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REDWOOD CITY, Calif., Oct. 10, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that on October 1, 2022, UnitedHealthcare ("United") released an update to its medical coverage policy ( number 2022T0567V ) and added language to indicate spinal cord stimulation (SCS) devices are not covered for treating chronic intractable back pain without prior spine surgery (NSBP). This policy becomes effective on December 1, 2022. All other elements of their SCS coverage policy remained as they were before, including their recent decision to cover the use of SCS for Painful Diabetic Neuropathy (PDN).
Prior to this change, United had no coverage policy regarding NSBP patients. The company will continue to utilize the outcomes of its SENZA-NSRBP randomized controlled trial for chronic intractable back pain patients without prior spine surgery to support the patient prior authorization and appeals process.
The company does not expect this coverage decision to have a material impact on its go-forward revenue, and currently estimates the potential impact on 2023 revenues could be no more than the low to mid-single digit millions of dollars.
"Although this update is disappointing, there were United NSBP cases getting approved (and denied) before this change, and that will continue to be the case moving forward on an individual patient basis depending on a patient's unique clinical history and medical necessity," stated D. Keith Grossman, Chairman, CEO and President of Nevro. "As part of our ongoing reimbursement and access initiatives, we will continue to urge United, as well as 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 very normal part of the market access pathway for new products and patient indications, and believe our continued generation of high-quality clinical evidence will ultimately carry the day, just as it has thus far with the PDN indication."
The company expects to present its two-year follow-up data for the SENZA-NSRBP randomized controlled trial at the NANS 2023 meeting in January 2023 with a publication of the data to follow.
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.
About Nevro
Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.
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, HFX Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.
To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.
Forward-Looking Statements
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: the company's expectations that the United coverage decision will not have a material impact on its go-forward revenue, and that it currently estimates the potential impact on 2023 revenues could be no more than the low to mid-single digit millions of dollars; the company's belief that NSBP cases will continue to be approved and denied moving forward on an individual patient basis depending on a patient's unique clinical history and medical necessity; the company's belief that its continued generation of high-quality clinical evidence will ultimately carry the day, just as it has thus 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 NANS 2023 meeting in January 2023 with a publication of the data to follow. 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 Annual Report on Form 10-K filed on February 23, 2022, 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.
Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Chief Corp Communications and Investor Relations Officer
650-433-3247 | julie.dewey@nevro.com
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SOURCE Nevro Corp.