In final draft guidance, the National Institute for Health and Clinical Excellence (NICE) has recommended two Novartis drugs - Tasigna (nilotinib) and Glivec (imatinib) - for the first-line treatment of chronic myeloid leukaemia (CML), but not Bristol-Myers Squibb's Sprycel (dasatinib).

The appraisal incorporates a partial review of previous NICE guidance published in October 2003, which recommended standard-dose (400mg) Glivec for treating first-line CML.

The new draft recommendations "reaffirm the use of imatinib as an effective treatment for the majority of patients and a cost-effective use of NHS resources," said NICE chief executive Sir Andrew Dillon. "We are also very pleased to be able to add a further treatment option for these patients, by recommending nilotinib," he added.

Although no trials directly comparing Sprycel and Tasigna were available, NICE's independent appraisal committee concluded from indirect comparisons that the two drugs could be considered equally as effective in treating CML, the Institute notes.

However, Sir Andrew pointed out that the Department of Health and Novartis have already agreed to provide Tasigna to the NHS at a discounted price, and that this reduction in cost enabled the committee to approve the Novartis drug for use on the NHS. The size of the discount remains confidential.

CML is a rare condition affecting around 560 people in the UK each year. The appraisal committee considered the results of clinical trials which showed that, statistically significantly, more people receiving Sprycel and Tasigna had a complete cytogenic response and a major molecular response than people receiving Glivec at 12-month follow-up. 

The panel also noted the views of clinical specialists and patient experts that Tasigna and Sprycel are more effective drugs, with a theoretically superior mechanism of action to standard-dose Glivec, although Glivec remains very effective for the majority of patients. 

Sprycel and Tasigna both cost over £30,000 per patient per year, and standard-dose Glivec costs £20,000, but Novartis has already agreed to supply Tasigna to the NHS at a discounted price.

The panel found that 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, while the ICERs for Sprycel compared with standard-dose Glivec exceeded £200,000 per QALY gained.