NICE RECOMMENDS JYSELECA®▼ (FILGOTINIB) ON NHS IN ‘LANDMARK’ DECISION FOR RHEUMATOID ARTHRITIS

NICE RECOMMENDS JYSELECA^®▼ (FILGOTINIB) ON NHS IN ‘LANDMARK’ DECISION FOR RHEUMATOID ARTHRITIS

• Guidance, for the first time in the UK, supports access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis (RA) - aiming to avoid irreversible damage as early as possible^[i]
• More than 400,000 people across the UK live with RA^[ii] and around 70% have moderate or severe disease^[iii]

London, UK, 21 January 2021 – Gilead Sciences, Inc. and Galapagos NV today welcomed the news that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of the daily oral pill, JYSELECA®▼ (filgotinib) on the NHS in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).ⁱ It is the first time in the UK that an advanced therapy has been recommended in 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.ⁱⁱ RA is a degenerative auto-immune disease that can cause life-threatening complications.^[iv] The sooner treatment begins, the better the chance of slowing disease progression.ⁱⁱ 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.^[v],[vi]

“This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA,” said Dr James Galloway, Consultant Rheumatologist at King's College Hospital. “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.” 

Filgotinib is a daily oral pill that can be given on its own (as a monotherapy) or used alongside another common RA medicine, called methotrexate.^[vii] Eligible patients with moderate or severe RA will have responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs).ⁱ 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. ⁱ

“Rheumatoid arthritis is a devastating condition that affects hundreds of thousands of people across the UK – young and old.” said Clare Jacklin, Chief Executive of the National Rheumatoid Arthritis Society (NRAS). “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.”

More than 400,000 people in the UK live with RA (around 380,000 in England), and it is recognised as a condition that can cause debilitating physical pain, affect mental health and require chronic care.ⁱⁱ Studies have shown that RA shortens life expectancy, with some estimates putting this at around 10 years.^[viii] Nearly 50% of patients diagnosed with RA suffer from mental health issues with 1 in 6 people having a major depressive disorder.^vi,[ix] RA is also a significant burden on the UK economy. Around a third of people diagnosed with RA stop work within two years of diagnosis^[x] and the combined cost of workdays lost due to osteoarthritis and RA in the UK was estimated at £2.58 billion in 2017 – estimated to rise to £3.43 billion by 2030.^v[1]

NICE guidance covers England. Wales and Northern Ireland are expected to follow the guidance with timelines for implementation currently under consideration. Filgotinib will be reviewed separately by the Scottish Medicines Consortium for use on the NHS in Scotland.