Given Imaging Receives Reimbursement Approval for PillCam COLON® in Japan Effective January 1, 2014
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare (MHLW) to provide reimbursement for Given Imaging's PillCam COLON. With this approval, Chuikyo established a reimbursement of 83,100 JPY, or roughly $840.00 USD (using current exchange rate), per capsule that is scheduled to go into effect on January 1, 2014. This decision follows regulatory clearance of PillCam COLON in July of this year by Japan's Pharmaceuticals & Medical Devices Agency (PMDA). The MHLW will determine the final indication for use for PillCam COLON in December as well as the amount for the professional fee."We thank the Japanese government for moving so quickly to provide reimbursement for PillCam COLON so that more patients can have access to a safe and effective diagnostic and screening tool for detecting diseases of the colon," said Homi Shamir, President and CEO, Given Imaging. "We are training our team now so that we can maximize this opportunity in 2014."Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only 27% of the population actually gets tested. After a physician identifies blood in a patient's stool, which can be a strong indication of colon cancer or other diseases, only 58% of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons. PillCam COLON's ease of use and minimally-invasive profile could appeal to those patients.