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NICE approves nilotinib for chronic myeloid leukaemia


The National Institute for Clinical Excellence (NICE) has recommended nilotinib (Tasigna) for the treatment of the chronic and accelerated phases of chronic myeloid leukaemia (CML) that is resistant or intolerant to standard-dose imatinib.

Dasatinib (Sprycel) and high-dose imatinib (Gilvec) are not recommended for CML treatment when it is resistant or intolerant to standard-dose imatinib.

“We are very pleased to be able to recommend nilotinib as a treatment option for the chronic and accelerated phases of this condition,” said Professor Carole Longson, Health Technology Evaluation Centre Director at NICE.

“The committee heard from clinical specialists that in practice dasatinib and nilotinib are equally as effective in treating both imatinib-intolerant and imatinib-resistant disease and would be preferred over high-dose imatinib for imatinib-resistant CML.

“Both treatments are expensive and cost over £30,000 per patient per year – CML is also a chronic condition, meaning the drugs will be used for a long period of time.

“However, during consultation on draft recommendations, the manufacturer of nilotinib agreed to provide the drug to the NHS at a discounted price. This reduction in cost enabled the independent committee to approve nilotinib for use on the NHS.”

Novartis, the manufacturer, has requested that the size of the discount remains confidential.
Both dasatinib, and nilotinib cost over £30,000 per patient per year.

Novartis has recently increased the price of imatinib, which means the cost per patient is now over £40,000 per year for the high dose of 800mg.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, National Health Service (NHS) bodies have been advised to make decisions locally on the funding of specific treatments.

This draft guidance does not mean that people currently taking dasatinib or high-dose imatinib will stop receiving them. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.


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