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There are so many misconceptions and ‘fake news’ surrounding prescribing ofFreestyle Libre sensors. This is not just emanating from the patient side, but people within CCGs (the local health board) often don’t know how to apply the national criteria. The following explanation covers NHS England only – the other countries have similar, but different criteria/rules.
So, the first piece of the jigsaw is the national criteria. I’m in the lucky position that I was asked to contribute to the detail of the national criteria due to my work to reduce the postcode lottery. I was therefore privy to the discussions that led to the final policy and the rationale behind the criteria. The criteria has quite a few pages, but they key is the appendix. The aim is for it to be clear and unambiguous. Here is the key area of the criteria:
Annex A: Criteria for NHS England Flash Glucose Monitoring Reimbursement
1. People with Type 1 diabetes OR with any form of diabetes on hemodialysis and on insulin treatment who, in either of the above, are clinically indicated as requiring intensive monitoring >8 times daily, as demonstrated on a meter download/review over the past 3 months
OR with diabetes associated with cystic fibrosis on insulin treatment
2. Pregnant women with Type 1 Diabetes – 12 months in total inclusive of postdelivery period.
3. People with Type 1 diabetes unable to routinely self-monitor blood glucose due to disability who require carers to support glucose monitoring and insulin management.
4. People with Type 1 diabetes for whom the specialist diabetes MDT determines have occupational (e.g. working in insufficiently hygienic conditions to safely facilitate finger-prick testing) or psychosocial circumstances that warrant a 6-month trial of Libre with appropriate adjunct support.
5. Previous self-funders of Flash Glucose Monitors with Type 1 diabetes where those with clinical responsibility for their diabetes care are satisfied that their clinical history suggests that they would have satisfied one or more of these criteria prior to them commencing use of Flash Glucose Monitoring had these criteria been in place prior to April 2019 AND has shown improvement in HbA1c since selffunding.
6. For those with Type 1 diabetes and recurrent severe hypoglycemia or impaired awareness of hypoglycemia, NICE suggests that Continuous Glucose Monitoring with an alarm is the standard. Other evidence-based alternatives with NICE guidance or NICE TA support are pump therapy, psychological support, structured education, islet transplantation and whole pancreas transplantation. However, if the person with diabetes and their clinician consider that a Flash Glucose Monitoring system would be more appropriate for the individual’s specific situation,
then this can be considered.
I’d suggest that the most likely criteria to meet for adults is Criteria 5 – this is the self-funding criteria. Reading it carefully, it requires a reduction in A1C since self-funding and to have met one of the other criteria prior to self-funding. This can be any of the other criteria. The one that is the most common will then be criteria 1. Whether you’re a self-funder or a potential new user, this criteria reads the same. So many people get this criteria wrong…the wording is clear unless people choose not to interpret it correctly:
“is clinically indicated as requiring intensive monitoring >8 times a day”
It doesn’t say anywhere here that you need to test >8 times…indeed less than 1% of T1s test that frequently. It’s not a sensible criteria for many people getting Libre if you read it as needing to prove 8+ tests, as almost nobody will get it. 8+ tests can be one criteria, but if you meet one of the other criteria, there is no need to meet that test.
The other criteria that is important is criteria 4. This is the one I call the psychosocial criteria. This is the most important criteria for children. Almost all children should meet this criteria. It is difficult to finger prick at school and may be particularly traumatic for minors. There is no need for psychological assessment for this or a diagnosis of ‘a condition’, it just needs to be difficult either mentally or physically to test. This criteria also applies to people who work in areas where it is difficult or undesirable to test traditionally. Areas where there’s food prep, in school, or heavy industry could be included. The patient just needs to convince their specialist.
Almost certainly, you’ll need to see a hospital specialist or a Diabetes Specialist Nurse (DSN). They will then give the instruction to your GP to put on your repeat for 6 months. They will then review at the end of 6 months against the Other Requirements criteria at the bottom of the appendix page. If they refuse, get the reason in writing and then ask for assistance, possibly via the UK Libre Facebook group page.
Unfortunately, NHS England is split into 195 CCGs. These broadly operate independently of each other and have their own budgets. Because the areas couldn’t decide what to do about Libre despite guidance, they were forced to change for the 2019/2020 financial year. They have had budget taken off them equal to prescribing Libre to 20% of their T1s for the whole financial year. They will be reimbursed that money in proportion to the amount of Libre they prescribe. These prescriptions must be via a community pharmacy and be issued from a GP. Quite a few CCGs don’t understand this and are in for a shock when they don’t get their money back.
It was difficult to get NHS England to agree to this, 20% of T1s was the most that they’d agree to. It’s around 80k sensors a month, so a large number. 20% is a minimum, not a maximum. Many CCGs had already decided to fund Libre, even back the first time it was allowed to be prescribed in November 2017. These areas weren’t reimbursed, this is a new policy from April 2019. They made the decision to fund, based on evidence, including reduction in test strip costs and improved outcomes, including HbA1C. There’s no reason to stop at 20%, savings should still be realised. Unfortunately, some areas, particularly in the East of England, don’t understand and are still being obstructive. The question I’d ask them is, can they justify wasting money due to them not agreeing with a policy designed and costed by experts? What is their justification in thinking they are better than the experts?
As for Type 2’s. It certainly isn’t a case of unfair discrimination or penalising Type 2’s. It is about economics and evidence. There is a lack of scientific evidence that Libre helps type 2’s – indeed there isn’t a consensus how much type 2’s need to test using traditional means. Additionally, for every one type 1 diabetic, there are nine type 2’s. There isn’t the budget to supply to all these and as yet, it hasn’t been identified which group (if any) might benefit. It seems obvious that insulin-dependent Type 2’s should be eligible. In Scotland, this has happened. Hopefully one day England will follow suit…but data is so poor, that it is not known how many insulin-dependent T2’s there are. Makes decisions rather hard!
So, my advice if you want Libre – check the criteria, make sure you meet what it says, then get an appointment at the hospital and don’t give up!
Nick Cahm (@cahmn or www.t1tenor.com)
Administrator – Facebook Freestyle Libre Users Group, including Libre Geeks, UK Users, USA Users and Libre Off-topic groups.
T1 Diabetic since 2007 and Libre user since 2014.
Please see this article here about the Maio Maio device which works with your free style libre to make it a full CGM, meaning no more scanning of your sensor to get results to your devices.