Renalytix AI hails new pathway to national Medicare coverage for KidneyIntelX
(RENX ) has hailed the efforts of Centers for Medicaid & Medicare (CMS) in establishing the Medicare Coverage of Innovative Technology (MCIT) pathway, which aims to provide national coverage to the US FDA Breakthrough Device program and market authorisation.
The AI-enabled in vitro diagnostics company said the decision will create a pathway for Beneficiary Access to its diagnostics platform, KidneyIntelX, a prognostic tool that can help slow the progression of kidney disease, for Medicare Beneficiary Kidney Disease Populations.
Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthrough designated device and will then continue for four years.
Following a four-year period, continued coverage for Medicare beneficiaries will be based on one of three methods; case-by-case coverage, a local coverage determination, or a national coverage determination.
Commenting on the effect of this new pathway, Tom McLain, President of RenalytixAI stated that, “Having a clear path to national Medicare coverage for innovative products like KidneyIntelX provides a major catalyst to drive the robust research and clinical development programs necessary to address major unmet medical needs such as kidney disease.”
The MCIT will also encourage “early engagement” with the US FDA in developing new diagnostic tests, including leveraging the many benefits of the Breakthrough Therapy Designation process, including priority reviews of needed technologies.
Shares in Renalytix AI have soared 165% in value since the beginning of April 2020 from 220p to open 6.84% higher this morning at 625p following the announcement.
The US FDA’s Breakthrough Therapy designation is a process designed to expedite the development and review of drug products that are intended to treat a serious condition.
RenalytixAI's lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019. After working closely with the US FDA review team assigned to KidneyIntelX the company submitted its DeNovo 510K application for clearance back in August 2020.
Assuming FDA clearance is received in 2021, Renalytix will opt in for the automatic four-year National Medicare coverage period. In addition to the MCIT coverage pathway for the test, Renalytix noted that it has already designed a prospective utility and outcome study.
The aim of its 2,000 patient study is to further demonstrate the clinical value of KidneyIntelX testing in delaying or preventing the progression of early-stage diabetic kidney disease.
McLain added, “We appreciate the opportunity to work with FDA and CMS to tackle the critical issue of early-stage prognosis to help slow or prevent kidney disease progression.
This new coverage pathway will facilitate accelerated access to KidneyIntelX for Medicare beneficiaries and their primary care doctors to help assure a better quality of life and save lives."
Kidney disease is now officially recognised as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD).
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