NICE thumbs up for Roche arthritis drug
pharmafile | July 2, 2010 | News story | Sales and Marketing | NICE, RoActemra, Roche
NICE has given preliminary approval to Roche’s RoActemra as an additional option for the treatment of moderate to severe rheumatoid arthritis.
The final draft recommendations green-light RoActemra (tocilizumab), in combination with methotrexate, for the treatment of moderate to severe active RA in people whose condition has responded poorly to one or more tumour necrosis factor alpha (TNF-α) inhibitors.
It is also indicated for patients that are contraindicated to Roche’s other RA and oncology drug MabThera (rituximab) or when MabThera is withdrawn because of an adverse effect.
Earlier draft guidance in March looked set to see reject RoActemra, with NICE’s appraisal committee asking for more additional information to be made available.
Now the Swiss pharma has managed to produce the necessary evidence for the cost-effectiveness body leading to its final draft guidance approval.
Dr Carole Longson, director of the centre for health technology at NICE, said: “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 moretumour 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was raised as a potentially important place for this drug in the treatment pathway during consultation on previous draft guidance.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.”
This preliminary approval comes two weeks after NICE approved five RA treatments in certain circumstances after treatment with a TNF inhibitor has failed in order to extend treatment options for RA patients.
Ben Adams
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