NICE says initial ‘no’ to ustekinumab for Colitis: Challenge this

21 January 2020

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NICE has decided not to recommend ustekinumab (Stelara) be made available on the NHS for moderate and severe Ulcerative Colitis.

This decision is the first stage of their review process, announced today.

Ustekinumab is a biologic drug that is currently used to treat moderate to severely active Crohn’s. It is usually given to people who have found that other drugs, including other biologic drugs such as adalimumab or infliximab, have not worked or cannot be tolerated.

What's happened so far?

NICE have been reviewing ustekinumab for use in Colitis – we submitted evidence to support the treatment being made widely available across the NHS in England, Wales and Northern Ireland. Scotland has its own process and are due to review the drug treatment shortly.

In our submission, which included experiences of people who have Colitis, we explained that current treatments do not work for everyone, ustekinumab offers a new way of effectively treating Colitis and may delay or prevent surgery.

What has NICE said?

Currently, NICE feels unable to recommend the drug treatment for Colitis due to ‘uncertainty’ around cost-effectiveness estimates and how effective the drug is in maintaining long-term remission in indirect comparisons to other treatments.

Read NICE’s full decision here

The impact of uncontrolled symptoms of Colitis can be devastating and debilitating. Current treatments simply do not work for everyone, so more treatment options are desperately needed. We hope that people living with Colitis will share their views on the need for more treatment options with NICE as it considers further evidence before making its final recommendation.

Sarah Berry,
Health Service Project Manager, Crohn's & Colitis UK

What next? Share your views.

People living with Colitis, patient organisations, doctors and other stakeholders will now submit further evidence to NICE to help make its final decision. We need your help.

Tell NICE what living with Colitis is like and how it has impacted on your life. We included some tips on how to do this below. 

Submit your response to the NICE consultation via the NICE website by Tuesday 11 February 2020.

If you would prefer to submit your views and experiences via email to us, please send your submission to by Thursday 6 February 2020 and we will this collate with others and forward these collectively. Please see below for instructions on how to anonymise anything you share with us. 

The final decision will be made by NICE and published in Spring 2020 and will affect people living in England, Wales and Northern Ireland.  

1. What is the point of sharing your views?

Members of the NICE Committee who consider drug treatments are knowledgeable but are not necessarily experts in each condition or treatment area they are asked to consider. Your experience will help inform their understanding and the impact that these have on your life and your family.

2. What kind of information might you include in your comments to NICE?

We have suggested some points you might want to include in your comments to NICE:

What is your experience of living with Colitis or supporting someone with Colitis? You may want to say a little about how your condition has progressed since diagnosis. 

In cases where your symptoms have failed to respond to conventional therapy, how did this impact your life? Conventional therapies include steroids, 5ASAs (e.g. mesalazine), immunosuppressants such as azathioprine, methotrexate and ciclosporin, and biological drugs like infliximab and adalimumab. If other drug treatments haven’t worked, what has been the impact of this on your health and life?

In cases where your symptoms have failed to respond to conventional therapy, what interventions were you offered? Interventions could include surgical intervention(s) or nothing? What was their impact on your health and life?

If you have used oral steroid therapy (e.g. prednisolone) on a long-term basis, what impact has this had on your health and life? 

What was the impact of surgery on you and your family (for example: mental wellbeing, physical symptoms, work or school, socialising or a family)? 


Please be aware that NICE do publish the comments they receive. Sometimes they redact (anonymise) comments from the public; however, this cannot be guaranteed. So, our advice would be to not include information you would not want shared publicly, for example:

• All direct telephone numbers and email addresses 
• Names, job titles 
• Home or office addresses 
• Names of your doctor or specialist – as this might also identify you
• Hospital or centre you were treated at – this might also identify you

What is NICE and why do Crohn's & Colitis UK participate in its work?

Before a medicine or technology (e.g. diagnostic test) can be recommended for routine use by the NHS, it is assessed for its clinical and cost effectiveness.

The UK bodies tasked with this job include the National Institute of Health and Care Excellence (NICE), Scottish Medicine Consortium (SMC) and All Wales Medicine Strategy Group (AWMSG)

Crohn’s & Colitis UK engages with these organisations to ensure that decision makers fully consider the difference potential treatments and technologies may make to the lives of people with Crohn’s and Colitis and their carers. We regularly respond to consultations, publicise opportunities to get involved and support patient experts to give evidence to appraisal committees. 

I have already been prescribed ustekinumab for my Colitis by the NHS, how will this this future decision affect my prescription? 

This recommendation is not intended to affect those with Colitis prescribed treatment with ustekinumab that was started in the NHS before this guidance was published.

People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Ustekinumab has been approved as an option for treating Crohn’s and this guidance will be unaffected.

I live in Scotland, Wales or Northern Ireland, what does this mean for me?

In Scotland, NHS Scotland will be looking at the decision separately through the Scottish Medicine Consortium and we will keep supporters updated through our website and social media channels.

In Wales, the All Wales Medicine Strategy Group (AWMSG) advise the Welsh government about whether they should be routinely available. The AWMSG do not usually review a medicine if NICE is planning to appraise the drug in the next 6 months. 

In Northern Ireland the Department of Health, Social Services and Public Safety (HPSS) look at guidance issued by NICE (they have one month to do this) and decide if it is relevant for Northern Ireland. They do not have to follow NICE’s recommendations. 

Share your views