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Six-Month Healthcare Resource Utilization Data from SENZA-PDN Randomized Controlled Trial Resulted in Reduction of the Largest Health-Related Cost Drivers In Patients with Refractory Painful Diabetic Neuropathy
Three-Year Longitudinal Analysis of Claims Data Showed Rechargeable Spinal Cord Stimulation Devices Appear Superior to Non-Rechargeable Devices Based on Steady Decrease in Medical Costs
REDWOOD CITY, Calif., Nov. 30, 2021 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced two poster presentations at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2021 virtual meeting. ISPOR is a leading professional society for health economics and outcomes research.
"In addition to the strong clinical efficacy that has already been shown in our landmark SENZA-PDN trial, these significant health economic results demonstrate a reduction in hospitalization rates and length of stay, two of the largest health-related cost drivers, in patients with painful diabetic neuropathy," said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. "We also plan to submit additional findings from the 12-month analysis of the health economic data for publication by the end of this year. Together, these data will be used to support physician referral decisions as well as our market access initiatives to expand payer coverage for this patient population."
Healthcare Resource Utilization in Patients with Painful Diabetic Neuropathy Treated with 10 kHz Spinal Cord Stimulation: Results from a Randomized Controlled Trial
The first poster presentation describes the healthcare resource utilization (HRU) differences between the two study cohorts of the SENZA-PDN Randomized Controlled Trial (RCT) at the six-month study endpoint with an objective of determining the effect of 10 kHz Spinal Cord Stimulation (SCS) + Conventional Medical Management (CMM) on HRU in refractory painful diabetic neuropathy (PDN) patients. The results showed a trend towards a reduction in hospitalization rates for 10 kHz SCS + CMM patients compared to patients treated with CMM alone. Furthermore, there was evidence of lower average length of stay per hospitalization for patients in the 10 kHz SCS + CMM arm than patients in the CMM alone arm. The study concluded that 10 kHz SCS appears to result in a reduction of the largest health-related cost drivers – hospitalization rates and length of stay – in patients with refractory PDN at six months. This abstract can be accessed at: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2021-3407/112471.
Pain Therapy with Spinal Cord Stimulation (SCS): Patient Characteristics and Healthcare Cost Implications Comparing Early and Late Therapy Start
The second poster presentation is a retrospective, longitudinal analysis of German health insurance claims data observed over a three-year span after SCS implantation analyzing differences in all health-related costs between the following groups: 1) Patients with a non-rechargeable (primary-cell) system vs a rechargeable system, and 2) Patients who received an SCS implant within one-year of their last spine surgery ("early-SCS") vs patients who received their SCS implant at least one-year after their last spine surgery ("late-SCS"). The study concluded that following SCS therapy, rechargeable neurostimulators seemed to be superior to non-rechargeable neurostimulators based on their steady decrease in costs, largely due to the need for replacements related to battery-life. Additionally, patients in the "early-SCS" cohort cost on average nearly €8,000 less per patient compared to patients in the "late-SCS" cohort. This poster can be accessed at: https://www.ispor.org/heor-resources/presentations-database/presentation/euro2021-3407/111766.
About the SENZA-PDN RCT
Nevro's SENZA-PDN study, the largest RCT of spinal cord stimulation treatment conducted for PDN, compares 10 kHz SCS + Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States. The primary endpoint of the study is a composite endpoint that includes the difference in proportion of treatment responders without deterioration of neurological deficits at three-month follow-up. Study participants continue to be followed out to 24 months.
The SENZA-PDN RCT 12-month data show sustained effectiveness of 10 kHz SCS and also includes the results for patients that crossed over from CMM to 10 kHz after six months. Subjects could opt to crossover to the other treatment arm if they had insufficient pain relief (<50%), were dissatisfied with treatment and were appropriate to proceed as determined by their physician. At six months, 82% of patients who met criteria in the CMM arm elected to crossover, vs none in the 10 kHz SCS + CMM treatment arm (p < 0.001).
Healthcare resource utilization (HRU) data were collected during the SENZA-PDN clinical trial. They included hospitalizations, considered a serious adverse event, as well as emergency department visits, physician office visits, and prescriptions at baseline, one, three, and six months. HRU was compared between PDN patients treated with 10 kHz SCS + CMM and those treated with CMM alone.
About Painful Diabetic Neuropathy (PDN)
The World Health Organization estimates 422 million adults with diabetes worldwide and prevalence (8.5%) that has nearly doubled over four decades.1 Diabetes may cause systemic damage with profound impact on health-related quality of life and is potentially life-threatening. Diabetic peripheral neuropathy is a common complication presenting as pain and other dysesthesias, including numbness, burning, or tingling. Approximately 20% of patients with diabetes will develop PDN, a progressive, potentially debilitating chronic neuropathic pain condition.2 In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that are refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.3,4
Internet Posting of Information
Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.
Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Senza, Senza II, Senza Omnia, HFX, HXF Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.
1 World Health Organization. (2016). Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
2 Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.
3 CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.
4 Trinity Partners Market Research 2017.
In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our plan to submit additional findings from the 12-month analysis of the health economic data for publication by the end of this year; and our expectation that these data will be used to support physician referral decisions as well as our market access initiatives to expand payer coverage for this PDN patient population. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Quarterly Report on Form 10-Q filed on November 8, 2021, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
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