Novartis disputes NICE thinking on chronic myeloid leukaemia

Novartis has said it disagrees with draft guidance from the National Institute for Health and Clinical Excellence (NICE) on the second-line treatment of Philadelphia-chromosome positive (Ph+) chronic myeloid leukaemia (CML).

NICE has published a consultation for its technology appraisal of the Novartis tyrosine kinase inhibitor nilotinib (Tasigna) and dasatinib (Sprycel) for patients with CML who have not responded to imatinib (Glivec). Its preliminary conclusion is that neither can be recommended because of uncertainty about how effective they are and their high acquisition costs.

Nilotinib was licensed in May 2009 for the treatment of chronic-phase Ph+ CML in adult patients resistant or intolerant to prior treatment, including imatinib. It was accepted by the Scottish Medicines Consortium in June 2009 for restricted use for the treatment of chronic-phase patients who are intolerant or resistant to imatinib. Novartis says patients who do not have access to nilotinib will have to take older, less effective alternatives and could face a poorer prognosis. The company submitted comments for the Appraisal Committee’s January meeting.

The appraisal is scheduled for publication in April. Nilotinib is also being appraised as a first-line treatment for CML, with publication scheduled for May 2011.