Medical Device Daily

Neurotech companies are on the verge of bringing to market a whole new world of neuromodulation devices to treat everything from chronic pain to depression and obsessive/compulsive disorder. One company is even developing a neural interface system to help patients with severe motor impairments control a computer cursor simply with their thoughts, improving their independence and ability to communicate.

But once these emerging technologies are on the market, what ensures that patients with mental health, behavioral health and neurological conditions have access to them? Will healthcare providers be receptive to these new therapies? Will reimbursement for such technologies be available?

A voluntary group in the health and human services sector have formed the National Task Force on Consumer Access to Emerging Neurotechnologies — created by Open Minds (Gettysburg, Pennsylvania), a national behavioral health and social service industry market research and management consulting firm — to ensure patient access to these new technologies.

“The funding in behavioral health is really very different from the rest of healthcare,” Monica Oss, CEO of Open Minds, told Medical Device Daily, underlining a key issue in this arena.

Until now, the therapeutic options in behavioral health have been limited almost entirely to psychotherapy or drugs, Oss said. “There’s never been a device or a procedure, other than ECT [electroconvulsive therapy],” she said, designed to treat such problems.

Thus, the task force was created, Oss said, to increase understanding within the payer, provider, and consumer advocacy communities of available new neurotechnologies; to promote standardized clinical decision-making criteria, consumer access, and reimbursement policies for appropriate neurotechnologies; and to promote equity in consumer access to new technologies for treatment of these conditions.

Oss said that executives and policymakers are increasingly aware of the new technologies coming online targeting mental health, neurological, and intellectual disability problems. “But it is likely that these new treatments won’t have the maximum clinical or financial impact that they could, because of both a lack of standardized payer policies to assess the appropriateness of the technologies, and challenges facing service provider organizations in adapting these new technologies to their clinical and administrative management structures.”

She said the team at Open Minds created the National Task Force on Consumer Access to Emerging Neurotechnologies “to proactively address these pending challenges.”

John Bower, COO for Northstar Neuroscience (Seattle), a company that has developed an implantable cortical stimulation system (the outer layer of the brain) to target different neurological diseases and disorders including stroke recovery and depression, applauded Open Minds’ effort to create an organization that will push for patient access to the emerging neurotechnologies.

“I think that advocacy groups and groups of experts in the field like this are extremely important in helping establish standards in patient care and making sure patients have access to emerging technology,” Bower said.

Although Northstar is still in the clinical trial phase with its product and has not yet faced the challenges of commercializing the device, Bower said the company recognizes the challenges other companies in the sector have faced and that Northstar is in the process of planning for such challenges.

First, Bower said it is important for companies to make sure that they have strong clinical data supporting the technology so that clinicians who care for patients with these disorders are receptive to making that technology part of their treatment. Patients with neurological diseases and disorders have been underserved by new therapies, he added.

“Groups like Open Minds play an important role in helping policy makers understand the potential positive impact that these technologies have for patients,” Bower said.

Open Minds said it has organized a founding group of 20 task force members — 18 of whom have been confirmed — and that it held an initial meeting Feb. 15 in Washington to discuss some of the issues facing the neurotech sector and to look at the first group of emerging technologies, those focused on the treatment of depression.

The launch meeting included presentations on research for the treatment of depression, review of current and emerging interventions for treatment-resistant depression, the current practice in evaluating treatment interventions for people with chronic diseases, the cost of treatment-resistant depression, and an overview of emerging neurotechnologies entering the marketplace.

According to Open Minds, the founding task force members directed the initial work of the task force, including: creation of models for understanding the economic value (and cost/benefit) of consumer access to neurotechnologies; development of prototypes for creating payer-specific evaluation criteria and clinical criteria for new neurotechnologies; creation of policy and position statements on reimbursement of and access to new neurotechnologies.

Open Minds said the launch meeting was sponsored by money from Cyberonics (Houston), a company currently focused on use of its vagus nerve stimulation system for dealing with treatment-resistant depression. And grants from other organizations and agencies in the neurotechnology field to further the task force’s initiatives are being pursued. Although Open Minds is a for-profit organization, Oss said the task force would be a non-profit.

One neurotech device working its way through the regulatory process is an implantable Andara OFS (Oscillating Field Stimulator) System from Cyberkinetics (Foxborough, Massachusetts). The Andara OFS is a nerve growth stimulator designed to partially restore sensation and motor function in acute spinal cord injuries.

Last month the company reported seeking a Humanitarian Device Exemption from the FDA to obtain market clearance for device (Medical Device Daily, Feb. 23, 2007). Cyberkinetics has also developed the BrainGate Neural Interface system, designed to improve the independence, mobility, and communication of patients with advanced amyotrophic lateral sclerosis (ALS) — commonly known as Lou Gehrig’s disease or Motor Neuron Disease — or other motor impairments.

The BrainGate is an investigational brain/computer interface consisting of an internal sensor to detect brain cell activity and external processors that convert brain signals into a computer-mediated output under the person’s own control (MDD, Oct. 17, 2006).

Another company in this sector, Advanced Neuromodulation Systems, (ANS; Plano, Texas), a division of St. Jude Medical (St. Paul, Minnesota), is attempting to use neurostimulation technology for the treatment of chest pain caused by angina, as well as lower back pain treatment. ANS also is involved with using deep brain stimulation for the treatment of depression.

Medtronic (Minneapolis) and Boston Scientific (Natick, Massachusetts) also are involved in the neurostimulation space for treatment-resistant depression and obsessive/compulsive disorder.

Founded in 1987, the more than 75 associates of Open Minds provide information services, executive education, market research and management consultation.

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