1 Recommendations

1 Recommendations

1.1 Tofacitinib, 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 anti-rheumatic drugs (DMARDs), only if:

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

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

1.2 Tofacitinib, 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 tofacitinib with the discount agreed in the patient access scheme.

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

1.4 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.

1.5 These recommendations are not intended to affect treatment with tofacitinib 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 trial evidence shows tofacitinib plus conventional DMARDs is more effective than conventional DMARDs alone for treating moderate and severe active rheumatoid arthritis that has not responded adequately to conventional or biological DMARDs.

Clinical trial evidence also shows that tofacitinib plus methotrexate is not worse in effectiveness than the biological DMARD adalimumab plus conventional DMARDs in people whose disease has responded inadequately to conventional DMARDs. Because there are no trials comparing tofacitinib with other biological DMARDs, the company did an indirect comparison. This shows that tofacitinib works as well as most of the biological DMARDs which NICE has already recommended in this indication.

Based on the health-related benefits and costs compared with conventional and biological DMARDs, tofacitinib plus conventional DMARDs 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)