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L'înformâtion et les sèrvices publyis pouor I'Île dé Jèrri

Trastuzumab (Herceptin) for HER2 - positive early breast cancer

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A decision made (27.02.06) to approve the use of Trastuzumab (Herceptin) for HER2 - positive early breast cancer.

Subject:

Trastuzumab (Herceptin® )for HER2-positive early breast cancer

Decision Reference:

MD-HSS-2006-0012

Exempt clause(s):

-

Type of Report: (oral (O) or written (W))

O

Telephone or email meeting?

-

Person giving

report (if oral):

Dr Graham Prince

Paul McCabe

Written Report title:

-

Name of Author:

-

Date of Report:

3 February 2006

Report File ref:

 

Decision(s):

To approve the use of Trastuzumab (Herceptin®) in accordance with the National Cancer Research Institute (NCRI) “UK Clinical Guidelines for the Use of Adjuvant Trastuzumab (Herceptin®) With or Following Chemotherapy in HER2-positive Early Breast Cancer”.

Reason(s) for decision:

Recent clinical trials have reported considerable therapeutic benefit in early breast cancer and also an early significant survival benefit.

Action required:

Signature:

Date of Decision:

 

 

 

 

 

 

 

Trastuzumab (Herceptin) for HER2 - positive early breast cancer

HEALTH AND SOCIAL SERVICES DEPARTMENT

Supporting Document to Decision Summary

Trastuzumab (Herceptin ® ) for HER2-positive early breast cancer

Oral report to Minister for Health and Social Services by Dr Graham Prince, Chairman of Health and Social Services Drugs and Therapeutics Committee and Paul McCabe, Chief Pharmacist, 3 February 2006.

Decision(s):

To approve the use of trastuzumab (Herceptin®) in accordance with the National Cancer Research Institute (NCRI) “UK Clinical Guidelines for the Use of Adjuvant Trastuzumab (Herceptin®) With or Following Chemotherapy in HER2-positive Early Breast Cancer”

Reason(s) for decision:

Trastuzumab is currently used to treat patients with recurrent HER2-positive breast cancer once standard chemotherapy has failed. It is licensed for this purpose.

Three recent clinical trials using Trastuzumab as adjuvant therapy for early breast cancer have reported considerably therapeutic benefit with around a 50% reduction in the risk of recurrence when Trastuzumab was given in conjunction with or following chemotherapy. The combined results of two of the trials are also showing an early significant survival benefit. Trastuzumab is not currently licensed for use in this way; however, such use is supported by the Health and Social Services Drugs and Therapeutics Committee.

Treatment with Trastuzumab for 12 months in accordance with the NCRI guidelines would cost approximately £20,000 per patient. It is estimated that approximately 5 patients per year would fulfil the criteria for treatment under the NCRI guidelines, representing an annual cost of approximately £100,000.

Paul McCabe

3 February 2006

 

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