NICE backs Tasigna and Glivec for CML, but turns down Sprycel

Final draft guidance from the UK's National Institute for Health and Clinical Excellence (NICE) has endorsed the first-line use of two Novartis products in patients with chronic myeloid leukaemia, but resulted in disappointment for Bristol-Myers Squibb.

NICE's latest guidance reaffirms its earlier opinion on Novartis' Glivec (imatinib) in CML, supporting use of a 400mg dose of the drug on the National Health Service in England and Wales, and also recommends the use of the company's follow-up Tasigna (nilotinib) product in these patients.

However, the agency concluded that BMS' Sprycel (dasatinib) was not cost-effective in CML, confirming its earlier guidance, despite the fact that "dasatinib and nilotinib could be considered equally as effective in treating CML".

The difference between the two drugs is that Novartis has offered a discounted price to the NHS for Tasigna which "enabled the independent committee to approve nilotinib for use on the NHS", according to NICE chief executive Sir Andrew Dillon.

Sprycel and Tasigna both have a list price of over £30,000 (around $47,500) per patient per year, while the 400mg dose of imatinib costs £20,000. Novartis has asked that the discount offered for Tasigna not be disclosed.

The NICE committee said the "most plausible" incremental cost effectiveness ratio (ICER) for Tasigna compared with standard-dose Glivec was considered to be £11,000 per Quality-Adjusted Life Year (QALY) gained. The ICERs for Sprycel compared with standard-dose Glivec exceeded £200,000 per QALY gained.

The draft guidance can still be appealed by consultees, but at the time of writing BMS had made no indication as to whether it would do so.

Novartis has shown in two phase III studies that Tasigna provides a superior molecular response to Glivec in Philadelphia chromosome-positive CML and has been growing fast, with sales up 74 per cent to $716m last year. The product now accounts for 19 per cent of Novartis' CML sales, catching up on Glivec which recorded sales of $4.66bn last year, up 9 per cent.

Sprycel recorded sales of $803m last year, a rise of 39 per cent.