The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of JYSELECA®▼ (filgotinib) on the NHS in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).1
The daily oral pill, from Gilead Sciences, Inc. and Galapagos NV, will be the first advanced therapy in the UK that has been recommended for people with moderate RA, offering thousands more the potential to achieve remission earlier – potentially slowing the irreversible damage and life-limiting symptoms RA can cause.2 The sooner treatment begins, the better the chance of slowing disease progression.2 With thousands of people potentially eligible, the recommendation could help improve many lives as well as lessen the significant societal burden RA has in England and Wales.5,6
Filgotinib can be given on its own (as a monotherapy) or used alongside another common RA medicine, called methotrexate.7 Eligible patients with moderate or severe RA will have responded inadequately to intensive therapy with two or more conventional disease-modifying antirheumatic drugs (DMARDs).1 Eligible patients with severe disease will also have wider access to filgotinib in line with criteria defined by NICE. Filgotinib is an advanced therapy which, in RA, is a term used to describe biologic DMARDs and targeted synthetic DMARDs.1
Dr James Galloway, Consultant Rheumatologist at King’s College Hospital said: “This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA. The goals of treatment in this condition are to control pain, prevent disability and improve quality of life. This requires us to act quickly to control the disease, preventing irreversible joint damage as soon as possible, for as long as possible. While no single medicine works for everyone, the addition of filgotinib is an important step forward that we believe will help more patients achieve remission, even when their disease is at a less advanced stage. This is welcome news that should allow people across the UK to have more time free from the pain and distress RA is capable of causing.”
Clare Jacklin, Chief Executive of the National Rheumatoid Arthritis Society (NRAS) said: “Rheumatoid arthritis is a devastating condition that affects hundreds of thousands of people across the UK – young and old. Being able to get the debilitating symptoms under control and ideally into remission, can be life changing and it is vital that people have the best chance of achieving this before it’s too late and permanent damage is done. Today’s decision is a remarkable step forward towards this goal and will allow more people to benefit from advanced therapy earlier in their disease pathway than ever before. For many, this could mean remaining in or getting back to work, fully enjoying family life or just getting on with simple things that many of us so often take for granted. Having an opportunity for earlier intervention will lead I hope to many living a life unburdened by RA.”
1 National Institute for Health and Care Excellence. Filgotinib for treating moderate to severe rheumatoid arthritis ID1632. Available at: https://www.nice.org.uk/guidance/proposed/gid-ta10541. Accessed: January 2021
2 National Rheumatoid Arthritis Society. What is RA? Available at https://www.nras.org.uk/what-is-ra-article Accessed: January 2021
3 Data on file. Gilead Science Ltd. UK-INF-2020-09-0025
4 NHS. (2019). Rheumatoid Arthritis. Available: https://www.nhs.uk/conditions/rheumatoid-arthritis/ Accessed January 2021.
5 Versus Arthritis, 2019. The State of Musculoskeletal Health 2019. Available at: https://www.versusarthritis.org/media/14594/state-of-musculoskeletal-health-2019.pdf Accessed: January 2021
6 Versus Arthritis. Versus Arthritis representation to the Budget 2018. September 2018. Key fact available at https://www.versusarthritis.org/media/1996/versus-arthritis-response-budget-2018pdf.pdf Accessed: January 2021
7 Filgotinib summary of product characteristics. Available at Jyseleca, INN-filgotinib (europa.eu) Accessed January 2021.
8 NRAS – How Is life expectancy affected by RA? Available at NRAS – National Rheumatoid Arthritis Society Accessed: January 2021
9 KCL. (2018). Mental health linked to disease flare of patients with rheumatoid arthritis. Available: https://www.kcl.ac.uk/news/mental-health-linked-to-disease-flare-of-patients-with-rheumatoid-arthritis-3 Accessed January 2021.
10 NICE. (2018). Rheumatoid arthritis in adults: management. Available: https://www.nice.org.uk/guidance/ng100/resources/rheumatoid-arthritis-in-adults-management-pdf66141531233989 Accessed January 2021.