Formulary Group Decisions August 2008
Approved for use in NHS Grampian
Adalimumab injection
Chronic bowel disorders, cytokine modulators BNF 1.5
Adalimumab injection
was authorised for restricted use for the treatment of severe, active Crohn's disease, in patients not responding to or relapsing on infliximab. Restricted to prescribing by clinicians experienced in the treatment of Crohn's disease, using strict selection criteria, careful monitoring of response and the maintenance of a patient register. Restricted funding approved by NHS Grampian to support use under strict protocol, hospital use only.
Chronic bowel disorders, cytokine modulators BNF 1.5
Adalimumab injection
Botulinum toxin type A complex injection, powder for reconstitution
Drugs used in essential tremor, chorea, tics, and related disorders BNF 4.9.3
Botulinum toxin type A injection was approved for inclusion in the GJF for restricted off-label use for anal sphincter injection for the treatment of chronic anal fissure in children unresponsive to dietary/laxative/behavioural therapy. Available for restricted use under specialist supervision at the discretion of clinicians experienced in the treatment of chronic anal fissures in children, hospital use only.
Drugs used in essential tremor, chorea, tics, and related disorders BNF 4.9.3
Botulinum toxin type A injection was approved for inclusion in the GJF for restricted off-label use for anal sphincter injection for the treatment of chronic anal fissure in children unresponsive to dietary/laxative/behavioural therapy. Available for restricted use under specialist supervision at the discretion of clinicians experienced in the treatment of chronic anal fissures in children, hospital use only.
Capecitabine tablets
Antimetabolites BNF 8.1.3
Capecitabine tablets
was approved for inclusion in the GJF for restricted use for the treatment of patients with advanced oesophageal and gastric cancer, suitable to receive combination chemotherapy in the Department of Oncology at ARI [
SMC 401/07]. Available for restricted use under specialist supervision, hospital use only.
Antimetabolites BNF 8.1.3
Capecitabine tablets
SMC 401/07]. Available for restricted use under specialist supervision, hospital use only.Docetaxel concentrate for intravenous infusion (Taxotere®)
Other antineoplastic drugs BNF 8.1.5
Docetaxel concentrate for intravenous infusion (Taxotere®) was approved for inclusion in the GJF for the induction treatment of patients with resectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil.
It is restricted to patients in whom induction chemotherapy is appropriate [
SMC 481/08]. Available for restricted use under specialist supervision, hospital use only.
Other antineoplastic drugs BNF 8.1.5
Docetaxel concentrate for intravenous infusion (Taxotere®) was approved for inclusion in the GJF for the induction treatment of patients with resectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil.
It is restricted to patients in whom induction chemotherapy is appropriate [
SMC 481/08]. Available for restricted use under specialist supervision, hospital use only.Imiquimod cream 5%
Preparations for warts and calluses BNF 13.7
Imiquimod cream 5% (Aldara®) was approved for inclusion in the GJF for restricted use for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contra-indicated or less appropriate. It should be restricted to use in patients after specialist advice [
SMC 385/07]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Preparations for warts and calluses BNF 13.7
Imiquimod cream 5% (Aldara®) was approved for inclusion in the GJF for restricted use for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contra-indicated or less appropriate. It should be restricted to use in patients after specialist advice [
SMC 385/07]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.Lidocaine 5% medicated plaster (Versatis®)
Local anaesthesia BNF 15.2
Lidocaine 5% medicated plaster (Versatis®) was approved for inclusion in the GJF for restricted use for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia)
[
SMC 334/06]. Approved for restricted use as per SMC 334/06, treatment may be initiated in either hospital or community. Prescribing advice will be made available via IMPACT.
Local anaesthesia BNF 15.2
Lidocaine 5% medicated plaster (Versatis®) was approved for inclusion in the GJF for restricted use for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia)
[
SMC 334/06]. Approved for restricted use as per SMC 334/06, treatment may be initiated in either hospital or community. Prescribing advice will be made available via IMPACT.Oxaliplatin injection
Other antineoplastic drugs BNF 8.1.5
Oxaliplatin injection was authorised for restricted off-label use for the treatment of patients with advanced oesophageal and gastric cancer, suitable to receive combination chemotherapy in the Department of Oncology at ARI. Available for restricted use under the control of the professional responsibility of the prescribing clinician, hospital use only.
Other antineoplastic drugs BNF 8.1.5
Oxaliplatin injection was authorised for restricted off-label use for the treatment of patients with advanced oesophageal and gastric cancer, suitable to receive combination chemotherapy in the Department of Oncology at ARI. Available for restricted use under the control of the professional responsibility of the prescribing clinician, hospital use only.
Pemetrexed injection (Alimta®)
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®)
SMC 342/07]. Available for restricted use under specialist supervision, hospital use only.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Clostridium botulinum neurotoxin type A (Xeomin®)

Drugs used in essential tremor, chorea, tics, and related disorders, Torsion dystonias and other involuntary movements BNF 4.9.3
Clostridium botulinum neurotoxin type A (Xeomin®)
for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults. For both indications, a similar improvement in symptoms has been shown compared to another clostridium botulinum neurotoxin type A [
SMC 464/08].
SMC 464/08].Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Aripiprazole oral formulations (Abilify®)
Antipsychotic drugs, Atypical antipsychotic drugs BNF 4.2.1
Aripiprazole oral formulations (Abilify®) are not recommended for use within NHS Scotland for the treatment of moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment [
SMC 498/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Antipsychotic drugs, Atypical antipsychotic drugs BNF 4.2.1
Aripiprazole oral formulations (Abilify®) are not recommended for use within NHS Scotland for the treatment of moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment [
SMC 498/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Micafungin intravenous infusion, powder for reconstitution (Mycamine®)
Antifungal drugs BNF 5.2
Micafungin intravenous infusion, powder for reconstitution (Mycamine®)
is not recommended for use within NHS Scotland for the treatment of
Antifungal drugs BNF 5.2
Micafungin intravenous infusion, powder for reconstitution (Mycamine®)
- oesophageal candidiasis in adult, elderly, and adolescent (≥16 years of age) patients for whom intravenous therapy is appropriate. The manufacturer did not supply any economic analysis and therefore the cost effectiveness could not be assessed. See [
SMC 497/08]. - for prophylaxis of Candida infection in adults, elderly, and children (including neonates) undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/μl) for 10 or more days. The manufacturer did not supply any economic analysis and therefore the cost effectiveness could not be assessed. See [
SMC 497/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for these indications.
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