In new draft guidance on the first-line treatment of chronic myeloid leukaemia (CML), the National Institute for Health and Clinical Excellence (NICE) has recommended Tasigna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

The new appraisal incorporates a partial review of previous guidance on the use of standard dose (400mg) Glivec for treating first-line CML and reaffirms it as a cost-effective use of NHS resources, says NICE.

"We are also very pleased to be able to add a further treatment option for these patients" by recommending Tasigna, added NICE chief executive Sir Andrew Dillon.

Although no trials directly comparing Sprycel and Tasigna were available, NICE's independent appraisal committee concluded from indirect comparisons that the two products could be considered equally effective in treating CML. Both drugs are expensive, costing over £30,000 per patient per year, and CML is also a chronic condition, which means that the treatments will be used for a long period of time, says NICE.

However, the Department of Health (DH) and Novartis have already agreed to provide Tasigna to the NHS at a discounted price, the level of which remains confidential, but this reduction in cost enabled the committee to approve the drug for CML on the NHS, the Institute adds. 

Standard-dose Glivec costs around £20,000 per patient per year, and the committee considered that the most plausible incremental cost-effectiveness ratio (ICER) for Tasigna compared with standard-dose Glivec was between £6,000 and £25,000 per quality-adjusted life year (QALY) gained. The ICERs for Sprycel compared with standard-dose Glivec exceeded £200,000 per QALY gained, it added.

NICE is now inviting comments on these preliminary recommendations for the use of Tasigna, Glivec and Sprycel in CML, a rare condition which affects around 560 people in the UK each year.

Novartis commented that it worked closely with the DH to establish a patient access scheme (PAS) for Tasigna and that it is "committed to ensuring that CML patients in the UK have access to effective life-extending medicines and receive parity of care with the rest of Europe."

"We are delighted with the NICE preliminary recommendation and will continue to work closely with the DH to ensure a positive Final Agreement Determination (FAD) early next year," said Panos Alexakos, oncology general manager  for Novartis UK & Ireland.

NICE also points out that it appraising the use of Sprycel, high-dose Glivec and Tasigna for the treatment of Glivec-resistant CML, and also the use of Sprycel and and Tasigna for people with CML for whom treatment with Glivec has failed because of intolerance.