One in, two out for CML

 NICE has recommended Novartis’ Tasigna (nilotinib) for the treatment of chronic myeloid leukaemia (CML) but failed to recommend Sprycel (dasatinib) and high dose Glivec (imatinib) in final guidance.

The Appraisal Committee concluded all three treatments provided clinical benefit for people with Glivec-resistant CML but opted for Tasigna when provided under the terms of a patient access scheme.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says that although Tasigna is “expensive” the discount enabled the Committee to approve its use.

NICE estimates that Tasigna costs more than £30,000 per patient, per year.

The Institute received two appeals on its final draft guidance not to recommend Bristol-Myers Squibb’s Sprycel and Novartis’ Glivec, but both of these were dismissed on all accounts.

When completing the FAD, it found that patients with Glivec intolerance generally had a higher response rate to Tasigna and Sprycel than those with Glivec-resistant CML. But a lack of evidence base meant the magnitude of the benefit was uncertain.

When considering the updated analysis submitted during consultation on the first draft from Novartis, the Committee concluded that the ICER of £22,800 per QALY gained for Tasigna compared with hydroxycarbamide was optimistic. But, when provided at a discounted rate, it was regarded as a cost-effective use of NHS resources.

However, the ICER for Sprycel compared with hydroxycarbamide would be more than £43,800 and could rise further. The Committee also noted that high-dose Glivec was more expensive and less effective than the other treatments under evaluation.

“We are very pleased to be able to recommend nilotinib as a treatment option for the chronic and accelerated phases in people who are resistant or intolerant to standard dose imatinib,” said Professor Longson.

CML is a very rare condition that affects around 560 in the UK each year. If treatment with Glivec does not work, current options include interferon-alfa, hydroxycarbamide or a bone marrow transplant.