Nigel Hawkes, Health Editor
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Patients with a crippling condition are to be denied a choice of treatment under guidance to be published by the Government’s drug watchdog today. The ruling will affect about 60,000 people with rheumatoid arthritis, which has seen improved treatment by modern drugs.
The National Institute for Health and Clinical Excellence (NICE) will reduce the options available by allowing patients to be given only one of a trio of highly effective drugs called antiTNFs. The overproduction of TNF, which stands for tumour necrosis factor, causes the immune system to turn against its own host, causing rheumatoid arthritis.
Charities representing sufferers from rheumatoid arthritis were outraged by the decision, and said that being able to try one drug after another was the key to finding the most effective treatment.
The Arthritis and Musculoskeletal Alliance called the decision “a prescription for pain”.
There are three antiTNF drugs: adalimumab (Humira), etanercept (Enbrel) and infliximab (Remicade). The drugs cost about £8,000 to £10,000 for a year’s treatment and in Britain they are prescribed for the most serious cases only when other treatments have failed.
At issue is the right of patients to try more than one drug to discover which works best for them, and to switch to a different treatment if the effect of the first drug begins to diminish.
Specialists who treat the condition said that the freedom to switch to different drugs was vital.
Professor Rob Moots, of the University of Liverpool, said: “It’s almost impossible to know which antiTNF will work for a patient at the outset. Before this decision we could try patients on each of the three treatments in turn to find one that was effective for them. Now we will only have one shot at success. This flies in the face of clinical judgment. Many patients will be left in astonishing pain, while knowing we haven’t explored all the options for them.”
NICE has argued that there was no evidence to prove that switching from one drug to another was a cost-effective use of NHS resources, but patients and charities disagreed.
Ailsa Bosworth, the chief executive of the National Rheumatoid Arthritis Society, has suffered from the disease for 28 years and has tried the three drugs. She said that it was wrong to offer patients only one chance of success. “It is a bitter blow to find that NICE is not recommending switching when consultants have been successfully switching patients for a number of years. I am on my third antiTNF and my inflammation is currently better controlled now than for many years,” she said.
“NICE is rewriting the rules of rheumatoid arthritis treatment in this country, ignoring the clinical effectiveness of drugs and ignoring the views of patients and clinicians.”
Results showed that about 70 per cent of patients had a good response from a second drug if the effects of the first started to wane, according to the British Society for Rheumatology. Charities and drug companies have the chance to appeal against the preliminary decision before final guidance from NICE is issued to the NHS in September. NICE will recommend that if antiTNF therapy is not working patients should be switched to the drug rituximab (Mabthera), which targets the disease in a different way. The antiTNF drugs and rituximab are usually given in conjuction with methotrexate, an older medication.
Ros Meek, the director of the Arthritis and Musculoskeletal Alliance, said: “NICE’s decision takes away access to a normal and independent life for the many thousands of people battling with the condition. It also totally contradicts Lord Darzi’s pronouncements in his recent review of the NHS – in particular his focus on patient choice and patient empowerment. It’s a prescription for pain.”
A spokeswoman for NICE said: “Consultees now have the opportunity to appeal against the draft guidance. Subject to an appeal being received, final guidance is expected in September 2008.” AntiTNF drugs were developed in Cambridge by César Milstein and Georges Köhler in the 1970s. A team at the Kennedy Institute of Rheumatology in London discovered that monoclonal antibodies targeted TNF. ‘Swap gave me back my life’
Case study
Anne Kakouris, from Acton, West London, is in no doubt that switching from one antiTNF to another has helped her back to a normal life. When she switched from Humira to Enbrel in April “it was like somebody opening a window,” she said. “My mood just lifted.”
Mrs Kakouris, 43, first developed rheumatoid arthritis seven years ago. “It started with one sore finger and progressed in six months to not being able to walk down the street. I thought my life was finished.”
Although Humira hadn’t helped much, she had to stay on it for long enough to prove that it wasn’t working. “At that point if they had said, ‘you’ve had your shot’, I don’t know what I would have done,” she said.
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