VNS Therapy Could Save Drug-resistant Epilepsy Patients Money Over 5 Years, Study Says

VNS Therapy Could Save Drug-resistant Epilepsy Patients Money Over 5 Years, Study Says

Vagus nerve stimulation (VNS) therapy can lead to more than $77,000 in cost savings over five years for patients with drug-resistant epilepsy (DRE), compared to anti-epileptic treatments, according to new research.

The study, “Expected Budget Impact and Health Outcomes of Expanded Use of Vagus Nerve Stimulation Therapy for Drug-Resistant Epilepsy,” appeared in the journal Advances in Therapy.

It was funded and directed by LivaNova, which is currently evaluating a new VNS therapy system.

About one-third of patients with epilepsy have DRE. They require more healthcare resources, including hospitalizations, emergency department and neurologist visits, than those successfully treated with anti-epileptic medications.

VNS therapy is one of the treatment options for DRE patients as young as 4. Despite the long-term proven effectiveness of VNS, the time to initial implant occurs about 20 years after the initial diagnosis and after an average of seven anti-epileptic drugs have been tried.

Dravet syndrome patients may be treated with VNS therapy. In children with Dravet syndrome, this approach has led to reduced seizure frequency and improved speech development, with no unwanted cognitive side effects.

The system contains two implantable components — a programmable electronic pulse generator connected to an electrical lead, which regularly stimulates the vagus nerve. Scientists think VNS therapy eases the overactive signaling in the brain that leads to seizures.

The vagus nerve is the longest nerve in the autonomic nervous system — a network of nerves and ganglia controlling involuntary body functions — and extends from the head to the abdomen. It supplies organs such as the heart, lungs, larynx, esophagus, and most of the digestive tract with nerves.

The study, conducted by RTI Health Solutions, aimed to estimate the budget impact and health outcomes of expanded VNS therapy use in U.S. patients ages 12 or older with DRE and partial-onset seizures. It was based on a theoretical number of people, estimated from previously conducted studies.

It calculated a total number of 1,536 eligible patients, based on an assumed one million-member health plan, with 84% of the estimated patients older than 12 and 0.94% having epilepsy. Partial-onset seizures were estimated in 57% of patients with epilepsy, 36% of whom had DRE.

The results showed that VNS resulted in an estimated net cost savings, primarily due to reduced seizure frequency beginning the second year after the placement of the device. The initial cost of placement and programming was offset 1.7 years after implant and represented a net cost savings of $77,480 per patient over five years — equivalent to a 21.5% cost reduction compared to treatment with anti-epileptics alone.

“The results of the current analysis, which used literature-based estimates, are consistent with and perhaps conservative compared with other published studies of the cost and resource use reductions that may be expected with VNS,” the scientists wrote.

“The ability to improve outcomes while reducing costs is an important area of focus in healthcare today. Our VNS Therapy System achieves this by reducing seizure frequency and by decreasing overall cost of treatment,” Edward Andrle, LivaNova’s general manager of neuromodulation, said in a press release.

Bryan Olin, LivaNova’s senior vice president for clinical, quality assurance and regulatory affairs, added: “By reducing seizure frequency with VNS Therapy, we may also see a positive impact on patients’ quality of life.”

Recently, LivaNova announced that its new VNS system, called SenTiva, was implanted in the first DRE patient, as part of a global CORE-VNS registry (NCT03529045)  launched by the company to assess the treatment’s safety, effectiveness, and clinical outcomes in a real-world setting. Three of the study’s authors are employees of LivaNova.

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