National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending the use of daily oral filgotinib (Jyseleca) on the NHS in England for the treatment of eligible adult patients with moderate to severe active rheumatoid arthritis (RA).
Filgotinib, with methotrexate, is now recommended as an option for treating active RA in adults whose disease has responded inadequately to intensive therapy with two or more conventional disease-modifying antirheumatic drugs (DMARDs), only if:
- disease is moderate or severe (a disease activity score [DAS28] of ≥3.2) and
- the company provides filgotinib according to the commercial arrangement (ACA).
- disease is severe (DAS28 >5.1),
- they cannot have rituximab, and
- the company provides filgotinib ACA.
- disease is severe (DAS28 >5.1) and
- the company provides filgotinib ACA.
Filgotinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the aforementioned criteria are met.
Clinical trials show that filgotinib with methotrexate or other conventional DMARDs is more effective than adalimumab with methotrexate or methotrexate alone for treating moderate to severe RA that has responded inadequately to two or more conventional DMARDs. It is also more effective than conventional DMARDs alone for treating moderate to severe active RA that has responded inadequately to biological DMARDs.
Dr James Galloway, Consultant Rheumatologist, King's College Hospital, said: “This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA.”
