US Medicare & Medicaid to require data collection as part of drug reimbursement
Vancouver, British Columbia--(Newsfile Corp. - June 6, 2023) - Cognetivity Neurosciences Ltd. (CSE: CGN) (OTCQB: CGNSF) (FSE:1UB) ("the Company" or "Cognetivity"), a technology company that has created a unique Artificial Intelligence (AI) powered brain health screening and monitoring platform for use in medical, commercial and consumer environments, is thrilled about the opportunity to facilitate the widespread rollout of recently approved Alzheimer's drugs in the USA following the Centers for Medicare & Medicaid Services' (CMS) agreement to provide coverage for fully approved FDA treatments.
In a press release on June 1, 2023, Medicare announced its decision to reimburse Alzheimer's drugs with traditional FDA approval, however, this is contingent upon physician and clinical team participation in collecting real-world evidence of effectiveness through a registry. Prior to this announcement, Medicare only covered treatments for patients participating in clinical trials, limiting broader access.
Cognetivity's groundbreaking product, CognICA™, has already demonstrated its effectiveness in tracking cognitive function in real-world settings during the treatment of Alzheimer's disease patients using Biogen's Aduhelm™ (aducanumab), which was approved by the FDA in June 2021. CognICA is being used successfully to screen hundreds of elderly individuals suspected of mild cognitive impairment, and accurately identifies those who show signs of cognitive problems and require further assessment. Following clinical diagnosis, the technology platform is also used to monitor changes in cognitive function among patients receiving monthly treatment. This provides clinicians with objective, repeatable and reliable measurement on patients' response to treatment.
This news is tremendously exciting for millions of patients and their caregivers, as it grants access to a wider population suffering from this devastating disease. According to the Alzheimer Association, more than 6 million Americans are living with Alzheimer's today, and by 2050, this number is projected to rise to nearly 13 million. However, this significant challenge remains in identifying the appropriate patients at an early stage and demonstrating evidence of cognitive improvement in real-world settings.
Sina Habibi, CEO of Cognetivity Neurosciences, commented, "We are thrilled to be in a unique position to play such a pivotal role in the effective targeting and delivery of newly approved Alzheimer's drugs in the US. Outstanding sensitivity to early-stage disease - the ability to measure small changes in brain function - and the ability to effectively monitor patient progress are CognICA's greatest strengths, as demonstrated in thousands of patients and numerous peer-reviewed publications."
This development comes on the heels of the April 25, 2023 announcement of the agreement with Mitsui Sumitomo Aioi Life Insurance, one of the largest insurance providers in Japan, to Provide CognICA Technology to its 4 million policyholder base.
Dr Habibi added "CognICA's continuously learning AI models allow for this challenge to be solved at scale, which will enable payers and providers to roll out these desperately needed treatments with confidence, and then monitor their effectiveness with unprecedented precision, providing valuable insights for clinicians and contributing to the required real-world evidence for coverage."
Cognetivity Neurosciences remains dedicated to utilizing its AI platform technology to transform the landscape of brain health globally, enhance the quality of care provided to patients and to reduce the burden and cost to providers and payers, following the company's vision of A Brighter Mind for a Fuller Life
About Cognetivity Neurosciences
Cognetivity is a technology company that has developed a cognitive testing platform for use in medical, commercial, and consumer environments. Cognetivity's CognICATM uses artificial intelligence and machine learning technology to test the performance of large areas of the brain to help detect early signs of cognitive dysfunction. CognICA is currently available for clinical use in the United States, United Kingdom, Europe, and the Middle East, with regulatory approval in other regions expected in 2023.
On behalf of the Board of Directors
"Sina Habibi"
Sina Habibi
Chief Executive Officer and Director
Forward-looking statements:
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