Today, Abbott shared with us via email several updates on the global expansion of FreeStyle Libre. Most notably, in Belgium, FreeStyle Libre will be fully reimbursed (100%) for type 1s and “partly” reimbursed (not defined) for type 2s on three or more injections per day. This is a nice victory in the tough EU reimbursement environment, and hopefully a good sign that EU payers are taking sensors more seriously – of course, it follows a positive reimbursement decision for CGM coverage in Germany just two weeks ago. (FreeStyle Libre was not included in that ruling.) In other news, FreeStyle Libre recently launched in Israel and Brazil, and launch will occur “in the coming weeks” in Argentina. According to the Brazilian website, pricing is similar to Europe at ~60 euros per 14-day sensor and each touchscreen reader. These launches come just one month after FreeStyle Libre came out in Australia, the first launch of the consumer (real-time) version outside the EU (the blinded Pro version is available in India). We take this as a positive sign that the capacity constraints are now put to rest. Finally, following last month’s launch in The Netherlands and Sweden, LibreLink, the free Android app for scanning FreeStyle Libre sensors, is now also available in the UK, Germany, and Italy. Abbott said that more countries in Europe will roll out the app in the coming weeks. FreeStyle Libre Pro (blinded) is still under FDA review as of ADA – more than 12 months now since the 2Q15 submission – and we confirmed last month that the real-time consumer version has not been submitted to FDA yet. Perhaps we’ll get an update in next week’s 2Q16 call. We’re not sure what is holding FreeStyle Libre Pro up at FDA, since it seems fairly low risk as a retrospective-only sensor. Regarding the real-time version of Libre in the US, we wonder how much an insulin-dosing claim is gating approval – all eyes will certainly be at FDA next week as Dexcom’s G5 is under discussion.
-- by Brian Levine, Adam Brown, and Kelly Close