NICE recommends trastuzumab (Herceptin) for advanced breast cancer

PRESS RELEASE
NICE recommends trastuzumab (Herceptin) for advanced breast cancer
The National Institute for Clinical Excellence has today issued guidance to the NHS in England and Wales on trastuzumab (Herceptin) for women with advanced breast cancer.

NICE has recommended that trastuzumab be available for women with HER2 positive advanced breast cancer either:

in combination with paclitaxel for women whose HER2 protein is measured as 3+.who have not had chemotherapy and for whom anthracycline treatment is not appropriate.

or on its own for women with breast cancer and HER2 levels of 3+ who have had at least two chemotherapy treatments for metastatic breast cancer. Previous chemotherapy must have included at least an anthracycline drug and a Taxane drug where these treatments are appropriate. It should also have included hormonal therapy in patients sensitive to oestrogen.

The Institute's Communications Director and Executive Lead for this appraisal, Anne-Toni Rodgers, said: "Today's guidance represents a major step forward for women with HER2 positive metastatic breast cancer. In summary these women have a protein on the surface their cancer cells, which means that their cancer is particularly fast growing. Today's guidance makes clear to the NHS that this drug is a clinically and cost effective treatment for such women and that it should be available across England and Wales.

"NICE appraisals have no fixed timescales as the process allows for appeals and extensions should specific evidence be required by the Independent Appraisal Committee that advises us. As we are a transparent organisation we always make available the earliest date that publication of our final guidance could occur should there be no appeals.

"The earliest the guidance on trastuzumab could have been available was December 2001. I am aware that concerns have been expressed that the Institute extended the timelines for this piece of work. I would like to be clear that NICE does not take such decisions lightly. This extension followed consultation with those patients, professionals and manufacturers involved in the appraisal. Feedback from this consultation suggested that there was additional evidence that could impact on the final decision. We felt it right that we allow the independent Committee that advises NICE the time it needed to analyse and consider this evidence before they gave us their final advice. We would obviously have liked to be in a position to issue the guidance earlier, but to ignore this evidence could have resulted in less robust advice which may not have reflected the true value of Herceptin to the NHS and patients.

"Finally NICE is a relatively new organisation and when we opened our doors there was a backlog of drugs and technologies waiting to be appraised. Many of these drugs were on sale before NICE was established and were subject to so called post code prescribing. The Department of Health asked NICE to look at these drugs because the NHS wanted clear guidance as to their value for patients. We have made it clear that in the future we would like to see more drugs and technologies referred to us at an earlier stage of their development as this would ensure that our guidance could be available to the NHS and patients shortly after the UK launch".

Ends

Notes for editors

1. HER2 levels should be measured using validated techniques and in accordance with published guidelines. NICE have recommended that laboratories offering these tests should participate in and demonstrate satisfactory performance in a recognised external quality assurance scheme

2. Cancer is a disease of the body's cells. Normally, all cells divide and reproduce themselves in an orderly and controlled manner. In cancer, the cells multiply without proper control and grow into a lump (which is called a tumour).

3. Approximately 32,000 new cases of breast cancer were reported in England and Wales in 1996. In 1998, breast cancer caused over 11,000 deaths in England and Wales and was the leading cause of death in women aged 35 to 54 years.

4. Between 16 20 percent of women diagnosed with breast cancer have metastatic disease . Around half of the women who are diagnosed with localised breast cancer will eventually develop metastatic cancer. It is called metastatic breast cancer if the cancer cells have spread to other parts of the body.

5. Some breast cancer involves a naturally produced protein in the body (called the epidermal growth factor). This protein attaches itself to another protein called HER2, which is found on the surface of the breast cancer cell. When combined they stimulate the cancer cells to multiply.

6. Approximately 15 to 20% of women with metastatic breast cancer over express HER2 at the 3+ level. The average period of survival after diagnosis with metastatic breast cancer is 18-24 months but this is reduced by up to 50% for those over expressing HER2.

7. Trastuzumab is a drug that specifically targets the HER2 protein. It attaches itself to the HER2 protein and prevents the protein that encourages cancer cell growth from reaching the cancer cell. It can be used on its own or in combination with another drug called paclitaxel. Patients who receive treatment with trastuzumab should be monitored for the possibility of cardiotoxicity.

8. These drugs are not a cure for breast cancer but the evidence is clear that they can extend life. The Appraisal Committee considered that a survival gain of approximately 10 months used in the economic evaluation was likely to be an underestimate of the true survival gain attributable to combination therapy.

9. The cost of implementing this guidance in England and Wales is estimated at £17 million.

Information on NICE

10. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from midday on 15th March 2002.

11. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

12. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.

13. The timeline for this appraisal was extended following consultation with consultees who asked for additional clinical data to be considered by the Committee. It was not possible to fully consider this evidence within the original schedule and the appraisal was therefore extended.

14. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.

15. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.