World Diabetes Day 2018. The day that NHS England had enough.
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.
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!