Death or profit: Flash, CGM and patient-centricity

As many people with T1D in the UK will know, there has been an ongoing dialogue between NHS England and the DVLA with respect to allowing the use of CGM and Flash monitoring in determining glucose levels relating to driving. The consultation has been underway for some time, and appeared to be going well. 

Until recently, when it became clear that it wasn’t, and that objections had been raised to the introduction of CGM and Flash on “patient safety grounds”. Now you might expect that these would come from healthcare professionals or patient representatives, but no. They came from companies involved in the manufacture of diabetes products. 

So far, there are no official names, but we are raising a freedom of information request to look further into this.

Then came the news from Partha Kar that a company had raised an objection to NHS England about the Libre announcement and was looking to challenge the entire process.

An altogether more outrageous frontal attack intended to stop the NHS funding the Libre, because they didn’t have their own product that fitted in to the new guidance.

Who might have the gall to do such a thing? Well a reasonably brief dig into the data suggests that it could easily be one of a number of companies.

Where to start?

The starting point for this is Partha Kar’s recent blog post, where he talked about instances of trust failure with diabetes tech companies. Here we’re going to look at the big one, where he spells out that:

Till one bypassed us all- and showed us all to be a divided ship. Like the Thanos snap, so much turned to dust- in an instant. It sucked as we had met the company concerned to assure…yet…

http://nhssugardoc.blogspot.com/2018/12/out-of-road.html

This and objections to the use of flash/CGM for driving are both identified in the blog. The latter is dealt with in the appendix to this page.

According to Partha’s blog, there was a wider strategy to open up access to D-Tech, but one company blew that one open when they no longer played by the rules of the alliance. Libre was supposed to be be a pathfinder, but instead, in attempting to manage their bottom line, someone decided that Libre wasn’t good for patients and appears to have gone over the heads of NHS England’s Diabetes team.

Who has most to lose?

Let’s take a look at some data. If you take a quick look at the widely available NHS BSA prescribing data, you can arrive at some interesting conclusions very quickly. As shown in the table below, three companies control more than 55% of the strip market in England and Wales. One has more than a quarter.

The one with more than a quarter of all strips is also the one with one of the most expensive strips, costing 32.42 pence per strip, that just happen to work in a bolus calculating meter that is given away on DAFNE. Overall, at a weighted average of 26.14 pence per strip, 60% of their sales are the most expensive ones.

Given they have 28.4% of the market overall, this means that they still command the largest share of the market with a single product line (more than 17% with the Aviva system alone), which is also the most expensive strip on the list.

Interestingly, the average cost for the second  and third placed companies is roughly 19.9 and 26.69 pence per strip respectively, with the most expensive for the third place costing 30.08 pence per strip and accounting for 68% of their market share, or 7.8% of the overall market. 

The table below shows the total amounts of money involved annually, based on the prescription data that we have. 

Given the above, it wouldn’t seem too unreasonable, based on scale of sales to suspect that one of the top eight might raise an objection to something that would impinge on their sales, however we can probably exclude Abbott as they would be making money from the Flash business. I can even imagine the case that collusion might take place between companies to ensure a spanner is put in the works.

But to use concerns about “Patient Safety” or “Patient Choice” as the argument rather than suggesting to the powers that be that they might lose money, as that might not go down so well with a government agency? One might consider that to be disingenuous.

The impact of Flash and CGM

Why might one of the test strip companies want to raise a request to senior bodies of the NHS to stop Libre. Well let’s review what the plan is for Libre. Taking a conservative view, it’s to have 25% of those with T1D using the Libre on the NHS, and gaining significant quality of life and outcome improvements in the process.

Which 25%? Well those who test in high volumes and those with high Hba1C values as a start (although NHS England’s guidance may change). So if you’re one of the big three and you can see this coming, you might look at that and think “25% of T1Ds going from 8 a day to 1 a day is likely to cost us sales”. If you are Roche, that could be worth the best part of £12,000,000. 

Overall, it would reduce the amount paid to test strip providers by around £37 million (regardless of the increased cost of using Libre). 

Now this fails to take into account the fact that most of those with Hba1C levels greater than 8.5% are likely to not be testing 8 times per day, but it doesn’t mask that there would be an overall impact on sales.

Putting it bluntly, the strip units of these global companies are facing an overall reduction in their revenues of between 20% and 30% in the UK as uptake of flash gets underway. You can see why they might want to push any change back until they were able to compete, even if it is only a small part of their global revenue.

You mentioned additional industry interventions?

Ah yes, I did, didn’t I?

Whilst all this was going on, from those who don’t have a CGM or Flash product, there was a direct approach to CCGs to try and increase options in respect of Flash. 

A letter came out from Glucomen, directly to CCGs, bypassing NHS England, that said they had something akin to flash and that it would appear in April 2019.

The initial commentary from the diabetes Healthcare world was “What is this?”. Glucomen had not been pushing a new CGM or Flash product, and there is little to no evidence of anything being available when you conduct extensive searches. There’s no evidence of ongoing clinical trials either, which would be needed for the NHS to fund something. In fact the only thing that shows up is the Glucomen Day, which dates back to 2010.

So what are they up to?

Some suggested they may not understand the UK processes, as a company originating from Italy, however they’ve been in the UK market for 30 years so this seems a little thin.

When this question was raised by NHS England directly they said that they do indeed have a product and it will be coming out in April 2019. Precisely when flash will be fully available under NHS England guidance.

It is clearly an attempt to protect market opportunity where a company hasn’t yet got a product to market. Unfortunately it also ignores the fact that the only available data for a flash based system is all from trials with Libre, so the only option in April 2019 for a flash based system is Libre. Come forth with data and clear the air, or don’t obfuscate by going directly to CCGs.

What can we take away from all of this?

Many of these companies describe themselves as patient-centric in one form or another, in fact, the images below are all taken from the websites of the biggest three of these companies:

And yet… One could argue that the actions described earlier are all counter to the ethos of these statements. Surely, if you are a corporate that has a mission that puts the patient at the forefront of what you do (or even state that your aim is to help improve time in range, as Roche do), that must include improvements in technology that make living with a long term condition easier (e.g. Eversense). Even if it’s not yours.

The activities we’re hearing about suggest that these types of statement need to be adjusted to include “…except where it limits our ability to generate revenue and returns for our shareholders.”

I don’t want to call the actions that have been described underhand, because they aren’t. They’re normal lobbying responses that corporates undertake when dealing with national bodies. I’m not going to judge whether they are right. They certainly leave a bad taste and they do seem to confirm an observation I heard from an industry insider who said that they’d never seen anything as “Wild West” as the MedTech industry.

So when a company tells you they are patient-centric, you might want to have another look at the conditions that accompany that statement…

Footnote

The Diabetes Technology Society has been running a project to identify the most accurate strips. The strips that passed their accuracy metrics were:

Trials Within Protocol Limits
Brand	Blood Glucose Monitor	Test Strip	Valid Trials	N	%
Bayer	Contour Next	Contour Next	312	311	100%
Roche	ACCU-CHEK AVIVA Plus	ACCU-CHEK AVIVA Plus	311	306	98%
Arkray	Walmart ReliOn Confirm (Micro)	ReliOn Confirm/micro	317	307	97%
Agamatrix	CVS Advanced	CVS Advanced	318	307	97%
Abbott	FreeStyle Lite	FreeStyle Lite	312	298	96%
Roche	Accu-Chek Smart View	ACCU-CHEK SmartView	320	305	95%

Of these, the top two were our more expensive brands as is the Abbott Freestyle Lite at 32.46 per strip, but the other three are lower cost. The ReliOn system isn’t available via the NHS, but the other two are, using different naming conventions:

• CVS Advanced = Agamatrix Wavesense Jazz:       17.48p per strip
• Accu-check Smartview = Accu-check Performa:   19.9p per strip

So if you feel that the costs of strips you are using are high, and you don’t use a bolus calculator, these are potential other options.

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Appendix

 

The revenues in driving

One of the points raised in Partha’s blog were two objections on a recent DVLA consultation about using Libre and CGM for driving. What might the costs to these companies be of that? If we turn to the National Travel Surveys that the UK Government runs annually, we find some interesting pointers. According to the 2016 data, the average number of trips made as a Driver in 2016 was 389. The 2017 data makes this information much more difficult to find, so for now we’ll use this number, as the change across all car trips from 2016-2017 is very minimal (591 in 2016 vs 594 in 2017).

So from this we know that annually, at least one finger prick is required 389 times a year. The average journey length is relatively low, and there is no indication of how long someone stays at their destination, so we’ll use this as the basis of the calculation.

The next thing we’d need to understand is how many people are driving. We can elect to use the number of cars or the number of people with driving licenses. Whilst 75% of the UK population holds a driving license, only 49% of the population could have been driving at any point in time given the number of vehicles available. So we’ll use that value and extrapolate it to the number of people with T1D. 

According to the JDRF, there are roughly 400,000 people in the UK with Type 1. Of these 29,000 are children, who obviously can’t drive. This leaves a population of 371,000. If we assume that 49% of these drive regularly, we have 181,790, who drive 389 times per year each. That’s 70,716,130 journeys, all requiring blood tests. Even if we assume only one test per trip, that’s still a lot of fingerpricking.

Of those, based on the earlier data, 55% are done by the three biggest providers. Now we’re at 38,893,970 tests, and the weighted average cost of a strip across the top 3 is 24.48 pence per strip. That works out at a whopping £9,521,243. That’s what one strip per driven journey costs annually to the NHS.

Now let’s put that into the context of the total spend with strip suppliers on the NHS. The total annual spend that was identified earlier for these three companies is some £86.3 million. On the basis of a single test per trip (which is likely to vastly underestimate the real “expected” use for driving), we looking at more than 10% of the overall revenue for these three companies alone being derived from the use of tests strips for driving.

Given the push to get Flash out to 25%-30% of people with Type 1 on the NHS, and the assumption that a further 20% may be funding flash or CGM themselves, by allowing the use of these technologies for driving, there is a clear and obvious hit to the strip manufacturers.

If 50% of people with type 1 were testing with Libre or CGM prior to driving, that would be a 50% reduction in strip revenues from driving, and we’ve already identified that this is an area worth an estimated 10% of the overall strip revenues for these companies. 

It amounts to at least a 5% reduction in strip revenues across the board, purely from driving, on top of the reductions in use (from roughly 8 per day to maybe one per day) that comes alongside funded use of the Libre. 

It’s clear why objections might be raised in a political forum in the guise of patient safety when faced with this sort of revenue impact.

There in black and white are the back of a fag packet calculations that offer some potential reasons as to why companies might have objected.