In new draft guidance, NICE has recommended nilotinib (Tasigna) and imatinib (Glivec), both made by Novartis, for the first line treatment of CML (chronic myeloid leukaemia). Dasatinib (Sprycel), made by Bristol-Myers Squibb is not recommended.
In response to the draft guidance NICE Chief Executive, Sir Andrew Dillon said: “This new appraisal incorporates a partial review of previous guidance on the use of standard dose (400mg) imatinib for treating first-line CML*. The new draft recommendations reaffirm the use of imatinib as a cost effective use of NHS resources and we are also very pleased to be able to add a further treatment option for these patients, by recommending nilotinib.”
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. These drugs are both expensive, costing over £30,000 per patient per year and CML is also a chronic condition, meaning the drugs will be used for a long period of time. 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.
The size of the discount remains confidential.
Consultees, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
For more information call the NICE press office on 0845 003 7782 or 07775 583 813.
Notes to Editors
About the guidance
1. The draft guidance will be available on the NICE website from 6 December 2011 at http://guidance.nice.org.uk/TA/Wave24/15
2. Chronic myeloid leukaemia is a rare condition that affects around 560 people in the UK each year.
3. Dasatinib and nilotinib both costover £30,000 per patient per year and standard dose imatinib costs £20,000. However, the manufacturer of nilotinib has already agreed to provide the drug to the NHS at a discounted price. The manufacturer has requested that the size of the discount remains confidential.
4. The most plausible ICER for nilotinib compared with standard-dose imatinib was considered to be between £6000 and £25,000 per QALY gained.
The ICERs for dasatinib compared with standard-dose imatinib exceeded £200,000 per QALY gained.
5. * In October 2003 NICE published guidance (technology appraisal guidance 70 http://guidance.nice.org.uk/TA70) recommending standard-dose imatinib (400mg) for the first-line treatment of chronic myeloid leukaemia (CML). High-dose imatinib was only recommended in the context of clinical trials.
6. NICE is also appraising the use of dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (part review TA70) and dasatinib and nilotinib for people with chronic myeloid leukaemia for whom treatment with imatinib has failed because of intolerance. Further information can be found on the website - http://guidance.nice.org.uk/TA/WaveR/105
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health
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This page was last updated: 06 December 2011