Nevro Announces Positive Coverage Update from Carelon Healthcare for the Treatment of Painful Diabetic Neuropathy
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The decision by Carelon Healthcare to expand spinal cord stimulation (SCS) coverage for painful diabetic neuropathy (PDN) represents a significant shift in the management of chronic pain for a large patient population. This policy change underscores the increasing recognition of the value of SCS therapies, particularly the high-frequency, paresthesia-free systems like Nevro's 10 kHz Therapy. From a policy perspective, it is imperative to note that such expansions are often influenced by robust clinical evidence and the potential to reduce long-term healthcare costs by providing more effective management of chronic conditions.
For the healthcare industry, this signifies a trend towards embracing advanced treatments backed by substantial clinical trials, such as the SENZA-PDN study cited. It also reflects a willingness to adapt coverage policies in response to emerging evidence of improved patient outcomes. The implications for stakeholders include potential cost savings from reduced reliance on traditional pain medications, which often have limited efficacy and undesirable side effects. Additionally, broader access to SCS may lead to improved health-related quality of life (HRQoL) for patients, which can have a ripple effect on overall healthcare expenditures.
Expanding coverage for Nevro's SCS system is likely to have a significant impact on the company's market share and revenue. With an additional 43 million lives covered, Nevro's financial performance could see a substantial boost, given the size of the potential patient pool. This expansion aligns with the growing prevalence of diabetes globally and the associated rise in PDN cases, which creates a larger addressable market for Nevro's product.
From a competitive standpoint, Nevro's 10 kHz Therapy's FDA approval for PDN treatment positions it favorably against other SCS devices. This could potentially lead to increased adoption rates by healthcare providers and a stronger bargaining position with other insurance companies. Market analysts would monitor the company's sales and revenue projections closely, as well as the adoption rate of the therapy post-policy implementation, to assess the financial impact on Nevro and the SCS market as a whole.
The expansion of SCS coverage for PDN patients by Carelon Healthcare may have a broader economic impact on the healthcare system. By providing coverage for a non-pharmacological treatment for PDN, there could be a shift in the economic burden from medication-based treatments to interventional therapies. This shift can potentially reduce the direct and indirect costs associated with medication side effects, non-adherence and medication management.
Moreover, the improvement in HRQoL and functionality for PDN patients could translate into economic benefits, such as reduced disability claims and increased productivity. Health economists would evaluate the cost-effectiveness of SCS therapies by comparing the upfront costs of the device and procedure against the long-term savings from improved patient outcomes and reduced use of other healthcare resources. The analysis would also consider the potential for SCS to prevent or delay the progression of PDN-related complications, which can lead to significant healthcare savings.
Spinal Cord Stimulation Coverage Policy to Include 43 Million Additional Covered Lives
The policy, which will go into effect on April 14, represents an increase in PDN patient coverage by nearly 43 million additional lives. Payers that utilize Carelon Healthcare include Anthem Blue Cross in
"Carelon's coverage policy expansion is good news for people with painful diabetic neuropathy as it will broaden access to Nevro's 10 kHz Therapy, the only high-frequency parasthesia-free SCS system FDA-approved to treat PDN," said Kevin Thornal, President and CEO of Nevro. "This coverage policy expansion is a further testament to Nevro's approach to expanding payer coverage, combining high-quality clinical trial data and individual case-by-case approvals through patient appeals and external reviews."
"Since the publication of the SENZA-PDN randomized controlled trial (RCT), the largest RCT studying SCS for PDN and the only paresthesia-free RCT demonstrating neurologic improvement, insurance companies have validated the value of major investments in meritorious research by broadening access to PDN patients," said David Caraway, MD, chief medical officer at Nevro. "We are confident that our extensive collection of clinical and real-world data will continue to serve as the foundation for additional coverage expansions by other prominent health plans."
Globally, the number of people with diabetes has quadrupled in the last two decades1, and PDN is one of its most common complications, affecting up to 25 percent of all people with diabetes. PDN symptoms can have a significant impact on quality of life. These symptoms include numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.2 Patients typically manage this complication with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects for patients.3 As a result, people with PDN suffer significantly reduced health-related quality of life (HRQoL), impaired functionality, and other comorbidities like sleep disorders, depression, and anxiety.4
To learn more about Nevro's 10 kHz TherapyTM for PDN visit: www.nevro.com.
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About Nevro
Headquartered in
Senza®, Senza II®, Senza Omnia®, and HFX iQ™ are the only SCS systems that deliver Nevro's proprietary 10 kHz TherapyTM. Nevro's unique support services provide every patient with HFX Coach™ support throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.
SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO, and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents.
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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 our belief regarding the positive impact on our business resulting from increased payor coverage. 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 continue to develop and 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; and our ability to attract and retain qualified personnel. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on February 21, 2023, as well as any subsequent reports filed with the Securities and Exchange Commission, 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:
Angie McCabe
Vice President, Investor Relations & Corporate Communications
angeline.mccabe@nevro.com
1 World Health Organization. (2016). Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
2 Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy.
3 Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in
4 Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in
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