NICE issues final guidance on trastuzumab

(Herceptin) for early breast cancer

NICE has today (Wednesday 23 August 2006) issued final guidance on Herceptin to the NHS, just three months after the drug was licensed by the regulatory authorities for use in early breast cancer. NICE recommends Herceptin for women with early stage HER2-positive breast cancer, except where there are concerns about the woman’s cardiac function.  

NICE Chief Executive Andrew Dillon said: “Our assessment of Herceptin shows that it is clinically and cost effective for women with HER2 positive early breast cancer. The guidance has been issued rapidly, to ensure consistent use across the NHS and was produced in draft form just 2 weeks after the licence extension for Herceptin was granted. We plan to continue appraising certain technologies rapidly and close to when they are licensed for the benefit of both the NHS, patients and their carers.”

NICE recommends:

• Trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).

• Cardiac function should be assessed prior to the commencement of therapy and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55% or less, or who have any of the following:

-     a history of documented congestive heart failure

-     high-risk uncontrolled arrhythmias

-     angina pectoris requiring medication

-     clinically significant valvular disease

-     evidence of transmural infarction on electrocardiograph (ECG)

-     poorly controlled hypertension.

• Cardiac functional assessments should be repeated every 3 months during trastuzumab treatment. If the LVEF drops by 10% from baseline and to below 50% then trastuzumab treatment should be suspended. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.

The appeal lodged by Newbury and Community Primary Care Trust against the Final Appraisal Determination in July was not upheld, details can be found on the NICE website at http://www.nice.org.uk/page.aspx?o=282270.  

(23/8/06)