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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

1 Recommendations

1.1 Adalimumab and infliximab, both with methotrexate, are recommended as options for treating active rheumatoid arthritis in adults, only if:

  • disease has responded inadequately to intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs) and

  • disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and

  • the companies provide adalimumab and infliximab at the same or lower prices than those agreed with the Commercial Medicines Unit.

1.2 Adalimumab can be used as monotherapy when methotrexate is contraindicated or not tolerated, when the criteria in 1.1 are met.

1.3 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.

1.4 Start treatment with the least expensive drug (taking into account administration costs, dose needed and product price per dose). This may vary because of differences in how the drugs are used and treatment schedules.

1.5 Take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DAS28 and make any appropriate adjustments.

1.6 Abatacept with methotrexate is not recommended, within its marketing authorisation, for treating moderate active rheumatoid arthritis in adults when disease has responded inadequately to 1 or more DMARDs.

1.7 Etanercept with or without methotrexate is not recommended, within its marketing authorisation, for treating moderate active rheumatoid arthritis in adults when disease has responded inadequately to DMARDs.

1.8 These recommendations are not intended to affect treatment with adalimumab, etanercept, infliximab or abatacept 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

This appraisal reviews some of the drugs (adalimumab, etanercept, infliximab and abatacept) recommended for severe rheumatoid arthritis in NICE technology appraisal 375 and considers them for moderate rheumatoid arthritis.

Filgotinib is the only advanced treatment option (biological and targeted synthetic DMARDs) currently available for moderate rheumatoid arthritis after 2 or more conventional DMARDs have not worked. The clinical evidence suggests that advanced treatments are likely to be similarly effective in both moderate and severe disease.

The most likely estimates suggest that adalimumab and infliximab after 2 or more conventional DMARDs are a cost-effective use of NHS resources. So, adalimumab with or without methotrexate, and infliximab with methotrexate, are recommended for people with moderate disease. The most likely cost-effectiveness estimates for etanercept and abatacept are higher than what NICE normally considers a cost-effective use of NHS resources. So, etanercept and abatacept are not recommended for treating moderate rheumatoid arthritis.