Formulary Group Decisions August 2010
Approved for use in NHS Grampian
LAT gel (lidocaine, adrenaline and tetracaine) - unlicensed product
Local anaesthesia BNF 15.2
LAT gel (lidocaine, adrenaline and tetracaine) was approved for restricted use as procedural analgesia in children, e.g. wound debridement, and repair. Unlicensed product restricted to use in RACH emergency department, recommended for hospital use only.
Local anaesthesia BNF 15.2
LAT gel (lidocaine, adrenaline and tetracaine) was approved for restricted use as procedural analgesia in children, e.g. wound debridement, and repair. Unlicensed product restricted to use in RACH emergency department, recommended for hospital use only.
Tinzaparin injection 10,000IU/mL (pre-filled syringe, Innohep®)
Parenteral anticoagulants BNF 2.8.1
Tinzaparin injection 10,000IU/mL (pre-filled syringe, Innohep®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the prevention of clotting in extra-corporeal circuits during chronic haemodialysis for adult patients only. Available for restricted use under specialist supervision, licensed for hospital use only.
Parenteral anticoagulants BNF 2.8.1
Tinzaparin injection 10,000IU/mL (pre-filled syringe, Innohep®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the prevention of clotting in extra-corporeal circuits during chronic haemodialysis for adult patients only. Available for restricted use under specialist supervision, licensed for hospital use only.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Paclitaxel albumin concentrate for intravenous infusion (Abraxane®)
Other antineoplastic drugs BNF 8.1.5
Paclitaxel albumin concentrate for intravenous infusion (Abraxane®) for restricted use for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated. SMC restriction: Use is restricted to patients who would otherwise receive docetaxel or 3-weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer.
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication
Not approved for use in NHS Grampian
Agomelatine tablets (Valdoxan®)
Other antidepressant drugs BNF 4.3.4
Agomelatine tablets (Valdoxan®) is not recommended for use within NHS Scotland [
SMC 564/09].
Indication under review: Treatment of major depressive episodes in adults.
When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome.
The manufacturer did not present a sufficiently robust economic analysis 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.
Other antidepressant drugs BNF 4.3.4
Agomelatine tablets (Valdoxan®)
is not recommended for use within NHS Scotland [
SMC 564/09].
Indication under review: Treatment of major depressive episodes in adults.
When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome.
The manufacturer did not present a sufficiently robust economic analysis 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.
Trabectedin injection (Yondelis®)
Other antineoplastic drugs BNF 8.1.5
Trabectedin injection (Yondelis®) is not recommended for use within NHS Scotland [
SMC 634/10].
Indication under review: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease.
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case 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.
Other antineoplastic drugs BNF 8.1.5
Trabectedin injection (Yondelis®)
is not recommended for use within NHS Scotland [
SMC 634/10].
Indication under review: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease.
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case 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.
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