was developed by Avraham Zangen, an Israeli scientist and Bar-Ilan University alumnus, while doing brain research at the US National Institutes of Health (NIH) in the late 1990s, along with Israeli physicist Yiftach Roth. Brainsway was established in 2003 as the marketing and research platform for the patented H-coil Deep TMS system, with Brainsway the exclusive licensee of the the NIH-owned patent. Initial development of the Brainsway device was done in Israel at Brainsway’s Jerusalem headquarters, with trials done at Tel Aviv University.
Uzi Sofer, CEO of Brainsway, said that it was “indeed an important piece of news that Optum, a division of United Health Group, which is said to have as many as 70 million customers, have included Brainsway’s TMS therapy system in its coverage guidelines.” Brainsway said that the company “hoped that the inclusion would spur sales of the devices in the US.”
Watch a user testimonial for Brainsway’s TMS system: