454 08 nelarabine (Atriance)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- nelarabine (Atriance) for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) (restricted)
Further Details:
NELARABINE (ATRIANCE)
- Nelarabine (Atriance) is accepted for restricted use for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens.
- It is restricted to patients in whom nelarabine is being used as a treatment to bridge to stem cell transplant and restricted to use by specialists in haemato-oncology. It is not cost-effective when used for palliation.
- The manufacturer estimated that in year one the budget impact would range from £72k to £107k, depending on the response to treatment. By year five, the budget impact would have increased to £362k or £535k depending on treatment response. Acceptance for restricted use means that the budget impact is likely to be less than the estimate. Lower supportive care costs may also affect some of the costs.
Notes for editors – Glossary:
1. T-cell acute lymphoblastic leukaemia (T-ALL) – A form of cancer of the bone marrow where white cells called lymphoblasts are found in unnaturally large numbers within the blood.
2. T-cell lymphoblastic lymphoma (T-LBL) – A type of cancer that starts in the lymphocytes, a type of white blood cell found within the immune system.
3. Stem cell transplant - This procedure gives cancer patients an intensive high dose of chemotherapy (and sometimes radiotherapy) to kill cancer cells. Also, the process gives healthy stem cells to the patient to help fight the cancerous cells.
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 or Colin McAllister on 07813 095930