Medical Device Daily Associate

Cyberonics (Houston) reported this week that the FDA has granted its request to shut down investigational testing of its electrostimulation device to treat depression.

The agency has allowed the company to officially close its investigational device exemption (IDE) covering all pre-market studies of Vagus Nerve Stimulation (VNS) Therapy in chronic or recurrent treatment-resistant depression (TRD), including the D-01 pilot study, the D-02 pivotal study and the D-20 treatment IDE.

The VNS Therapy System was approved by the FDA last July for use in the treatment of chronic TRD patients (Medical Device Daily, July 19, 2005).

To ensure that all TRD IDE study patients continue to have access to VNS Therapy, Cyberonics also said it is providing a lifetime reimbursement guarantee to all study patients and VNS Therapy service providers.

The company will provide reimbursement for VNS Therapy services at standard rates in the event that third-party payers deny post-approval coverage to patients in the D-01, D-02 and D-20 studies.

“The lifetime reimbursement guarantee that we're providing to patients that were in the studies is largely without precedent in the world of [medical] devices, because it's standard operating procedure in devices that once you have FDA approval and the IDE studies are closed, basically those patients are on their own,“ Skip Cummins, chairman and CEO of Cyberonics, told Medical Device Daily.

Cummins said this lifetime reimbursement is consistent with the company's mission to improve the lives of people who are touched by chronic TRD and pharmaco-resistant epilepsy.

“Consistent with that mission, and showing confidence that we have that payers are ultimately going to grant Americans with TRD the same universal access that Americans with epilepsy have, we have taken the extraordinary step of providing patients with a lifetime reimbursement guarantee which in essence insures that they have uninterrupted access to VNS Therapy,“ he said.

Cummins stressed that the move to provide the lifetime reimbursement “was in no way required by the FDA.“

The company also reported the formation of a $15 million TRD Indigent Access Program, similar to its B.J. Wilder Therapy Access Program in epilepsy, to provide indigent Americans with TRD access to VNS Therapy.

Through this program, the company said it would provide up to 200 VNS Therapy Systems per year over a five-year period in this program to qualified patients through experienced hospitals and trained psychiatrists.

“Official closure by FDA of all TRD studies conducted under an investigational device exemption, the lifetime reimbursement guarantee for TRD IDE study patients and the $15 million TRD Indigent Access Program will facilitate accomplishment of that mission by providing more Americans with TRD access to the first and only FDA-approved treatment option for their lifelong and life-threatening illness,“ Cummins said.

He added that the official closure of the IDE for TRD “confirms that VNS Therapy for its approved indication for use is neither experimental nor investigational. Studies under an investigational device exemption are done to demonstrate the safety and effectiveness of devices for a proposed indication for use. We have no plans and there are no FDA requirements for Cyberonics to conduct further depression studies of VNS Therapy as an investigational device for its approved indication.“

Cummins said he hopes that these moves on the part of the company will demonstrate to payers the degree of confidence that the company has in its VNS Therapy. He said the company still has a way to go before it generates the reimbursement numbers that it believes the therapy merits.

“Only about 10% of the [TRD] patients so far that have come into our insurance verification and education authorization system have so far been granted access to VNS. The access is not yet universal,“ Cummins said.

That being said, he noted that more than 85 different third-party payers, including 19 different Blue Cross/Blue Shield plans, United Healthcare, Cigna, Aetna, Humana and several regional Medicare carriers have to date granted at least one U.S. patient with TRD access to VNS Therapy and several state Medicaid programs now have the same coverage policy for both epilepsy and depression.

The company is still awaiting a Centers for Medicare & Medicaid Services (CMS; Baltimore) national coverage policy decision for use of the VNS Therapy in TRD patients, a process that as mandated by the government takes nine months from the time a company submits for such an approval. However, that process can take much longer.

In the case of VNS Therapy in pharmaco-resistant epilepsy, Cummins said it took nearly two years after FDA approval for that use in 1997 for the company to get a favorable national coverage decision from CMS.

“Our goal in depression is to beat the epilepsy precedent,“ he said, noting that the company is now five months into that process for the TRD indication.

While awaiting a CMS national coverage decision, Cummins questioned why many private payers still have not granted coverage for use of the system in TRD patients when they already allow it in epilepsy patients and the therapy's mechanism of action in both patient groups is essentially the same, and if anything, the studies for the TRD group offer even more robust and compelling efficacy and safety data.

“I don't see the justification or rationale for denying fully informed use in appropriate patients by payers,“ he said.

The company said that consistent with the requirements of the majority of device approvals over the past five years, Cyberonics is required by the FDA to conduct post-market studies.

“In our case, we originally planned, and were subsequently required by FDA's approval order, to conduct a dosing study and long-term patient outcome registry to elucidate the optimal dosing, predictors of response and long-term outcomes of patients treated with post-approval VNS Therapy,“ said Cummins, adding that Cyberonics' post-approval TRD development plan “goes well beyond the FDA approval requirements and includes mechanism of action research and several clinical studies all within the TRD approved indication for use.“

As part of FDA's approval order, Cyberonics is required to conduct a 450-patient post-market dosing study and a 1,000-patient, five-year patient outcome registry.

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