Anti-TNF Drugs

George Freeman Excerpts

Wednesday 9th December 2015 Westminster Hall

[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.

[Oliver Dowden (Hertsmere) (Con)]

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—

[Mrs Anne Main (in the Chair)]

Order. Interventions must be brief. I call the Minister.

[George Freeman]

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.