Remsima (infliximab) accepted for restricted use in NHS Scotland by the Scottish Medicines Consortium
Patients in Scotland suffering from inflammatory conditions including rheumatoid arthritis (RA), Crohn’s Disease (CD), ulcerative colitis (UC), and psoriasis will now have access to a new wave of biological medicines. Remsima® (infliximab) is a new biosimilar medicine which has the potential to bring significant savings to the NHS without compromising patient care. Patient access follows a review of Remsima by the SMC, which has accepted Remsima for restricted use in line with SMC and Health Improvement Scotland (HIS) advice for the originator medicine Remicade® (infliximab), in RA, UC (adults and paediatric), CD (adults and paediatric), psoriasis and psoriatic arthritis.1
Remsima has been specifically developed to be highly similar to the existing biological medicine, the anti-tumour necrosis factor (anti-TNF) medicine Remicade (infliximab), and the advice provided by the SMC mirrors that of Remicade. Biological medicines have changed the lives of many people with inflammatory conditions by transforming clinical outcomes, improving quality of life, slowing disease progression and reducing disability.2, 3 But they are expensive for the NHS. At a time when the NHS in Scotland is facing significant cost pressures,4 biosimilar medicines can provide crucial savings. It is estimated that Remsima will provide cost savings in excess of 30 percent below the NHS list price of Remicade, although exact pricing will be determined locally through NHS contracts.
The inflammatory conditions for which Remsima is indicated are chronic, incurable, long-term conditions that can be painful, debilitating, destroy quality of life and take away people’s ability to work.5 Some are on the increase; cases of children with inflammatory bowel disease (Crohn’s Disease and ulcerative colitis) in Scotland have risen by 75% over recent decades.6
It is estimated that in the UK, IBD affects as many as 620,000 people.7 There is a south/north gradient to the incidence of IBD in the UK with rates being highest in Scotland.7
There are nearly 60,000 people in Scotland with rheumatoid arthritis and every year just over 2,500 people are diagnosed.8 Over 100,000 people in Scotland have psoriasis.9
Remsima was authorised by the European Medicines Agency (EMA) after undergoing a comprehensive comparability assessment versus the originator, Remicade. This included clinical trials involving 850 patients in 20 countries and 54 non-clinical tests to confirm its quality, efficacy and safety; demonstrating that there were no clinically meaningful differences between the two medicines.10
Andrew Roberts, Director of Market Access, Napp Pharmaceuticals Limited said: “We are delighted with the SMC decision and the fact that the SMC has issued advice which is in line with the originator medicine should provide further reassurance to clinicians and patients in Scotland. Remsima offers considerable savings for NHS Scotland and we hope that Scottish clinicians and budget holders will work together to realise the full potential that biosimilar medicines offer for the benefit of patients and the NHS.”
Remsima is a type of biologic medicine called an anti-TNF. It binds and blocks tumour necrosis factor alpha (TNF), an inflammatory substance naturally produced in the body that is over-produced in a range of inflammatory conditions.10
Remsima has already been successfully launched in other European countries such as Norway, Portugal and Ireland. In Norway for example, approximately one third of infliximab used is now Remsima, rather than the originator brand.11
Remsima has been authorised by the European Medicines Agency (EMA) for the same indications as Remicade® (infliximab), its reference medicine in the following disease areas:10, 12
- Adult Crohn’s disease
- Paediatric Crohn’s disease
- Ulcerative colitis
- Paediatric ulcerative colitis
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
Please refer to the Remsima Summary of Product Characteristics (SPC) for a full list of indications.12
1. Scottish Medicine Consortium (SMC) advice. Available at: https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1006_14_infliximab_Remsima/infliximab_Remsima.
2. Ma X and Xu S. TNF inhibitor therapy for rheumatoid arthritis (review). Biomedical Reports 2013; 1: 177–184.
3. NCAPOP: IBD biologics report 2013 [Accessed February 2013] http://www.hqip.org.uk/ibd-biologics-2013/
4. NHS in Scotland 2013/14. Prepared by Audit Scotland. 2014. www.audit-scotland.gov.uk/docs/health/2014/nr_141030_nhs_finances.pdf
5. National Institute for Health and Clinical Excellence (NICE). Biologic drugs for the treatment of inflammatory ?disease in rheumatology, dermatology and gastroenterology. Commissioning guide, November 2012. [Accessed December 2014]
6. Henderson P et al. Rising Incidence of Paediatric Inflammatory Bowel Disease in Scotland. Inflamm Bowel Dis, 2012;18:999-1005
7. Standards for the Healthcare of People who have Inflammatory Bowel Disease (IBD). IBD Standards. 2013 Update. The IBD Standards Group.
8. National Rheumatoid Arthritis Survey 2010; RA and work.
9. Diagnosis and management of psoriasis and psoriatic arthritis in adults. A national clinical guideline. SIGN Guidelines. October 2010.
10. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Remsima (infliximab); June 2013. [Accessed January 2015] http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
11. Inflectra and Remicade tracking – Norway. Prepared by IMS Health for Mundipharma International Ltd: September 2014
12. Napp Pharmaceuticals. Remsima summary of product characteristics.
Source: Napp Pharmaceuticals Limited