In response to evidence and experience shared by people living with Ulcerative Colitis, and patient and professional organisations, the National Institute for Health and Care Excellence (NICE) has reversed its decision not to recommend ustekinumab (Stelara) for people with Ulcerative Colitis.
From September 2020, people living with moderate to severely active Ulcerative Colitis who have found that other treatments, including other biologic drugs such as adalimumab or infliximab, have not worked or have caused major side effects can be prescribed ustekinumab by the NHS.
Ustekinumab (Stelara) is already in use for Crohn’s, psoriasis and psoriatic arthritis. It works in a different way from other biological drugs by targeting two naturally occurring proteins which play a key role in inflammatory and immune responses. The first dose of ustekinumab is given intravenously – through a drip into a vein in your arm - and further doses as a subcutaneous injection (under the skin), which can you can do at home yourself, every 8 or 12 weeks.
How was this decision made?
This decision is the last stage of NICE’s review process. Crohn’s & Colitis UK 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 announced on 13th April 2020 that ustekinumab had been accepted for use in Scotland.
In our submissions, we explained that current treatments do not work for everyone, and ustekinumab offers a new way of effectively treating Colitis and may delay or prevent surgery.
NICE took the initial decision not to recommend ustekinumab for Colitis due to ‘uncertainty’ around clinical and cost-effectiveness in indirect comparisons to other treatments. However, following the opportunity to further submit evidence, NICE revisited its decision. Publication of the decision was initially halted due to the COVID-19 outbreak. Working alongside clinicians, we wrote to the CEO of NICE highlighting the need for medicines that can be delivered at home at this time keeping people safe and reducing demand on the NHS.
We are delighted that NICE have revisited its decision and will now recommend ustekinumab for use in Colitis. The impact of uncontrolled symptoms of Colitis can be devastating and debilitating. Current treatments simply do not work for everyone, so having as many potential treatment options available as possible enables a personalised approach. The importance of the patient voice is clear in these appraisals.
How can I be prescribed ustekinumab?
The choice of treatment between ustekinumab or another biologic medicine should be made on an individual basis after discussion between the person living with Colitis and their clinician about the advantages and disadvantages of the treatments available.
When will ustekinumab become available?
Ustekinumab should be available to adults with Ulcerative Colitis in England and Wales within three months of publication of the final guidance. In Northern Ireland, NICE guidance goes through a local review process, which begins once NICE has issued their final draft guidance.