In final guidance, the National Institute for Health and Clinical Excellence (NICE) says that, following the offer of a discount, it is able to recommend the use of Novartis' Tasigna (nilotinib) for the treatment of chronic myeloid leukaemia (CML).

Specifically, the final guidance says that NICE recommends Tasigna for the chronic and accelerated phases of CML that is resistant or intolerant to standard-dose imatinib (Novartis' Glivec), and that it does not recommend Bristol-Myers Squibb's Sprycel (dasatinib) or high-dose Glivec for this use.

"CML is a chronic condition, meaning the drugs will be used for a long period of time and, at over £30,000 per patient per year, nilotinib is expensive. However, the manufacturer has agreed to provide it to the NHS at a discounted price. This reduction in cost enabled the independent committee to approve nilotinib for use," said Professor Carole Longson, director of the health technology evaluation centre at NICE.

Novartis, which has requested that the size of the discount should remain confidential, welcomed NICE's final backing for Tasigna, and it was described as "excellent news" by Richard Clark, professor of haematology at the Royal Liverpool University Hospital.

"This ends a period of uncertainty about whether the NHS would support [Tasgna's] costs," said Prof Clark. "This means that all patients in England and Wales who require nilotinib as a second-line treatment can receive this on the NHS. Nilotinib is already available in Scotland for such patients," he added.

Novartis Oncology says it has worked closely with the Department of Health (DH) to establish a Patient Access Scheme (PAS) for Tasigna. "Our priority is to ensure that as many patients as possible can benefit from innovative therapies, like nilotinib, which we have developed to address unmet meets in difficult-to-treat diseases," said Panos Alexakos, oncology general manager at Novartis UK & Ireland. 

"By working in partnership with the DH, we have succeeded in ensuring that patients and health services benefit from the most cost-effective option available for first- and second-line Philadelphia chromosome-positive CML," he said.

- Earlier this month, Health Secretary Andrew Lansley told Parliament that the government will establish "an effective compliance regime" to ensure that Primary Care Trusts (PCTs) make available all drugs which are recommended by NICE.

This had not been the case under the previous Labour government, but, through the compliance regime and "a new NICE collaboration imperative….we will make certain that where NICE gives a positive appraisal for medicine that it is automatically included," Mr Lansley told MPs.