1 Recommendations

1 Recommendations

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

  • disease is severe (a disease activity score [DAS28] of more than 5.1) and

  • the company provides sarilumab with the discount agreed in the patient access scheme.

1.2 Sarilumab, 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 sarilumab with the discount agreed in the patient access scheme.

1.3 Sarilumab, 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 sarilumab with the discount agreed in the patient access scheme.

1.4 Sarilumab can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria in sections 1.1 and 1.2 are met.

1.5 Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.

1.6 These recommendations are not intended to affect treatment with sarilumab 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

Clinical trials showed sarilumab plus methotrexate or conventional DMARDs to be more effective than methotrexate or conventional DMARDs for treating moderate to severe active rheumatoid arthritis that has not responded adequately to conventional DMARDs. The trials also showed that for treating severe active rheumatoid arthritis that has not responded adequately to conventional DMARDs, sarilumab alone is more effective than adalimumab alone.

Because there are no trials comparing sarilumab with other biological DMARDs, the company did an indirect comparison. This showed that sarilumab with conventional DMARDs (including methotrexate) or alone works as well as most of the biological DMARDs that NICE has already recommended.

Based on the health-related benefits and costs compared with conventional and biological DMARDs, sarilumab plus methotrexate or sarilumab alone is recommended as a cost-effective treatment for severe active rheumatoid arthritis, in line with previous recommendations in NICE technology appraisal guidance on:

  • National Institute for Health and Care Excellence (NICE)