From the April 2017 issue of HealthCare Business News magazine
After FDA approval in July 2016, the Centers for Medicare & Medicaid Services established a payment for the facility component of the procedure that went into effect this year. The next step is to approach both regional Medicare intermediaries and private insurance companies to cover and reimburse the treatment, which will ultimately allow a great number of patients access to this innovative treatment.
The timeline printed on the next page shows the eight-year pathway of focused ultrasound for the treatment of tremor and the Focused Ultrasound Foundation’s role in its progress. Collaboration has been key to accelerating the timeline to bring this new treatment to patients as quickly as possible. From the early days of this effort, the collective discussion of multiple stakeholders in workshops and meetings convened by the Foundation helped to develop the road map. These early discussions identified essential tremor as a good target for focused ultrasound treatment and designed the first clinical trial.
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Public-private partnerships between the Foundation, industry and academic institutions enabled the funding of the pilot and pivotal clinical trials. The pivotal trial involved eight prominent academic sites and brought together neurosurgeons, neurologists and their teams from around the world to assess the safety and efficacy of this therapy. Engagement with patient advocacy organizations helped to raise awareness for the new treatment as the pivotal trial recruited patients and preliminary results were published. Early release and widespread accessibility of data from these important clinical trials has enabled additional trials for other brain indications as well as technical, projects to improve the focused ultrasound procedure.
Having learned valuable lessons from the essential tremor pathway, the field is branching out to treat other neurological conditions. Clinical trials are ongoing in the U.S. for Parkinson’s tremor and dyskinesia and epilepsy, and are on the horizon for OCD, depression and dystonia. With continued collaboration within the growing focused ultrasound community of researchers, clinicians, manufacturers, foundations and other stakeholders, rapid progress is expected.
On the horizon
Recent developments demonstrate focused ultrasound’s reach far beyond that of a simple tool for ablation. The first-in-human trial using it to noninvasively and temporarily open the blood-brain barrier (BBB) is ongoing, enabling more effective delivery of chemotherapy into patients’ malignant brain tumors. In this trial, a chemotherapy agent and gas-filled micro-bubbles are infused into the bloodstream of a patient with a brain tumor. Focused ultrasound is applied to areas in the tumor and surrounding brain, causing the micro-bubbles to vibrate, loosening the tight junctions of the cells that comprise the BBB and allowing delivery of the chemotherapy to the targeted tissues.
