Formulary Group Decisions July 2010
Approved for use in NHS Grampian
Brinzolamide/timolol eye drops (Azarga®)
Treatment of glaucoma BNF 11.6
Brinzolamide/timolol eye drops (Azarga®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. Use is restricted to patients who do not tolerate the ocular side-effects of dorzolamide/timolol (Cosopt®). Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Treatment of glaucoma BNF 11.6
Brinzolamide/timolol eye drops (Azarga®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. Use is restricted to patients who do not tolerate the ocular side-effects of dorzolamide/timolol (Cosopt®). Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.Carmustine 7.7mg implant (Gliadel®)
Alkylating drugs BNF 8.1.1.
Carmustine 7.7mg implant (Gliadel®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation.
Carmustine implants are recommended as an option for the treatment only for patients in whom 90% or more of the tumour has been resected, treatment should be supervised by specialist neurosurgeons.
The specialists should also have access to:
Alkylating drugs BNF 8.1.1.
Carmustine 7.7mg implant (Gliadel®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation.
Carmustine implants are recommended as an option for the treatment only for patients in whom 90% or more of the tumour has been resected, treatment should be supervised by specialist neurosurgeons.
The specialists should also have access to:
- multidisciplinary teams to enable preoperative identification of patients in whom maximal resection is likely to be achievable
- magnetic resonance imaging (MRI) to enable preoperative identification of patients in whom maximal resection is likely to be possible, and
- image-directed technology, such as neuronavigation, for use intraoperatively to assist the achievement of maximal resection.
Available for restricted use under specialist supervision, recommended for hospital use only.
L-tryptophan tablets
Other antidepressant drugs BNF 4.3.4
L-tryptophan tablets was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of resistant depression, after trials of standard antidepressant drug treatments have failed and as an adjunct to other anti-depressant medication. Available for restricted use under specialist supervision, treatment to be initiated in hospital prior to handover.
Other antidepressant drugs BNF 4.3.4
L-tryptophan tablets was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of resistant depression, after trials of standard antidepressant drug treatments have failed and as an adjunct to other anti-depressant medication. Available for restricted use under specialist supervision, treatment to be initiated in hospital prior to handover.
Methotrexate injection 50mg/mL (Metoject®)
Drugs affecting the immune response BNF 13.5.3
Methotrexate injection 50mg/mL (Metoject®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
For patients in whom parenteral methotrexate is appropriate, this is the first licensed parenteral formulation for this indication. Available for restricted use under specialist supervision recommended for hospital use only.
Drugs affecting the immune response BNF 13.5.3
Methotrexate injection 50mg/mL (Metoject®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
For patients in whom parenteral methotrexate is appropriate, this is the first licensed parenteral formulation for this indication. Available for restricted use under specialist supervision recommended for hospital use only.
Pivmecillinam 200mg tablets
Mecillinams BNF 5.1.1.5
Pivmecillinam 200mg tablets was approved for inclusion in the Grampian Joint Formulary for restricted use on the recommendation of a microbiologist for the treatment of urinary tract infections resistant to other more commonly used agents. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a Microbiologist.
Mecillinams BNF 5.1.1.5
Pivmecillinam 200mg tablets was approved for inclusion in the Grampian Joint Formulary for restricted use on the recommendation of a microbiologist for the treatment of urinary tract infections resistant to other more commonly used agents. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a Microbiologist.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Somatropin injection (Omnitrope®)
Hypothalamic and anterior pituitary hormones and anti-oestrogens BNF 6.5.1
Somatropin injection (Omnitrope®) as per [
SMC 598/10] is accepted for use within NHS Scotland.
Somatropin (Omnitrope®) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference recombinant human growth hormone (somatropin (Genotropin®).
The British National Formulary advises that it is good practice to use the brand name when prescribing biological medicinal products.
Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Hypothalamic and anterior pituitary hormones and anti-oestrogens BNF 6.5.1
Somatropin injection (Omnitrope®)
as per [
SMC 598/10] is accepted for use within NHS Scotland.
Somatropin (Omnitrope®)
is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference recombinant human growth hormone (somatropin (Genotropin®).
The British National Formulary advises that it is good practice to use the brand name when prescribing biological medicinal products.
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
Betamethasone valerate medicated plaster (Betesil®)
Topical corticosteroids BNF 13.4
Betamethasone valerate medicated plaster (Betesil®) is not recommended for use within NHS Scotland [SMC 622/10].
Topical corticosteroids BNF 13.4
Betamethasone valerate medicated plaster (Betesil®) is not recommended for use within NHS Scotland [
SMC 622/10]. Indication under review: Treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides. Due to its particular pharmaceutical form, betamethasone medicated plaster is suitable for chronic plaque psoriasis localized in difficult to treat areas (e.g. knees, elbows and anterior face of the tibia on an area not greater than 5% of the body surface).
In phase III studies in patients with mild to moderate plaque psoriasis, betamethasone medicated plaster was superior to non-occluded betamethasone cream, assessed using the psoriasis area and severity index score and psoriasis global assessment.
However, the manufacturer did not submit a sufficiently robust economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
In phase III studies in patients with mild to moderate plaque psoriasis, betamethasone medicated plaster was superior to non-occluded betamethasone cream, assessed using the psoriasis area and severity index score and psoriasis global assessment.
However, the manufacturer did not submit a sufficiently robust economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Fluticasone furoate nasal spray (27.5 micrograms/metered spray, Avamys®)
Drugs used in nasal allergy BNF 12.2.1.
Fluticasone furoate nasal spray (27.5 micrograms/metered spray, Avamys®) was not recommended for inclusion in the Grampian Joint Formulary as a second-line treatment for primary allergic rhinitis. Due to the lack of comparative evidence against mometasone, or evidence of safety in children it was considered that fluticasone furoate did not represented a significant advantage over mometasone. Classified - approved by the SMC but currently not recommended for use in NHS Grampian. Cost effective alternatives are available.
Drugs used in nasal allergy BNF 12.2.1.
Fluticasone furoate nasal spray (27.5 micrograms/metered spray, Avamys®)
was not recommended for inclusion in the Grampian Joint Formulary as a second-line treatment for primary allergic rhinitis. Due to the lack of comparative evidence against mometasone, or evidence of safety in children it was considered that fluticasone furoate did not represented a significant advantage over mometasone. Classified - approved by the SMC but currently not recommended for use in NHS Grampian. Cost effective alternatives are available.Trastuzumab Intravenous infusion (Herceptin®)
Other antineoplastic drugs BNF 8.1.5
Trastuzumab Intravenous infusion (Herceptin®) is not recommended for use within NHS Scotland [
SMC 623/10].
Other antineoplastic drugs BNF 8.1.5
Trastuzumab Intravenous infusion (Herceptin®)
is not recommended for use within NHS Scotland [
SMC 623/10]. Indication under review: in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Trastuzumab is indicated only in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.
The addition of trastuzumab to doublet chemotherapy has shown benefits in terms of overall and progression-free survival and tumour response.
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
The addition of trastuzumab to doublet chemotherapy has shown benefits in terms of overall and progression-free survival and tumour response.
The manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Ofatumumab concentrate for solution for infusion (Arzerra®)
Pharmacotherapeutic group: monoclonal antibodies
Ofatumumab concentrate for solution for infusion (Arzerra®) is not recommended for use within NHS Scotland [
SMC 626/10].
Pharmacotherapeutic group: monoclonal antibodies
Ofatumumab concentrate for solution for infusion (Arzerra®)
is not recommended for use within NHS Scotland [
SMC 626/10]. Indication under review: the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab.
Interim analysis of a non-randomised, single-arm small study in a subgroup of patients refractory to fludarabine and alemtuzumab found that ofatumumab produced a response rate of 58%.
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.
Interim analysis of a non-randomised, single-arm small study in a subgroup of patients refractory to fludarabine and alemtuzumab found that ofatumumab produced a response rate of 58%.
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.
Olanzapine long acting injection (ZypAdhera®)
Antipsychotic depot injections BNF 4.2.2
Olanzapine long acting injection (ZypAdhera®)
is not recommended for use within NHS Scotland [
SMC 624/10]. Indication under review: Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
The pivotal study showed comparable efficacy of olanzapine long-acting injection to oral olanzapine in preventing relapse in stabilised patients over 24 weeks. Supervision requirements in relation to the risk of post injection syndrome may limit the benefit of decreased frequency of administration.
The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
The pivotal study showed comparable efficacy of olanzapine long-acting injection to oral olanzapine in preventing relapse in stabilised patients over 24 weeks. Supervision requirements in relation to the risk of post injection syndrome may limit the benefit of decreased frequency of administration.
The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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