WARREN, N.J.--(BUSINESS WIRE)--Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel, enzyme-based products, announced the publication of a consensus statement supporting the clinical outcomes of RELiZORB® (immobilized lipase cartridge) and advocating for improved payer coverage and patient access. The consensus statement was published in the July issue of the Journal of Cystic Fibrosis and was signed by over 60 health care professionals, including 45 M.D.’s, practicing at Cystic Fibrosis Institutions of Excellence across the country who combined have treated approximately 450 patients with RELiZORB.
The consensus statement characterizes RELiZORB as a “physiologically superior product,” with “proven success in a real-world setting,” which “can produce measurable, clinically relevant benefits.” The statement further observed that, “despite its effectiveness and intuitive sense, RELiZORB is frequently unavailable to patients due to the vicissitudes of insurance approvals in the US.” This lack of access prompted the authors to develop an independently prepared consensus statement to highlight these patient challenges.
The signatories stated that: “…our obligation as advocates for our patients is to support access to this innovation” and that “use of an immobilized lipase cartridge to support enteral feedings is making a positive difference for many patients with CF and is a rational alternative to the historical but illogical current standard of care.” The signatories concluded: “A new, effective tool is tantalizingly within reach and we call on insurance providers to make it possible for us to use it.”
The goal of enteral feeding is to increase caloric intake to support optimal weight gain in those at nutritional risk. RELiZORB is a medical device that breaks down critical fats in enteral formulas immediately prior to ingestion, mimicking the function of the digestive enzyme lipase that is normally secreted by the pancreas. Two published pivotal clinical trials on RELiZORB in pediatric and adult patients met their primary endpoints demonstrating an almost 3-fold increase in the absorption of key Omega-3 fatty acids after a single RELiZORB use and normalized fat absorption over 90 days with daily RELiZORB use. The safety and efficacy of RELiZORB has further been validated by real world reported experience from a number of academic institutions. CMS issued a permanent and unique reimbursement code for RELiZORB (B4105) with an effective date of January 1, 2019.
“The passion and commitment of these healthcare providers and the Cystic Fibrosis Foundation to ensure that effective treatments are made available to patients reinforces our ongoing efforts to work with payers to increase access to RELiZORB by ensuring that medical coverage policies reflect the clinical value of RELiZORB,” said Dr. Eric First, Chief Medical Officer at Alcresta Therapeutics.
For more information on RELiZORB, please visit www.relizorb.com.
About Alcresta Therapeutics, Inc.
Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer and pancreatitis, and is developing platform applications for patients with short bowel syndrome (SBS) and prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by top-tier investors: Athyrium Capital Management, Bessemer Venture Partners, HealthQuest Capital, Frazier Healthcare Partners, and Third Rock Ventures. More information can be found at www.alcresta.com.