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Patients' groups have welcomed the decision by the National Institute for Health and Clinical Excellence (NICE) to give the go ahead to two new drugs for arthritis and one for multiple sclerosis.
NICE has approved for use in the NHS in England and Wales rituximab (MabThera) for severe active rheumatoid arthritis and adalimumab (Humira) for active and progressive psoriatic arthritis. It also recommended natalizumab (Tysabri) to treat rapidly evolving, severe relapsing-remitting multiple sclerosis.
Rituximab in combination with methotrexate will be available to NHS patients who have failed to respond to other antirheumatoid drugs, including at least one tumour necrosis factor (TNF) inhibitor. But NICE says that the treatment should continue only if there is an “adequate” response to the new drugs.
Adalimumab will be available to patients with peripheral arthritis who have three or more tender joints and three or more swollen parts and who have not responded to the more standard antirheumatoid drugs. It should be discontinued if the patient has made no progress after 12 weeks.
Arthritis Care's chief executive, Neil Betteridge, called the decision on rituximab “an enlightened triumph.”
He said, “The search for effective treatment can be a long, agonising journey, littered with dashed hopes. Now there's no excuse to deny this drug on anything but clinical grounds.”
Around 40000 people in England and Wales with rheumatoid arthritis have the most severe form of the disease, and around 30% of these do not respond to anti-TNF drugs. They are the ones who will benefit most from NICE's decision.
Mr Betteridge said, “Pinpointing the right drug is a race against time to match a given individual to what's most suitable—so the more options available, the better.”
Recent trials showed that rituximab reduced symptoms of rheumatoid arthritis by more than 50% in more than a third of patients, although some patients reported a higher likelihood of serious infection (Lancet doi: 10.1016/S0140-6736(07)60784-3).
Earlier this month NICE angered arthritis patients' groups by ruling in draft guidance that abatacept (Orencia), another drug for severe rheumatoid arthritis, was not cost effective and should not be made available on the NHS.
It is estimated that around 3000 people with severe relapsing-remitting multiple sclerosis could benefit from the decision to make natalizumab available on prescription. The type of multiple sclerosis that is receptive to this drug is defined by two or more disabling relapses in one year and one or more gadolinium enhancing lesion showing on magnetic resonance imaging (MRI) or a significant increase in T2 lesion load in comparison with a previous MRI scan.
Rituximab and adalimumab are already available in Scotland after an earlier ruling by NICE's counterpart, the Scottish Medicines Consortium. The consortium initially rejected the use of natalizumab but is now reviewing that ruling. A decision is expected in September.
Health trusts in England and Wales have three months from 22 August to ensure that the approved drugs are available to all NHS patients who meet the criteria.
For more information go to www.nice.org.uk.