Biggest change to treatment of RA since the introduction of biologics in the early 2000s

14 July 2021

Last month we brought you the news about the Draft Final decision from NICE regarding treatment of ‘moderate active’ RA with some advanced therapies and we’re now delighted to say that as of 14th July this is now Final Guidance. This is an incredible achievement after years of campaigning and has the potential to improve the lives of thousands of people in England and Wales. To manage expectations though for those of you who maybe in this ‘moderate’ category this change will not happen at speed. We are still living through extraordinary times and rheumatology departments are struggling with staffing levels and waiting list backlogs therefore it will take months potentially the best part of the next 12 months or so to assess patients’ disease state and ensure appropriate escalation of treatment to these therapies for those who meet the criteria. To read more you can find the final guidance at www.nice.org.uk/guidance/ta715

Evidence-based recommendations on adalimumab, etanercept, infliximab and abatacept for adults with moderate rheumatoid arthritis who have tried conventional DMARDs but they have not worked. The recommendations also apply to biosimilar products of the technologies that have a marketing authorisation allowing the use of the biosimilar for the same indication.

10 June:

The National Rheumatoid Arthritis Society are extremely excited to announce that today 10 June, 2021, the National Institute for Health and Care Excellence (NICE) has issued draft guidance that gives approval for certain anti-TNF therapies to be prescribed for people with so-called ‘moderate’ rheumatoid arthritis (full and final guidance will be issued in July).

These drug options, now accessible at an earlier stage than has ever been possible previously, will give thousands of people living with moderate active disease hope of a significantly better quality of life, ending years of living with disease that is not optimally controlled.  Rheumatoid Arthritis is a painful, progressive, systemic autoimmune disease which affects absolutely every aspect of a person’s life and the impact that this news will have on many thousands of people’s lives, living with RA, cannot be underestimated.

Given the pressure the NHS is currently under and the impact that COVID has had on rheumatology services, it will take time to reflect these changes in clinical practice and people with RA that falls into the category of ‘moderate’ should be aware of this. Patients ​who may be affected by this decision will need to wait a little longer, however, before the changes will be implemented into clinical practice. NRAS asks for understanding and support of the rheumatology health professionals and commissioners who will be handling this guidance implementation alongside the backlog legacy of the pandemic.

Until now only those people with severe disease i.e. having a disease activity score (DAS28) of greater than 5.1, have been able to have advanced biologic and targeted synthetic disease modifying therapies prescribed for them as part of their NHS treatment. The many thousands of people living with active RA but not quite reaching the 5.1 score though have not be able to access these medicines.

Since the advent of NICE in the early 2000s, the UK has had to live with the highest barriers within Western Europe to accessing such therapies. There are no such eligibility restrictions in Ireland and many other European countries where choice of treatment is determined by the prescribing clinician being able to use the most appropriate treatment in collaboration with the patient, free from cost restrictions.

The inequity of access to proven, effective medications throughout the last two decades for the many thousands of people living with active, destructive and debilitating disease was the driving force behind NRAS’ campaign over the last 3 years, to challenge NICE’s eligibility criteria to access advanced therapies for those with ‘moderate’ disease. It also ends the dichotomy between the NICE RA Guideline and NICE Guidance. NRAS partnered with the British Society for Rheumatology (BSR) in the campaign with our first formal discussions on the topic with NICE and NHS England taking place at BSR’s offices in February 2019.

This decision is a real milestone in our efforts to improve equity of access to effective treatments for the many thousands of people who live with disease that is inadequately controlled, and therefore has a detrimental impact on the quality of their day to day lives. For some it will mean that they don’t have to give up work, or will enable them to get back to work. For others it will mean being able to start doing hobbies, activities and sports that they had had to give up, and for many it will mean being able to get back to a more normal life with their families, doing more and being able to enjoy more. Going forward it will mean that people with moderate disease don’t have to wait suffering, sometimes for many years – inadequately treated – until their disease is ‘severe’ enough and they have sustained irreversible damage or become disabled before being able to access advanced treatment. If standard disease modifying drugs don’t work in getting their RA under control or into low disease activity state, they will be able to move immediately onto an advanced therapy if they meet the new criteria i.e. DAS28 score of greater than 3.2 and their disease has not responded to two conventional DMARDs. This is massive change and will improve the emotional and physical wellbeing of many thousands of people. My NRAS colleagues and I couldn’t be more delighted.

Ailsa Bosworth, National Patient Champion and who was CEO at the time of the start of this campaign

When anti-TNF drugs were first approved for clinical use over twenty years ago, it was already apparent that this class of treatment could greatly improve the quality of life for many people living with rheumatoid arthritis. And we now have a huge amount of experience in the use of these drugs in people with severe disease activity which confirms an excellent track record of generally high benefit and low risk. It is wonderful news that NICE have now approved the use of certain anti-TNF agents for people with a more moderate level of disease activity who nevertheless have debilitating symptoms. There is great hope that this will help some of these individuals achieve a better quality of life. Anti-TNF may not be a suitable treatment for everyone with moderate disease activity as the rheumatologist will need to discuss the potential benefits as well as any possible risks on an individual basis. But it is the case that the outlook for people in the UK living with rheumatoid arthritis is better than ever before!

Prof. Peter Taylor, Norman Collisson Professor of Musculoskeletal Sciences and Chief Medical Advisor to NRAS

Alongside NRAS, the British Society for Rheumatology, (BSR) have been providing data to support people with moderately active RA to have advanced therapies. An independent review of the evidence the BSR commissioned over seven years ago failed to persuade NICE to allow treatment for moderate patients but at least ensured biologic drugs remained available for those with more severe disease. The recent reduction in cost of some drugs meant that the time was right to press NICE to change their guidance and at last allow those with moderately active RA to have appropriate treatment. It’s been a pleasure working with NRAS on this.

Dr. Frank McKenna

High levels of pain, physical disability, sleep difficulties and fatigue are all prominent symptoms of ‘moderate’ disease leading to quality of life issues, problems with employment and often mental health and emotional issues. This decision by NICE to allow access to a limited number of the available and approved biologics is a significant step forward. It will not only make a massive difference to individual patients but will improve the experience of rheumatology health professionals who have felt, until now, constrained and restricted in their autonomy to prescribe what they believe will make a real difference to their patients. Being able to offer the right treatment at the right time will also benefit not only the health service in the long term, with reducing the levels of long-term disability, but also the economy and society with more people being able to stay working and being more active in their communities. NRAS is delighted with this real game-changing decision by NICE.

Clare Jacklin, NRAS Chief Executive

NRAS would also like to acknowledge the important contribution to this campaign that Professor Peter Taylor (NRAS Chief Medical Advisor), Dr. Frank McKenna, and Dr. James Galloway have made. Their commitment and unwavering support in so many ways, has been instrumental in helping us and the BSR to achieve our goal of getting access to advanced therapies for people with moderate and sustained active disease. 

A recent published NRAS study (Nikiphorou et al, Rheumatology Advances in Practice, Volume 5, Issue 1, 2021, rkaa080) looking at the level of suffering of people with ‘moderate’ disease, highlighted that people not currently treated with advanced therapies experience profound difficulties in everyday living with rheumatoid arthritis, across a broad range of measures. The NRAS study surveyed over 600 people with RA in the UK who have active disease but, until now, have been unable to access these advanced therapies. 90% had experienced flares of their disease in the previous 12 months with almost a quarter experiencing 6 or more flares.

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Key Facts for Journalists Who are NRAS? The National Rheumatoid Arthritis Society (NRAS) is the only UK patient organisation supporting those affected by Rheumatoid Arthritis (RA) as well as Juvenile Idiopathic Arthritis (JIA). Founded in 2001, NRAS also supports the families of those living with RA or JIA as well as the health professionals who […]