Vedolizumab is a biological drug, like the anti-TNFs mentioned above, although it works in a different way. Clinical trial data show promising results for efficacy and safety, although as a new drug, there is limited long-term safety data.
Following initial submissions from organisations earlier in the year, and a first appraisal meeting, which involved patient experts nominated by Crohn's & Colitis UK, NICE is now inviting members of the public to comment on their draft guidance which is based on evidence of cost and clinical effectiveness.
In its draft guidance, NICE recommends vedolizumab as a treatment option for moderately to severely active Ulcerative Colitis where conventional therapies have failed. However, it is not recommended for those who have already had treatment with anti-TNF drugs, except when they could not tolerate these.
Crohn's & Colitis UK very much welcomes this early indication that there will an additional and promising new treatment option available for people with Ulcerative Colitis, for whom current options are very limited. This is an important and positive development. However, we are very disappointed that this may not be available to those who have not had a response to, or have lost response to treatment with a TNF-alpha inhibitor. For people in this situation, there may be no other options except surgery, with all the implications that this can bring. We will be urging NICE to reconsider extending access to vedolizumab to include those most in need.
This is now open for public consultation and we would encourage you to register your view directly with NICE. (Please note that there is a separate appraisal of vedolizumab for Crohn's and there will be an opportunity to comment on this in the coming weeks. The final decision about infliximab, adalimumab and golimumab for moderate to severe UC is expected in the next two weeks and we will post updates on both of these in the same way).
The final guidance is expected in April 2015.
What you can do
Submit your own comments to the NICE consultation via the NICE website (www.nice.org.uk/guidance/indevelopment/gid-tag450/consultation) by 5.00pm on Wednesday 17th December.
Tips and advice you might want to think about when sharing your views and experiences
NICE's public call for comments is an opportunity for people with Ulcerative Colitis to let NICE know about the impact of the condition, especially where it has been difficult to achieve sustained remission through conventional treatments (e.g. corticosteroids, mercaptopurine or azathioprine) and anti-TNF drugs (e.g. infliximab, adalimumab or golimumab).
It would be particularly valuable to comment if you have used anti-TNFs and these have not worked for you or you have lost response to them over time and can describe the physical, mental and social impact this has had on your life.
Your experience will help inform the Committee's understanding of the impact of living with Ulcerative Colitis on the lives of individuals and their families.
If you would prefer to submit your views and experiences via email to us, please send your submission to ppr@crohnsandcolitis.org.uk and we will collate your submissions with others and forward these collectively.
Keep in touch
If you are planning to comment, we would really appreciate if you could share your submission with us, to inform our work in this area. You can do this by sending a copy to ppr@crohnsandcolitis.org.uk.
Please also use this email address if you have any questions or you want to keep in touch with our campaigns and wider work through our monthly e-newsletter.
We will communicate NICE's final decision on our website.
