Roll up, roll up. The #Freestyle Libre postcode lottery has started. You gotta be in it to win it….

Earlier today, the first NHS England CCG response to the Libre appeared on Twitter, from the East of England Priorities Advisory Committee. Looking to the future, bright and rosy it was not. In fact it said this:

So let’s look at what they think. Point one is self explanatory. Point two is essentially saying that “Until we see this in a NICE guideline, go on, get stuffed”, before we get to point three which says “We want to see a whole bunch of evidence to prove that the Libre is cost effective”. And then we dig into the cost.

So let’s start with the East of England committee’s view of cost. Well they’ve clearly had their meeting before the price on the drug tariff was revealed, as at £35 per sensor, the annual cost is £910 for the sensors, plus a reader, for which we don’t yet have a price. But let’s assume they haven’t got those on a discount. That would be £48 ex-vat, giving a total cost of £958 in year one and £910 annually after that. Indeed, if we don’t buy readers and make people use their smartphones, then it’s £910. Full Stop. Let’s start off by saying that’s a little bit naughty.

Now let’s look at the second error in their calculation. They’ve done a cost calculation based on actual use of finger prick strips, not what NICE recommendations are (which, given the earlier reference to NICE recommendations really is not playing fair!!!).

NICE recommendations for SMBG (self monitoring of blood glucose) are:

1.6.11 Support adults with type 1 diabetes to test at least 4 times a day, and up to 10 times a day if any of the following apply:

• the desired target for blood glucose control, measured by HbA1c level (see recommendation 1.6.6), is not achieved
• the frequency of hypoglycaemic episodes increases
• there is a legal requirement to do so (such as before driving, in line with the Driver and Vehicle Licensing Agency [DVLA] At a glance guide to the current medical standards of fitness to drive)
• during periods of illness
• before, during and after sport
• when planning pregnancy, during pregnancy and while breastfeeding (see the NICE guideline on diabetes in pregnancy)
• if there is a need to know blood glucose levels more than 4 times a day for other reasons (for example, impaired awareness of hypoglycaemia, high‑risk activities). [new 2015]

1.6.12 Enable additional blood glucose testing (more than 10 times a day) for adults with type 1 diabetes if this is necessary because of the person’s lifestyle (for example, driving for a long period of time, undertaking high‑risk activity or occupation, travel) or if the person has impaired awareness of hypoglycaemia. [new 2015]

The target values for blood glucose levels are:

1.6.13 Advise adults with type 1 diabetes to aim for:

• a fasting plasma glucose level of 5–7 mmol/litre on waking and
• a plasma glucose level of 4–7 mmol/litre before meals at other times of the day. [new 2015]

1.6.14 Advise adults with type 1 diabetes who choose to test after meals to aim for a plasma glucose level of 5–9 mmol/litre at least 90 minutes after eating. (This timing may be different in pregnancy – for guidance on plasma glucose targets in pregnancy, see the NICE guideline on diabetes in pregnancy.) [new 2015]

1.6.15 Agree bedtime target plasma glucose levels with each adult with type 1 diabetes that take into account timing of the last meal and its related insulin dose, and are consistent with the recommended fasting level on waking (see recommendation 1.6.13). [new 2015]

So, if we’re to check waking levels and before each meal and before bed, that’s five times a day. This CCG is therefore being disingenuous in stating the costs of once and four times daily testing, as that’s clearly not what is stated in the NICE guidelines.

Now then, let’s also assume that, like the average person, we drive to work. The DVLA requires us to test no more than two hours before getting in the car. In the morning, waking or breakfast tests might cover that, but it’s unlikely in the evening, so now we’re at six tests daily.

Then let’s assume that we play sport, go to the gym, or do some other activity that is likely to affect our glucose levels. Now we’ve reached eight tests per day. And we still don’t know anything about our post-prandial levels. So if we want to manage ourselves the best that we can, we’ve arrived quite quickly at that ten times daily comparison number, without trying.

So East of England committee, your cost basis of once, or four times, daily, while reflecting real world usage due to people not liking to finger prick, doesn’t really stand up against the NICE recommendations that you asked for for the Libre.

On a ten tests a day model, the East of England committee has used the NICE Guideline cost data.

So far then, we’re talking about £958 vs £1,059.

If we bring our friends, the DVLA back into it, and assume that we are driving twice a day, every day, this means that we will need an additional 15 packs of strips. That’s an extra £217 over the course of the year, taking us up to £1,175

But we’re also being a little disingenuous here again, as the reality is that we stopped at 10 strips in our earlier recommendations, because that’s where NICE evidence stops, and to achieve good management and the target Hba1C of 6.5%, we know full well that we won’t get away with only 10 strips a day.

And then of course, this takes the typical CCG approach to looking at costs. It says, “what does it cost here and now?” and pays no attention to future costs. It also surreptitiously says “We’re not going to look until someone’s done the proper cost analysis that’s been done for all other monitoring methods in the NICE guidance and unequivocally demonstrated that it’s better than SMBG”, i.e. Appendix P of the evidence, which covers the cost effectiveness of various monitoring solutions.

Short cutting through that, we see that at 10 times a day testing, the average drop from the UK baseline Hba1C of 9.11% is to 7.21%. This provides, based on the DCCT study, a reduction in the relative risk of developing the long list of complications that NICE uses, from five times more likely than a non-diabetic to roughly two times more likely than a non-diabetic.

Now if we look at the QALYs (Quality-Adjusted Life Years) analysis that was done for SMBG 2 vs SMBG 10 (that’s 2/day vs 10/day) by NICE, there’s a surprisingly small increase in QALYs, given the change in relative risk that the baseline drop in Hba1C presents in the UK.

Of course this also ignores the cost (which goes back to the CCG) of treatment for any of these complications.

But here’s the rub. If we go back to the costs that we’ve just reviewed, and take Abbott’s own data, the average number of time people scan with these devices is more than 16 times a day. There is no evidence base for this amount of SMBG. The one thing we can be sure of is that it would significantly exceed the £20,000 ICER threshold in place if it was done with SMBG.

Secondly, they recorded an Hba1C drop from 8% to 6.7%. That’s a relative risk change from 3x to roughly 1.5x.

But let’s go back again to our cost model. The CCG has used the NICE evidence to disregard the cost of the Libre. Looking back through this, I’d argue that it’s much closer than the evidence that they’ve put forward suggests, even if you drive.

And then, of course, there’s the captured data looking at Hypo reduction.

• Reduction in hypoglycemia: Time spent below glucose levels of 70, 55 and 45 mg/dL decreased by 15 percent, 40 percent and 49 percent

The data captured from the devices shows a significant reduction in severe hypoglycaemia levels. This is something that the QALYs analysis completely ignores and that the NICE evidence states that there is no evidence for in the presented SMBG data.

So how can that be completely ignored in a CCG cost based analysis? For as we know, the cost of hypos varies dependent on the required treatment, and hospitalisation results in a cost of £240 for an ambulance or £700 if you take up a bed for a day, and £940 if you end up requiring both. Costs which go back to the CCG.

In other words, if you stop one, single, severe hypo that results in an ambulance being called out, by using the Libre, you save more than the difference between the Libre and the SMBG 10 costs.

Our numbers change to look like this:

• SMBG10 + one severe hypo = £1,299
• Libre plus strips for driving = £1,175

But we’re left in the position that a CCG can look at this and say, “Well that’s not a proper cost effectiveness analysis. I want QALYs, ICER, NMB and everything else”.

And there it’s over to both us and our healthcare practitioners. We need to work together to ensure that the data that CCGs are using is relevant, applicable, and ultimately demonstrates that there really are benefits to this (and other) technologies.

The postcode lottery has started. Let’s make sure that everyone’s a winner….