NICE 2001/ 031
Issued: 25 Sept. 2001
Press release
The National Institute for Clinical Excellence has today issued guidance on the use of fludarabine for leukaemia and taxanes for breast cancer to the NHS in England and Wales.
Treatment of people with cancer is one of the key priorities for the NHS and the Institute has been asked to provide guidance on a range of anti-cancer drugs and other aspects of clinical practice. In each appraisal NICE involves the groups that represent people with the cancer, the health professionals responsible for their care and the manufacturers of the technology.
Over the past few months NICE has provided guidance on treatments for ovarian, breast, colorectal, brain, pancreatic, and lung cancer. Further guidance on new technologies for colorectal, breast and ovarian cancer together with drugs for leukaemia and lymphoma is expected in the future.
Andrew Dillon, the Institute's Chief Executive, said, "The guidance issued today is another step towards providing the people in England and Wales with uniform access to medicines that have proven of value in the management of cancer. As the guidance is written for people with cancer as well as health professionals, it will help them with the decisions they need to make about their treatment."
On Fludarabine Mr Dillon added, "fludarabine is a relatively new treatment available as tablets or as an injection. Our guidance indicates that people with B-cell chronic lymphocytic leukaemia who have had to stop their first chemotherapy treatment, for example because it was causing side effects or their disease had progressed, should consider treatment with fludarabine. Tablets, rather than injection is the preferred method of taking the drug. 7 out of 10 people with this type of cancer are over 60 and chemotherapy means taking medication every day for a number of days and repeating this every month for around 6 months. The tablets allow people to take their medication at home, rather than making daily trips to hospital and spending time in bed receiving an infusion. Obviously this has advantages for both the person with the cancer, and for the NHS."
On the topic of Taxanes for breast cancer Mr Dillon said "NICE is committed to reviewing each of its guidance at intervals varying from one to three years. We have now reviewed our guidance on the use of taxanes for breast cancer. The review again involved the national groups that represent women with breast cancer, the health professionals who treat them and the manufacturers. The guidance we have issued today on the use of taxanes for breast cancer replaces that we issued in June 2000. We have appraised all the evidence, including new evidence on the use of docetaxel in combination with doxorubicin for the treatment of advanced or metastatic breast cancer in patients who have not previously had cytotoxic therapy. The new evidence has not caused us to change our original guidance and therefore that advice stands. Women with advanced breast cancer will continue to benefit from these drugs"
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Notes for Editors
Background - Cancer
| 1. | 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. |
| 2. |
The type of treatment given for a cancer depends on many factors. These include:
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| 3. | Chemotherapy is the use of anti-cancer drugs to destroy cancer cells. Chemotherapy may be used on its own to treat cancer or it may be used with other drugs, with surgery and/or with radiotherapy. |
| Taxanes for Breast cancer | |
| 4. | The taxanes are a type of anti-cancer drugs known as cytotoxic drugs and they are used during chemotherapy. |
| 5. | There are two taxane drugs available in the UK, docetaxel (Taxotere) and paclitaxel (Taxol). They both cost about £1,500 per course of treatment and each patient may need up to six courses. |
| 6. | Docetaxel in combination with doxorubicin has recently been licensed in the UK for the treatment of advanced or metastatic breast cancer in patients who have not previously had cytotoxic therapy. New evidence on this treatment was considered during the appraisal but was insufficiently robust to justify a change in the Institute's guidance. |
| 7. |
NICE guidance states:
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| 8. |
The decision as to which product should be used should be taken by the responsible clinician in discussion with the patient. During this discussion they should take into account the following randomised controlled trial (RCT) evidence for the use of the taxanes in advanced breast cancer which shows improved initial response to the treatment and an increase in the time before the disease progresses:
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| 9. | In June 2000 the guidance estimated the cost of taxanes to treat advanced breast cancer would cost the NHS around £20m each year. As the guidance remains the same there is no additional cost to the NHS. |
| Fludarabine for chronic lymphocytic leukaemia | |
| 10. | Chronic lymphocytic leukaemia (CLL) is cancer of the white blood cells (lymphocytes). People with CLL have abnormal white blood cells that prevent the red blood cells, the normal white blood cells and the platelets (particles that have a role in the clotting of blood) from working properly. This can stop the blood from clotting, cause anaemia (lack of iron in the blood) and expose people with CLL to infections. |
| 11. | CLL is the most common form of leukaemia. It affects mainly older people - about 7 out of 10 people diagnosed with CLL are over the age of 60. Twice as many men as women are affected. The length of time people live with CLL depends on how far the disease has progressed when it is first diagnosed. |
| 12. | Treatments for CLL vary depending on the stage of the disease. For people at an early stage, there is no evidence that treatment with drugs has any benefits and may cause harm. Initial treatment is usually 'watchful waiting', during which the condition is carefully monitored for any change. If the disease progresses, or if diagnosis is made at a later stage, a series of treatments using combinations of chemotherapy drugs are available. These treatments can themselves sometimes cause harm to the person taking them. Doctors and patients will therefore discuss the benefits and the possible disadvantages of treatment before starting. |
| 13. | Fludarabine is a chemotherapy drug. It works by preventing cancer cells reproducing and can therefore slow down the progression of the disease. It can be given either by a drip or by tablet. This treatment is given every day for 5 days and is called a 'treatment cycle'. The treatment cycle is then repeated every 28 days for up to 6 cycles. If the drug is given by a drip, then the person with CLL usually has to visit hospital on each day of the cycle. If it is given as a tablet then the person with CLL may need to visit the hospital less often. |
| 14. | Side effects of fludarabine include nausea (feeling sick), vomiting and hair loss. There can also be some more severe long-term side effects relating to the blood and ability to fight infection. |
| 15. |
NICE has recommended to the NHS that
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| Previous cancer guidance | |
| 16. |
NICE has issued guidance on the following technologies for cancer. All guidance documents are available from the NICE web site. (www.nice.org.uk either visit the completed appraisals section of technology appraisals, or use the search engine (top right hand side of the NICE screen) to find all the documents, including press releases on the topic you are seeking). • Breast cancer - taxanes (paclitaxel and docetaxel) |
| 17. | Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from midday on Tuesday 25th September 2001. |
| 18. | 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. |
| 19. | 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. |
| 20. | NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. NICE 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. |
| 21. | Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. |
| 22. | 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, NICE will produce audit tools for use in the clinical setting. |
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