Formulary Group Decisions March 2008
Approved for use in NHS Grampian
Zoledronic acid 5mg solution for infusion (Aclasta®)
Bisphosphonates and other drugs affecting bone metabolism, Bisphosphonates BNF 6.6.2
Zoledronic acid 5mg solution for infusion (Aclasta®) was approved for inclusion in the GJF for treatment of osteoporosis in post-menopausal women at increased risk of fractures. Intravenous zoledronic acid is restricted to use in patients who are unsuitable for or unable to tolerate oral treatment options for osteoporosis. Treatment initiation should be under specialist supervision.
This preparation is licensed for administration once a year and has been shown to reduce the incidence of vertebral and hip fractures over 3 years compared with placebo [
SMC 447/08]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Bisphosphonates and other drugs affecting bone metabolism, Bisphosphonates BNF 6.6.2
Zoledronic acid 5mg solution for infusion (Aclasta®) was approved for inclusion in the GJF for treatment of osteoporosis in post-menopausal women at increased risk of fractures. Intravenous zoledronic acid is restricted to use in patients who are unsuitable for or unable to tolerate oral treatment options for osteoporosis. Treatment initiation should be under specialist supervision.
This preparation is licensed for administration once a year and has been shown to reduce the incidence of vertebral and hip fractures over 3 years compared with placebo [
SMC 447/08]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.Infliximab intravenous infusion (Remicade®)
Chronic bowel disorders, Cytokine modulators BNF 1.5
Infliximab intravenous infusion (Remicade®) was approved for inclusion in the GJF for the treatment of severe, active Crohn's disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contra-indications for such therapies.
In an open label study 88% of patients had a clinical response following the induction regimen and this was maintained at one year in significantly more patients receiving infliximab every 8 weeks compared with every 12 weeks [SMC 448/08]. Available for restricted use under specialist supervision, licensed for hospital use only.
Chronic bowel disorders, Cytokine modulators BNF 1.5
Infliximab intravenous infusion (Remicade®) was approved for inclusion in the GJF for the treatment of severe, active Crohn's disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contra-indications for such therapies.
In an open label study 88% of patients had a clinical response following the induction regimen and this was maintained at one year in significantly more patients receiving infliximab every 8 weeks compared with every 12 weeks [
SMC 448/08]. Available for restricted use under specialist supervision, licensed for hospital use only.
Not approved for use in NHS Grampian
Maraviroc tablets (Celsentri®)
HIV infection BNF 5.3.1
Maraviroc tablets (Celsentri®) as 150 mg and 300mg tablets is not recommended for use within NHS Scotland in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. When added to optimised background therapy, maraviroc was associated with a significant reduction in viral load compared with addition of placebo in heavily pre-treated patients. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by [SMC 458/08].
HIV infection BNF 5.3.1
Maraviroc tablets (Celsentri®) as 150 mg and 300mg tablets is not recommended for use within NHS Scotland in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. When added to optimised background therapy, maraviroc was associated with a significant reduction in viral load compared with addition of placebo in heavily pre-treated patients. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by [
SMC 458/08]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Paliperidone tablets m/r (Invega®)
Antipsychotic drugs, Atypical antipsychotics BNF 4.2.1
Paliperidone tablets m/r (Invega®) is not recommended for use within NHS Scotland for the treatment of schizophrenia.
Paliperidone has been shown to be superior to placebo in reducing symptoms of schizophrenia. However, there are limited statistical comparative data versus other atypical antipsychotics.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by [SMC 453/08].
Antipsychotic drugs, Atypical antipsychotics BNF 4.2.1
Paliperidone tablets m/r (Invega®) is not recommended for use within NHS Scotland for the treatment of schizophrenia.
Paliperidone has been shown to be superior to placebo in reducing symptoms of schizophrenia. However, there are limited statistical comparative data versus other atypical antipsychotics.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by [
SMC 453/08].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Retapamulin 1% ointment (Altabax®)
Antibacterial preparations BNF 13.10.1
Retapamulin 1% ointment (Altabax®) is not recommended for use within NHSScotland for the short term treatment of the following superficial skin infections: Impetigo and infected small lacerations, abrasions, or sutured wounds. 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 [SMC 472/08].
Antibacterial preparations BNF 13.10.1
Retapamulin 1% ointment (Altabax®) is not recommended for use within NHSScotland for the short term treatment of the following superficial skin infections: Impetigo and infected small lacerations, abrasions, or sutured wounds. 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 [
SMC 472/08].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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