540 09 rituximab (MabThera)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Tuesday) accepted the following new drugs for use within NHSScotland:
- Rituximab (MabThera) is accepted for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide (restricted).
Further Details:
RITUXIMAB (MABTHERA)
- Rituximab (MabThera) is accepted for restricted use within NHSScotland for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide.
- Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in practice. Evidence in patients over 70 years of age is limited.
- Rituximab is restricted to use by specialists in haematology and haemato-oncology.
- The manufacturer estimated the budget impact of rituximab would be £1.57m in year 1 rising to £1.59m in year 5 based on 118 and 120 patients treated respectively. These figures were based on the number of patients who receive first-line treatment who are eligible for rituximab combination therapy.
Notes for editors – Glossary:
- Chronic lymphocytic leukaemia (CLL) – Chronic lymphocytic leukaemia (CLL) is a cancer of the lymphocytes. It is the most common type of leukaemia. In CLL, the lymphocytes multiply too quickly and live too long, so there are too many of them circulating in the blood. Over a period of time the abnormal cells replace the normal white cells, red cells and platelets in the bone marrow.
Notes for editors – About SMC:
1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.
4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation 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.
For further information, contact Stephen Ferguson on 07779 329 689.