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MANCHESTER, England

Celltrion Healthcare calls for the NHS to consider lowering the threshold for starting biologics in patients with rheumatoid arthritis (RA) and to put plans in place to increase patient access to biological treatment.

According to recent findings published in the Annals of the Rheumatic Diseases, disease activity and the use of biological disease-modifying anti-rheumatic drugs among patients with RA vary from country to country, due to different contributing factors, such as per capita GDP, drug affordability and reimbursement policies.¹

There are set thresholds in disease activity before biologics can be used in RA patients, but these thresholds vary across Europe. The percentage of patients who are treated with an anti-TNF-α (an effective class of treatment that reduces inflammation and pain) is 24% or higher in countries such as Italy and France, however, in the UK this drops to just 15%. This is because in the UK a patient must have a higher DAS-28 (a measure of how severe the disease is) threshold of 5.1 compared to only 3.2 in other European countries. ^2,3,4 Despite the National Institute for Health and Care Excellence (NICE) widely acknowledging that appropriate biological treatments are clinically effective for all subgroups of RA patients, access to these therapies remains restricted in UK on grounds of cost-effectiveness.⁵

Speaking at the Health and Care Innovation Expo 2018 taking place on 5 and 6 September, Dr. Ben Parker, Consultant Rheumatologist, Manchester University Hospitals, NHS Foundation Trust says, “A UK patient’s burden of disease must be much more severe before they qualify for biologic therapy, compared to a French patient. As a treating physician, I strongly believe that this inequality needs to be addressed so that our patients can realize the same benefits of early treatment as their European neighbors.”

The National Rheumatoid Arthritis Society (NRAS) and British Society for Rheumatology (BSR) concur that in the UK “eligibility criteria (DAS-28 of more than 5.1) are set too high.” and state, within their “Biologics…The Story So Far” publication, that “The BSR and others, including NRAS, will continue to make the case to NICE for reducing the required DAS-28 score from 5.1”.⁶

According to NHS’s recent savings data, NHS England saved £324m in the last financial year by switching from using 10 higher priced medicines to better value biosimilars and generic medicines which are considered to be equally effective and safe alternatives. Switching patients to biosimilars of these biologics led to significant cost savings: infliximab biosimilars delivered £99.4 million in savings, etanercept biosimilars delivered £60.3 million, and rituximab biosimilars delivered £50.4 million, for a cumulative savings of over £220 million in cancer and autoimmune diseases such as rheumatoid arthritis and inflammatory bowel diseases.⁷

Mr. HoUng Kim, Head of Strategy and Operations at Celltrion Healthcare said, “We have identified clear disparities in access to biologics across Europe. Patients diagnosed with less than severe disease activity should be able to get just as good and cost-effective benefit from biologics as patients with severely active disease, as this will help them achieve a better quality of life. With the proven savings, gained through the use of biosimilars, this could be a real opportunity for the NHS to address these concerning inequalities.”

— Ends—

Notes to editors:

About rheumatoid arthritis

In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.⁸ Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.

About CT-P13 (biosimilar infliximab)

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima^® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra^®. CT-P13 is approved in more than 88 countries (as of August 2018) including the US, Canada, Japan and throughout Europe.

About Celltrion Healthcare

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/

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¹ Bergstra S, Branco J, Vega-Morales D et al. Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registry. ARD 6 July 2018. Available at https://ard.bmj.com/content/early/2018/07/06/annrheumdis-2018-213289 [Last accessed August 2018].
² Deighton C, Hyrich K, Ding T et al. BSR and BHPR rheumatoid arthritis guidelines on eligibility criteria for the first biological therapy. Rheumatology 2010; 49 (6): 1197–1199.
³ Jonsson B, Kobelt G, Smolen J. The burden of rheumatoid arthritis and access to treatment: uptake of new therapies. Eur J Health Econ 2008; 8 (2): 61–86.
⁴ Global Data Forecast and Market Analysis – Rheumatoid Arthritis. Published January 2017 [Last accessed August 2018]
⁵ NICE Technology appraisal guidance [TA375]. Published: 26 January 2016. Available at https://www.nice.org.uk/guidance/ta375 [Last accessed August 2018].
⁶ National Rheumatoid Arthritis Society. Biologics… The Story So Far. September 2013. Pg 29. Available at https://www.nras.org.uk/data/files/Publications/Biologics-.pdf [Last accessed August 2018].
⁷ NHS Improvement UK. The NHS saves £324 million in a year by switching to better value medicines. Published 31 July 2018. Available at https://improvement.nhs.uk/news-alerts/nhs-saves-324-million-year-switching-better-value-medicines/ [Last accessed August 2018].
⁸ NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed August 2018].

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