NHS regulator to approve rheumatoid arthritis treatment
NICE changes its mind and new guidance recommends tocilizumab (RoActemra) for RA. Arthritis charity calls it an important breakthrough
2nd July 2010 - The NHS regulator is planning to approve tocilizumab as an additional option for treatment of moderate to severe rheumatoid arthritis.
Earlier draft guidance in March went against recommending the medication, but the approvals committee has since looked at additional information.
Tocilizumab is a modern ‘biologic’ (made from living material) and is used to reduce inflammation in the joints, to help prevent long term damage. Other drugs which act in a similar way are already available, but patients do not always respond or respond well to them.
Tocilizumab is given as an intravenous infusion (IV drip) over one hour once every four weeks. The cost for tocilizumab for a patient is around £9,295 a year.
Tocilizumab, in combination with methotrexate, is recommended for the treatment of moderate to severe active rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more tumour necrosis factor alpha (TNF-α) inhibitors - and whose rheumatoid arthritis has responded inadequately to rituximab - or in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.
Dr Carole Longson, Director of the Centre for Health Technology at NICE, says in a statement: “Having received the extra data we requested from the manufacturer, we’re pleased to be able to make positive draft recommendations on tocilizumab for people who cannot have rituximab to treat their rheumatoid arthritis.
“These provisional recommendations say that tocilizumab is an option if there has been an inadequate response to one or more tumour necrosis factor alpha (TNF-α) inhibitors and where rituximab has also produced an inadequate response or where it is contraindicated or has produced undesirable side effects.
“The use of tocilizumab after rituximab was raised as a potentially important place for this drug in the treatment pathway during consultation on previous draft guidance. The additional information provided by the manufacturer on use in these circumstances has enabled the appraisal committee to now produce positive recommendations - which we hope will be good news for people with rheumatoid arthritis.”
Arthritis Care reaction
Neil Betteridge, Arthritis Care chief executive and vice president of the European League against Rheumatism (EULAR), says in a statement: “Arthritis Care welcomes this decision as an important breakthrough. Although there are a number of treatments available for people with rheumatoid arthritis (RA), they simply don’t work for everyone - and when this happens, it can leave people with RA in intense pain, unable to work, and often struggling to walk. For those most affected, access to the widest range of treatment options will give them the best chance of keeping this painful and potentially disabling disease under control.”
He’s concerned the guidance doesn’t go far enough. “Clinicians will have little leeway in prescribing tocilizumab - it will still only be available as a ‘last resort’ drug to patients who have failed on at least one anti-TNF and have subsequently not responded to rituximab, except for those for whom it is contraindicated,” says Betteridge.
He adds: “So while this ruling is positive, NICE has yet to extend choice to the point where clinicians are able to prescribe the best available treatments to their patients, and ensure that they have timely access to the most effective drugs.”
Until now, tocilizumab was only available in Scotland, after it was approved by the Scottish Medicines Consortium in January. Until NICE issues final guidance, local NHS organisations in England will make their own decisions about funding the treatment.