following a full submission:
nilotinib 150mg hard capsules (Tasigna®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.
First-line treatment with nilotinib in newly diagnosed patients has resulted in significantly higher molecular and cytogenetic response rates compared to the standard tyrosine kinase inhibitor. Further longer term follow-up data are needed to confirm the duration of this response and assess the impact on disease progression and overall survival.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nilotinib. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland.
Download detailed advice155KB (PDF)
Medicine details
- Medicine name:
- nilotinib (Tasigna)
- SMC ID:
- 709/11
- Indication:
- For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Superseded
- Date advice published
- 08 August 2011
SMC advice was superseded by NICE MTA 251: Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (April 2012). This advised that nilotinib is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive CML if the manufacturer makes nilotinib available with the discount agreed as part of the patient access scheme (PAS).
NICE MTA 251 was withdrawn in December 2016 but the NICE MTA 251 advice for nilotinib remains valid in NHSScotland.