Evidence-based recommendations on etanercept (Enbrel) for treating severe psoriasis in adults.
Since this guidance was published an equality consideration has been raised about the PASI instrument. When using the Psoriasis Area Severity Index (PASI), healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.
The recommendations also apply to etanercept biosimilar products that have a marketing authorisation allowing the use of the biosimilar for the same indication.
The European Medicines Agency (EMA), the European Union body which is responsible for monitoring the safety of medicines, has withdrawn the marketing authorisation for MerckSerono's psoriasis drug efalizumab (Raptiva).
The EMA's Committee for Medicinal Products for Human Use has reviewed possible links between the drug and a rare but deadly brain infection and said the benefits of efalizumab no longer outweigh its risks, because of safety concerns, notably the occurrence of progressive multifocal leukoencephalopathy. As a result the British national formulary has been updated to say that efalizumab should not be prescribed for patients who are not already taking it. Treatment for patients who are taking efalizumab should be reviewed.
Therefore, NICE has withdrawn its guidance on the use of efalizumab for the treatment of adults with psoriasis. Guidance on the use of etanercept for the treatment of adults with psoriasis remains the same and in force.
Guidance development process
Is this guidance up to date?
We reviewed the evidence in September 2010. 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 change 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.