Baricitinib, 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 baricitinib with the discount agreed in the patient access scheme.
Baricitinib, 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 baricitinib with the discount agreed in the patient access scheme.
Baricitinib 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 or 1.2 are met.
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.
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.
These recommendations are not intended to affect treatment with baricitinib 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 baricitinib plus conventional disease-modifying antirheumatic drugs (DMARDs) to be more effective than conventional DMARDs alone for treating severe active rheumatoid arthritis that has not responded adequately to conventional or biological DMARDs. Some trial evidence also suggests that in people who have not previously had DMARDs, baricitinib works as well when taken alone as it does when taken with conventional DMARDs.
Baricitinib plus conventional DMARDs was also shown to have similar effectiveness to the biological DMARD adalimumab in people whose disease has responded inadequately to conventional DMARDs. Because there are no trials which compare baricitinib with other biological DMARDs, the company did an indirect comparison. Baricitinib was shown to work 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, baricitinib plus conventional DMARDs was recommended as a cost-effective treatment, in line with previous recommendations in: