Oral Answers to Questions
Debate between Tania Mathias and George Freeman(8 years, 6 months ago)
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Dr Tania Mathias (Twickenham) (Con)
3. What steps he is taking to encourage the use of biosimilar medicines in NHS treatment.
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
The biosimilars—the generic versions of biologic products—represent part of the extraordinary range of new drugs that are becoming available for the benefit of our patients. The Government are committed to ensuring access to drugs for UK patients at the highest level of quality and safety, and to ensuring that effective biosimilar medicines are available. That is why we are leading, not just here but in Europe, the regulatory regime through the Medicines and Healthcare Products Regulatory Agency as the lead assessor and rapporteur. In the NHS, the chief pharmaceutical officer, Keith Ridge, and the commercial medicines unit in my directorate have put together a framework agreement for biosimilars, and through the medicines optimisation programme we are looking specifically at biosimilars, and we have set up a national biosimilars medicines group.
Dr Mathias
I thank my hon. Friend for that answer. May I ask also that where NHS pharmacists are involved in oncology clinics, there is a higher prescribing of biosimilars? What steps are in place to encourage more oncology clinics to involve NHS pharmacists at the start of the patient’s treatment journey?
George Freeman
Not surprisingly, my hon. and, in this field, learned Friend makes a very important point. We have set up a number of initiatives to that very end: to make sure that our pharmacologists and pharmacists in the system are alert and have all the information they need to increase the prescription of biologics and the generic versions, biosimilars. I will happily write to her, describing a range of initiatives that are in place which we are pursuing to that end.
Digital Records in the NHS
Debate between Tania Mathias and George Freeman(8 years, 6 months ago)
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George Freeman
My hon. Friend makes an interesting point. I will come to our plans, and to the process and timetable for setting out the national data guardian’s recommendations on how we should proceed. I would expect that one of her recommendations will be about the importance of communicating to the public and patients why data are so important. As part of the annual National Institute for Health Research Parliament day that I launched, we might have a themed event focused on the power of data and why they are so key to a 21st century NHS.
Dr Mathias
We have been talking about the speed with which the Government should be digitalising records, hence the idea of a chief of information for the NHS. I believe that the public are already ahead of the Government. That is the problem—I fear that the Government may already be too late. There are too many apps out there, too many different clinicians are doing different things and too many patients are devising their own systems. We are behind everybody else.
George Freeman
My hon. Friend makes an excellent point. She knows my frustrations with the situation, and the truth is that healthcare is digitalising very fast. That is not just driven by commercial app manufacturers. As she says, many doctors are developing apps for their own benefit and that of their patients. Many patients are also developing apps. The revolution is coming. Part of our strategy is to ensure the digitalisation of the NHS, which is no mean undertaking. In fact, I would liken it to Crossrail and HS2 as a global project. It is the digitalisation of the world’s fifth biggest employer—a vast undertaking. There are a number of lessons to be learned from previous Government initiatives.
In many ways, we are catching up. The challenge is to catch up in a way that understands the pace at which healthcare is digitalising and seeks not to monopolise, but to provide an aircraft carrier—a mother ship—on which the exploding range of various digital healthcare products can land. I have mixed my metaphors in an ugly way there, but the challenge is to turn the NHS into a catalyst for leading and unlocking NHS leadership in digitalisation.
I totally accept the point made by my hon. Friend the Member for Twickenham that, in many ways, we are catching up and trying to provide a platform for leadership in a rapidly emerging space. In response to the point that she and my hon. Friend the Member for The Cotswolds made about the need for leadership in the NHS, I can confirm that NHS England is about to appoint a chief information technology officer. A major part of that function will be to be lead champion, to explain and to be a point of patient information in the NHS.
Through the creation of my role, we have for the first time created a single ministerial portfolio with responsibility for this area. Until the post was created, every Minister in the Department had a little bit of information and digitalisation in their portfolio, which in many ways was appropriate but also meant that there was no single point of leadership. Part of my mission is to ensure that the Department brings that together.
The three great pillars that require the quiet revolution of digitalisation include research and individual care. However, I want to touch on the third pillar, which is system safety and performance. The NHS is the fifth biggest employer in the world. It is an incredible public service and an incredibly complex set of organisations. We talk of it as if it were one, but under the national health service’s magnificent initials are a whole range of GPs, hospitals and care providers, which all operate independently within a healthcare system. We are building the railway tracks for patients’ records to move along, so that we integrate them. A fundamental part of that, in addition to research and individual care, is ensuring that the NHS can deliver an essential contract with patients in a 21st century health system. We have a duty to know where best practice is and where worst practice is. We should not have to rely on whistleblowers to put themselves at huge personal risk by sighting and highlighting worst practice. The computer will do it for us.
The other day, I looked at a piece of software that was developed—for a very small amount of money, by the way—by an Oxford academic. It shows prescribing data for one important class of drugs across the whole of NHS England. There is one outlier, and it happens to be in Norfolk, which is why I took a particular interest. It is clear that there is a very small group of GPs that somebody has not got the guidance to or rung up. I am sure that as soon as those GPs have the information, their prescribing practice will fall into line with the rest of the country.
That is computing power being used to promote patient safety and efficiency. The third pillar—system safety and performance—is important, and one of the lessons from the Francis report is that we need to use data much better to identify best and worst practice. When people ask why we are doing this, I suggest that it is for those three noble purposes, which support each other. The digitisation of the system should drive patient care, system safety and research, and the same datasets run between them.
Crucially, the Secretary of State and I understand that the whole digitisation programme has to be rooted and covenanted in deep and profound respect for public and patient trust and confidence. I am not revealing a state secret by saying that I am not sure that that has necessarily been the case until now, for a whole range of reasons, but partly because Government have seen digitisation as inevitable and, as my hon. Friend the Member for Twickenham suggests, slightly overdue, and therefore not something that needs to be announced. Of course, the Government are always coy about admitting problems, but I am not coy about saying to people that we are still running the NHS, in large part, on paper and cardboard, which is a problem that needs to be solved.
Unless we describe the problem clearly, we will not carry the public with us in solving it. My magnificent local hospital, the Norfolk and Norwich, has a data repository with 10 miles of shelving on which patient records are kept, held together by treasury tags and paperclips. I do not know about other Members, but I am not prepared to say to my constituents that that is an appropriate way to store their information, and indeed, my information, my mother’s information and my children’s information. Each hospital separately stores records of which patients came to it and when, which does not speak to a properly joined-up system. It is a national health service—the clue is in the name—and when someone clutches their chest in an unfamiliar bit of the country, they expect the national health service to know who they are. That is one of the benefits of a national health service. From the point of view of properly integrating, we need to explain to people where the current system is not able to deliver.
It is for that reason, and because we want to carry public trust and confidence, that the Secretary of State and I are shifting from what I crudely characterise as an agenda that, to the extent that it has been discussed publicly, has been called long overdue, essential for the running of the system, and something that patients do not need to worry too much about. Well, we only have to say the words “big data” and “big government” to most people in this country for them to be alert to the risks of what might be happening behind their back. I am trying to do it differently by saying to people “This is an urgent, overdue, phenomenally exciting and complex project that we are doing in the interests of patients,” for the reasons I have just set out. Public trust and confidence are essential to the project, and I am not revealing any state secrets by saying that NHS England’s care.data consultation last year did not demonstrate global best practice in consulting patients. It was a well-intentioned leaflet that was sent to every house, which of course does not mean that every person in the country read it, and for many people the wording was as confusing as it was enlightening. That is one of the reasons why the Secretary of State and I have gone to such lengths.
We have appointed the first ever national data guardian in Dame Fiona Caldicott, a widely respected expert in the field, to advise us on the right protocols and safeguards for ensuring that public and patients can have trust and confidence in the system. Dame Fiona has carried out an extraordinarily detailed piece of work, and her recommendations will be landing on our desks imminently. She has considered the whole range of issues, including consent; how many data should naturally flow in the system for it to function; which data transactions should be subject to additional patient consent; what the standards should be; and what the relationship between the various bodies should be in terms of accountability. That work is very important.
We have gone further and asked the Care Quality Commission to carry out a major piece of work on best practice in the system today and to set a benchmark so that we can hold the system to account. We have set up the digital maturity index, and this spring each clinical commissioning group has had to report, for the first time, on the level of digitisation in its local health economy, and we are building that into the CCG annual assessment framework so that people will be able to click on My NHS and see heat maps of the extent of digitisation across the country, which will help us to identify best and worst practice and to accelerate the roll-out.
We have also appointed Professor Bob Wachter, the American digital health expert, to come over and help us consider the cultural issues of ensuring that the NHS is properly training and supporting practitioners. It is about the human element, because we can have as many systems and technologies as we want, but it ultimately comes down to culture, practice and patients’ records being respected and treated appropriately by the system. I hope Members can see that we are taking seriously the need to put in place a series of measures that carry public trust and confidence.
Dr Mathias
Will the Minister ensure that there is a two-way exchange of information and transparency so that, if the NHS has my medical data, I am always offered, in a secure form such as a personal Dropbox, or whatever form I wish, everything that the NHS has on me? Every patient must be offered all the data that the NHS has on him or her.
George Freeman
Unsurprisingly, my hon. Friend makes an excellent point. She will know that my first parliamentary foray into this space was by championing a ten-minute rule Bill on patients’ rights to patient data. Like her, I believe that, in addition to the three noble pillars I set out, there is a fourth pillar. Not only does the digitisation of health have benefits for the system in delivering healthcare in a safer, higher quality and better way but, almost more importantly, it helps the transition of healthcare from something that, in the 20th century, was essentially done to patients by a largely benign health state—an essentially passive model of “Come to us when you are sick, and we will treat you as best we can. You can then return to normality”—to a model of healthcare for the 21st century that is all about empowering active healthcare citizenship by modern citizens. We give them the information, and we allow them to understand and take control of their health and life choices, not in a punitive way or in a way that says, “If you don’t, or if you are irresponsible, you will be ineligible,” but in a way that tries to inspire and promote a culture of active healthcare citizenship.
Putting information in the power of patients and their loved ones, in the same way as in banking and in all other important aspects of our lives, will pay huge public health benefits, with people using information and data to drive lifestyle choices. Indeed, Members are already seeing that. One of the ironies of this space is that some of the most rapid digitisation driven by patients is by the so-called “worried well”—those who take their healthcare seriously and are using Fitbits and other devices to monitor calorie intake, exercise and sleeping patterns to keep themselves out of hospital. The system should use those technologies to try to deliver better care, and we want to integrate the two so that more and more patients are able to harness such technologies to empower themselves. Ultimately, the Secretary of State and I want to get to a point where that transparency and empowerment drives the relationship with healthcare recipients, as healthcare citizens, choosing where to have their surgery and holding the system to account. Intelligent digital transparency is the greatest driver of a modern healthcare system so that every day, every hour and every week the massive diagnostic and treatment footprint of the NHS is mapped digitally, allowing patients to know that they are actually controlling the system, which is there for them.
Some clinicians, particularly GPs, take a different view—that the sovereignty of their relationship with their patient means that their patient’s data belong to the clinician, which is an interesting point. Most patients feel that their data belong to them and that they should have access to their data. There are ethical issues, as well as the question of the appropriate relationship between clinician and patient, and in no way do I want technology to get in the way of, or to undermine, that sovereignty. Indeed, the clinicians to whom I speak say that the digitisation revolution allows them to focus their professionalism and judgment on what really brought them into clinical practice, which is dealing with their patients, while the computer does what they no longer have to do—recording and accessing in a split-second all the information the clinician needs to make their judgments. Technology can support that relationship, rather than undermining it.
Dr Mathias
In defence of the clinicians out there, I am sure the majority believe that the patients they serve are sovereign.
Anti-TNF Drugs
Debate between Tania Mathias and George Freeman(8 years, 11 months ago)
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This information is provided by Parallel Parliament and does not comprise part of the offical record
The Parliamentary Under-Secretary of State for Life Sciences (George Freeman)
May I start by thanking and congratulating the hon. Member for Leeds North East (Fabian Hamilton) on securing the debate? I am grateful to him for giving me advance notice of the issues he has raised. We serve our constituents best in debates such as this when there is a spirit of non-partisan co-operation, and he is the very embodiment of that.
The hon. Gentleman spoke incredibly fluently on behalf of his constituent, Samara Ullmann. He and I have discussed this issue, and he has raised it with the Department in recent months. I pay tribute to his work on his constituent’s behalf and, most of all, to Samara and all of those who suffer with this condition. One of my privileges in this ministerial role is to see the extraordinary patience, fortitude, courage and force of life spirit with which so many people with ill-met or unmet conditions survive. It drives me on in my work to try to accelerate the landscape and get innovate medicines and treatments to those people more quickly.
I will say something about the condition and then try to address the points raised by the hon. Gentleman. As most Members here will perhaps know, uveitis, or inflammation of the uveal tract, is the term used to describe inflammation of any structure within the eye that, when very severe, may cause visual loss. It can lead to blindness through either direct damage to the light-sensitive retina or secondary complications such as glaucoma. Uveitis is uncommon. It is estimated that two to five in every 10,000 people will be affected by it in the UK every year. It usually affects people aged 20 to 59, but can also occur in children. Despite being uncommon, it is a leading cause of visual impairment in the UK.
Dr Mathias
Just for information, the other problem with uveitis, apart from blindness, is intense pain.
George Freeman
My hon. Friend makes an excellent point. Patients experience a whole range of associated conditions.
In severe cases, treatment to try to prevent sight loss requires drugs that suppress immune cells. The drugs in standard use across the world include prednisolone and immunosuppressant drugs, which work in over 60% of patients. For the remainder, the drugs do not work or the patients suffer serious side effects that prevent the drugs from being used to their full potential. The next step in treatment is the use of a group of drugs known as biologics. As the hon. Member for Leeds North East said, those drugs are very specialised and designed to focus on specific molecules released during inflammation from cells, suppressing the inflammation in doing so.
TNF inhibitors are biologic drugs that suppress the physiologic response to tumour necrosis factor, which is part of the inflammatory response. Humira and Remicade are two anti-TNF alpha treatments that are licensed and NICE-approved for the treatment of adults with a range of conditions, including rheumatoid and psoriatic arthritis, ankylosing spondylitis and inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. In terms of the latter, I understand that the hon. Gentleman has been supporting his constituents by raising awareness for those living with a debilitating bowel disease by supporting Crohn’s and colitis awareness week, which has just ended. NICE has not yet appraised any anti-TNF drugs for the treatment of uveitis. I shall say more about that in a moment.
Decisions about funding for new treatments and drugs that are for rarer conditions, such as uveitis, and which have not been considered by NICE are made by NHS England as part of its specialised commissioning function. NHS England operates a horizon-scanning process to identify new treatments, and its clinical reference groups advise on the development of services for patients and keep published evidence under review. When NICE is not considering a therapy, NHS England can examine the evidence base and may propose commissioning treatments through its commissioning policy development process.
Turning to clinical experts, my hon. Friend the Member for Twickenham (Dr Mathias) made a really important point. Much as I would like to be able to pull a lever and accelerate treatments in response to very eloquent advocacy in this House, it is completely appropriate—I can see the hon. Member for Leeds North East nodding—that such decisions are made by the patients, clinicians and clinical experts, advised by NICE on the basis of the very best evidence available. Sometimes the collection of that evidence and the processing of those appraisals can be frustratingly slow, not least for the patients, but it is important that the process is done well.
The clinical experts at NHS England have considered the use of Humira and Remicade as treatment options for adult patients with severe refractory uveitis. NHS England concluded that there was insufficient evidence to support the routine commissioning of those treatments. NHS England is, however, awaiting publication of the Visual clinical trial report in order to consider revising its commissioning policy in the light of the study’s outcomes. The trial report is expected to be published in a peer review journal in early 2016, at which stage NHS England will consider submitting a revised policy as an in-year service development.
The use of Remicade for children with severe refractory uveitis has also been considered by NHS England. Again, NHS England concluded that there was, as yet, insufficient evidence to support its routine commissioning at this time. That decision will be reviewed in April 2017.
On 11 November, NHS England published an interim clinical commissioning policy on the use of Humira for children with severe refractory uveitis with onset in childhood. Its use is recommended in children aged two to 18 who meet the clinical criteria set out in the policy. The policy, which has been developed by NHS England’s clinical reference group for specialised ophthalmology services with support from clinicians and patient representatives, will benefit children whose sight is threatened by the condition, and for whom other treatments have proven ineffective. That is on an interim basis pending further evidence from the Sycamore clinical trial. The interim policy will be reviewed in 2016, once the full Sycamore trial data have been published. Humira for severe refractory uveitis in children is being commissioned and funded by NHS England through specialist regional centres.
I want to mention individual funding requests, which are important in this context. All treatments for uveitis up to and including the use of immunosuppressants remain funded by clinical commissioning groups. As hon. Members know, the NHS is legally required to fund treatments recommended in NICE technology appraisal guidance. In the absence of such guidance, any funding decisions should be made by NHS commissioners, including NHS England in respect of specialised services, based on an assessment of all the available evidence and an individual patient’s clinical circumstances.