Formulary Group Decisions October 2011


Not approved for use in NHS Grampian

 
In the absence of a submission from the holder of the marketing authorisation.
Bromfenac (Yellox®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product eye drops
Eye BNF 11
Bromfenac (Yellox®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product eye drops are not recommended for use within NHS Scotland.
Indication: treatment of postoperative ocular inflammation following cataract extraction in adults.
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 NHSScotland [ Link opens in new windowSMC 740/11].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
Conestat alfa (Ruconest®)
Antihistamines hyposensitisation and allergic emergencies BNF 3.4
Conestat alfa (Ruconest®) is not recommended for use within NHS Scotland.
Indication: treatment of acute angioedema attacks in adults with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency.
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 NHSScotland [ Link opens in new windowSMC 745/11].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
Eribulin (Halaven®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs BNF 8.1.5
Eribulin (Halaven®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: eribulin monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.  Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
In a randomised, phase III, open-label study eribulin-treated patients had 2.5 months additional survival compared to the comparator, treatment of physicians choice, which included a range of single agent chemotherapy treatments.
The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC [ Link opens in new windowSMC 726/11].
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.
Drugs affecting the immune response, cytokine modulators BNF 1.5.3
Infliximab (Remicade®) is not recommended for use within NHS Scotland.
Indication under review: Treatment of moderately active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
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 [ Link opens in new windowSMC 739/11].
Following NHS Quality Improvement Scotland's endorsement of the National Institute for Health and Clinical Excellence (NICE) multiple technology appraisal guidance No 187, infliximab is recommended as a treatment option in severe active Crohn's disease.
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.
Quetiapine (Seroquel XL®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Antipsychotic drugs, second-generation antipsychotic drugs BNF 4.2.1
Quetiapine (Seroquel XL®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication: Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
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 [ Link opens in new windowSMC 744/11].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
Rosuvastatin (Crestor®)
Lipid-regulating drugs BNF 2.12
Rosuvastatin (Crestor®) is not recommended for use within NHS Scotland (as a second-line treatment option for the primary prevention of cardiovascular events for patients in whom simvastatin is contra-indicated or not tolerated).
Indication under review: Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event as an adjunct to correction of other risk factors.
In a randomised, placebo-controlled, double-blind, multi-centre study, treatment with rosuvastatin was associated with a significantly reduced risk of first cardiovascular event versus placebo in patient sub-groups deemed to be high-risk when assessed using the Framingham equation and the SCORE algorithm.
The submitting company did not present sufficiently robust economic analysis to gain acceptance by SMC [ Link opens in new windowSMC 725/11].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
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