The Pharmaceutical Journal
Vol 268 No 7191 p419-425
30 March 2002

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National Institute for Clinical Excellence (www.nice.org.uk)

NICE clearance for new arthritis drugs

Use of the anti-tumour necrosis factor (anti-TNF) therapies infliximab (Remicade) and etanercept (Enbrel) has been given the green light by the National Institute for Clinical Excellence.

Last week NICE recommended that the two drugs should be made available (infliximab only in combination with methotrexate) as treatment options for adults with active rheumatoid arthritis who have not responded adequately to at least two disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate. The choice of agent used should be determined by consultation between the patient and the clinician responsible, taking into account differences in treatment schedules and patient preferences, NICE says.

At the same time, NICE issued guidance on the use of etanercept for the treatment of juvenile idiopathic arthritis (JIA). It recommends that etanercept is used for children aged four to 17 years with active polyarticular-course JIA whose condition has not responded adequately to, or who are intolerant of, methotrexate.

In both sets of guidance NICE advises that the drugs are prescribed in accordance with existing protocols (British Society for Rheumatology and British Paediatric Rheumatology Group guidelines). These protocols set out the criteria for eligibility for treatment with anti-TNF therapy. In addition, the NICE guidance states that only consultant rheumatologists, or consultant paediatric rheumatologists in the case of JIA, should prescribe these drugs.

The guidance also pays attention to the possibility of drug-related toxicity with anti-TNFs. It recommends that prescribers register patients with the appropriate Biologics Registry and that they forward information on dosage, outcome and toxicity on a quarterly basis. Treatment should be withdrawn in the event of severe drug-related toxicity, or if there is a of lack of response at three months in adults and six months in children.

Ailsa Bosworth, president, National Rheumatoid Arthritis Society, welcomed the guidance. She said: "Anti-TNF treatments have previously been blighted by postcode prescribing. ... Commissioners now need to secure funding immediately to ensure these treatments are provided for the people who need them." Dr Peter Prouse, British Society for Rheumatology, said that the recommendations from NICE would have a massive impact on arthritis services. "The evidence supporting the effectiveness of anti-TNFs is striking," he added.

NICE estimates that the cost of implementing both pieces of guidance in England and Wales will be between £58m and £78m per year (£3m for JIA and between £55m and £75m for RA). It notes that the methods of administration for each drug are different and that this has implications for service provision. Widespread use of infliximab could lead to greater demand for day-case facilities (because of the need for infusion in a hospital setting), whereas use of etanercept could place greater demand on outpatient facilities, it says. NICE points out that patients are normally able to administer their own etanercept and refers to the Enbrel Home Care service, set up by Wyeth (manufacturer of Enbrel). Wyeth suggests that use of this home delivery service would result in savings of up to 10 per cent.

Copies of the full guidance are available on the NICE web site (www.nice.org.uk).