1 Recommendations

1 Recommendations

1.1 Filgotinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs), only if:

  • disease is moderate or severe (a disease activity score [DAS28] of 3.2 or more) and

  • the company provides filgotinib according to the commercial arrangement.

1.2 Filgotinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:

  • disease is severe (a DAS28 of more than 5.1) and

  • they cannot have rituximab and

  • the company provides filgotinib according to the commercial arrangement.

1.3 Filgotinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if:

  • disease is severe (a DAS28 of more than 5.1) and

  • the company provides filgotinib according to the commercial arrangement.

1.4 Filgotinib can be used as monotherapy when methotrexate is contraindicated or if people cannot tolerate it, when the criteria in sections 1.1, 1.2 or 1.3 are met.

1.5 Choose the most appropriate treatment after discussing the advantages and disadvantages of the treatments available with the person having treatment. If more than 1 treatment is suitable, start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may vary from person to person because of differences in how the drugs are taken and treatment schedules.

1.6 Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. If this initial response is not maintained at 6 months, stop treatment.

1.7 When using the DAS28, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any adjustments they consider appropriate.

1.8 These recommendations are not intended to affect treatment with filgotinib that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with severe rheumatoid arthritis have a number of advanced treatment options (biological and targeted synthetic DMARDs) available to them if their disease has not responded well enough to 2 or more conventional DMARDs. These advanced treatment options are currently not available for people with moderate rheumatoid arthritis.

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 rheumatoid arthritis that has not responded well enough to 2 or more conventional DMARDs. It is also more effective than conventional DMARDs alone for treating moderate to severe active rheumatoid arthritis that has not responded well enough to 1 or more biological DMARDs.

There are no trials comparing filgotinib with the full range of biological and targeted synthetic DMARDs in severe disease. However, an indirect comparison shows that filgotinib with conventional DMARDs (including methotrexate) works as well as the biological and targeted synthetic DMARDs recommended by NICE.

The most likely cost-effectiveness estimates show that filgotinib with methotrexate is an acceptable use of NHS resources for some people with moderate and severe rheumatoid arthritis (see sections 1.1 to 1.3).

The cost effectiveness of filgotinib monotherapy is more uncertain but is still likely to be within what NICE considers an acceptable use of NHS resources, therefore it is recommended.

  • National Institute for Health and Care Excellence (NICE)