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
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Equity of access to healthcare has been an underpinning theme of the NHS since its inception.
The concerns raised in this area by Freestyle Libre® encapsulate many of the wider issues facing non-medicines technologies. Unlike medicines, the published evidence base supporting adoption is often weak. This issue is not unique to the UK but for a variety of reasons, is unlikely to change.
Does this then mean that resources should be committed only to areas where there is strong evidence in the form of randomised controlled trials and meta-analyses, even if the gains demonstrated are marginal? Were this to be the case, there is an associated opportunity cost which may prevent patients from gaining access to devices and technologies of great benefit to them.
For Freestyle Libre, the main evidence is from 2 randomised controlled trials (RCT) (1,2). Methodological weaknesses mean the risk of bias in these studies cannot be excluded. In such circumstances, alternative sources of evidence and measures of value may be valid and useful.
The Scottish Health Technologies Group used a bespoke economic model to inform their advice (3). Initial findings from a de novo cost effectiveness analysis showed that Freestyle Libre® is cost-effective for people with Type 1 diabetes mellitus (T1 DM) and for people with Type 2 diabetes mellitus (T2 DM) who are intensive insulin users and self-monitor their blood glucose levels. The incremental cost-effectiveness ratio (ICER) for Freestyle Libre® compared with standard self monitoring of blood glucose (SMBG) ranged from £2,459 to £12,340 per quality-adjusted life year (QALY) in T1 DM and from £4,498 to £18,125 in T2 DM, depending on the modelling approach considered. One-way sensitivity analyses indicated Freestyle Libre® was still likely to be cost-effective under a wide range of scenarios and cost saving against SMBG when a mean number of eight blood glucose tests per day was considered. Their probabilistic sensitivity analysis also indicated that Freestyle Libre® is likely to be cost-effective.
This modelling could be supported by real world data if users share data with their care team.
Additional evidence of benefit may come from patient experience and treatment satisfaction. These are increasingly recognised by health technology assessment bodies as independent measures of value when making recommendations. Diabetic patients and their carers have been diligent in making a strong case.
Freestyle Libre® highlights the challenges facing patients, health technology assessment agencies and key decision makers in first recognising the value (or otherwise) of new non - drug technologies and subsequently achieving equity of access. Evidence should inform decision making wherever possible but if patients are to gain access to new technologies which are not medicines, the search for that evidence may need to go beyond the conventional gold standard RCT, systematic review or meta-analysis.
1. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Lancet. 2016;388(10057):2254-63.
2. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline J-P, Rayman G. Diabetes Therapy. 2017;8(1):55-73.
Competing interests: No competing interests
I share Partha Kar's frustration with postcode lotteries. However, his remarks suggest ire directed at CCGs. Postcode lotteries are an explicit result of government policy - the smoke-and-mirrors of 'local decisions by local people' - which abdicates responsibility whilst providing insufficient funds for first world care, let alone fully implementation of NICE guidance.
In an unhappy few years as a CCG Lead for Clincal Effectiveness, I attempted to include this message in replies to MPs' letters about CCG decisions impacting their constituents. I hope Partha Karr will also direct his efforts to the root cause of the disease.
Competing interests: I remain a member of a CCG IFR panel, in a county with MPs exclusively from the ruling party.
Would you drive a car without a speedometer? Or with a fuel gauge you could interrogate only 4 times a day and at discomfort to yourself? If not, then maybe glucose monitoring is where evidence-base must step back and patient choice and common sense take over?
It turned out to be a shrewd marketing move on the part of Abbott to make their Flash Glucose Monitor "Libre" available to the public direct, bypassing medical say-so. Yes, it came at a cost to the individual, and not an inconsiderable one, but its popularity soon spread. It spread by social media and word-of-mouth, not to mention that photo of our Prime Minister in a long red sleeveless dress standing alongside the President of the USA with her sensor clearly visible.(1)
Those of us who work in diabetes had clients turning up for 6 monthly review who had bought their own "Libre", taught themselves how to use it and described it changing their lives. Sometimes their HbA1c had dropped by 10mmol/mol or more. More often they were delighted to be finger-pricking less and aware of their glucose and its direction of travel more. They could see if they were "heading for a hypo" and intervene before the situation acquired urgency. Teachers could surreptitiously swipe their arm with a 'phone-like gadget without the humiliation of drawing blood in front of a class of teenagers.
And those of us who work in diabetes want our clients who can't afford the sensors to have the same liberation from living without knowledge of where their glucose is taking them.
It feels to me as if people with type 1 diabetes are being penalized for having a common condition. The cost of "Libre" sensors would not be insurmountable if it were tackling a rarer illness or one more imminently life-threatening. But the very prevalence of type 1 diabetes should be the NHS's most effective bargaining tool. The NHS needs at a national level to strike a deal with Abbott (and let's hope there are competitors on their way) which means the sensors are affordable. Leaving rationing to CCGs is not a sensible, patient-focused or evidence-based way forward.
Competing interests: I have family members who use a variety of glucose monitoring devices.
Re: Patients with type 1 diabetes are missing out on flash glucose devices, finds BMJ investigation. Many patients with more conditions are missing out.
Clinical Commissining Groups = CCGs
Dear Mr Black
I know Her Majesty (or at least her Government) wants to curb expenditure.
They could not care less how the patients cope.
The “Commissioners” are superfluous layer of nominees unaccountable to the public.
Let them be abolished. If NICE is doing its job, then who needs these “Groups“?
Remember the BONFIRE OF THE QUANGOES promised once?
Many Guy Fawkes' Days have come and gone.
Let these CCGs be abolished. Let doctors use their CLINICAL JUDGEMENT.
Competing interests: No competing interests
Postcode lotteries for care always cause great angst in NHS watchers. But that isn't the biggest problem here. The incoherent criteria written by CCGs and their medicine optimisation committees are far more worrying as they will severely damage our ability to make better decisions in the future.
Part of the postcode lottery happens because some CCGs have not adopted any standards at all for prescribing the Freestyle Libre devices. Other have adopted a variety of strict criteria (like the North of England RMOC example used in the article, but often much worse and less coherent).
But few of those clinical criteria make any sense. They look like a set of clinical excuses cooked up after a financial decision to prescribe Libre as little as possible. They certainly don't look like they are targeted at the groups of diabetics most likely to get short and long term benefits from using Libre (and therefore save the CCG the significant future costs of dealing with higher levels of complications).
For example, most type 1 diabetics don't test their blood glucose often enough (we don't issue enough conventional test strips for all type 1s to come close to the 8-10 tests a day that are required for decent control and the typical diabetic is probably testing only 3-4 times a day with many testing even less frequently). But most criteria start by saying Libre should only be prescribed to those already testing at least 8-10 times a day. And the criteria then impose further limits based on the frequency of serious hypos or DKA hospitalisations. Surely the right target group is the people who would avoid ever being in such serious trouble if they tested their glucose more frequently now? In other words more or less the opposite of the current criteria.
Some CCGs argue that they are waiting for better evidence of the benefits from continuous testing. But the prescribing criteria make it harder to get that evidence as they don't target the groups most likely to benefit. Even if we learned about the benefits to the narrowly defined eligible groups that would tell us almost nothing about the benefits to the majority of type 1 diabetics.
NHS Clinical Commissioners argue, correctly, that "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..." which would be fine if that is what CCGs were doing. If their criteria said "we don't know the long term costs and benefits of Libre so we will hold off large scale prescribing until that evidence is clear" then we would have a basis for improvement and a clear set of criteria about what improvements we would have to demonstrate to show that Libre is a major benefit for a limited cost. But the current guidance limits any ability to learn about the benefits for most diabetics by setting ridiculous, incoherent criteria for current prescribing. Criteria which are dishonest in pretending that the rules are clinical when they are actually financial.
If the issue is whether the benefits are large compared to the cost when compared to other treatments then we can have a sensible debate comparing Libre to, for example, warfarin replacements where prescribing costs have risen in the last 5 years from ~£20m/year to over £300m/year because new drugs are 20 times the cost of warfarin (and for modest gains in outcomes). The worst case cost of Libre versus current costs (taking not account savings from lower use of conventional blood tests) are probably £100m-£150m for the whole of England.
Libre is an odd case in cost terms as well which none of the CCG guidance has recognised. IF diabetics used current blood-glucose tests as much as experts think they should (say 8-10 tests/day) then Libre would save money. The only reason why Libre would be more expensive is because most diabetics don't use conventional technology as much as they should because it is painful and inconvenient. It seems an odd goal for the NHS to rely on patient non-compliance to keep costs down, but that is the implication of current guidance.
Yes, a postcode lottery is bad. But incoherent prescribing criteria by CCGs based on spurious clinical criteria is much worse and will have longer lasting and damaging impact on the health of all their populations as it entrenches bad practice in how to make good decisions when new drugs and technologies appear.
Competing interests: self funding Libre user.