§ Paul FlynnTo ask the Secretary of State for Health what assessment he has made of the side effects of anti-TNF therapies for the treatment of rheumatoid arthritis. [26022]
§ Jacqui SmithI apologise to my hon. Friend for the delay in responding to this question. I refer my hon. Friend to the reply that my right hon. Friend the Secretary of State gave my hon. Friend the Member for Blackpool, North and Fleetwood (Mrs. Humble) on 5 March 2002,Official Report, column 192W.
The anti-TNF therapies are selective immunosuppressants which inhibit tumour necrosis factor. Two anti-TNF therapies, Enbrel (etanercept) and Remicade (infliximab) have been authorised by the European Commission, and are used to treat highly active rheumatoid arthritis in adults, who have failed to respond to at least two standard disease-modifying anti-rheumatic drugs.
As with all new medicines, the manufacturers of anti-TNF therapies were required to conduct extensive clinical trials, the results of which were carefully assessed by European Union regulatory authorities including the Medicine Controls Agency (MCA) before the marketing authorisations were granted. The MCA and its independent body, the CMS, evaluated any adverse effects seen during the clinical trials.
Since these medicines have been marketed, the MCA has continuously monitored them to detect previously identified adverse effects. Any potential issues are 614W reviewed by the Committee for Proprietary Medicinal Products (CPMP), the European advisory body on medicines safety to ensure that the potential benefits of the medicine outweigh the possible risks. Information regarding adverse effects associated with Remicade was issued to health professionals in February 2001 in the bulletin, Current Problems in Pharmacovigilance.
The known side-effects of anti-TNF medicines are included in the product information provided to doctors and patients. Based on such information and according to clinical need, these medicines are prescribed under the supervision of specialist clinicians experienced in the diagnosis and treatment of rheumatoid arthritis. Like all medicines, anti-TNF therapies will continue to be monitored by the UK MCA to ensure the risk:benefit balance continues to be favourable.
§ Brian CotterTo ask the Secretary of State for Health what recent assessment has been made by NICE on the provision of anti-TNF therapy for people with severe rheumatoid arthritis. [40428]
§ Jacqui SmithAs announced on 16 November 2000, as part of its work programme the National Institute for Clinical Excellence (NICE), has been asked to appraise the use of infliximab (Remicade) and etanercept (Enbrel) in the treatment of rheumatoid arthritis for adults and etanercept only for juvenile idiopathic arthritis (JIA). Unless there are appeals, NICE expects to issue its guidance in March 2002 for etanercept for JIA and guidance on the etanercept and infliximab for adults in April.