Mainstay Medical has announced the publication of a paper, titled “Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact”, in the journal Neurosurgery. The paper contains a review of patients from the pivotal ReActiv8-B study, and the effect of ReActiv8 restorative neurostimulation on known drivers of direct and indirect long-term healthcare costs.
High-impact pain, defined as pain present on the majority of days for six months or more with substantial restrictions to participation in work, social, and self-care activities, has been linked to much higher direct healthcare costs per year than moderate- or low-impact pain states, a Mainstay press release details.
The results of the recently published study show that patients “overwhelmingly converted” from a high-impact pain state to a low-impact pain state after two years of ReActiv8 therapy. In a completer analysis of those patients available at two years and having work data (n=146), 103 (70.5%) were high-impact pain patients at baseline. After two years, 15 (10.3%) patients remained in the high-impact pain state, while 124 patients (85%) were in the low-impact pain category.
Chris Shaffrey (Duke University, Durham, USA) said: “It is incredibly impressive to see a novel therapy that is able to successfully treat chronic mechanical low back pain, not only clinically, but also in a way that has a positive economic impact on the healthcare system and the employers of these patients. Physicians across multiple specialties should strongly consider providing ReActiv8 for their patients earlier in their care continuum based on these results.”
Chris Gilligan (Brigham and Women’s Hospital/Harvard Medical School, Boston, USA), principal investigator of the study, added: “Restorative neurostimulation continues to prove long-term clinical benefits but, until now, we were unsure of the economic impact. This publication is the first step in proving how ReActiv8 can take high-impact pain patients, costing a significant amount of annual direct and indirect healthcare costs, and not only improve their pain, disability, and quality of life, but also reduce healthcare costs in the process.”
In looking at indirect drivers of economic impact, this study examined presenteeism—the reduced ability to perform occupational tasks because of back pain—as well as absenteeism—the number of days missed from work because of low back pain. At baseline, approximately 50% of patients experienced significant restrictions on work participation resulting in notable presenteeism and/or absenteeism, while fewer than 50% reported no work problems. After two years, more than 80% of patients reported no impact or only minor impact to their work participation due to low back pain. According to Mainstay, it was “especially noteworthy” that 88% of patients were not missing any work days due to low back pain after two years.
The pain impact data from this publication suggest the potential for a significant reduction in direct and indirect healthcare utilisation levels and costs for patients using ReActiv8, Mainstay claims. In addition, the durability of the clinically meaningful improvements in pain and function demonstrated in the study are consistent with a restorative mechanism of action, which indicates that—in the long term—these improvements in pain impact health states will be maintained.