Question for Short Debate (Lords) on Health: Diabetes - Oct 31

To ask Her Majesty’s Government what assessment they have made of the provision of new technologies, such as flash glucose monitoring systems, for type 1 diabetes patients throughout England and Wales.

My Lords, I have declared on more than one occasion the interest of one member of my family in the treatment of type 1 diabetes. I have taken part in many debates on diabetes and I am grateful to Diabetes UK and JDRF for the vigour of their campaigning and their advice.

 

The incidence of diabetes has doubled in 20 years, making it the fastest-growing health crisis. By 2025, it is estimated that 5.2 million people will be living with it. It costs the NHS £10 billion every year, largely spent on dealing with preventable conditions. Direct and indirect costs are much more. Tonight, I shall concentrate on type 1 diabetes. Although its effect has some of the characteristics of type 2 diabetes—I am not a medical man—it is largely a different problem, it is not connected to lifestyle and it strikes people of all ages, some of whom are very young.

 

Some years ago, I went to various research centres at universities. I went to Oxford, and I met Dr Hovorka’s team at Cambridge, my old university. I went to London, where ground-breaking research was taking place on the failure of the pancreas to produce insulin and its replacement but, so far as I know, results are limited. Over the last few decades, new technologies have transformed the way diabetes is treated and monitored and can help to reduce diabetes-related complications in the long term.

 

Tonight, I want to deal with the flash glucose monitoring system. Diabetes patients have to constantly monitor their blood glucose levels day and night. The flash system is a major advance over routine finger pricking. It works by inserting a small sensor into the upper arm. A reader device then scans the sensor and displays blood levels instantly, indicating whether they are going up or down. If patients can reduce their test strip use, which is presently done eight or more times a day, the expense of the flash sensor is cost-neutral or even cost-saving. Such self-management leads to lower fluctuations in glucose levels and fewer expensive complications in the future. Patients will have a reduced number of hypoglycaemic incidents, which lead to expensive ambulances and hospital admissions.

 

When it was announced some years ago that the Prime Minister had been diagnosed with type 1 diabetes, I wrote an encouraging note to her based on my family’s experience. I was delighted to notice that, at last year’s Lord Mayor’s Banquet, she proudly wore her sensor on her upper arm. No one would question the energy she puts into her official duties.

 

The heart of this debate is the countrywide variation in the availability of the sensor on the National Health Service. A few months ago, it was made available on the NHS drugs tariff in principle to NHS patients in the UK on prescription. On 5 July, the Minister stated that the NHS was committed to ensuring the principle of universal access and proudly claimed that the technology was,

 

“available across the country where clinicians think it is … appropriate”.—[Official Report, 5/7/18; col. 635.]

 

I was absolutely delighted. However, on 9 October, I had to draw attention to what was happening in practice. Only approximately 71% of the country is able to obtain the device. The hold-up is not with clinicians, who want to prescribe where appropriate, but with the clinical commissioning groups. They differ in their criteria. The noble Earl, Lord Courtown, replying very helpfully, faced up to this situation. He said:

 

“Many CCGs perform very well, but some do not provide this service. They are being encouraged to do so”.—[Official Report, 9/10/18; col. 10.]

 

 

I would specifically like to know three things. First, how are they being encouraged? Secondly, when can we expect universal NHS access to this important tool? Thirdly, is this situation because more than half of the areas in England and Scotland did not have training policies in place to support prescribing the device? Is it a question of resources? There has been some progress and it might be that this is now down to a third of areas not having supporting policies.

 

The lack of prescribed sensors is grossly out of proportion in England to Wales, Northern Ireland and Scotland. Let me tell your Lordships the grim facts. Where they are not available, patients have to pay privately around £1,200 a year. I am glad that they seem to be provided in my former industrial constituency; that amount would be out of reach for many of my former constituents. The present postcode lottery is a scandal, partly due to the differing criteria in too many CCGs. Patients in Coventry can get NHS access to sensors, but not those in Birmingham at the time the briefing was prepared. Likewise, they are available in Manchester but not in Liverpool.

 

I understand that the Secretary of State is deeply interested in new technologies. Diabetes UK has proposed a dedicated new national fund to support greater adoption of new diabetes technologies. This would operate over a fixed period and, coupled with the purchasing power of the NHS, would secure access to key products at fixed value for money. Diabetes UK believes that such a unified driving force would achieve considerable savings. What is the Government’s view of the proposal to set up a new fund of this kind?

 

Diabetes UK, working with NHS England, has developed a consensus guideline for type 1 diabetes technology. Its aim is to see a pathway in every area to ensure fair and equal access to the technology. The Secretary of State accepts that failure to deal comprehensively with diabetes could lead to a major health crisis, that there are modern technologies that could be available countrywide and that substantial savings could be made. So will the Minister raise with his boss, the Secretary of State, the idea of appointing one Minister and one senior official to deal with, take charge of and monitor the whole of the field of diabetes, which will cost so much money to the NHS as a whole?

My Lords, I refer to my interests in the register. I congratulate the noble and learned Lord, Lord Morris of Aberavon, on securing this debate and on his personal tenacity in pursuing the important issue of helping people with type 1 diabetes to secure access to new technologies that might help them to manage their condition better. My own interest in diabetes is long term and personal. My father was one of the first people to benefit from the development of insulin in the 1920s; he developed diabetes probably as a result of the shock he experienced having a leg amputated following injuries to it during the First World War. Because of insulin he was able to live quite a long life for someone born in 1889. I was born in 1960, when he was 71. His survival for so long was testament to the effectiveness of insulin in saving lives and helping people to live with a condition that, until then, had been known to have fatal effects for thousands of years.

 

I was diagnosed with type 2 diabetes at the relatively young age of 34, almost 25 years ago. My lifestyle, related to my work in politics, was extremely poor for a long period. By the time that I was 45, I was on insulin as well as tablets. In my late 40s, I was warned that even the maximum levels of every form of medication available would not sustain me into my 50s unless I changed that lifestyle fundamentally.

 

However, changes to lifestyle are not so relevant to people with type 1 diabetes, and not always achievable for those of us with type 2 diabetes. The consequences of poor diabetic control are the same for people with either type 1 or type 2 diabetes. My own poor diabetic control some years ago is probably responsible for the fact that both my feet now suffer from a condition called foot drop. This means that I need to wear ankle foot orthoses, known as AFOs, and, like all other diabetics, I have to take great care of my feet.

 

I have been fortunate to receive great support from the diabetic team at St Thomas’ Hospital. I was there yesterday and was pleased to be told that my long-term control, as measured by my HbA1c blood glucose level, remains very good at present. It has been helped by changes in lifestyle, including those that have resulted from a GP referral for some physical fitness training—which I certainly needed—the acquisition of my Fitbit monitor and recognition that I needed to eat more healthily and consume fewer products filled with sugar, which for many people is a very addictive ingredient.

 

I know from friends with type 1 diabetes how much harder it is for them to maintain good control, whatever they do. They have to test their blood with finger-prick tests eight or more times per day and can observe their blood sugar levels increasing rapidly or falling dramatically, sometimes without any apparent explanation. The emergency services all too often have to pick up someone who has collapsed, with many people thinking that they are perhaps drunk when in fact they are suffering from a “hypo”. I experience hypos rarely, but type 1 diabetics are much more vulnerable to them.

 

The problems associated with both types of diabetes have grown rapidly in prevalence and are likely to do so even more in future. Diabetes UK said on Monday that some 500 people with diabetes die prematurely each week. I regularly read distressing accounts of how more than 6,000 foot amputations per year result from diabetic-related conditions, many of which are preventable. If not managed effectively, poor diabetic control results in loss of sight, kidney disease and a much greater prevalence of strokes and heart disease.

 

The most recent NHS National Diabetes Audit report on complications and mortality shows that men and women between the ages of 35 and 64 living with type 1 diabetes are three to four times more likely to die prematurely than those without the condition. Men and women in the same age range who have type 2 diabetes are up to twice as likely to die prematurely.

 

What can be done? Control is of course the key, and I have no doubt that wider use of FreeStyle Libre, a flash glucose monitoring system, is assisting a number of people, particularly those with type 1 diabetes, to improve their control. I have looked at the Medtech innovation briefing from NICE and the devices appear immediately cost effective compared with, let us say, the costs of 10 finger-prick tests per day. The evidence of benefit to long-term blood sugar control is not yet so clear, but I know from my own experience that behaviour is changed in a positive direction when you are regularly alerted to your blood sugar levels. This is, in my view, much more likely to be the case with such a flash monitoring device than with the more traditional blood glucose meter.

 

There was very strong evidence in the report suggesting that users of a flash glucose monitoring device suffered far fewer hypos, experiences that can be very unpleasant and quite dangerous. The fact that such devices can now potentially be prescribed as a result of their inclusion in Part IX of the England and Wales drug tariff a year ago is very welcome but, as the noble and learned Lord, Lord Morris of Aberavon, said, there is still far too much variation between CCGs in their provision, and the guidelines from NICE are very restrictive. In the recent Question that he referred to, he suggested that around 30% of CCGs are not yet considering prescribing these devices.

 

I know that the aim of reducing variation in the management and care of people with diabetes by 2020 is included in the NHS England mandate, but can the Minister tell us a little more this evening about exactly how this will be achieved? There are implementation plans to facilitate the wider provision of flash glucose monitoring systems; how are these progressing? We all know that we need to rely on NICE conducting some sort of cost/benefit analysis for any such product, but is the Minister satisfied that its processes for analysing the costs and benefits of new technologies aimed at improving diabetic control are sufficiently long term? Does he accept that any such analysis for public policy should factor in all the long-term costs to the NHS and the welfare system of poor diabetic control, as well as the wider benefits to the economy and to society of helping people to achieve good control?

 

Flash glucose monitoring, real-time continuous glucose monitoring and insulin pumps may all provide technological solutions to help people with type 1 diabetes live healthier and happier lives for very much longer. There is, for example, a much greater provision of insulin pumps in the United States than in this country, and this is not simply because the US has a greater love of technology than we do. Overall, the US healthcare system is known to be massively inefficient and ineffective compared to our own NHS but, with an insurance-based model, you know that the insurance companies evaluate the long-term costs to their businesses of dealing with the complications that arise from poor diabetic control. These insurance companies appear to have decided, on sound business grounds, that much greater provision of insulin pumps saves them money in the long run, to say nothing of the wider benefits to patients and everyone else.

 

I look forward to the Minister’s comments on these issues and what he has to say about how technological innovation may help some of the problems associated with diabetes.

My Lords, I congratulate my noble and learned friend for putting this debate before the House this evening. I congratulate him and the noble Lord, Lord Rennard, on their excellent contributions to this debate: they have actually covered most of the waterfront on this. As my noble and learned friend said, in November 2017, flash glucose monitors were made available on the NHS after petitions from various organisations and people who thought that this new technology should be accessible to those living with type 1 diabetes across the UK. I join the other speakers in thanking Diabetes UK and others for their briefing.

 

Flash glucose monitoring is a major advance over routine finger-prick glucose monitoring. It is easier, quicker and less painful. The density of data and the ability to follow trends in glucose levels, which are not available from less frequent blood glucose testing, has been shown to help patients improve glucose control and reduce hypoglycemia. I have two friends with type 1 diabetes, both of whom use this technology, and both say that it is an enormous improvement in how they manage their conditions. Flash GM can be used alongside routine finger-prick testing to check their blood glucose levels. It can also be used as a management tool to obtain a more detailed picture of an individual’s glucose profile. Flash GM devices should be made available to any adult or child with type 1 diabetes and to people with other forms of diabetes when intensive insulin therapy becomes necessary because of severely reduced pancreatic function.

 

The short-term use of flash GM by healthcare professionals as a management tool, sometimes referred to as troubleshooting, can help someone who is having difficulty achieving their personalised treatment target or who is troubled by frequent hypoglycemia, hyperglycemia or both. It is clear from the debate that ongoing funding for flash GM sensors should be made available, on the condition that the person demonstrates active management of their glucose levels or progress towards achieving and maintaining their personalised treatment target. This should be assessed at least annually. People who use flash GM should have a good understanding of intensive insulin therapy and how to self-manage their diabetes. The completion of a structured diabetes education programme, as recommended by NICE, is absolutely vital.

 

People who use flash GM will still need access to test strips and meters for use in certain circumstances; for example, current DVLA regulations stipulate that people should use finger-prick testing of glucose levels before driving. Once flash GM devices are on the NHS Prescription Services drug tariff, local health decision-makers should make sure that flash GM readers and sensors are listed in the local formulary. That is the nub of the matter—and probably the point at which I should say that I am a member of a CCG board—because we are talking about availability becoming a postcode lottery, as my noble and learned friend said. While various CCGs have approved the use of flash glucose monitoring, it is still not available in certain locations due to either being under review, and so only tested on a sample of people, or simply not having been authorised. Local decision-makers have decided against prescribing flash monitoring in 52 areas in England, according to the latest information given to me by Diabetes UK. Thousands more people with diabetes await decisions by 38 CCGs across England and nine health boards in Scotland, which are currently reviewing their policies.

 

With the knowledge of the benefits of flash GM, and with some people across the country having access to it already, it seems unfair to deprive others of the chance to use it because of their location. During Prime Minister’s Question Time earlier this month, the Prime Minister, who uses one of these devices herself, stated that this is not a one-size-fits-all situation and:

 

“There is no one system that is right for everyone”.—[Official Report, Commons, 17/10/18; col. 634.]

 

 

But at the moment not everyone with diabetes even has the chance to test whether or not that is true.

 

I have a couple of questions for the Minister, in addition to those already asked. Will the Government and NHS England commit to a diabetes technology fund, as my noble and learned friend suggested, as part of the new NHS 10-year plan, to support the rapid rollout of new cost-saving technology? What they can do to ensure that CCGs follow nationally developed guidance on access to technology and treatments? Having to create 200 different policies for every new technology is just duplicating effort and means that it will take years to ensure equitable access—if this is ever achieved. This seems a ridiculous way to respond to the new technologies that are available and will become more widely available. This is a problem that will grow, not decrease. Finally, will the Government look at making funding available, as my noble and learned friend said, in the current NHS spending review, to pump-prime access to these life-changing and cost-effective diabetes technologies?

My Lords, first, I thank the noble and learned Lord, Lord Morris, for instigating this high-quality debate, and the small but select group of Peers who have contributed to it. I will attempt to answer all the questions, as seems only reasonable.

 

The noble and learned Lord, Lord Morris, mentioned the letter I wrote to him—or perhaps it was a Written Answer—about the principle of universal access. Obviously, that principle is at the foundation of the NHS and is one to which the Government are absolutely committed. Part of that commitment means making sure that when effective technologies come around—whether digital, devices, drugs or diagnostic—people have access to them once their benefit is proven. Diabetes is no different. As the noble and learned Lord, Lord Morris, and the noble Lord, Lord Rennard, brought out, this is a growing public health crisis: 400,000 people alive today in the UK have type 1 diabetes, many more have type 1 and type 2. The cost is not just the £10 billion a year but the lives and the quality of life being lost. It is a major public health crisis, with very individualised consequences, as the noble Lord, Lord Rennard, brought to life from his own family’s experience. That is the challenge.

 

With regard to the NHS more broadly, it is fair to say that in this country we are very good at coming up with new ideas—innovating—but traditionally poor at the uptake, or adoption, of good ideas. We have been carrying out a review over the past year with NHS England and the Office of Life Sciences, and we have found that the description I just gave is reasonably accurate. A lot of the money that we spend on supporting innovation is at the upstream end—coming up with new ideas—so that we are doubling down on our strengths while not addressing our weakness, the uptake of new technologies. That is the topic of discussion tonight.

 

Before turning to flash monitoring, I will give a few examples of how we are trying to address this weakness. The first is through the accelerated access collaborative, now chaired by the noble Lord, Lord Darzi. It recently announced a list of seven high-potential technology areas and 11 rapid-uptake products that are already on the market, and for which an evidence base exits, but are not being taken up. Currently they apply to cancer, heart disease and MS—not, it has to be said, diabetes, but there will be further rounds once the accelerated access pathway is considered, so that new technologies for treating diabetes will be able to apply through that route. That initiative involves all the key players—NHS England, the Department of Health, industry, and so on—so that we are sure that we horizon-scan, know what is coming and do not get caught out when new technologies come along that can have a really life-changing effect.

 

Secondly, we are strengthening the Academic Health Science Networks; they spot these innovations and make sure that they can be spread. One example, which has been adopted through that route, is a free app launched by the Oxford AHSN diabetes clinical network, brilliantly titled Monster Manor. It is a game that encourages children with type 1 diabetes to track their blood glucose readings and become more engaged in their diabetes management. It is very important to ingrain those habits early on.

 

We have also expanded the NHS test-bed programme, a couple of whose projects are focused on the management of diabetes. One, in Greater Manchester is called My Diabetes My Way—again a digital platform—and is designed to help people self-manage. In south London the diabetes test-bed is working with Year of Care Partnerships to train GP practices to adopt a more collaborative approach with patients, to support self-management using digital technologies. There is, therefore, good technology going on; it is getting into the service and the challenge, as ever, is to make sure that it is spread.

 

This brings me to flash glucose monitoring, which is clearly an incredibly exciting technology. I was delighted to be able to sign it on to the tariff last year as FreeStyle Libre—that is one brand, there are others. Everyone, from the Prime Minister downwards, can attest to its benefits, but it is worth saying—as the noble Baroness, Lady Thornton, brought out—that it is a new product with quite limited clinical trials data and economic analysis, so it is appropriate that we take a more staged approach. I will explain how we are doing that—there is cause for optimism.

 

In relation, however, to the role of NICE, I can assure the noble Lord, Lord Rennard, that NICE takes long-term perspectives into account in its economic analysis. The cost per QALY approach tries to take a broad measure of quality—QALY stands for quality-adjusted life years—so that we can make sure that all the benefits, not just health but social and other benefits, are accounted for. The challenge, however, is that because this is a new, exciting technology that we want to get on to the tariff, there is not yet the data to enable us to understand exactly for whom it works and when. That is why it has been up to CCGs to prescribe it and develop their prescribing policies. As the noble Baroness, Lady Thornton, pointed out, it is not for everyone—not least those who are not in a position to carry out the high levels of monitoring and use that it requires.

 

The noble and learned Lord, Lord Morris, asked what we are doing to encourage its use. I can tell him that a regional medicines optimisation committee was asked to provide advice to support local decision-making. I would be interested to understand, perhaps as a follow-up, whether Camden CCG—where I think the noble Baroness, Lady Thornton, sits on the board—has found that useful. The committee was tasked to provide that advice to deliver much more consistent policy-making and it has produced a set of criteria for use by GPs, CCGs and others. At the start of the year, NHS England wrote to GP groups to remind them of their responsibilities and of the guidance that exists.

 

We have seen some progress. About 70% of CCGs—144 of them—have now approved FreeStyle Libre for use and are putting together plans to bring it forward. If we look at spend on patches, for example, in November a year ago CCGs provided 421 sensor packs at a cost of £15,000. In August 2018 that figure was 14,412 packs at a total cost of £500,000—so there has been a fairly steady ramp-up. As we go along, we are of course gathering information about which populations this is most suitable for. Ultimately, this is the responsibility of CCGs; I know that that in itself is a cause of discussion, shall we say, and debate about whether that is a proper role. But as evidence grows about for whom it will be most beneficial, we will clearly have a better opportunity to define who should have immediate access to it and who should have access only after other routes have been pursued.

 

I will not detain the House by talking about the various other things that we are doing to support diabetes, other than to say that obviously a huge amount of work is being done. The noble and learned Lord, Lord Morris, asked about responsibility. We have a national programme for diabetes, and health checks and personalised and tailored support are being provided. It has been incredibly effective: about 250,000 people have been referred to the service and just over 100,000 have taken up the offer of a programme—so we are starting to see that kind of lifestyle support going in.

 

I was asked what we are doing specifically to support diabetes technology. While it would not be right to have a fund only for diabetes, as we develop the long-term plan—which we are looking to publish very soon—we are intending to explain in it how we have a much more systematic approach to spotting new technologies, getting them into the system, gathering data on them, establishing their efficacy and value for money, and then ramping them up through a much greater national push so that we deal with the issue of postcode variation. That is something I hear about all the time from patient groups, industry and clinicians themselves. We are conscious that it is a long-standing weakness of our service but is also something that we can do something about. I hope that as we move ahead with the long-term plan in the next few weeks, and with the updated sector deal that we are working on, noble Lords will see policies going into place which provide that—for the benefit not just of diabetes sufferers but everyone in this country.

 

I hope that I have managed to answer all the questions that the noble and learned Lord asked. Obviously I would be delighted to discuss this with him further afterwards, but I thank him again for bringing this very important topic for debate in this House.