Celgene vastly underestimated costs of AML drug, says NICE

NICE has said Celgene's Vidaza (azacitidine) should not be funded by the National Health Service, estimating it costs the health system more than ten times as much as estimated by the manufacturer.

The cost-effectiveness watchdog said in first draft guidance that Vidaza should not be routinely funded in adults aged 65 years or older not eligible for haematopoietic stem cell transplant with acute myeloid leukaemia, with more than 30% marrow blasts.

A cost-effectiveness analysis provided by Celgene gave a Quality Adjusted Life Year (QALY) of around £20,000 compared with a conventional care regimen – but NICE said that errors in Celgene's calculations and other factors meant the cost could be as high as £240,000 per QALY.

The decision was made using NICE's old methodology for assessing cancer drugs, which has been superseded by a new system that came into play at the beginning of this month.

But a spokesperson for NICE said the new way of thinking will be considered at the next stage of the appraisal process, when a committee will meet to draw up a second draft that takes into account views expressed during a consultation period.

However the spokesperson said the QALY will remain unchanged, unless Celgene can supply new data to sway the committee. Final guidance is due in July.

NICE had been reviewing cost-effectiveness of Vidaza in this use, for which it received a European licence in 2008.

Celgene's cost estimate is in line with NICE's £20-30,000 per QALY threshold, which it uses to decide whether medicines should be funded.

But NICE said it had found errors in Celgene's analysis that increased the cost-effectiveness ratio to more than £62,000.

After adjustments for other factors including the number of treatment cycles required, and treatment required after Vidaza treatment, NICE said an independent cost effectiveness committee found the "most plausible" cost per QALY was as high as £240,000.

Wim Souverijns, vice president and general manager at Celgene UK & Ireland, said: "We are committed to collaborating with NICE throughout their appraisal process of azacitidine in acute myeloid leukaemia."

Professor Charles Craddock, professor of haemato-oncology at the University of Birmingham, said he hoped NICE would reconsider its decision as many patients were unable to tolerate the standard of care.

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