Canada and Mexico regulatory bodies approve FreeStyle Libre for non-adjunctive use in adults with type 1 and type 2 diabetes – June 29, 2017

Executive Highlights

  • In a very exciting update, Abbott’s FreeStyle Libre has received regulatory approval for non-adjunctive use in Canada and Mexico for adults with both type 1 and type 2 diabetes! A Canadian launch will occur in the coming months, and two insurers have already agreed to reimburse it. Launch timing was not provided for Mexico, though the approval actually came through a couple months ago.
  • In Canada, FreeStyle Libre will initially be sold direct-to-consumer for cash pay at a similar cost to that in Europe (~$68/sensor, ~$37 per reader) and online without a prescription.
  • According to the IDF’s 2015 Diabetes Atlas, Abbott’s addressable market for FreeStyle Libre could have increased by as much as ~14 million patients (diagnosed in Mexico and Canada) – we especially hope the device will take hold in Mexico, where an expected ~16% of the adult population has diabetes.
  • The US is now the only major region in North America in which FreeStyle Libre has not been approved for use.

Hot off the press, Abbott just announced that FreeStyle Libre has been approved by Health Canada for use in Canadian adults with type 1 and type 2 diabetes, and a company rep told us that it also received approval in Mexico a couple months ago! Not all details have been hashed out for both markets at this point, but Abbott notes that the sensor will launch with a fingerstick replacement (non-adjunctive) claim in both countries, similar to the label in Europe.

The Canada will launch will occur “in the coming months." Notably, Canada (and most likely Mexico) will initially be a cash-pay market, with pricing similar to that offered in Europe (~$68 per sensor, $37 per reader). The sensor will be ordered online without a prescription, though the press release also indicates that the device will be reimbursed by two major Canadian insurers – a continuation of strong reimbursement momentum across the world.

These approvals are a very big deal for Abbott on two fronts: First, the size of the addressable market just grew by some ~14 million people (diagnosed in Mexico and Canada), according to the 2015 IDF Diabetes Atlas. Late last year, Mexico declared a public health emergency over diabetes and obesity, as one in seven adults in the country has diabetes (the 22nd highest rate in the world). As of mid-April, there are 300,000+ people in the world using FreeStyle Libre, and Abbott stands to see this number increase considerably. From a patient perspective, the entrance of an inexpensive real-time sensor, no calibration, and discretion is obviously appealing – in the real-world setting, patients scan a median of 16 times per day, and up to 50!

FreeStyle Libre (real-time consumer version) was submitted to FDA back in 3Q16 for both adjunctive and non-adjunctive claims, but the FDA has yet to issue a ruling. Soon, the device will be available in 37 countries, including all major regions of North America save for the US, and the body of evidence supporting approval grows daily – two RCTs (IMPACT and REPLACE), 300,000+ real-world users, plus real-world data from a 55,000+ cohort showing safety and efficacy of non-adjunctive use. We keep hearing about concerns of accuracy in hypoglycemia and a lack of alarms, and we’ll be fascinated to see how FDA evaluates the risk-benefit and mountain of real-world and clinical evidence here. Of course, there are countless BGMs out there that are either painfully inaccurate, or worse, not used at all because fingerstick testing is burdensome.

  • The exact wording on the label with respect to non-adjunctive use is similar to that in Europe: “A finger stick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycemia or impending hypoglycemia is reported by the system or when symptoms do not match the system readings.”

Close Concerns Questions

Q: Since the April update, how many more people are using FreeStyle Libre globally? How much could this number go up with introduction in Canada and Mexico?

Q: Which FreeStyle Libre countries are growing the fastest?  

Q: Will Abbott pursue reimbursement in Mexico?

Q: What is the direct-to-consumer willingness to pay for CGM in Mexico and Canada?

Q: How young do the approvals go? The SELFY study (presented at ADA) demonstrates safety and efficacy in children down age 4 – will this indication be pursued?

Q: How will these approvals impact Dexcom and Medtronic, particularly once FreeStyle Libre comes to the US?

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