World Diabetes Day 2018. The day that NHS England had enough.
The announcement
If you hadn’t seen it, NHS England issued a press release early this morning, which brings to an end the post code lottery that access to the Freestyle Libre has become.
As many will be well aware, 144 out of 195 CCGs in England had made the Libre available by this point (fewer than three quarters of the total) and the criteria under which people could access it were variable and in some cases extremely restrictive. Diabetes UK has had a long running campaign to redress the inequality, and Partha Kar has been pushing hard to align CCGs with the national point of view.
Well no more. As the announcement says:
NHS England will ensure the device, which is the size of a £2 coin and sits on the arm, is available on prescription for all patients who qualify for it in line with NHS clinical guidelines.
From April 2019, these patients will be able to receive it on prescription from their local GP or diabetes team helping them to better manage their blood sugar levels.
According to the press release, this means that 20%-25% will qualify for the Libre, instead of the current 2%-3% of the people with Type 1 in England.
Partha Kar is quoted as saying that the funding for this comes from next year’s funding growth for local health groups, which is why access to the Libre on prescription is being touted for April 2019. I assume this means that the 3.6% funding increase from 2019-2020 is what will be used to fund this approach, in light of any other source of information relating to funding increases.
The other point that I pick out of this statement is that it will be for “all patients who qualify for it in line with NHS clinical guidelines“.
Clinical Guidelines and their impact
As it stands at the moment, the NHS clinical guidelines that we have stem from the Regional Medicines Optimisation Committee (RMOC) meeting in October 2017. Those state that:
It is recommended that Freestyle Libre® should only be used for people with Type 1 diabetes, aged four and above, attending specialist Type 1 care using multiple daily injections or insulin pump therapy, who have been assessed by the specialist clinician and deemed to meet one or more of the following:
1. Patients who undertake intensive monitoring >8 times daily
2. Those who meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycemia as described in NICE TA151) where a successful trial of FreeStyle Libre® may avoid the need for pump therapy.
3. Those who have recently developed impaired awareness of hypoglycaemia. It is noted that for persistent hypoglycaemia unawareness, NICE recommend continuous glucose monitoring with alarms and Freestyle Libre does currently not have that function.
4. Frequent admissions (>2 per year) with DKA or hypoglycaemia.
5. Those who require third parties to carry out monitoring and where conventional
blood testing is not possible.In addition, all patients (or carers) must be willing to undertake training in the use of Freestyle Libre® and commit to ongoing regular follow-up and monitoring (including remote follow-up where this is offered). Adjunct blood testing strips should be prescribed according to locally agreed best value guidelines with an expectation that demand/frequency of supply will be reduced.
Given it’s only one of the above criteria that need apply and that the results we’ve seen from ECED show that those with higher Hba1C values benefit more from this technology, it’s worth digging into the criteria more carefully.
Across England in the National Diabetes Audit from 2016-2017, some 70% of people with T1D had an Hba1C value that was greater than 7.5%, it seems likely that significantly more than 25% of those living with T1D may be eligible for the use of Libre on the basis of Hba1C level alone.
In addition, many of those who achieve a value below 8.5% will be testing frequently, potentially more than 8 times per day, dragging a further cohort into accessibility for the Libre. The NDA data suggests that 30% of PWD in England have Hba1C levels below 7.5%, and to achieve this really requires significant testing or self funding of Libre or CGM, so there are likely to be significant gains there.
Finally, criteria number five would seem to apply to all children with diabetes under 10. Third party monitoring is required, and whilst they are sleeping, traditional finger prick monitoring is not appropriate.
Expectation
Taking these factors into account, this can only be seen as a positive move, and the more people that have access to life improving, and long term cost reducing technology, can only be a good thing. Based on the above review of the RMOC criteria, it would seem that significantly more than 20%-25% of those living with T1D will be eligible for this on prescription.
And of course the other factor in all of this? That NHS England has gained a vast amount of knowledge about dealing with medtech rollout in the UK and how to enable it more effectively. As a result, future technological advances will be undertaken with the Libre lessons learned foremost in mind.
The future certainly looks bright!
This sounds like great news but I am wondering if it is answer that is being looked for ie getting people’s A1cs safely down to normal. The 70% above 7% is pretty disturbing.
I am wondering if we will see a repeat of what happened in the DCCT (more insulin was used to bring people’s a1cs down to 6.5%, rather than diet, and in this intensive treatment group the occurrence of severe hypos increased threefold)? People will have more knowledge about how their BGLs are behaving and may start employing more correction doses, which are a pretty blunt instrument, to try to bring their levels into the normal range. IMO a strategy of eating to match the way the insulin works is also called for.
I have always thought the freestyle without the alarm would be a wonderful measure for people not on insulin and controlling the disease just with diet and exercise. Once you need insulin, the alarms become invaluable. They can alert you quickly enough to take action, keeping in mind the quick acting insulins take 1-3 hours to reach full activity. I am not sure of the value of the Freestyle to people without hypo awareness. I know it is costly, and I appreciate the inching forward in better treatment though.
There is evidence from a number of UK clinics that educated use of the Freestyle Libre is enabling reductions in Hba1C – the Edinburgh Centre for Endocrinology and Diabetes has published some very interesting data, and other centres across Europe are too.
I think that without the level that continuous traces give you, decision making is much harder, and the realtime trace showing just how cake, for example, affects people is likely to do more than just increase insulin doses as more people realise how insulin really works. That’s also a part of the education that HCPs are being given in relation to helping PWD with learning about the Libre.
I agree about your last point relating to those not using insulin, but as you say, one step at a time.
On the point of alarms, though, they’re a bit of a mixed bag. Those who struggle with variable glucose levels get a lot of alarms, and as a result, suffer alarm fatigue, and as a result, stop using CGM. Libre provides an insight without being in your face about it, and can be done according to your schedule, providing continuous data in a fingerprick paradigm. Don’t underestimate how much that appeals to a lot of people. There are an awful lot who don’t want the alarms. On the other hand, if you struggle with lack of hypo awareness, I’d agree. It’s not a great deal of value as far as I can see.
I see item 2 being a sticking point:
“2. Those who meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycemia as described in NICE TA151) where a successful trial of FreeStyle Libre® may avoid the need for pump therapy.”
For those already on a pump will we see use of the Libre via prescription as a pathway for taking the pump away? Whilst I imagine the idea is that people would go on the Libre before a pump it does leaves the door open for the CCGs to see this as a route for taking pumps away. Considering how some of the CCGs have acted you can see why we might think that.
Whilst I can understand that point of view, the decision maker in pump supply is, as far as I understand it, the pump clinic consultant. As a result, the CCG isn’t in a position to make that demand.
I can, however, see a clinic putting someone on a Libre in an effort to reduce pump roll outs, which may have one of two effects. Either Hba1C and variability will go down and they will have been proven right, or use of the Libre will demonstrate things like raging Dawn Phenomenon requiring additional insulin shots, pushing someone firmly into a pump category, and once on a pump, obviously the number of times that you need to test per day goes up meaning you’ll keep the Libre…. 😉
If you are right that almost all T1s will potentially be eligible then this will end up as a first come first served situation and further allocation will cease once the funding ceiling is hit.