Abbott’s Freestyle Libre. FDA approved at last. What does this mean?

Two days ago, Abbott announced they had received FDA approval for the Freestyle Libre, some 3 years after European approval. That feels like a long time, but let’s take a slightly obtuse look at why this might be and what they’ve been up to. To me, it looks like a very clever marketing story.

A little bit of history (and maybe some story telling)

The Libre launched in Europe in October 2014, and as an early adopter, it quickly became clear this was almost a Beta product launch. It had approval, sure, but the reality was that we were helping Abbott to refine their product and customer service model, perhaps with a view to entering what’s clearly the most lucrative market for healthcare in the world. Just imagine the scene in the Abbott Diabetes Care boardroom….

“Ah my evil associates…. I have a plan. One so cunning you could stick a tail on it and call it a weasel….”

“What’s that Mr Abbott? Will it make us 100 billion dollars?”

“Oh yes…..” ***Evil cackle*** “Let phase one begin….”

Whilst that may be a little unfair to the Abbott team, if we walk back to the start of the Libre journey, we know that the early release garnered such massive interest that Abbott was unable to match demand and had to restrict access. That Libres appeared on eBay at extortionate prices and that it took more than six months to clear the backlog.

We also know there was a fair amount of consternation in the online community about sensor inaccuracies and failures, and plenty of discussion about the adhesive, how it failed, how it caused reactions, burned, etc,. All of these, from what we see today, appear to have been addressed in some shape or form. I myself have written a lot about those aspects.

The one massive thing it had going for it was a European market place ripe for picking. In T1-land, CGM in most of Europe was a rarity. It was (and remains) expensive, it wasn’t provided (for the most part) on any country’s insurance or healthcare provisioning scheme, and in some places, the suppliers that Dexcom had picked were often considered unscrupulous by healthcare professionals and end users alike. Medtronic’s system was renowned for being unreliable, expensive, inaccurate and short lived. In short, there was a huge empty space for something that had a much lower cost, no long term lock in provided almost the same type of information.

Cost and Impact

And the Libre arrived. At a swoop it was over £1000 cheaper annually than the Dexcom solutions on offer. If you bought into it you didn’t feel guilty for not using it as you didn’t have expensive kit gathering dust and it provided the type of data that many of us had been crying out for. At the same time Abbott was working to capture data to provide the evidence they needed for submission to various provider schemes (in some cases in ways that people weren’t too happy about), mainly by using a process that , every time you connected the reader to your computer, it uploaded your data to a server in the US.

One of the results of the Libre release in Europe was a price drop in Dexcom products. It was now “less expensive”, and if you use it off label, it works out to be roughly the same price as Libre does. It still doesn’t have the sales due to the lack of provider coverage though, and rumour has it that Dexcom have just about given up on getting a great deal more penetration in Europe.

We’ve also seen that in Europe, a number of people have migrated from Libre to Dexcom, having used it as an adjunct to finger pricking. Almost like an introduction to CGM. It’s difficult to assess how large these numbers are, and it’s unlikely to be a trend that we see in cases where the supply is provided by the local healthcare provider.

It’s fair to say it’s had a much wider reaching impact as people have learned about their diabetes in ways they never had before and have had data that they can now use. It’s been revealing for users and HCPs alike.

Broadening the appeal

But this wasn’t all that there was to what Abbott were doing in Europe. They’d also been doing so much more. Aside from multiple trials, seeding hospitals with “Free” devices and hooking the population, they’d been working with various healthcare professionals to put together the “Triangle of Diabetes Care” – a model for using the Libre with patients.

This was a clever move. In the UK it aligned Abbott with the healthcare world, as Abbott developed, funded and reviewed a “Continuous Professional Development” (CPD) programme that gave HCPs (who must undertake a minimum amount of CPD each year in the UK) an easy way to learn about a way of providing better diabetes care, using the Freestyle Libre as a very helpful tool in this process. A blinding piece of marketing if ever there was one.

What was even more impressive is that by setting this up, they were able to refine their model for future roll out, back to that lucrative market again…

So here are the building blocks. Healthcare professional involvement, easy access to the market, patients as guinea pigs. And yet, the patients have mostly loved being guinea pigs in this case.

What’s the deal in the US?

Fast forwarding to the present day, and we’re in a place where the FDA has finally approved the Libre. What has been approved is somewhat different to the European release though. Bearing in mind that the FDA approval approach is one of “This item must not cause harm though its use” rather than the EMA approach, which is “It must do what the marketing says it does” and you can understand a little of why.

So then, what’s been approved? Well, it seems, based on the press releases, to be the following:

• A ten day usage period (exceeding any competitor by 3 days, and matching Dexcom’s announcement for the G6)
• A 12 hour start up period (that’s right 12 hours as opposed to one in Europe)
• That the FDA has given approval for dosing from the Libre

What Abbott seems to have sought approval for, then, is a complete alternative to finger pricking. This isn’t just about an alternative glucose monitor, it’s about replacing fingerpricking entirely. Given the experiences in Europe relating to sensor accuracy, this explains the reasoning behind the 12 hour start up and 10 day usage. In the accuracy study they released 18 months ago, the first day was recognised as being less accurate. 72% of results were in the Clarke Error Grid Zone A compared to 88% on day 2 and days 10-14 were not held out to be remarkably different, although accuracy on Day 14 was shown to drop to 85% instead of 88%. I assume that Abbott have been able to refine the data set since then and given the litigious nature of healthcare in the US, you can understand why they wouldn’t want to have people dosing where there may be known questions over accuracy.

Some European users may dispute the wisdom of dosing from the Libre device given the oft raised issues of sensor defects in the various social media support groups, but Abbott presumably has enough data to provide evidence that these are, in reality, few and far between. Given some of the feedback that organised studies also produced, you might ask questions about accuracy as well, however, the independent investigations that Pierre Vandevenne has done suggest that Libre and Dexcom G4 (505) tend to align, with the Libre providing its data with less of a lag (with the obvious caveats relating to physiology and everyone not being the same).

A different sales pitch

This is where the Libre sales pitch differs from Europe in a subtle but important way. In Europe, it was pitched as “Why prick when you can scan?”, with the caveat that a user needs to prick for meal bolus management and whenever the reader was showing high or low readings.

In the US, it seems to be marketed as “You can do it without fingersticks*”. Now the star is quite important as it contains the following caveat:

*Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.

Based on the press release and this statement, it would appear that Abbott has refined the Libre to be accurate enough for dosing and included a “test your blood alert”. This shifts the paradigm for its use rather. It is now a full replacement for finger pricking rather than an addition to it that provides useful continuous data. That’s a very large change in purpose. For all we know, it may have been the plan all along. It also begs the question as to whether we’ll see an update for this in Europe.

They are clearly embarking on a similar marketing approach as that in Europe, reaching out to end users, but you can’t simply buy this OTC. It seems that a prescription is required, which is a surprise. There’s another reason for the use of the term CGM in the marketing, and I think it’s in this screen grab:

See that small print? It states Medicare now covers CGMs. The use of the term CGM is to allow Medicare users to get the Libre. Even though we know it’s not really CGM.

But the other key point about this sales pitch is that it isn’t really targeting current CGM users. It’s really offering the group who don’t have, can’t get on insurance or can’t afford personally something different. It’s saying “Here, you no longer need to finger stick, except when we prompt you”. It’s not Dexcom who needs to be worried in this case, it’s Roche, Ascensia, and all of the other finger pricking providers. Abbot is going after them with a device that is supposed to massively reduce the need for their bread and butter.

It’s a case of prick yourself once every ten days, instead of 10 times a day. Or even, prick yourself once every ten days, and get some data rather than have no data because you don’t like finger pricking. It’s the 40th-80th percentile that they’re aiming for. And given how we’ve seen behaviour changes in Europe, that’s not something to ignore.

Let’s then think about the implications of this in the insurance driven market. You have a device that means you require minimal test strips. For Abbott, that’s easy. They can supply test strips as the Libre can use them. Now they go to the insurance companies and they offer them a deal. Reader, sensors and test strips, at a cut down price, as long as they give  exclusivity on the test stips, especially as the supply requirement has gone down.

In recent discussions with HCPs over the news relating to the Libre on the NHS, this is an area that has stuck a chord. The idea that with little effort, people with diabetes who used not to fingerprick can now get useful data, is something that HCPs are very enthusiastic about. In preparing the guidelines for funding in the UK, a number have expressed an eagerness to ensure that those who test less and are deemed to have “worse control” get access as this is seen as a way to improve their access to data and reduce the long term risks.

That’s a decent sized market…

What about the Diabetes Care Triangle? How does that come into it?

If we look at this aspect of the Abbott model, it’s a key part of their outreach. It provides a structure in which to use Libre. We might argue that this is already how T1D is approached, however, in many cases, it’s not how T2D is looked at. I think that’s where Abbott is trying to use this. As I mentioned in previous posts on the topic, the US T2 market is huge, and getting a foothold here would be a massive money spinner.

In their documents which are sadly no longer available, they originally stated a set of learning outcomes, of which the following stand out:

• Understand that self-managed glucose monitoring has a significant impact on blood-sugar control for patients with type 1 and type 2 diabetes and is most valuable if performed in a structured way
• Distinguish between patterns of glycaemic variability that are due to variation between different days and those that are due to variation within a single day and how this relates to behaviour or therapy
• Understand that pattern recognition through self-managed glucose monitoring can improve outcomes for the patient with type 1 or type 2 diabetes but this requires that patients test their glucose routinely several times a day and that this must be effectively captured, aggregated and analysed.
• Explain flash glucose monitoring technology, which continuously measures and stores glucose data via a small disposable sensor worn on the back of the upper arm

The bold italics are mine, but you can see that in training HCPs with an accredited course, they were focusing on all types of diabetes and on getting uptake of the Libre system.

Let’s suppose, then, that lessons have been learned from this model. It would be interesting to understand how this is being provided to US HCPs. Getting them to accept the ideas in the training and then recommend these to their T2 clients with a prescription would be a massive win, although the pricing that comes out will depend on insurance coverage. If I was Abbott, I’d be spending a lot of time on this as an approach.

Social media discussions have also focused a lot on the original marketing materials, noting that the original focus of Libre in those was T2. This is obviously a huge opportunity, and with the mechanics of the healthcare system in the US, I wouldn’t be at all surprised to see this put into action.

And of course. That’s where the money is.

Any views on pricing?

Talking of money, let’s come back to that price point. In Europe, provider coverage has been a big deal, and in the UK the provider rate is some 70% of the price to consumers. Given the insurance model in the US and the ten day usage limitation, how will Abbott price these up? Consumer price in the UK is roughly $65. Provider price is $47. With a reduced life, and to encourage sales, will either of those be lower than Europe? Or will it follow the likes of insulin pricing? We don’t know at this point.

What else might be in consideration?

As I’ve said before, let’s also not forget Leisure industry use. I’m aware of personal trainers in the UK considering using this technology with clients to improve their understanding of insulin response when trying to undertake body transformation. With this on prescription in the US, it seems to limit that use, in what I’d have expected would be a huge market.

On the other hand, the familiarisation of the FDA with the Libre sensor technology and the early clearance for dosing suggests that follow up products will potentially be covered for dosing. Is this an early indicator for Abbott’s wholesale re-entry into the CGM market with much more consumer friendly (both use- and price-wise) products than the Navigator? Given the already announced partnership with Bigfoot, this would come as no surprise.

And finally, what of WeAreNotWaiting and third party Libre add-ons? Whilst these exist already (and we expect will provide access to the Libre data in that 12hr warm up period, if the European experience is anything to go by), they come with caveats, best expressed by Pierre Vandevenne. There is a lot going on in the sensor and with the best will in the world, the solutions presented can’t be clinically trialled, so they come with a warning to be slightly wary.

Any conclusions from all of this?

It’s quite difficult to draw anything concrete until we see the FDA submission data and things like pricing. This certainly presents something new in the US market. Self monitoring of glucose, without fingerpricking. That’s likely to be a win for many. The question it really raises, and I can’t answer is who will it affect the most?

Companies that rely on blood testing strips as their prime earner? This could easily impact them. CGM companies? Well it’s marketed as a CGM, even without the transmission of data. If someone uses Libre in place of fingerpricking, would they ever make a jump to a CGM? What does it mean for CGM funding in the context of insurance?

One thing is for sure. It shakes up the monitoring industry in the US and both CGM and strip makers should be examining their strategies with care.