New Biological Drug Treatment Approved in Scotland

13 July 2017

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Crohn’s and Colitis UK are thrilled that the Scottish Medicines Consortium (SMC) has approved a new biological drug treatment for adults with moderate to severe Crohn’s Disease in Scotland.

SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines. The SMC has completed its assessment of 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 SMC in April. It is important for SMC members to fully understand how a new medicine impacts the quality of life of patients and carers. This enables them to make a fully informed decision on whether or not to recommend a new medicine. 

Patient group submissions to SMC, like this one on ustekinumab, provide unique knowledge about what it's like to live with a condition and can make a huge difference to the final decisions.

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 as well as providing a new treatment option for some people for whom other treatments have not worked. One of our two Patient Experts gave compelling evidence to the National Institute for Health and Care (NICE) Appraisal committee in England backed up our evidence to the SMC:

 Ask any of my family or close friends what a difference they have seen in my outlook on life, my appetite, my energy, and my ability to do things that I'd never contemplated before, and they won't hesitate to tell you that I've never been as well as I have been since being on this trial. Only two months ago, I completed my first ever half marathon - having taken up running 18 months before.

To have had the opportunity to have ustekinumab has been nothing less than life-changing. Crohn's is such a debilitating, frustrating and life-limiting disease - so to have found a drug that lifts that burden from me to such an extent has been wonderful. It's my sincere hope that I can continue to take this drug for as long as it continues to work for me.

 Patient Expert

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.

Having announced in April that NICE had recommended ustekinumab as a new treatment option for adults with Crohn’s Disease in England and Wales, we are now excited to be able to announce that the SMC has followed suit.

In our submission, we outlined the many challenges of living with Crohn’s Disease including pain, fatigue, frequent need to use the toilet, fear of incontinence, isolation and stigma, emotional issues and negative effects on family members, work, study and social life. We explained that many people do not respond to some or all of the current treatment options or cannot tolerate them and may have a very poor quality of life as a result.

This ruling gives access to a desperately needed additional treatment option and ensures equity of access across the UK. Ustekinumab offers hope to patients for whom current therapies are ineffective.

Nancy Greig, Health Policy & Public Affairs Officer
Crohn's and Colitis UK

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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. 

Find out more information about treatments for Inflammatory Bowel Disease, or visit the support for you section on our website.