The psychiatric disorder market remains, in our view, the last and greatest frontier for the neurotechnology industry. And while there has been significant progress in deep brain stimulation, cortical stimulation, and implanted vagus nerve stimulation as therapies to treat psychiatric disorders, the path to commercialization has proven to be far shorter for noninvasive neuromodulation therapies that treat psychiatric disorders.
As we report in our article on page 1 of this issue, there have been several recent developments in this space, including Neuronetics’ successful IPO and FDA approval of BrainsWay’s magnetic stimulation system to treat obsessive-compulsive disorder. While noninvasive brain stimulation cannot deliver the precise targeting that DBS offers, it is a foot in the door, so to speak, into psychiatrists’ offices—offices that heretofore have largely been stocked with pharmaceuticals like anti-depressants and anti-psychotics. The availability of noninvasive neuromodulation therapies for multiple indications—MDD and OCD at least for now—represents an important milestone in the maturity of this market segment. And if a significant number of patients and clinicians can achieve even some degree of success with these therapies, it may whet the appetite of psychiatrists, patient advocacy groups, payers, and regulators for a more precise and personalized therapeutic regimen that implanted therapies can deliver.
Of course the reverse is also true—if stories start circulating about patients who are not helped or even made worse by noninvasive neuromodulation therapies, it could seriously impede the market development of implanted devices. Our only hope is that regulators, reimbursement agencies, and professional societies will cut neuromodulation the same slack that they have for drug therapies.
The dirty little secret that’s not so secret anymore is that a significant proportion of the MDD population is resistant to pharmaceutical therapies. It would be ridiculous, in our opinion, to dismiss a neuromodulation therapy that only achieves 50 percent response rate when many antidepressant drugs fail to do much better than that. When you consider that neuromodulation trials are generally working with the hardest cases—the refractory population—you can’t expect them to achieve the same response rate as if they were working with the population as a whole. We continue to believe that regulators and clinical trial sponsors should endorse a non-inferiority trial design that compares long-term response of neuromodulation therapy to conventional antidepressant therapy.
It’s in the interest of all parties—patients, their families, therapists, and payers—to have a level playing field as we evaluate new therapies for psychiatric disorders.
Editor and Publisher