PAS sways Tasigna decision

NICE has recommended the use of Tasigna (nilotinib) and Glivec (imatinib) for the first-line treatment of chronic myeloid leukaemia (CML), but failed to recommend Sprycel (dasatinib) in final draft guidance.

The guidance reaffirms the use of standard dose Glivec and recommends the use of Tasigna after Novartis agreed a Patient Access Scheme with the DH to lower its cost.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “very pleased to be able to add a further treatment option” for patients.

CML is a rare condition that affects around 560 people in the UK each year.

NICE’s independent Appraisal Committee considered the results of clinical trials and noted the views of clinical specialists and patient experts when conducting the appraisal.

It found that more patients receiving Tasigna and Sprycel had a complete cytogenetic response and a major molecular response than people receiving Glivec at 12-month follow-up.

Also, experts said that Tasigna and Sprycel are more effective than standard-dose Glivece with a theoretically superior mechanism of action, although this option remains very effective.

The Committee concluded that available evidence suggests Tasigna and Sprycel provide superior clinical benefit as measured by surrogate outcome measures to standard-dose Glivec in people with chronic phase CML – despite no direct head-to-head data being available.

“Although no trials directly comparing dasatinib and nilotinib were available, the Committee concluded from indirect comparisons that dasatinib and nilotinib could be considered equally as effective in treating CML,” said Sir Andrew Dillon.

“However, the Department of Health and the manufacturer of nilotinib have already 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.”