Formulary Group Decisions March 2010


Not approved for use in NHS Grampian

Azacitidine injection (Vidaza®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Antimetabolites BNF 8.1.3
Azacitidine injection (Vidaza®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product  is not recommended for use within NHS Scotland.
Licensed indication under review: 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).
Azacitidine therapy produced a significant increase in overall survival compared with conventional care regimens in previously untreated higher-risk MDS patients [ Link opens in new windowSMC 589/09].
However, the manufacturer did not present a sufficiently robust economic analysis and their justification for the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.

Everolimus tablets (Afinitor®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Everolimus tablets (Afinitor®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product  is not recommended for use within NHS Scotland.
Licensed indication under review: the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
Everolimus, in conjunction with best supportive care (BSC), increased median progression-free survival (PFS) by three months compared with placebo plus BSC in heavily pre-treated patients with metastatic renal cell carcinoma [ Link opens in new windowSMC 595/10].
However, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.  The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.

In the absence of a submission from the holder of the marketing authorisation.
Temsirolimus Concentrate for intravenous infusion (Torisel®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Temsirolimus Concentrate for intravenous infusion (Torisel®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product  is not recommended for use within NHS Scotland.
Licensed indication under review: the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [ Link opens in new windowSMC 617/10].
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHS Scotland.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.