HODDESDON, England, December 15, 2014 /PRNewswire/ --

NICE says 'yes' to REMICADE^®(infliximab), HUMIRA^®(adalimumab) and SIMPONI^®(golimumab) for adult patients with moderately to severely active ulcerative colitis 

The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Document (FAD) recommending REMICADE^® (infliximab), HUMIRA^® (adalimumab) and SIMPONI^® (golimumab), within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis (UC) in adults whose disease has responded inadequately to conventional therapy including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies.^[1] SIMPONI is recommended only if MSD provides the 100mg dose at the same cost as the 50mg dose, as agreed in the patient access scheme.

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Additionally, the NICE FAD recommends REMICADE, within its marketing authorisation, as an option for treating severely active UC in children and young people aged 6-17 years whose disease has responded inadequately to conventional therapy, including corticosteroids and mercaptopurine or azathioprine, or who cannot tolerate, or have medical contraindications for, such therapies. This is the first time that children with moderately to severely active UC have been granted access to these therapies in the UK. Previously, access was limited to children with acute severe UC as an alternative to ciclosporin, and in Scotland only.^[2]

Chris Probert, Professor of Gastroenterology at the University of Liverpool, Honorary Consultant Gastroenterologist at Royal Liverpool Hospital, chair of the IBD Committee for the British Society of Gastroenterology and vice-chair of the Clinical Advisers Committee for Crohn's and Colitis UK, says: "This is great news for our patients with ulcerative colitis. It is the first new class of drugs to be approved by NICE for ulcerative colitis and is a valuable tool in our armamentarium in the fight against ulcerative colitis. Hopefully most patients will not require such drugs, but it is a great comfort to know that we can use them when we need to."

The NICE recommendation marks a significant step-change in improving access to treatment options for patients with moderately to severely active disease. Previous NICE guidance restricted the use of biologic therapies only for those hospitalised with severe UC, leaving those with moderately to severely active UC facing surgery if conventional therapies failed.

Helen Terry, Director of Policy at patient organisation Crohn's and Colitis UK, says: "This is fantastic news for people with moderate to severe ulcerative colitis as it gives them much-needed additional treatment options.  We know that these drugs can be life-transforming for people who live with these extremely debilitating symptoms, and who have had problems or no success with other treatments and may be facing surgery.  We very much welcome this landmark decision."

In September 2014 NICE issued preliminary guidance^[3] not recommending the use of biologic treatments for moderately to severely active UC, and since then stakeholders have been working with NICE to explore the benefits of this new class of drugs for patients. NICE has now changed the preliminary guidance, widening the treatment options available for these patients if conventional therapies fail and offering a much-needed alternative to colectomy (removal of the colon).  

The NICE Technology Appraisal Guidance (TAG) is scheduled for publication in January 2015. Once final guidance (TAG) is issued by NICE) for a drug, the NHS must usually provide funding within three months of the guidance being published.

SIMPONI and REMICADE are reimbursed for ulcerative colitis in more than 25 countries in Europe, as well as in USA and Argentina, where REMICADE and SIMPONI are marketed by Janssen.

Unmet patient needs 

The news comes at a time when research has uncovered the level of unmet needs among patients with UC, and their dissatisfaction with treatment options. Findings from the Ulcerative Colitis Condition, Attitude, Resources and Educational (UC CARES) study^[4] across 11 European countries and funded by MSD, show that 87% of the 250 patients in the study with moderately to severely active ulcerative colitis treated with conventional therapies (such as corticosteroids, aminosalicylates and thiopurines) failed to achieve control of their condition.

Additionally, a recent online survey among 684 people with ulcerative colitis in the UK, commissioned and funded by MSD, was run in collaboration with the UK charity Crohn's and Colitis UK (CCUK), surveying its members for their experiences of UC. The survey results reveal that the majority of patients state that the most commonly reported impacts of the disease on their lives are on their emotional state (in terms of depression, anger or anxiety levels) (76%), ability to get adequate rest/sleep (75%), and taking sick days off work (70%).^[5] Those who have had a colectomy were more likely to suffer from these impacts.^[5] If they could go back in time, nearly half (46%) of those that had the surgery said they would ask for more information on the treatment choices available.^[5]

Notes to editors: 

Simponi^® (golimumab)^[6]

Golimumab is a human monoclonal antibody that targets and neutralises tumour necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  Golimumab is the first four-weekly, subcutaneous biologic therapy approved for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. The approved dose of golimumab for a person weighing less than 80kg is an initial dose of 200mg, followed by 100mg at week 2 and then 50mg every 4 weeks thereafter. For patients weighing 80kg or more, golimumab is given as an initial dose of 200mg, followed by 100mg at week 2 and then 100mg every 4 weeks thereafter. Golimumab is available either through the SmartJect autoinjector/prefilled pen or a prefilled syringe as a SC administered injection.  Other licensed indications for Simponi include the three rheumatology diseases: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.^[6]  Simponi is a Registered Trademark owned by Centocor, Inc. and licensed to Merck and Co., Inc., Whitehouse Station, New Jersey, USA.

Please refer to the Summary of Product Characteristics for full information on 'Simponi' including contraindications, precautions, special warnings and side effect information. Available from: https://www.medicines.org.uk/emc/medicine/28316/SPC/Simponi+100+mg+solution+for+injection/  

Remicade^® (Infliximab)^[7]

Remicade is a chimeric human-murine monoclonal antibody that targets and neutralises tumour necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.  Remicade is an intravenous biologic therapy approved for the treatment of severely active UC, in children and adolescents aged 6 to 17 years, and adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. The approved dose of Remicade is 5mg/kg given as an intravenous infusion followed by additional 5mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8.  Other licensed indications for Remicade include in gastroenterology: paediatric Crohn's Disease (CD) (6-17yrs), Adult CD, Fistulising CD; three rheumatology diseases: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, and Psoriasis in dermatology.^[7]  Remicade is a Registered Trademark owned by Centocor, Inc. and licensed to Merck and Co., Inc., Whitehouse Station, New Jersey, USA.

Please refer to the Summary of Product Characteristics for full information on 'Remicade' including contraindications, precautions, special warnings and side effect information. Available from: https://www.medicines.org.uk/emc/medicine/3236

About UC 

Ulcerative colitis is a debilitating form of inflammatory bowel disease (IBD), that causes inflammation and ulceration in the inner lining of the large intestine (colon) or rectum (proctitis).^[8] The most common symptoms of UC include abdominal pain and bloody diarrhoea. Patients also may experience fatigue, weight loss, loss of appetite and rectal bleeding.^[8]

Around 146,000 people in the UK suffer from ulcerative colitis,^[9] an autoimmune disease that causes the body to attack healthy tissue and leads to inflammation and ulceration of the large intestine and rectum.^[8]  Each year, between 6,000 and 12,000 people are diagnosed with the condition,^[10]  with the peak age of diagnosis between the ages of 15 and 25 years, followed by a smaller peak between 55 and 65 years.^[9]  Within current guidelines, surgery may be considered as an option to remove the affected colon (colectomy) when standard medications do not control the disease.

About MSD 

We believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information visit http://www.msd-uk.com. MSD is a trade name of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A.

References 

1. National Institute for Heath and Care Excellence. Final Appraisal Determination on infliximab, adalimumab and golimumab for the second line treatment of moderately to severely active ulcerative colitis. December 2014. Available at:  http://www.nice.org.uk/guidance/gid-tag357/resources/ulcerative-colitis-moderate-severe-infliximab-review-ta140-adalimumab-review-ta262-golimumab-2nd-line-id695-final-appraisal-determination-document
2. Scottish Medicines Consortium. Infliximab 100mg powder for concentrate for solution for infusion (Remicade®). 11 March 2013. Available from: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/854_13_infliximab_Remicade/infliximab_Remicade
3. National Institute for Health and Care Excellence (NICE). Ulcerative colitis (moderate, severe) - infliximab (review TA140), adalimumab (review TA262) & golimumab (2^nd line) [ID695]: Guidance consultation. Available at: http://www.nice.org.uk/guidance/indevelopment/gid-tag357/consultation . Last accessed: December 2014.
4. ECCO 2014. Poster presentation.  Van Assche, G., et. al., Disease Control and Unmet Needs Among Moderate to Severe Ulcerative Colitis Patients Treated with Conventional Therapies in Europe: The UC Cares (Ulcerative Colitis Condition, Attitude, Resources and Educational Study) Study. 2014
5. MSD Data on File. Survey of patients with ulcerative colitis. September 2014. GAST-1132487-0000.
6. SIMPONI.  Summary of Product Characteristics.  October 2014.  Available from: https://www.medicines.org.uk/emc/medicine/28316/SPC/Simponi+100+mg+solution+for+injection/  Accessed on 10 December 2014
7. REMICADE. Summary of Product Characteristics. August 2014. Available from: https://www.medicines.org.uk/emc/medicine/3236 Accessed 10 December 2014.
8. Crohn's and Colitis UK. Ulcerative Colitis. Available at: http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Ulcerative-Colitis.pdf. Accessed 9 December 2014.
9. National Institute for Health and Care Excellence.  Ulcerative colitis: Management in adults, children and young people. June 2013.  Available at: http://publications.nice.org.uk/ulcerative-colitis-cg166. Last accessed 10 December 2014.
10. Crohn's and Colitis UK.  Parents Need To Talk! Available at: http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/NACC_National_Parent_to_Parent_Service.pdf . Last accessed 10 December 2014.

For further information please contact

Funda Suleyman (MSD)
+44(0)1992-455389
funda.suleyman@merck.com

Yasmin Ghariani (Pegasus)
+44(0)1273-712045
yghariani@thisispegasus.co.uk

SOURCE Merck Sharp & Dohme