azacitidine 100mg powder for suspension for injection (Vidaza)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) did not accept the following new drug for use within NHSScotland:
- Azacitidine (Vidaza) for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML). The manufacturer did not present a sufficiently robust economic analysis and their justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
Notes for editors – Glossary:
Haematopoietic stem cell transplantation (SCT) – Medical procedure that involves transplantation of hematopoietic stem cells. It is most often performed for people with diseases of the blood or bone marrow, or certain types of cancer.
Myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML) – MDS, CMML and AML are all conditions affecting the bone marrow which interfere with its ability to make healthy blood cells. MDS comprises a varied group of blood disorders characterised by a reduction in the number of blood cells, complications of infection and bleeding, and a risk of progressing to AML. AML is a form of cancer that affects early myeloid cells which are not mature and accumulate in the bone marrow, and interfere with the production of red blood cells, platelets and white blood cells. AML is the most common type of leukaemia affecting adults and its incidence increases after 40 years of age. CMML is a rare blood cancer that occurs in later life with age of onset being 70 years, and is characterised by high numbers of white blood cells called monocytes.
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.