Anti-TNF Drugs

Fabian Hamilton Excerpts

Wednesday 9th December 2015 Westminster Hall

[Fabian Hamilton (Leeds North East) (Lab)]

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.

[Jim Shannon (Strangford) (DUP)]

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—

[Jim Shannon]

Does the hon. Gentleman agree that that is a good idea?

[Fabian Hamilton]

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.

[Mr Andrew Smith (Oxford East) (Lab)]

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?

[Fabian Hamilton]

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.

[Dr Tania Mathias (Twickenham) (Con)]

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?

[Fabian Hamilton]

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?