FreeStyle Libre receives national reimbursement in Japan for type 1 and type 2 insulin users over six years old – August 31, 2017

Abbott just announced this morning that Japan’s Ministry of Health Labour and Welfare has granted FreeStyle Libre national reimbursement status for people over six years old using insulin. According to the press release, Japan has over one million insulin users. This reimbursement win follows national reimbursement in France, and is notably more expansive – France’s decision covered those using insulin multiple times per day, making the product accessible to “hundreds of thousands of people.” New to us, Japan and South Africa are the only territories worldwide in which both the professional and consumer versions of FreeStyle Libre are approved. (Could the US be #3?) With this approval, FreeStyle Libre is now available in 40 countries, and patients can obtain full or partial reimbursement in 16 of them. (For context, Dexcom CGM is available in 41 countries, according to its global website, though we’re not sure how many have full/partial reimbursement.) Other recent (or impending) launches include Argentina (back from the previous mid-2016 guidance), Colombia, Mexico, and Canada. We’re thrilled to see availability, and especially coverage, of the factory calibrated sensor expanding so rapidly – Abbott reps told us on a call that the worldwide user base is still 300,000+, though we assume the magnitude of the “+” has grown since the last update in Abbott’s July call. The product remains under FDA review following submission ~one year ago in 3Q16. As of Abbott’s 2Q17 earnings call, there were no updates on timing, but the last guidance in 4Q16 predicted a fast-approaching 2H17 approval (which could be any time before December 31). During the most recent Abbott earnings conference call, CEO Mr. Miles White was still optimistic regarding FDA approval, but expressed impatience, commenting on Abbott’s “good active dialogue [with the FDA] … I just wouldn’t forecast it, I just don’t know.”

-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close