Patients with type 1 diabetes are missing out on flash glucose devices, finds BMJ investigationBMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4675 (Published 07 November 2018) Cite this as: BMJ 2018;363:k4675
Tens of thousands of UK patients with type 1 diabetes are being denied the potential benefits of “flash” glucose monitoring devices because they are not being recommended in some areas, an investigation by The BMJ has found.
Flash glucose monitoring, which works from a sensor attached to the skin, has been available on prescription since 1 November 2017. Users get glucose readings by scanning the sensor with a portable reader or a smartphone app. The reading shows an arrow that indicates whether glucose concentrations are rising or falling.
Abbott’s FreeStyle Libre is currently the only such device available in the UK.
NHS England has advised clinical commissioning groups which patients should get prescriptions for the devices (box 1). It said that the flash device has the potential to improve patients’ quality of life, supports self management, and could save money in the long term by reducing complications and hospital admissions, although it has acknowledged gaps in the evidence base. But a year after the device became available, around a quarter of CCGs in England are not recommending it for patients even if they meet NHS England’s criteria, The BMJ’s investigation shows.
Who should get a FreeStyle Libre prescription?
The NHS’s Regional Medicines Optimisation Committee for the North of England says that, at present, FreeStyle Libre should be used only by people with type 1 diabetes aged 4 years or above who need to have multiple daily injections of insulin or insulin pump therapy and who meet one or more of the following criteria1:
Undertake intensive monitoring at least eight times a day
Meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4 mmol/mol)) or disabling hypoglycaemia (as described in NICE guidance TA151)
Have recently developed impaired awareness of hypoglycaemia
Frequent admissions (at least two a year) with diabetic ketoacidosis or hypoglycaemia
Require third parties to carry out monitoring and where conventional blood testing is not possible.
Partha Kar, NHS England’s associate national clinical director for diabetes, estimates that only around 3% to 5% of patients with type 1 diabetes in England have access to the sensor on the NHS. If CCGs were following guidance correctly, he believes this figure should be closer to 20% or 25%, if not higher.
He said that some CCGs were merely paying “lip service” to offering access to the devices and that variation in how the criteria were being applied had led to an unacceptable postcode lottery.
“I think some of it [CCGs’ resistance] is financial, but also some people are just finding a reason to say no. One CCG said to me, ‘We don’t think the evidence is there.’ And I said, ‘Well, how is the evidence there for London, Manchester, Liverpool, Brighton but not for you? How does that work?’ That’s just ridiculous,” he said.
Emma Wilmot, a consultant diabetologist at University Hospitals of Derby and Burton NHS Foundation Trust, treats some patients who can get the device and others who can’t. “I’ve had to say to patients, ‘I’m really sorry, you don’t meet the criteria because your GP is not in the right area.’ They are absolutely gutted. I’ve had patients even considering moving [to another] GP a few miles down the road so that they’d be in Derbyshire and they’d meet the criteria,” she said.
Other patients were making “huge sacrifices” to fund the device themselves, she said. “My worry is the people who aren’t in a position to self fund it. The most deprived people in the population often have the least access.”
Around 400 000 people in the UK have type 1 diabetes. This includes the prime minister, Theresa May, who uses FreeStyle Libre and recently told parliament that it was available on the NHS.
Data disclosed by CCGs to The BMJ in response to freedom of information requests show that some CCGs have made the devices available to hundreds of patients through their GPs and have spent thousands on prescriptions. But other CCGs say that the devices are prescribed only by secondary care clinicians. Some CCGs are imposing stricter access criteria than those recommended by NHS England (box 2), leading GPs to ignore this advice if they think the device will help their patients.
How patients are facing a postcode lottery
The proportion of patients with type 1 diabetes who are receiving a prescription for FreeStyle Libre on the NHS varies across the country
CCGs with highest proportions
Isle of Wight: 24.6%
Eastern Cheshire: 23.3%
South Lincolnshire: 17.1%
Wigan Borough: 15.9%
South West Lincolnshire: 15.3%
CCGs with lowest proportions
Dorset: 0% (of 4007 patients with type 1 diabetes)
Leicester City: 0% (2034)
Wakefield: 0% (1871)
South Worcestershire: 0% (1560)
Hull: 0% (1487)
Hartlepool and Stockton-on-Tees: 0% (1487)
Source: UK prescribing data to July 2018, collated by Nick Cahm
Official prescribing data collated by the diabetes campaigner Nick Cahm and shared with The BMJ indicate that only 2% of patients in England with type 1 diabetes are getting FreeStyle Libre on GP prescription, a much smaller proportion than the 11% in Scotland, 16% in Wales, and 35% in Northern Ireland.
As at July 2018 GP prescribing data showed that only two of 195 CCGs in England had prescribed FreeStyle Libre to more than 20% of patients with type 1 diabetes, and only 15 CCGs had prescribed it to more than 10%. Twenty five CCGs had issued no prescriptions at all.
Cahm told The BMJ, “Lots of the variation doesn’t need to be there. Being a type 1 diabetic is the same whether you’re in Birmingham, London, or Northern Ireland. It doesn’t seem to be logical. Decisions should be made by a specialist advisory panel.”
Julie Wood, chief executive of NHS Clinical Commissioners, which represents CCGs, said, “Unfortunately the NHS does not have unlimited resources, and ensuring patients get the best possible care against a backdrop of spiralling demands, competing priorities, and increasing financial pressures is one of the biggest issues CCGs face.
“Clinical commissioners have a responsibility to consider the needs of their whole populations, reduce inequalities, and improve quality of care while living within the funding they are given, and it is right that they should follow a due process when considering new medicines and technologies to ensure they are making the most effective use of the limited NHS pound.”
Ignoring CCG advice
The BMJ has learnt that some GPs are ignoring their CCGs if they haven’t recommended flash monitoring for prescribing.
Birmingham and Solihull CCG, the largest in England, with an estimated 6560 patients with type 1 diabetes, initially told GPs that patients should be able to get the FreeStyle Libre only if the GP submitted an individual funding request. This was in contrast to nearby Wolverhampton and Dudley CCGs, which made the sensor available.
Birmingham and Solihull CCG has since backtracked after it was challenged by Birmingham Local Medical Committee, the body that represents GPs in the area, which argued that the CCG did not have the legal or professional jurisdiction to impose such restrictions on GPs.
Bob Morley, secretary of Birmingham LMC, told The BMJ, “Clearly the CCG’s position put practices in a very difficult position, so we challenged it robustly. It breached the GMS/PMS contract regulations that the GP must provide a prescription if something is available on NHS prescription and a GP feels that their patient will benefit from it. And professionally, the CCG was trying to interfere with the clinical autonomy of GPs, who must act in the best interests of the patients.”
After the LMC challenged its decision, Birmingham and Solihull CCG sent a clarification of its position to the LMC, acknowledging that it could not demand individual funding requests from GPs.
Peter Scott, chair of Solihull LMC, said he had “scrupulously” prescribed FreeStyle Libre to a small number of his patients against his CCG’s previous policy because he believed that it would improve their lives. He told The BMJ, “I’m not contrite in any sense. I have had feedback from all of my patients [with FreeStyle Libre prescriptions], and it’s been glowing. Their quality of life is much better, their diabetic control is much better, and in all of them their HbA1c has fallen.”
Elsewhere, the seven CCGs in Suffolk and Norfolk told The BMJ that GPs in their areas had been prescribing FreeStyle Libre against the CCGs’ advice and that they were currently reviewing their policies.
Kar, who has been lobbying CCGs to adopt NHS England’s guidance, said, “Lots of GPs are saying, ‘I’m going to do it [prescribe it].’ I thought this was inevitable at some stage. if people are at the door of their GP, what is the GP supposed to do?”
Long term gains ignored
Cahm said that some CCGs were thinking only about their short term finances rather than the long term gains that could occur if patients with type 1 diabetes had better control of their condition and experienced fewer complications in years to come.
“They are expecting the payoff now, but it’s not going to happen,” he said. “The risk of complications is unknown, and those costings don’t show themselves in the short term. My view is that the CCGs should be trusting the experts. At the moment it comes down to the ability of specialists in the area to drive it and show the business case.”
Wilmot believes that the FreeStyle Libre is proving to be one of the biggest “life changing” advances in type 1 diabetes care for many years, alongside the DAFNE (dose adjustment for normal eating) educational course and insulin pump therapy.
“I’ve lost count of the number of times I’ve said to people in clinic, this is the best HbA1c you’ve had in a decade. That’s the level of impact it’s having on some people,” she told The BMJ. “But also, the reason that we strive to reduce complications is to maintain quality of life. And actually, by preventing people having access to the Libre you are compromising their quality of life compared with what it could be.”
Demand exceeds supply
Abbott, manufacturer of the FreeStyle Libre, has been experiencing “unprecedented demand.” A spokesperson said that people who had a prescription for the device were getting it but added, “For the time being our web shop is restricted to existing customers who can purchase three sensors every 25 days, with free shipping. Potential new customers looking to purchase the system can sign up to a waiting list on our website to be notified when they are able to order the product.”
Experiences of patients
Sue Briggs, 63, from Somerset, who had type 1 diabetes diagnosed in 2008
I was self funding Libre for 18 months before I got flash on the NHS. Within a couple of months of using it my HbA1c (in mmol/mol) fell from the lower 50s (around 7.0 in the old units) to the lower 40s (around 6.0). My consultant was very supportive and asked my GP to prescribe it, who said yes.
The impact of the extra information you get with Libre is really something. When driving, for example, if I had a blood glucose reading of 5 versus a Libre reading of 5 with a downward arrow I would react in different ways.
The flash has reduced the amount of glucose testing strips I use, from around 10 a day to maybe five. It helps me to head off the highs and the lows, and I stay in [the glucose target] range so much more.
The eight hour graph has given me so much more information about what I eat. When I got my Libre I saw the spike [in glucose] after eating breakfast. Previously, I had no idea that was happening, because I would test two hours later, when I’d be back on target. Libre helped me to change the timing of my bolus injections.
The downloads that I share with my consultant help us both make decisions about my care.
I think that funding decisions are made for the short term, and what we’re talking about is heading off long term conditions. I don’t want to lose my feet in 20 years’ time, and I’m confident that because I manage myself well now there’s a lot less chance of that happening. I’m also more likely to keep my hypo awareness, so I can save the NHS money by avoiding emergency admissions.
Victoria Hill, 24, whose type 1 diabetes was diagnosed in 2000 when she was aged 6
I come under Bristol, South Gloucestershire and North Somerset CCG. Gloucestershire and South Somerset [the neighbouring CCGs] have both said yes to prescribing FreeStyle Libre; it’s just ours that said no.
I was put on a trial with the Libre when I was under care in Cardiff around 18 months ago. Within two weeks my blood sugar came down at a ridiculous rate. The major difference has been knowing what my blood sugars were doing overnight. And from that data I adjusted my insulin: I split my long lasting from once a day to twice a day. After the two week trial I paid for [Libre] for about four months, and in that time my HbA1c went (in old units) from 9.2 to 7.9. I wasn’t really doing anything different in what I was eating or how I was exercising: it was purely just reading the data and adjusting from that knowledge.
When I was buying a house I couldn’t afford to keep paying for Libre, and over about seven months my HbA1c went back up to 8.6, even though I felt I was doing the same as when I had the Libre.
After we had moved I could afford it again. I’ve been using it now for six months, and two weeks ago my HbA1c was 6.6. I’m absolutely chuffed—it is life changing. I’ve been on multi-syringes and then moved to pens, but this is the one thing that has made a difference to my life overall.
It is the most frustrating thing in the world that in Gloucester, which is 5 miles down the road, they are getting it on prescription and I’m not. Why are they more deserving than me? I am able to afford this, but there are people out there who can’t, and they are really missing out.