QURE is pleased to have contributed to the critical clinical utility data in Crescendo’s dossier, which lead to a positive coverage and reimbursement decision made by Palmetto GBA.
San Rafael, California (PRWEB) October 28, 2013
QURE Healthcare is pleased to announce that one of its clients, using QURE’s core Clinical Performance and Value (CPV®) vignettes, has received coverage and reimbursement approval from the Center for Medicare and Medicaid Services (CMS). QURE works with life sciences companies to conduct prospective randomized clinical studies that determine if products demonstrate clinical utility. Establishing clinical utility, which demonstrates the usefulness of a test for clinical practice, is one of the most significant hurdles facing new technologies and their investors.
Dr. Peabody, QURE’s founder and President, says, “For far too long molecular diagnostic companies have assumed that if the test worked they would be reimbursed. Unfortunately, this is not the case—in today’s payor environment, securing coverage and reimbursement is every bit as important as demonstrating clinical efficacy. The key for diagnostic companies is to show that their test changes how a clinician cares for a patient.”
QURE’s client, Crescendo Bioscience, Inc. developed an exciting new multi-biomarker blood test (Vectra DA) that measures disease activity in rheumatoid arthritis (RA) by integrating 12 key proteins consistently associated with the biology of RA into one single, objective and quantitative score to help physicians make more informed patient management decisions. RA impacts over 1.5 million patients in the U.S. and, if left unchecked, leads to crippling deformities and loss of function. With approval, Vectra DA is now a covered benefit for Medicare beneficiaries with RA in the United States.
Paul Finkle, QURE’s COO commented, “Molecular diagnostic companies need to start generating utility data early on in product development. By working with QURE, Crescendo was able to present clinical utility data far faster than with a traditional clinical trial, or frankly, with any other methodology.”
QURE’s case-mix adjusted on-line CPV® vignettes give an industry-validated measure of physician behavior. QURE randomizes providers to a physician group who receives the new diagnostic and a control group. All providers take the CPV® vignette cases at baseline and after randomization. Using a “before and after” study design makes it possible to causally link the introduction of a novel diagnostic test to changes in physician behavior, for example patient management, unnecessary testing, and appropriate use of expensive therapeutics.
Dr. John Peabody, added, “For Crescendo, generating targeted clinical utility data in parallel with its other clinical studies created a strategic window that other companies will want to emulate. They were able to submit a complete dossier to their CMS carrier that demonstrated both clinical benefit and clinical utility.” The results from QURE's CPV® vignette clinical utility studies were published in PLoS ONE in May 2013. Recent media coverage in Inc. magazine affirms Crescendo’s tremendous growth and paints a very positive economic outlook for the company.
Dr. Peabody expressed his enthusiasm and reiterated his continued support for Crescendo. “QURE is pleased to have contributed to the critical clinical utility data in Crescendo’s dossier, which lead to a positive coverage and reimbursement decision made by Palmetto GBA. We are committed to working with our clients, to conduct the best science and establish whether novel diagnostics contribute to patient welfare and overall savings.”
About Crescendo Bioscience®, Inc.
Crescendo Bioscience is a molecular diagnostics company focused in rheumatology and located in South San Francisco, CA. Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insights to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company’s website at http://www.CrescendoBio.com.
About QURE Healthcare
QURE Healthcare is based in the San Francisco Bay Area and uses its proprietary technology, Clinical Performance and Value (CPV®) vignettes, to measure and improve the quality of healthcare. QURE applies CPV® vignettes to a variety of clinical services by addressing two fundamental challenges, quality improvement and reimbursement. In Life Sciences we rapidly, affordably and scientifically create clinical utility data for molecular diagnostic companies. The ease, validity and affordability of CPV™ vignettes also attracts a wide array of other clients including payers, hospital systems, and medical technology companies, medical licensing and education institutions as well as international health development organizations. For more information visit http://www.qurehealthcare.com.