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Celgene's Vidaza approved by NICE

Following improvements to its patient access scheme, NICE has changed its decision and recommended Vidaza (azacitidine) for the treatment of myelodysplastic syndromes (MDS)

As a result of changes made by Celgene to its patient access scheme, the National Institute for Health and Clinical Excellence (NICE) has recommended Vidaza (azacitidine) for the treatment of patients in England and Wales with myelodysplastic syndromes (MDS) and acute myeloid leukaemia.  

The final appraisal determination (FAD) recommending Vidaza within its licensed indication is conditional on the manufacturer providing azacitidine at a discounted cost as part of a patient access scheme.

"We applaud the positive FAD from NICE that will provide patients more widespread access to a therapy that has been shown to prolong survival in these incurable blood cancers," said Robert J Hugin, CEO of Celgene Corporation.

In November 2010, NICE refused to recommend the use of Vidaza on the NHS claiming that the drug was not cost effective, even under a patient access scheme where Celgene would offer the drug with a seven per cent reduction in the acquisition cost. Celgene has now increased its contribution under the patient access scheme but agreed with the Department of Health that the figure would remain confidential. 

Dr Carole Longson, health technology evaluation centre director at NICE said: "Azacitidine is the first drug that has been developed specifically for treating myelodysplastic syndromes. It is not a cure, but it does have the potential to extend patients' lives by an average of nine months. It is a very expensive drug, but the manufacturers have submitted a patient access scheme where the cost will be reduced. We are therefore very pleased to be able to recommend azacitidine as a cost effective use of NHS resources."

This FAD for the appraisal and the draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS.

Myelodysplastic syndromes (MDS) are a group of bone marrow disorders, where the marrow doesn't produce enough of one or more types of blood cells. The majority of patients with MDS receive best supportive care in current clinical practice and some patients receive low dose chemotherapy. There are approximately 700 patients with MDS in England and Wales. 

17th February 2011

From: Healthcare

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