Anti-TNF Drugs

Tania Mathias Excerpts

Wednesday 9th December 2015 Westminster Hall

[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?

[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.