Lani
08-24-2006, 07:13 AM
Including specific cardiac precautions which might be informative to all:
NICE Issues Final Guidance On Trastuzumab (Herceptin) For Early Breast Cancer
Main Category: Breast Cancer News
Article Date: 23 Aug 2006 - 0:00am (PDT)
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 nice.org.uk/page.aspx?o=282270.
About NICE
The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
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 and procedures within the NHS
-- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
About process for appraising medicines in the UK
NICE issues guidance on the clinical and cost effectiveness of selected new and existing drugs for the NHS in England and Wales. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency/European Medicines Evaluation Agency.
NICE has introducing a new, rapid process to enable faster guidance on life-saving drugs which have already been licensed and on new medicines close to when they first become available. Details can be found on the NICE website at www.nice.org.uk/page.aspx?o=278604.
NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
National Institute for Health and Clinical Excellence (NICE)
MidCity Place
71 High Holborn
London WC1V 6NA
UK
http://www.nice.org.uk
NICE Issues Final Guidance On Trastuzumab (Herceptin) For Early Breast Cancer
Main Category: Breast Cancer News
Article Date: 23 Aug 2006 - 0:00am (PDT)
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 nice.org.uk/page.aspx?o=282270.
About NICE
The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
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 and procedures within the NHS
-- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
About process for appraising medicines in the UK
NICE issues guidance on the clinical and cost effectiveness of selected new and existing drugs for the NHS in England and Wales. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency/European Medicines Evaluation Agency.
NICE has introducing a new, rapid process to enable faster guidance on life-saving drugs which have already been licensed and on new medicines close to when they first become available. Details can be found on the NICE website at www.nice.org.uk/page.aspx?o=278604.
NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
National Institute for Health and Clinical Excellence (NICE)
MidCity Place
71 High Holborn
London WC1V 6NA
UK
http://www.nice.org.uk