BlueCross BlueShield of Tennessee Medical Policy Manual

Responsive Neurostimulation for the Treatment of Refractory Partial Epilepsy

DESCRIPTION

Responsive neurostimulation (RNS) for the treatment of epilepsy involves the use of one or more implantable electric leads that serve both as seizure detection and neurostimulation function.  The device is programmed using a proprietary algorithm to recognize seizure patterns from electrocorticography output and to deliver electrical stimulation with the goal of terminating a seizure. Generally, individuals who are candidates for RNS are severely debilitated and have few other treatment options.

One device, the NeuroPace RNS┬« System, has received U.S. Food and Drug Administration approval for treatment of refractory focal (also referred to as partial) epilepsy.  The device includes a neurostimulator that is placed in the skull and leads that are placed in the seizure-originating areas of the brain.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

In November 2013, NeuroPace® received FDA marketing approval through the premarket approval process.

SOURCES

Bergey, G., Morrell, M., Mizrahi, E., Goldman, A., King-Stephens, D., Nair, D., et al. (2015). Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology, 84 (8), 810-817. (Level 2 evidence)

BlueCross BlueShield Association. Evidence Positioning System. (4:2018) Responsive neurostimulation for the treatment of refractory focal epilepsy (7.01.143). Retrieved March 19, 2019 from http://www.evidencepositioningsystem.com. (24 articles and/or guidelines reviewed)

Cox, J., Seri, S., & Cavanna, A. (2014). Clinical utility of implantable neurostimulation devices as adjunctive treatment of uncontrolled seizures. Neuropsychiatric Disease and Treatment. 2014:10, 2191-2200. (Level 1 evidence)

ECRI Institute. Emerging Technology Evidence Report. (2015, May) Closed-loop implantable neurostimulation (RNS System) for reducing seizures in refractory epilepsy. Retrieved April 4, 2016 from ECRI Institute. (76 articles and/or guidelines reviewed)

ECRI Institute. Product Brief. (2018, September). NeuroPace RNS Systems (NeuroPace, Inc.) for treating epilepsy. Retrieved March 19, 2019 from ECRI Institute. (9 articles and/or guidelines reviewed)

Heck, C., King-Stephens, D., Massey, A., Nair, D., Jobst, B., Barkley, G, et al.  (2013). Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: Final results of the RNS System Pivotal trial. Epilepsia. 55 (3), 432-441, (Level 1 evidence)

Larkin, M., Meyer, R., Szuflita, N., Severson, M., & Levine, Z. (2016). Post-traumatic, drug-resistant epilepsy and review of seizure control outcomes from blinded, randomized controlled trials of brain stimulation treatments for drug-resistant epilepsy. Cureus, 8 (8), e744. (Level 1 evidence)

Morrell, M, et al. (2011). Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 77, 1295. (Level 1 evidence)

Rolston, J., Englot, D., Wang, D., Shih, T., M.D. and Chang, E. (2012) Comparison of seizure control outcomes and the safety of vagus nerve, thalamic deep brain, and responsive neurostimulation. Neurosurgery Focus; 32 (3), e14.

U.S. Food & Drug Administration (2013, November). Center for Devices and Radiological Health. Premarket Notification Database P100026 (NeuroPace®). Retrieved January 22, 2015 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  7/11/2015

MOST RECENT REVIEW DATE:  4/11/2019

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