Formulary Group Decisions January 2009
Approved for use in NHS Grampian
Bevacizumab solution for intravitreal injection
Miscellaneous ophthalmic preparations BNF 11.8
Bevacizumab (solution for intravitreal injection) [unlicensed indication] was approved for inclusion in the GJF for restricted use for the treatment of CNV due to myopia, angioid streaks or inflammation. Available for restricted use for intravitreal injection only; administered by ophthalmologists experienced in intravitreal injections, hospital use only. Use should be documented by robust ongoing audit or be part of a research programme.
Miscellaneous ophthalmic preparations BNF 11.8
Bevacizumab (solution for intravitreal injection)
[unlicensed indication] was approved for inclusion in the GJF for restricted use for the treatment of CNV due to myopia, angioid streaks or inflammation. Available for restricted use for intravitreal injection only; administered by ophthalmologists experienced in intravitreal injections, hospital use only. Use should be documented by robust ongoing audit or be part of a research programme.Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Anidulafungin intravenous infusion (Ecalta®)
Antifungal drugs BNF 5.2
Anidulafungin intravenous infusion (Ecalta®)
is accepted for restricted use within NHS Scotland for the treatment of invasive candidiasis in adult non-neutropenic patients.
Anidulafungin has been shown to be at least as effective as an alternative antifungal in a study of patients, the majority of whom had candidaemia. Its use is restricted to patients who are unable to tolerate fluconazole or have invasive candidiasis that is resistant to fluconazole.
is accepted for restricted use within NHS Scotland for the treatment of invasive candidiasis in adult non-neutropenic patients.
Anidulafungin has been shown to be at least as effective as an alternative antifungal in a study of patients, the majority of whom had candidaemia. Its use is restricted to patients who are unable to tolerate fluconazole or have invasive candidiasis that is resistant to fluconazole.
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Etonogestrel/ethinylestradiol vaginal ring (NuvaRing®)
Combined hormonal contraceptives BNF 7.3.1
Etonogestrel/ethinylestradiol vaginal ring (NuvaRing®) is not recommended for use within NHS Scotland for contraception [
SMC 502/08]
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Combined hormonal contraceptives BNF 7.3.1
Etonogestrel/ethinylestradiol vaginal ring (NuvaRing®) is not recommended for use within NHS Scotland for contraception [
SMC 502/08]
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Etravirine tablets (Intelence®)
HIV infection, Non-nucleoside reverse transcriptase inhibitors BNF 5.3.1
Etravirine tablets (Intelence®) in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is not recommended for use within NHS Scotland for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients [
SMC 530/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
HIV infection, Non-nucleoside reverse transcriptase inhibitors BNF 5.3.1
Etravirine tablets (Intelence®)
in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is not recommended for use within NHS Scotland for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients [
SMC 530/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Extended-release epidural morphine suspension for injection (Depodur®)
Opioid analgesics BNF 4.7.2
Extended-release epidural morphine suspension for injection (Depodur®) is not recommended for use within NHS Scotland for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.
Extended-release epidural morphine has shown some advantages in terms of efficacy versus a single-dose of epidural opioid. Evidence for clinical efficacy was obtained from studies that do not reflect current practice for epidural analgesia in NHS Scotland. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by the SMC [SMC 528/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Opioid analgesics BNF 4.7.2
Extended-release epidural morphine suspension for injection (Depodur®) is not recommended for use within NHS Scotland for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.
Extended-release epidural morphine has shown some advantages in terms of efficacy versus a single-dose of epidural opioid. Evidence for clinical efficacy was obtained from studies that do not reflect current practice for epidural analgesia in NHS Scotland. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by the SMC [
SMC 528/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Lapatinib tablets (Tyverb®)
Other antineoplastic drugs BNF 8.1.5
Lapatinib tablets (Tyverb®) is not recommended for use within NHS Scotland, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have progressive disease following prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
In a randomised open-label study the median time to progression for lapatinib plus capecitabine was significantly longer than for capecitabine monotherapy. There was no significant difference in overall survival.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC and, in addition, the justification of the treatment's cost in relation to its health benefits was not sufficient [SMC 526/09].
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
Lapatinib tablets (Tyverb®)
is not recommended for use within NHS Scotland, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2) and who have progressive disease following prior therapy including anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.
In a randomised open-label study the median time to progression for lapatinib plus capecitabine was significantly longer than for capecitabine monotherapy. There was no significant difference in overall survival.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC and, in addition, the justification of the treatment's cost in relation to its health benefits was not sufficient [
SMC 526/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Pemetrexed injection (Alimta®)
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®) in combination with cisplatin, is not recommended for use within NHS Scotland for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology.
In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin to another platinum-based combination regimen, treatment with pemetrexed plus cisplatin resulted in a small improvement in median survival in patients with a non-squamous histology.
Pemetrexed plus cisplatin provided better tolerability and more convenient administration.
The manufacturer did not present a sufficiently robust economics case to gain acceptance by SMC [SMC 531/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®)
in combination with cisplatin, is not recommended for use within NHS Scotland for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology.
In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin to another platinum-based combination regimen, treatment with pemetrexed plus cisplatin resulted in a small improvement in median survival in patients with a non-squamous histology.
Pemetrexed plus cisplatin provided better tolerability and more convenient administration.
The manufacturer did not present a sufficiently robust economics case to gain acceptance by SMC [
SMC 531/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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