REDWOOD CITY, CALIFORNIA., October 10, 2022 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical devices company that delivers comprehensive, life-changing solutions for the management of chronic pain, today announced October 1, 2022UnitedHealthcare (“United”) issued an update to its health insurance policy (Number 2022T0567V) and additional wording to indicate that spinal cord stimulation (SCS) devices are not covered for the treatment of chronic intractable low back pain without prior spinal surgery (NSBP). This policy is effective on December 1, 2022. All other elements of their SCS coverage policy remained as before, including their recent decision to cover use of SCS for painful diabetic neuropathy (PDN).
Prior to this change, United did not have a coverage policy for NSBP patients. The company will continue to use the results of its SENZA-NSRBP randomized controlled trial in patients with chronic intractable low back pain without prior spinal surgery to support patient prior approval and the appeal process.
The Company does not anticipate that this coverage decision will have a material impact on its future revenue and currently estimates that the potential revenue impact in 2023 could be in the low to mid single-digit million range.
“While this update is disappointing, prior to this change, cases were approved (and denied) by United NSBP and will continue to be on an individual patient basis, dependent on a patient’s unique clinical history and medical need,” he explained to D . Keith Grossman, Chairman, CEO and President of Nevro. “As part of our ongoing reimbursement and access initiatives, we will continue to urge United and other payers to appropriately consider compelling Level 1 clinical evidence, such as the NSBP data we and our investigators have produced. We view these decisions as a normal part of bringing new products and patient indications to market and believe that our continued generation of high-quality clinical evidence will ultimately win, as has been the case with the PDN indication to date.”
The company expects to present its two-year follow-up data for the SENZA-NSRBP randomized controlled trial at the 2023 NANS conference in January 2023 with publication of the data.
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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 prospective investors to periodically consult the Nevro website for important information about Nevro.
headquarters in Redwood City, California, Nevro is a global medical technology company focused on delivering comprehensive, life-changing solutions that continue to set the standard for lasting patient outcomes in the management of chronic pain. Beginning with a simple mission to help more patients suffering from debilitating pain, the company developed its proprietary 10 kHz therapy, an evidence-based, non-pharmacological innovation that has impacted the lives of more than 80,000 patients worldwide. Nevro’s comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the management of chronic trunk and extremity pain and painful diabetic neuropathy. Senza®, Senza II® and Senza Omnia™ are the only SCS systems to deliver Nevro’s proprietary 10 kHz therapy. Nevro’s unique support services provide each patient with HFX Coach™ during their pain relief and each physician with HFX Cloud™ insights for improved patient and practice management.
The Senza® System, Senza II™ System, and Senza® Omnia™ System are the only SCS systems to deliver Nevro’s proprietary 10 kHz therapy. Senza, Senza II, Senza Omnia, HFX, HFX Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.
In addition to historical information, this press release contains forward-looking statements that reflect the Company’s current beliefs and expectations of management made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: the Company’s expectations of United coverage decision will not have a material impact on its future revenue and that it currently estimates that the potential revenue impact in 2023 could be no more than the low to mid single-digit millions; the Company’s belief that NSBP cases will continue to be approved and denied on an individual patient basis, depending on a patient’s individual clinical history and medical need; the Company’s belief that its continued generation of high-quality clinical evidence will ultimately prevail, as it has done so far with the PDN indication; and the Company’s expectations that it will present its two-year follow-up data for the SENZA-NSRBP randomized controlled trial at the 2023 NANS conference in January 2023 with publication of the data. These forward-looking statements are based on information currently available to us or our current expectations, speak only as of the date of this release, 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 amount and availability of third-party payer reimbursements 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 technology; our ability to conduct our business without infringing on the intellectual property rights and proprietary technology of others; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors are included with those more fully described in our Annual Report on Form 10-K, filed on February 23, 2022, and any reports we may file in the future with the Securities and Exchange Commission, could 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 to update or revise any such forward-looking statements, except as required by law.
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SOURCE Nevro Corp.