Memorandum

Abbott FreeStyle Libre obtains national reimbursement in France, for type 1s and type 2s ages 4+ who use insulin multiple times per day – May 8, 2017

Abbott announced this morning that it has obtained national reimbursement for FreeStyle Libre in France for type 1 and type 2 patients ages four and up who use insulin multiple times per day. Wow! This broad coverage decision is a huge win for Abbott, as France is the second largest global market for FreeStyle Libre (next to Germany), and potentially makes the product available to “hundreds of thousands of people.” Libre was the first glucose sensing product to obtain the ASAIII category (provides added clinical value over current standard of care) from the French Health Technology Assessment body in July 2016, and is now the first to see that categorization carried through to a national reimbursement victory. What a tremendous access win, particularly given how easy it is to teach and learn. Abbott now markets FreeStyle Libre consumer (real-time) in 30+ countries, 13 of which have either full reimbursement (France, Belgium, Austria, and Luxembourg) or partial reimbursement (including Germany, Sweden, Italy, and the Middle East; see table below). CEO Mr. Miles White commented on the 1Q17 call that the FreeStyle Libre is achieving “unprecedented” reimbursement across the EU – even in Germany, where it was excluded from the “CGM” decision last summer – and still growing very well in markets where patients pay out of pocket. We’re not surprised by the trend – the device boasts strong hypoglycemia data from RCTs REPLACE and IMPACT, real-world data presented at ATTD in 55,000+ users, and a price point that is less expensive than current CGM products. The press release notes that there are now “over 300,000” FreeStyle Libre users worldwide, a more specific update than “about 300,000” as of the 1Q17 call. We still await a decision from FDA, where the real-time consumer version has been under review since 3Q16. A 2H17 launch timing was last shared in 4Q16, but the device was submitted for both adjunctive and non-adjunctive (replacement) labeling, and FDA is tough to predict. Mr. White expressed his impatience on the record on the 1Q17 call. Back on the EU – we’re hearing lots of positivity about contracts they are winning. And, with the standard of care changing, we believe there is lots of room for multiple successful businesses.

  • As a reminder, Dexcom is still awaiting a reimbursement decision in France (see 1Q17), and we’ll be interested to see how a positive decision (should it come through) compares to FreeStyle Libre’s quite broad criteria. Insulet launched in France last year and shared a lot of enthusiasm about the market during the 1Q17 call today.
  • Abbott shared the following FreeStyle Libre reimbursement details with us, and noted that other national and regional negotiations are underway in Europe.

Country/Region

Reimbursement details

France

Full (National reimbursement)

Belgium

Full (national reimbursement)

Austria

Full (national reimbursement)

Luxembourg

Full (national reimbursement)

Germany

>50% of people with diabetes covered by a number of large, public sick funds (health insurance companies)

Sweden

~100% of all MDIs covered; reimbursed by all regions

Italy

“Several regions” have agreed to make FreeStyle Libre available to people with diabetes

Middle East

“Several large accounts” are providing reimbursement

 

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