Issued: 28th March 2002
PRESS RELEASE
NICE recommends the selective use of rituximab for follicular non-Hodgkin's lymphomaThe National Institute for Clinical Excellence has recommended the use of rituximab (MabThera) for some patients with follicular non-Hodgkin's lymphoma (NHL).
Rituximab is recommended for the treatment of stage 3 or 4 follicular NHL when a patient is considered to be unsuitable for conventional chemotherapy treatment ('last-line treatment'). A record of each patient treated and how they have responded should be kept to help obtain more information on how well this drug works.
Rituximab is not recommended for patients with stage 3 or 4 follicular NHL for whom otherconventional chemotherapy treatments are still available.
Andrew Dillon, Chief Executive of NICE said, "Rituximab is an important addition to the treatment options available to people for people with follicular non-Hodgkin's lymphoma. Our guidance will help ensure consistency in its use across the NHS in England and Wales."
Ends
Notes for Editors
Follicular NHL
1. Non-Hodgkin's lymphomas (NHLs) are cancers that affect the lymphatic system and lymph nodes. The lymphatic system is a network of vessels in the body that carry fluid called lymph from tissues (for example skin and muscle) into the blood stream. At various points in the lymphatic system there are lymph nodes that act as filters to prevent foreign particles in the lymph entering the bloodstream. Follicular lymphomas are a type of NHL.
2. NHL is graded using systems that help doctors to identify how far the cancer has developed. The guidance issued by NICE applies to follicular NHLs that are stage 3 or 4. Stage 3 is when the cancer affects the lymph nodes on both sides of the body and stage 4 is when the cancer has spread throughout the body.
3. Every year about 9000 people are diagnosed with NHL in the UK. This represents about 2% of people who have cancer. NHL is slightly more common in men than women and is more common in people over the age of 75. It is estimated that between 22% and 40% of people with NHL have follicular lymphoma. Most people with follicular NHL are diagnosed when they are in stage 3 or 4 of the disease, because there are often no symptoms at earlier stages of the disease. It is not known what causes NHL.
4. The treatment given for follicular NHL depends on when the disease is diagnosed. In the early stages of the disease, treatment known as 'watchful waiting' is often used, during which the condition is carefully monitored for any change. As the disease progresses, or if diagnosis is made at a later stage, it can be treated with a series of chemotherapy drugs.
Rituximab
5. Rituximab (MabThera, produced by Roche) is an antibody that targets cancer cells in the lymphatic system. Rituximab is licensed for patients with stage 3-4 follicular lymphoma for whom chemotherapy hasn't worked or who are in relapse for a second or subsequent time after chemotherapy.
6. Rituximab is given by infusion - that is through an intravenous drip - on days 1, 8, 15, and 22 of treatment. A second course of rituximab may sometimes be given to patients who have responded to a first course of treatment.
7. The side effects of rituximab are very different from those of most forms of chemotherapy. 9 out of 10 patients experience some side effects, but these are usually mild to moderate. The most common side effects are mild fevers and chills that are short-lived and usually happen when the drug is first given.
8. The cost of the drug for the course described above is about £4,900. The combined cost of administering the drug, of associated tests and of treating adverse events has been estimated to be up to about £1,600, but may be less in clinical practice.
9. The cost to the NHS of implementing the will depend on the number of patients in, and funding arrangements for, the case series.
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 28th 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 an appeal by consultees. Some aspect s of this appeal were upheld and the Appraisal Committee was asked by the appeal panel to reconsider the evidence submitted. Full details of the appeal can be found on the NICE website at www.nice.org.uk
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.
