Formulary Group Decisions June 2010
Approved for use in NHS Grampian
Actichlor Plus tablets
Actichlor Plus tablets was approved for use for environmental disinfection and disinfection of equipment for patients in isolation due to suspected or confirmed Norovirus or Clostridium difficile Infection (CDI) and to decontaminate blood spillages. Available for general use, recommended for hospital use only.
Actichlor Plus tablets was approved for use for environmental disinfection and disinfection of equipment for patients in isolation due to suspected or confirmed Norovirus or Clostridium difficile Infection (CDI) and to decontaminate blood spillages. Available for general use, recommended for hospital use only.
Carvedilol tablets
Beta-adrenoceptor blocking drugs BNF 2.4
Carvedilol tablets was approved for restricted off-label use for prophylaxis against variceal bleeding in patients with portal hypertension. Available for restricted use under specialist supervision and treatment to be initiated in hospital prior to handover. Use is restricted to initiation by gastroenterologists.
Beta-adrenoceptor blocking drugs BNF 2.4
Carvedilol tablets was approved for restricted off-label use for prophylaxis against variceal bleeding in patients with portal hypertension. Available for restricted use under specialist supervision and treatment to be initiated in hospital prior to handover. Use is restricted to initiation by gastroenterologists.
Systane®, eye drops and single-use eye drops
Tear deficiency, ocular lubricants, and astringents BNF 11.8.1
Systane®, eye drops and single-use eye drops, was approved for inclusion in the Grampian Joint Formulary for the treatment of dry eyes following failure of therapy with first-line agents. Available for general use, treatment may be initiated in either hospital or community.
Tear deficiency, ocular lubricants, and astringents BNF 11.8.1
Systane®, eye drops and single-use eye drops, was approved for inclusion in the Grampian Joint Formulary for the treatment of dry eyes following failure of therapy with first-line agents. Available for general use, treatment may be initiated in either hospital or community.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Epoetin alfa (Binocrit®)
Drugs used in hypoplastic, haemolytic, and renal anaemias BNF 9.1.3
Epoetin alfa (Binocrit®)
is accepted for use within NHS Scotland for:
Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients:
is accepted for use within NHS Scotland for:
Treatment of symptomatic anaemia associated with chronic renal failure in adult and paediatric patients:
- treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
- treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.
Epoetin alfa (Binocrit®)
is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference product (epoetin alfa (Eprex®)). Unlike some other erythropoiesis-stimulating agents, Binocrit® is only licensed for administration by the intravenous route in the indications under review. The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.
is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference product (epoetin alfa (Eprex®)). Unlike some other erythropoiesis-stimulating agents, Binocrit® is only licensed for administration by the intravenous route in the indications under review. The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Corifollitropin alfa (Elonva®)
Other endocrine drugs BNF 6.7
Corifollitropin alfa (Elonva®) is not recommended for use within NHS Scotland for the treatment of Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) programme.
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.
Corifollitropin alfa (Elonva®)
Other endocrine drugs BNF 6.7
Corifollitropin alfa (Elonva®)
is not recommended for use within NHS Scotland for the treatment of Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) programme.
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.
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Miglustat capsules (Zavesca®)
Drugs used in metabolic disorders BNF 9.8.1
Miglustat capsules (Zavesca®) is not recommended for use within NHS Scotland for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.
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.
Miglustat capsules (Zavesca®)
Drugs used in metabolic disorders BNF 9.8.1
Miglustat capsules (Zavesca®)
is not recommended for use within NHS Scotland for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease.
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.
ADVICE: following a re-submission
Lapatinib (Tyverb®)
Other antineoplastic drugs BNF 8.1.5
Lapatinib tablets (Tyverb®) is not recommended for use within NHS Scotland.
Indication under review: in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours over-express ErbB2 (HER2) and who have progressive disease following prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Lapatinib (Tyverb®)
Other antineoplastic drugs BNF 8.1.5
Lapatinib tablets (Tyverb®)
is not recommended for use within NHS Scotland.
Indication under review: in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours over-express ErbB2 (HER2) and who have progressive disease following prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Mifamurtide (Mepact®)
Malignant disease and immunosuppression BNF 8
Mifamurtide (Mepact®) is not recommended for use within NHS Scotland.
Licensed indication under review: in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.
Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.
Mifamurtide has been shown to increase overall survival compared to multi-agent chemotherapy alone in patients under 30 years with newly-diagnosed resectable osteosarcoma.
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 analysis.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Malignant disease and immunosuppression BNF 8
Mifamurtide (Mepact®)
is not recommended for use within NHS Scotland.
Licensed indication under review: in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.
Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.
Mifamurtide has been shown to increase overall survival compared to multi-agent chemotherapy alone in patients under 30 years with newly-diagnosed resectable osteosarcoma.
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 analysis.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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