Evidence-based recommendations on adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), rituximab (MabThera) and abatacept (Orencia). These drugs are for adults with severe rheumatoid arthritis who have tried other disease-modifying antirheumatic drugs (DMARDs) but cannot tolerate them or they haven’t worked well enough.
The recommendations also apply to biosimilar products of these technologies that have a marketing authorisation allowing the use of the biosimilar for the same indication.
This guidance replaces NICE technology appraisal guidance on:
- rituximab for the treatment of rheumatoid arthritis (TA126) and
- abatacept for the treatment of rheumatoid arthritis (TA141).
It partially replaces NICE technology appraisal guidance on the clinical effectiveness and cost effectiveness of etanercept and infliximab for rheumatoid arthritis and juvenile polyarticular idiopathic arthritis (TA36).
The price of abatacept has recently increased to £302.40 (excluding VAT) for a 250-mg vial. The manufacturer of abatacept has agreed a simple discount with the Department of Health as part of PPRS modulation with the result that the acquisition cost to the NHS remains the same as considered in the development of TA195 at £242.17 (excluding VAT) per 250-mg vial, until NICE next reviews the guidance on abatacept for this indication.
This change therefore does not affect the recommendations in TA195.
Guidance development process
Is this guidance up to date?
We reviewed the evidence in September 2013. We found nothing new that affects the recommendations in this guidance.
Next review: This guidance will be reviewed if there is new evidence that is likely to affect the recommendations.
The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.