Memorandum

Abbott launches FreeStyle Libre (consumer version) in Australia – June 2, 2016

Abbott announced earlier this week the launch of its factory-calibrated FreeStyle Libre system (consumer version) in Australia. The news marks the first launch of the consumer product outside the EU, coming a few months after approval from the Therapeutic Goods Administration (TGA) in February. The Australian website is currently live and we’ve learned that the touchscreen reader and 14-day sensor are being sold for $95 AUS (~62 euros) – roughly the same price from the original EU launch price of 60 euros for the reader and sensor. This seems to be the price of Libre in all available markets, though are looking to confirm this with management. From what we can tell, Libre has maintained the replacement claim in Australia (based on the “no fingersticks” marketing). The device is indicated in all insulin-dependent adults in Australia – those aged 18+ vs. ages 4+ in the EU; we assume the company will pursue a pediatric indication in Australia. Well known Australian diabetes advocate Renza Scibilia, from Diabetes Australia wrote a blog about her experiences with Libre here – like other type 1 patients, she relies strongly on the alarms from traditional CGM but had a terrific experience with this technology. “It is so simple and I found it incredibly accurate. Insertion of the sensor was painless and simple and the device is tiny. (I sited it on the inside of my arm, so it was very safely tucked away and didn't get caught on anything!) Costs here are AUD$95 for the reader and $95 for the (14 day) sensor. There is no subsidy or reimbursement, so fully self-funded at this stage.” She offered some speculation on reimbursement: “However, there is noise about CGM funding after our next federal election and, although not CGM, Libre sensors would probably end up being covered. No confirmed details as yet as to who this will be available to. Depends who gets elected!” We’re not sure if there are plans to file the retrospective, blinded FreeStyle Libre Pro with the TGA (available in India). There are no updates on the US timing of FreeStyle Libre Pro (slated for a ~mid-2016 launch) or US consumer version, which Abbott CEO Miles White has implied, in a best case scenario (“I would optimistically hope”) could come to the US before the end of 2016. We hope to hear updates on US and Australian plans at ADA next week, where the company’s poster (868-P) and Sunday night corporate symposia will include results from the six-month outcomes study in type 1s: IMPACT (n=225 type 1s on MDI or pumps, A1c <7.5%). We’re very surprised they are not delivering these results from the podium during Scientific Sessions themselves – this may have had to do with late-breaker timing, etc – but we there to be great interest in these results.

-- by Varun Iyengar, Adam Brown, and Kelly Close