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Anti-TNF Drugs

Volume 603: debated on Wednesday 9 December 2015

I beg to move,

That this House has considered prescription of anti-TNF drugs.

It is a pleasure to serve under your chairmanship, Mrs Main. I am grateful for the opportunity to speak about NHS prescription of anti-tumour necrosis factor drugs, a subject on which I have become somewhat familiar since I was contacted more than two months ago by my constituent, Samara Ullmann.

Before I move on to why I requested the debate and to define what anti-TNF drugs are and their uses, it may be helpful to give you, Mrs Main, the Minister and other Members present the background as to why this specialist medication will make such a difference to my constituent and so many others.

Samara Ullmann, who is now 29 years old, was born in my constituency in 1986. At the early age of just two, her parents noticed that she was walking with a limp. Worried about her clear inability to walk without pain, her parents took her to her local GP, who referred her to Leeds general infirmary where she was diagnosed with a condition known as juvenile idiopathic arthritis. The terrible condition affected both of little Samara’s legs, her wrists, her ankles and her knees. Her parents were told by the hospital that it was likely that she would have to be in a wheelchair by the time she reached the age of 10. From the age of two and until she was six, she had to wear splints on both her legs.

Professor Anne Chamberlain supervised Samara’s treatment over the next few years. During Samara’s visits to Leeds general infirmary every three to four weeks she was given hydrotherapy, physiotherapy and a cocktail of drugs. Her parents were told that little else could be done for her, which was confirmed by some of the country’s top rheumatologists.

From the age of six, Samara started having problems with both her eyes, which developed uveitis, a common effect of JIA. By the time she was seven, a cataract had developed in her left eye and was removed, but it was left considerably weakened so that, by the time she reached the age of 11, she had completely lost the sight in that eye. Fortunately, her right eye continued to function normally, although when she reached the age of 14 she needed laser treatment on that good eye and was understandably frightened that she would be left completely blind.

The JIA improved considerably by the time Samara reached 17, but sadly her left eye had to be removed because it was both blind and painful. After three months, she was fitted with a prosthetic glass eye, which fortunately is able to move to a limited extent with her functioning eye. The Minister may be able to imagine the terrible effect that all of that had on a teenage girl growing up in the early part of this century. Her self-confidence was badly damaged, too.

As the arthritis gradually abated, Samara was left with a common consequence of the condition, refractory uveitis, which often causes blindness even with the best treatments currently available. Her right eye—her only eye—is now severely affected. So far, despite a paralysed iris, a stuck-down pupil and a developing cataract in her remaining eye, her sight has been partially protected by the use of a drug called mycophenolate, which together with methotrexate is commonly used to treat uveitis.

Those drugs impair the white blood cells that promote the inflammation that causes uveitis. However, despite treatment with those drugs over the past eight years, the vision in Samara’s only eye continues to deteriorate. That is why her eye specialist at Calderdale Royal hospital in Halifax, Mr Teifi James, believes that in order to save her sight, she needs to be prescribed an anti-TNF drug such as Humira—adalimumab.

An anti-TNF drug is a monoclonal antibody that specifically targets tumour necrosis factor alpha. Because of the way in which it is manufactured, it is called a biologic. TNF is involved in causing inflammation in a number of autoimmune and immune-mediated disorders. Those diseases probably cause too much TNF to be produced, modifying the body’s immune response and causing inflammation. Anti-TNF drugs reduce the amount of TNF in the body. They are expensive and may have side effects that could be severe, but, with appropriate monitoring and care, such effects are rare. In fact, they are much less common than the many problematic side effects of corticosteroids.

I thank the hon. Gentleman for bringing this issue to Westminster Hall. The Minister will be seeking to improve the success rate of anti-TNF drugs. Many universities across the United Kingdom are looking at how to improve medication for those with eye ailments. We have two in Northern Ireland, which are Queen’s University Belfast and, in particular, Ulster University—

I thank the hon. Gentleman for that intervention. He is right. The more studies carried out across the country at university level, the better it will be for patients suffering from refractory uveitis.

The anti-TNF drugs switch off the molecule that creates the inflammation in the first place and are therefore far more effective than corticosteroids in cases such as Samara’s. I am sure that Queen’s University Belfast and many others can confirm that.

Last year, Samara married her fiancé, Ben, and the couple now want to start a family. However, it is not at all advisable for her to become pregnant while taking mycophenolate, because it may well cause a miscarriage or birth defects. An anti-TNF drug could allow her to retain her eyesight and probably to conceive safely and be able to see her child grow up.

Let me move on to why adalimumab or infliximab should be available immediately on NHS prescription for adults with sight-threatening uveitis. I am aware that the National Institute for Health and Care Excellence is about to conduct a multiple-technology appraisal of adalimumab and infliximab and that responses to the draft must be received by 16 December—this time next week. From my conversations with Teifi James, one of the country’s leading eye surgeons, and from my research into that treatment it would seem that drugs such as Humira are highly effective in the treatment of uveitis, so much so that researchers in the Sycamore trial in Bristol, to which the Minister referred in his letter to me of 4 November, have stopped recruiting to it because the children being treated are doing so well on the drug. However, NHS England did not take that into account when it made its most recent decision on the use of adalimumab and infliximab for the treatment of adult uveitis alone.

According to Mr James, approximately 120 patients with sight-threatening uveitis are waiting for anti-TNF treatments in England, whereas patients in Scotland currently have access to adalimumab and infliximab. Treatment using Humira costs just under £10,000 a year per patient, which means that approval of the use of this drug for treating refractory uveitis alone would cost no more than £1.2 million a year.

I commend the argument that my hon. Friend is making on behalf of his constituents. I too have been contacted by a constituent about this issue, who points to the excellent work being done by the Olivia’s Vision charity, which my hon. Friend may have heard of. My constituent says:

“My daughter currently suffers from Uveitis and is receiving Infliximab to treat the condition, so far successfully. I would like to live in the hope that this would be available to her in the future should her conditions change, and indeed others to whom this could be a sight saving drug.”

Is it not important that patients such as my constituent’s daughter have that assurance?

I agree with my right hon. Friend. In fact, the Olivia’s Vision charity has been in touch with me and offered its full support for this debate and any future effects of it, which will hopefully include a decision from the Government that both infliximab and adalimumab will be available on the NHS. Those anti-TNF drugs are clearly completely effective in the treatment of refractory uveitis alone. I will talk a bit about the effects of anti-TNF drugs on other conditions.

I greatly appreciate the hon. Gentleman giving me time to speak. For information, I am an eye doctor. Does he agree that what is important with severe conditions such as refractory uveitis is the principle that it must be up to the senior clinician—no one else; not NHS England and not a Minister—to decide if and when these treatments should be prescribed, and that the clinician must not be prevented from doing so?

I am grateful to the hon. Lady for her contribution, especially given her expert knowledge in the field. I agree 100% with her; it should be for clinicians to make such judgments and decisions, provided the drug is deemed safe. Enough testing and evaluation has so far been done to show that these drugs are not only safe but highly effective.

The point I was going to make, before those helpful interventions, was that it would cost no more than £1.2 million per year for all the patients in England to be treated with adalimumab or infliximab. To put that in context, I ask this question of the Minister: what would be the cost of paying benefits to all the young adults—most of the sufferers are young, working adults—who will suffer from sight-threatening uveitis for the rest of their lives if they lost their remaining sight for lack of a sight-saving drug that has already proven highly effective, as the hon. Member for Twickenham (Dr Mathias) said? Surely the taxes that they pay now and will pay in the future would more than outweigh the cost of allowing the use of this medication, never mind the additional cost of paying benefits to blind people who can no longer be as economically productive.

Teifi James is one of about 50 eye surgeons in England who specialise in the management and treatment of uveitis, out of a total of around 1,200 eye consultants in the country. He and his colleagues know from their work and the clinical evidence that adalimumab and infliximab work well, yet they are being denied the opportunity to prescribe that sight-saving treatment. Members may be forgiven for assuming that the use of biologic drugs such as adalimumab is a novel step, but that is not so. Teifi James first used Campath, one of the original monoclonal antibody therapies, to treat ocular disease as long ago as 1997. Uveitis specialists had been effectively using infliximab and adalimumab in appropriate cases for over a decade since 2000, until the NHS reorganisations changed the commissioning regulations. English uveitis specialists are frustrated that the treatments they had been using have become inaccessible as a consequence of recent changes to NHS commissioning.

If Samara or any of the other 120 young adult sufferers of uveitis were suffering from another condition as well, such as Crohn’s disease or arthritis, they could be prescribed these drugs, which would prevent the further development of uveitis. Sadly, however, without multiple conditions, uveitis alone cannot be treated with Humira or similar anti-TNF medication. I hope the Minister and anyone else listening to this debate will agree that that is highly unfair and just plain wrong.

As I have said, Samara’s remaining vision in her right eye is now failing. Mr James can operate on her eye to remove the cataract and correct the problems she is currently experiencing, but he is reluctant to do so unless she is established on treatment with Humira. He feels that the risks are too great on her present medication.

I hope the Minister will answer the following questions when he responds. First, does he acknowledge that time is of the essence and that young adults in danger of losing their eye sight cannot wait for sight-saving treatment much longer? Secondly, will he use the points I have made today to persuade NICE to speed up its review? Thirdly, will he offer my constituent, Samara Ullmann, and the 120 other patients like her the hope that a treatment senior clinicians say is highly effective can be used for their benefit without further delay? Finally, does he agree that Samara should have the chance to have a family and to see her children grow up, just like every other parent in the country?

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.

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.

The Minister talks about need. In a similar vein to other Members, I would like to highlight the need of a constituent of mine—a young lady called Olivia, aged 15, who is totally reliant on self-funded anti-TNF treatments to retain her eyesight. She is very concerned that when she reaches adulthood, she may no longer have access to that, which is why her parents, also constituents, have created a charity called Olivia’s Vision. Again, I ask—

My hon. Friend has eloquently raised his point. I am happy to look into that with him afterwards.

NHS England will consider individual funding requests for treatments not recommended by NICE to treat individuals whose clinician can demonstrate clinical exception. The NHS constitution states that patients have the right to expect local decisions on the funding of drugs and treatments

“to be made rationally following a proper consideration of the evidence.”

If an NHS commissioner decides not to fund a drug, it has a duty to explain that decision to the constituents of the hon. Member for Leeds North East and others.

I want to turn quickly to the hon. Gentleman’s specific questions and then deal with a couple of questions that really sit under this whole debate. Let me respond to his four questions. I completely agree that time is of the essence to anyone in danger of losing their eyesight and, yes, people should have the chance to have a family and we need to make sure that we are supporting patients in the appropriate way. We are working to speed up the process, so that effective medicines get to patients much more quickly, but we need to know that they work and to make sure that the benefits they bring to patients are commensurate with their cost to the NHS, which is why we have NICE, a world-leading expert in health economics.

I must clarify that NICE is not currently appraising either adalimumab or infliximab for uveitis. However, it is consulting stakeholders on a proposal to include adalimumab within the scope of the technology appraisal guidance that it is developing on its two other drugs for the treatment of uveitis. A final decision on referral will be taken once NICE has concluded that consultation. I am aware that evidence is emerging on the use of these drugs on the treatment of uveitis in adults. When the full evidence is available, both NICE and NHS England will be able to take that into account when considering whether anti-TNF treatments should be made routinely available on the NHS.

In the remaining moments, I want to touch on the underlying issues that this debate has helpfully flagged up. The pace of change in the biomedical space, the rate at which new drugs are being discovered and the power of genomics and informatics, giving us a new insight into diagnosis and treatment, is putting pressure on our traditional methods of assessing drugs. Traditionally, NICE has worked on a one-size-fits-all, health benefit, “yes or no”, quality-adjusted life-year basis. I have launched the accelerated access review partly to look at how we can better use the genomics and informatics in our health system and give NICE more freedoms to be able to fast-track treatments to the patients who we know will benefit.

That touches on the question of off-label use of drugs. When there is a proven benefit outside of an on-label indication, we need to be much better at getting that information to clinicians, so that they can prescribe drugs in an off-label indication more quickly. The burden of proof needs to be not only right, but appropriately set, so that where there is clear evidence, the system can respond more quickly.

The hon. Gentleman made an important point about the cost of benefits. The system at the moment is not great at measuring the full cost of a condition downstream, which is partly why we are putting such efforts into the digitalisation of the health service and into being able to measure the cost of treatment and a disease condition. When we have a benchmark of what the cost is to society after a diagnosis, we will have a much better benchmark for rewarding innovation.

I will happily deal with any other questions offline. We have had a very short amount of time, but I hope I have tackled the hon. Gentleman’s specific questions. I am grateful to him for raising the issue, and I hope I have given some signal as to where in the coming weeks and months we may be able to expect some helpful progress.

Question put and agreed to.