The Pharmaceutical Journal
Vol 277 No 7415 p241
26 August 2006

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Trastuzumab for early HER2-positive breast cancer approved by NICE

Trastuzumab (Herceptin) has been approved by the National Institute for Health and Clinical Excellence for the treatment of women with early-stage HER2-positive breast cancer who do not have cardiac problems. The guidance, published three months after trastuzumab was licensed for this indication, was developed using the single technology appraisal, a rapid assessment process introduced by NICE last year (PJ, 12 November 2005, p600).

NICE recommends trastuzumab, given at three-week intervals for one year or until disease recurrence (whichever is the shorter period), as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy. However, it specifies that cardiac function should be assessed before treatment is started and women with a left ventricular ejection fraction of 55 per cent or less, or with specified cardiac problems (see Panel right), should not be offered trastuzumab.

Cardiac function assessments should be repeated every three months throughout treatment. If the left ventricular ejection fraction drops by 10 per cent, or falls below 50 per cent, treatment should be suspended, says NICE. It adds that trastuzumab may be restarted after further cardiac assessments and a discussion with the patient about the risks and benefits of therapy.

An appeal by Newbury and Community Primary Care Trust following publication of the final appraisal determination for trastuzumab in July was not upheld. The PCT wanted clarification on patients’ eligibility for treatment and highlighted that some women would benefit from shorter courses of trastuzumab. It also raised concerns about the longer-term risks and benefits of the drug being unknown.

Alaster Rutherford, head of medicines management, Bristol North PCT (Teaching), believes that health communities will find implementing this guidance a challenge, both financially and organisationally. “I have particular concerns about how past patients, for example those who completed chemotherapy seven months ago, are to be handled, because the guidance does not give a clear steer on how to implement this technology retrospectively,” he told The Journal. “With estimated annual costs across Bristol, North Somerset and South Gloucestershire of over £2m, this decision will inevitably impact upon other areas of health provision to enable us to find this money.”