NICE approves trastuzumab for early stage breast cancer

BMJ 2006; 332 doi: (Published 15 June 2006) Cite this as: BMJ 2006;332:1409
  1. Susan Mayor
  1. London

    Trastuzumab (Herceptin) should be used to treat women with early stage HER2 positive breast cancer except where there are concerns about cardiac function, says draft guidance for England and Wales and separate guidance for Scotland published last week.

    The draft guidance was published by the National Institute for Health and Clinical Excellence (NICE), the body that advises on use of treatments by the NHS, only two weeks after the drug was licensed for use in early breast cancer.

    It recommends the drug as a treatment option for women with early stage HER2 positive breast cancer after surgery, chemotherapy (whether neoadjuvant or adjuvant), and radiotherapy (if applicable). Trastuzumab should be given at intervals of three weeks for one year or until recurrence of the disease, whichever is the shorter period.

    Similar guidance was issued at the same time by the Scottish Medicines Commission, which recommended its use across Scottish health boards.

    Clinical trials have indicated that trastuzumab may be associated with cardiotoxicity in a small number of women, so the NICE guidance recommends that doctors assess patients' cardiac function before starting the drug. It should not be offered to women who have a left ventricular ejection fraction of 55% or less or who have a history of documented congestive heart failure, high risk uncontrolled arrhythmias, angina pectoris requiring treatment, clinically significant valvular disease, evidence of transmural infarction on electrocardiograph, or poorly controlled hypertension.

    Women treated with trastuzumab should have their cardiac function assessed every three months while they remain on the drug. It should be stopped if their left ventricular ejection fraction drops by 10% from baseline and to below 50%. A decision to resume the drug should be based on further cardiac assessment and a fully informed discussion between the individual patient and her clinician of the risks and benefits.

    The Scottish guidance made similar recommendations. It noted that trastuzumab will be available to patients from now on, but its safe introduction may require additional service infrastructure to support the requirement to monitor cardiac function before, during, and after treatment in some centres. NHS Scotland has said that this should be achieved in a matter of weeks.

    Andrew Dillon, the chief executive of NICE, said: “Herceptin is clinically and cost effective in the early stage of HER2 positive breast cancer.” A statement from Roche, the company marketing trastuzumab, said that NICE's finding that the drug was cost effective was based on an analysis-which included a submission from Roche-indicating that the cost of trastuzumab per quality adjusted life year (QALY) was £2387 (€3500; $4400). The company compared this with the cost of statins, where the cost per QALY ranged from £10 000 to £16 000 for all age groups, it said.

    The Scottish Medicines Commission estimated that around 300 patients a year will be prescribed trastuzumab in Scotland, at an estimated recurring annual cost of £7.7m.

    The NHS Confederation, which represents many NHS organisations, warned that implementation of the new guidance could see cutbacks elsewhere. Over the past few months several women have taken their primary care trusts to court and overturned the trusts' decisions not to treat them with trastuzumab.

    Gill Morgan, chief executive of the NHS Confederation, said: “There is no doubt that this will present a significant financial challenge to some NHS organisations.”

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    NICE's draft guidance is at The Scottish guidance is at

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