Crohn’s and Colitis UK are thrilled that the National Institute of Health and Care Excellence (NICE) have recommended a new biological drug treatment for adults with moderate to severe Crohn’s Disease.
The NICE Appraisal Committee assess the clinical and cost-effectiveness of drugs for use by the NHS. Subject to there being no appeals, NICE have approved ustekinumab (also called Stelara) for people who have found that conventional therapy or a type of treatment called TNF-alpha inhibitors (infliximab or adalimumab) either don’t work for them, have stopped working or can’t be tolerated.
This important decision comes after Crohn’s and Colitis UK submitted evidence directly to the NICE appraisal committee in March, alongside our nominated patient experts who made powerful personal statements.
We explained in our evidence that having control of the symptoms of Crohn’s Disease can have a life changing effect; enabling people to resume work and everyday activities. Claire Purkiss - one of two Patient Experts - gave compelling evidence to the committee about the value of the drug.
“I was fortunate enough to receive ustekinumab as part of a drug trial when I was experiencing one of my worst ever flares. I had an excellent response and have since been well enough to have my two children. It is such brilliant news that this drug will now become more widely available to those with Crohn's disease and hopefully help many more of us to keep living healthy happy lives.”
Ustekinumab (Stelara) is already in use for psoriasis and psoriatic arthritis. It works in a different way from other biological drugs, currently available for Crohn’s Disease, by targeting two specific, naturally occurring proteins which play a key role in inflammatory and immune responses. The first dose of ustekinumab would be given intravenously and further doses as a subcutaneous injection (under the skin), which can be self-administered, every 8 or 12 weeks.
“We are delighted that NICE has recommended ustekinumab as a treatment option for adults with Crohn’s Disease. The impact of uncontrolled symptoms of Crohn’s Disease can be profoundly debilitating and current treatment options simply do not work for everyone. This ruling gives access to a desperately needed additional treatment option to those who may otherwise have been condemned to living with unmanageable disease progression with devastating impact on their quality of life.”
Subject to the decision passing without Appeal, adults with Crohn’s Disease in England and Wales could expect NICE to issue its official guidance by the summer and for the drug to be made available later this year. NICE guidance is subject to a local review process in Northern Ireland, which begins once NICE has issued their final draft guidance.
In Scotland, The Scottish Medicines Consortium is currently appraising ustekinumab and plans to produce its own guidance in July 2017. Crohn’s and Colitis UK will be submitting evidence in response to their call for evidence.
The choice of treatment between ustekinumab or another biological therapy should be made on an individual basis after discussion between the patient and their clinician about the advantages and disadvantages of the treatments available.