2001/13 NICE issues Guidance on Temozolomide for Brain Cancer

Press Release

NICE 2001/013 Issued: 27 April 2001

The National Institute for Clinical Excellence has today advised the NHS in England and Wales, that the drug temozolomide may be offered as second line chemotherapy treatment for patients suffering from recurrent malignant glioma (brain cancer) in the following circumstances:

• They have a tumour that it has been shown to be malignant through microscopic examination of the tumour cell.

• Imaging tests have shown that the tumour has re-occurred or is progressing.

• They have a Karnofsky performance status greater than or equal to 70. (Karnofsky is a measure given by a health professional to a patient's ability to perform certain ordinary tasks).

• It is expected that they will live for 12 weeks or more, at the start of the temozolomide treatment.

Temozolomide is only recommended as the initial chemotherapy treatment for patients with brain cancer when they are taking part in a clinical trial.

Anne-Toni Rodgers, (a Director or NICE and Executive Lead for this appraisal), said, "Around 600 people per year with recurrent brain cancer (malignant glioma) receive chemotherapy. For some of these people this 'first line' chemotherapy fails. The guidance today means that for those people whose chemotherapy has failed and whose condition allows it, temozolomide should be available. This means that around 150 people per year will have this option"

Notes for Editors

Background

1. Malignant glioma is the most common form of brain tumour. In England and Wales it affects about 4 people in 100,000 and there are about 3,500 new cases in the UK each year. Brain tumours account for only 2 in 100 cancer deaths. Just over halve the first time brain cancers occur in men. Around 29 out of 100 adults with this type of cancer survive one year after diagnosis and 13 out of 100 survive 5 years.

2. Symptoms may be general and others may be specific to the area of brain where the tumour is located. General symptoms include headache, loss of appetite, feeling sick, vomiting, seizures, drowsiness, personality changes, and a slowing down of mental processes such as knowing, thinking, learning and making judgements. More specific symptoms could include difficulties with hearing, speech, walking, dexterity, seeing difficulties, and mood disturbances.

3. Treatment of malignant glioma varies from country to country. In the UK, about 3 out of 10 people with brain cancer receive only supportive care with steroids, with or without anticonvulsants.

4. More intensive treatment is offered to patients with less severe disability. The tumour is removed as far as possible, but can usually not be fully removed because the tumour infiltrates surrounding tissues. The remaining tumour tissue undergoes radiotherapy (treatment with radiation therapy).

5. Most (at least 7 out of 10) malignant gliomas recur after initial treatment. Options for further treatment at this stage are limited and offer symptom relief, not a cure for the cancer. Evidence that the tumour is progressing (growing) after this radiation therapy is used as a sign that it may be appropriate to start chemotherapy (this is known as 'first-line' chemotherapy treatment).

6. Chemotherapy treatment options are limited because the currently available agents have only a small chance of being effective. High dose oral procarbazine is often used in combination with lomustine and vincristine as the standard first line chemotherapy. This may be referred to as a PCV regimen. Lomustine is sometimes used alone as first line therapy. The likelihood of response depends on age, tumour type and how well the patient was when they started treatment.

7. Currently about one third of people whose tumour recurs after initial treatment are suitable for first line chemotherapy - about 500 to 600 people per year.

8. As temozolomide is not currently licensed for adjuvant chemotherapy treatment of malignant glioma, its use in this indication has not been considered in this appraisal

The Technology

9. Temozolomide (Temodal) is a chemotherapy treatment which given orally daily for 5 days out of 28. It is toxic to cancer cells because it crosses from the blood supply into the brain where it stops a part of the cancer cell replicating itself. Side effects include nausea, vomiting, fatigue and headache.

Implications for the NHS

10. The current UK price of this drug is £1,176 per 5-day cycle for a daily dose of 340 mg for those who have not had prior chemotherapy, and £934 for those who have.

11. Currently, chemotherapy is used for about 500 to 600 people with recurrent malignant glioma per year. The number of patients for whom first line chemotherapy fails and whose condition will allow sufficient benefit from temozolomide as a second-line therapy is likely to be only a small proportion of these, perhaps 25%. It is therefore assumed that 150 patients per year would be eligible for temozolomide treatment under this guidance. If they were to receive an average of 4 cycles, the incremental cost would be about £6,400 per person. This would amount to about £1 million in aggregate, per year, for the NHS.

General Information

12. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 12pm (lunchtime) on Friday 27th April 2001.

13. 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.

14. 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.

15. 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.

16. NICE appraises new and existing health technologies, as selected by the Department of Health and the National Assembly for Wales and 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.