Formulary Group Decisions December 2009
Approved for use in NHS Grampian
Topical Carmustine 0.04% in Unguentum Merck
Alkylating drugs BNF 8.1.1
Topical Carmustine 0.04% in Unguentum Merck is available for restricted use under specialist supervision as a second-, third-line option for the treatment of patches and plaques of mycosis fungoides. Unlicensed product available for restricted use under specialist supervision, hospital use only. Use is restricted to prescribing by consultant dermatologists. Due to the unlicensed nature of this cytotoxic topical preparation, topical carmustine 0.04% in Unguentum Merck will not be included in the Grampian Joint Formulary but will be available for restricted use on a time-limited basis (2 years).
Alkylating drugs BNF 8.1.1
Topical Carmustine 0.04% in Unguentum Merck is available for restricted use under specialist supervision as a second-, third-line option for the treatment of patches and plaques of mycosis fungoides. Unlicensed product available for restricted use under specialist supervision, hospital use only. Use is restricted to prescribing by consultant dermatologists. Due to the unlicensed nature of this cytotoxic topical preparation, topical carmustine 0.04% in Unguentum Merck will not be included in the Grampian Joint Formulary but will be available for restricted use on a time-limited basis (2 years).
Danaparoid injection
Parenteral anticoagulants BNF 2.8.1
Danaparoid injection was approved for inclusion in the Grampian Joint Formulary for restricted use as a treatment option for heparin-induced thrombocytopenia. Available for restricted use under specialist supervision and recommended hospital use only.
Parenteral anticoagulants BNF 2.8.1
Danaparoid injection was approved for inclusion in the Grampian Joint Formulary for restricted use as a treatment option for heparin-induced thrombocytopenia. Available for restricted use under specialist supervision and recommended hospital use only.
Docetaxel (concentrate for intravenous infusion)
Other antineoplastic drugs BNF 8.1.5
Docetaxel (concentrate for intravenous infusion) is available for restricted off-label use under specialist supervision as monotherapy for patients with advanced oesophagogastric cancer who progress after standard first-line chemotherapy with platinum-based regimens and are not eligible for, or decline clinical trial participation. Licensed product requested for off label use, recommended for hospital use only. Use is restricted to prescribing by consultant oncologist experienced in the treatment of oesophagogastric cancer, and use is subject to audit.
Other antineoplastic drugs BNF 8.1.5
Docetaxel (concentrate for intravenous infusion) is available for restricted off-label use under specialist supervision as monotherapy for patients with advanced oesophagogastric cancer who progress after standard first-line chemotherapy with platinum-based regimens and are not eligible for, or decline clinical trial participation. Licensed product requested for off label use, recommended for hospital use only. Use is restricted to prescribing by consultant oncologist experienced in the treatment of oesophagogastric cancer, and use is subject to audit.
Duloxetine 30mg and 60mg capsules (Cymbalta®)
Treatment of diabetic nephropathy and neuropathy BNF 6.1.5
Duloxetine 30mg and 60mg capsules (Cymbalta®) was approved for inclusion in the GJF for restricted use for the treatment of diabetic peripheral neuropathic pain in adults
[
SMC 285/06]. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist. Use is restricted to initiation by prescribers experienced in the management of diabetic peripheral neuropathic pain as second- or third-line therapy. Discontinue treatment if inadequate response after two months; review treatment at least every three months.
Treatment of diabetic nephropathy and neuropathy BNF 6.1.5
Duloxetine 30mg and 60mg capsules (Cymbalta®) was approved for inclusion in the GJF for restricted use for the treatment of diabetic peripheral neuropathic pain in adults
[
SMC 285/06]. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist. Use is restricted to initiation by prescribers experienced in the management of diabetic peripheral neuropathic pain as second- or third-line therapy. Discontinue treatment if inadequate response after two months; review treatment at least every three months.Haelan® Tape
Topical corticosteroids BNF 13.4
Haelan® Tape (polythene adhesive film impregnated with fludroxycortide 4 micrograms /cm2) was approved for inclusion in the GJF for restricted use for overnight topical administration of steroid for well defined localised eczematous/ inflammatory rash and dermatosis. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist. To be prescribed on the advice of a Dermatologist for the treatment of steroid responsive skin conditions where occlusive therapy is considered beneficial.
Haelan® Tape (polythene adhesive film impregnated with fludroxycortide 4 micrograms /cm2) is available for restricted off-label use for the treatment of overgranulated wounds. Licensed product requested for off-label use, treatment may be initiated in either hospital or community.
Romiplostim (Nplate®)
Other immunomodulating BNF 8.2.4
Romiplostim powder for solution for injection (Nplate®) was approved for inclusion in the Grampian Joint Formulary for restricted use in adults:
Other immunomodulating BNF 8.2.4
Romiplostim powder for solution for injection (Nplate®) was approved for inclusion in the Grampian Joint Formulary for restricted use in adults:
- for chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)
- as second line treatment for non-splenectomised patients where surgery is contra-indicated.
Romiplostim is restricted to use in patients with severe symptomatic ITP or patients with a high risk of bleeding. Available for restricted use under specialist supervision and recommended for hospital use only.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Vildagliptin tablets (Galvus®)
Other antidiabetic drugs BNF 6.1.2.3
Vildagliptin tablets (Galvus®) is accepted for use within NHS Scotland for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance.
Vildagliptin is also licensed for use in combination with metformin or thiazolidinedione drugs for the treatment of type 2 diabetes. SMC has already issued advice on use in combination with metformin. As this submission from the manufacturer related only to the use of vildagliptin in combination with a sulphonylurea, SMC cannot recommend the use of vildagliptin in combination with thiazolidinedione drugs. Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Other antidiabetic drugs BNF 6.1.2.3
Vildagliptin tablets (Galvus®)
is accepted for use within NHS Scotland for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance.
Vildagliptin is also licensed for use in combination with metformin or thiazolidinedione drugs for the treatment of type 2 diabetes. SMC has already issued advice on use in combination with metformin. As this submission from the manufacturer related only to the use of vildagliptin in combination with a sulphonylurea, SMC cannot recommend the use of vildagliptin in combination with thiazolidinedione drugs. 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
Eslicarbazepine acetate (Zebinix®)
Control of epilepsy BNF 4.8.1
Eslicarbazepine acetate (Zebinix®)
is not recommended for use within NHS Scotland for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
The efficacy of eslicarbazepine acetate in terms of the reduction in standardised seizure frequency was demonstrated in three 12-week placebo-controlled studies. There are no clinical studies comparing eslicarbazepine acetate to other anti-epileptic drugs, and a mixedtreatment indirect comparison was undertaken to show equivalent efficacy of eslicarbazepine acetate and a single other anti-epileptic drug.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit [SMC 592/09].
is not recommended for use within NHS Scotland for adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.
The efficacy of eslicarbazepine acetate in terms of the reduction in standardised seizure frequency was demonstrated in three 12-week placebo-controlled studies. There are no clinical studies comparing eslicarbazepine acetate to other anti-epileptic drugs, and a mixedtreatment indirect comparison was undertaken to show equivalent efficacy of eslicarbazepine acetate and a single other anti-epileptic drug.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit [
SMC 592/09].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Haelan® cream/ointment
Topical corticosteroids BNF 13.4
Haelan® cream/ointment (Fludroxycortide 0.0125%) was not recommended for inclusion in the GJF for the off-label treatment of overgranulated wounds.
Not recommended for use in NHSG - will not be included in Grampian Joint Formulary for this indication.
Topical corticosteroids BNF 13.4
Haelan® cream/ointment (Fludroxycortide 0.0125%) was not recommended for inclusion in the GJF for the off-label treatment of overgranulated wounds.
Not recommended for use in NHSG - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation.
Tolvaptan 5mg and 30mg tablets (Samsca®)
Posterior pituitary hormones and antagonists, Antidiuretic hormone antagonists BNF 6.5.2
Tolvaptan 15mg and 30mg tablets (Samsca®) is not recommended for use within NHSScotland for the treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
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 NHSScotland [SMC 605/10].
Tolvaptan 15mg and 30mg tablets (Samsca®)
is not recommended for use within NHSScotland for the treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH).
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 NHSScotland [
SMC 605/10].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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