MSD: New NICE Guidance on Biologics Expands Treatment Options for Patients with Moderately to Severely Active Ulcerative Colitis

HODDESDON, England--()--The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the use of biologic therapies for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients. REMICADE® (infliximab, MSD), SIMPONI® (golimumab, MSD) and HUMIRA® (adalimumab, AbbVie) are recommended, within their marketing authorisations, as options for treating moderately to severely active ulcerative colitis 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 100 mg dose at the same cost as the 50 mg dose, as agreed in the patient access scheme.1

This final guidance, known as a Technology Appraisal Guidance (TAG), marks a significant step-change in the treatment options available for patients with moderately to severely active disease, with previous guidance restricting the use of these newer biologic therapies to those hospitalised with severe UC. Previously, those with the moderate to severe form of the disease who were not hospitalised faced undergoing colectomy (removal of the colon) if conventional therapies such as corticosteroids and mercaptopurine or azathioprine failed. The final guidance now means patients have alternative options if conventional therapies fail.

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.”

Guidance Includes Children & Young Adults

Children throughout the UK with severely active UC will now be able to access a biologic therapy. Previously, access was limited to children with acute severe UC as an alternative to ciclosporin, and in Scotland only.2 The NICE TAG 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 for those who cannot tolerate, or have medical contraindications for, such therapies.1

Once a TAG is issued by NICE, the NHS has a three-month period in which to implement the guidance and provide funding, which means that eligible patients will be able to gain access to these treatment options on the NHS.

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

Impact of UC on Patients’ Lives

A recent online survey, funded by MSD, and run in collaboration with the UK charity Crohn’s and Colitis UK, surveying its members for their experiences of UC, revealed that some of the commonly reported impacts of the disease on patients’ (n=684) lives are on their emotional state in terms of depression, anger or anxiety levels (76%), the ability to get adequate rest/sleep (75%), and taking sick days off work (70%).3 Also, nearly half (46%) of those respondents who have had a colectomy (n=61) reported more than six flare ups in the past two years compared with 19% of those who had not had this surgery (n=623).3

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SIMPONI® (golimumab)4

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 (during maintenance therapy), 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.4 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: www.medicines.org.uk/emc/medicine/28316/SPC/Simponi+100+mg+solution+for+injection/

REMICADE® (Infliximab)5

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.5 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: 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).6 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.6

Around 146,000 people in the UK suffer from ulcerative colitis,7 an autoimmune disease that causes the body to attack healthy tissue and leads to inflammation and ulceration of the large intestine and rectum.6 Each year, between 6,000 and 12,000 people are diagnosed with the condition,8 with the peak age of diagnosis between the ages of 15 and 25 years, followed by a smaller peak between 55 and 65 years.7 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

At 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 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 www.msd-uk.com. The company is known as Merck in the United States and Canada. Everywhere else, we are known as MSD.

References

1. National Institute for Heath and Care Excellence. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262) Technology Appraisal Guidance TA 329. Available at: www.nice.org.uk/guidance/ta329/informationforpublic. Last accessed: February 2015.

2. Scottish Medicines Consortium. Infliximab 100mg powder for concentrate for solution for infusion (Remicade®). 11 March 2013. Available from: www.scottishmedicines.org.uk/SMC_Advice/Advice/854_13_infliximab_Remicade/infliximab_Remicade. Last accessed: February 2015.

3. MSD Data on File. Survey of patients with ulcerative colitis. September 2014. GAST-1132487-0000.

4. SIMPONI. Summary of Product Characteristics. January 2015. Available from: www.medicines.org.uk/emc/medicine/28316/SPC/Simponi+100+mg+solution+for+injection/. Last accessed: February 2015.

5. REMICADE. Summary of Product Characteristics. August 2014. Available from: www.medicines.org.uk/emc/medicine/3236. Last accessed: February 2015.

6. Crohn’s and Colitis UK. Ulcerative Colitis. Available at: www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Ulcerative-Colitis.pdf. Last accessed: February 2015.

7. National Institute for Health and Care Excellence. Ulcerative colitis: Management in adults, children and young people. June 2013. Available at: www.nice.org.uk/guidance/cg166/resources/guidance-ulcerative-colitis-pdf. Last accessed: February 2015.

8. Crohn’s and Colitis UK. Parents Need To Talk! Available at: www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/NACC_National_Parent_to_Parent_Service.pdf. Last accessed: February 2015.

Contacts

MSD
F Suleyman
01992 455389
funda.suleyman@merck.com
or
Pegasus
Yasmin Ghariani
01273 712045
yghariani@thisispegasus.co.uk

Contacts

MSD
F Suleyman
01992 455389
funda.suleyman@merck.com
or
Pegasus
Yasmin Ghariani
01273 712045
yghariani@thisispegasus.co.uk