Update on Herceptin appraisal
What has happened?
NICE has not issued final guidance to the NHS. What NICE has done is publish draft guidance on the use of Herceptin for women with early stage HER2-positive breast cancer. These draft recommendations are subject to an appeal period that closes on 28 June 2006.
During this period, registered stakeholder organisations - including those representing healthcare professionals, patients and carers - can decide whether to appeal against the draft guidance. If there are no appeals, NICE expects to issue final guidance at the beginning of July 2006.
What has NICE said?
NICE's draft recommendations are:
- Herceptin, given at three-week intervals for one 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 before starting therapy and Herceptin 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 three months during Herceptin treatment. If the LVEF drops by 10% from baseline and to below 50% then Herceptin treatment should be suspended. A decision to resume Herceptin 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.
What does this mean for women with breast cancer?
Although NICE has not issued final guidance on Herceptin's use, this is good news for women with early HER2-positive breast cancer. NICE has provisionally recommended that Herceptin should be made available to these women except where there are concerns about the woman's cardiac function. If there are no appeals against these recommendations, NICE hopes to issue final guidance to the NHS at the beginning of July 2006. This will mean that all women eligible for this treatment should receive it no matter where they live in England and Wales.
What happens in the interim?
The Department of Health have made it clear that there are no national restrictions on the NHS using Herceptin in the interim and that the draft guidance provides a strong steer that PCTs can take into account in their considerations.
This page was last updated: 24 June 2010