Abbott Laboratories is announcing new private insurance coverage for a novel implantable medical device to treat neuropathic pain, a stubborn type of pain that can drive patients to long-term opioid use.
The device, known today as the Proclaim DRG neurostimulator, was sold by Minnesota's St. Jude Medical until Abbott acquired the company in January 2017. Abbott had cited St. Jude's line of neurostimulation devices, including its DRG stimulator, as a key motivation for buying the company and bolstering its growing medical device therapies.
On Tuesday, insurer Aetna unveiled a national coverage decision that opens up coverage for Abbott's Proclaim DRG neurostimulator, expanding access to the device for about 22 million people in Aetna fully-insured and self-insured plans, Abbott said. The device is also covered by Medicare, but other major private insurers are still evaluating it for possible coverage.
"It's encouraging to see private payers like Aetna review the clinical data and outcomes, then choose to provide access to DRG stimulation for their members," Abbott neuromodulation vice president Keith Boettiger said in a statement.
The Proclaim DRG (previously known as the Axium neurostimulator) works by sending mild electric stimulation to a dense cluster of nerves in the spinal column called a dorsal root ganglion (DRG). Implantable neurostimulators like the Proclaim DRG use electricity to disrupt or block the nerve activity that leads to the sensation of chronic pain.
Neurostimulators have long been used to stimulate nerves and block pain signals, but the Proclaim DRG is unique in that it targets a specific cluster of neurons at the base of spinal nerves. These DRG structures transmit signals from sensory nerves to the brain, including real pain signals and also the chronic burning and shooting pain that can happen when nerves or surrounding tissues are damaged.
The U.S. Food and Drug Administration approved the device in 2016 to aid in the management of moderate to severe intractable pain of the lower limbs in adults with two forms of complex regional pain syndrome, including people with confirmed and unconfirmed nerve injuries that cause chronic pain. (Patients in the study that led to approval of the device were eligible only after they failed to get relief from at least two drug therapies, and they remained on their pharmacologic therapies during the study.)
An Aetna spokesperson on Tuesday referred questions about the coverage policy back to Abbott, whose spokesperson said Aetna's coverage is in line with the FDA's approved indications for the device.
Abbott said that extending coverage of devices like the Proclaim DRG supports the goals of the FDA and Medicare to improve access to non-opioid alternatives for pain management.
As the human toll of the opioid-abuse epidemic spreads, medical device makers across the nation have been keen to point out that their therapies do not rely on addictive medications to achieve relief. Minnesota health technology companies offer many different non-opioid treatments, from continuous peripheral nerve blocks to radio-frequency ablation of nerves.
Electric neuromodulation therapies like the Proclaim DRG don't work for everyone, which is part of the reason why companies like Abbott offer a noninvasive weeklong trial device for a temporary evaluation of the technology, before committing to getting an implantable medical device.
St. Jude's long-term implantable Axium stimulator, which it acquired by buying Spinal Modulation, Inc., in 2015, was upgraded and renamed in 2017 to a new platform that allows for Bluetooth communication with an iPod Touch patient controllers and iPad Mini physician programmers.