War on Drugs
Although the neurotech device industry is currently pursuing a range of clinical application areas, up until now, the major revenue source has been the chronic pain market. Industry heavyweights like Medtronic, St. Jude Medical, and Boston Scientific still get the lion’s share of their neuromodulation revenue from sales of spinal cord stimulation systems.
One of the largest impediments to growth of pain neuromodulation devices has been the pharmaceutical industry and the enormous influence drug manufacturers have had on clinicians, regulatory agencies, and insurers. Particularly in this new era of comparative effectiveness, cost-justifying a $10,000 to $15,000 neurostimulation device has been more challenging given the ready availability of pain medications such as opioids at what seems to be a fraction of the cost. Some insurers and state workers’ compensation agencies have clamped down on SCS reimbursement and the CMS recently denied coverage for TENS pain stimulators altogether.
But the competitive landscape may be changing soon. According to a new position statement from the American Academy of Neurology, the risk of death, overdose, addiction, or serious side effects with prescription opioids outweigh the benefits in chronic, non-cancer conditions such as headache, fibromyalgia, and chronic low back pain. “More than 100,000 people have died from prescription opioid use since policies changed in the late 1990s to allow much more liberal long-term use,” said Gary Franklin, research professor in the Department of Environmental & Occupational Health Sciences in the University of Washington School of Public Health in Seattle and a Fellow with the AAN. “There have been more deaths from prescription opioids in the most vulnerable young to middle-aged groups than from firearms and car accidents. Doctors, states, institutions, and patients need to work together to stop this epidemic.”
Studies have shown that 50 percent of patients taking opioids for at least three months are still on opioids five years later. A review of the available studies showed that while opioids may provide significant short-term pain relief, there is no substantial evidence for maintaining pain relief or improved function over long periods of time without serious risk of overdose, dependence, or addiction.
What remains to be seen is whether regulatory agencies and insurers will now give the pharmaceutical industry the level of scrutiny the device industry would have experienced in the wake of a significant device failure or negative clinical trial. We hope that when CMS calculates the comparative effectiveness of opioids for pain, they factor in the cost to society of the addiction epidemic the pharmaceutical industry has created.
Those TENS devices are starting to look pretty reasonable right now.
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