In final 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.

This appraisal incorporates a partial review of previous guidance published in October 2003 where standard dose (400mg) imatinib was recommended for treating first-line CML (technology appraisal guidance 70).

In response to the guidance Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "The recommendations reaffirm the use of imatinib as an effective treatment for the majority of patients and 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. However, the manufacturer of nilotinib has already agreed with the Department of Health 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."

This guidance does not mean that people currently taking dasatinib for the first line treatment of CML will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Ends

Notes to Editors

About the guidance

1. The guidance will be available on the NICE website from 25 April 2012 at TA251. Embargoed copies of the guidance are available from the NICE press office on request.

2. Chronic myeloid leukaemia is a rare condition that affects around 560 people in the UK each year.

3. The Committee considered the results of the clinical trials, which showed that statistically significantly more people receiving dasatinib and nilotinib had a complete cytogenetic response and a major molecular response than people receiving imatinib at 12-month follow-up. The Committee also noted the views of the clinical specialists and patient experts that nilotinib and dasatinib are more effective drugs with a theoretically superior mechanism of action to standard-dose imatinib, although imatinib remains very effective for the majority of patients. The Committee concluded that the available evidence suggests that dasatinib and nilotinib provided superior clinical benefit as measured by surrogate outcome measures than standard-dose imatinib in the first-line treatment of people with chronic phase CML.

4. Two comparative clinical trials were presented to the committee, one that compared dasatinib with imatinib and one that compared nilotinib with imatinib. No trials directly comparing dasatinib and nilotinib were available. However, the Committee found from indirect comparisons that there was insufficient evidence to distinguish between dasatinib and nilotinib in terms of clinical effectiveness.

5. Dasatinib and nilotinib both cost over £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 level of the discount is commercial in confidence. It is the responsibility of the manufacturer to communicate the level of discount to the relevant NHS organisations. Any enquiries from NHS organisations about the patient access scheme can be directed to the manufacturer

6. The most plausible ICER for nilotinib compared with standard-dose imatinib was considered to be £11,000 per QALY gained. The ICERs for dasatinib compared with standard-dose imatinib exceeded £200,000 per QALY gained.

7. In October 2003 NICE published guidance (technology appraisal guidance 70 TA70) on 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. The guidance recommended 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.

8. In January 2012 NICE published guidance (technology appraisal guidance 241 TA241) recommending nilotinib as a possible treatment for some people with chronic myeloid leukaemia (CML). High dose imatinib and dasatinib were not recommended.

About NICE

9. 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

10. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

11. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services

Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

12. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.