Formulary Group Decisions December 2010
Approved for use in NHS Grampian
Extended release nicotinic acid/laropiprant tablets (Tredaptive®)
2.12 Lipid-regulating drugs
Extended release nicotinic acid/laropiprant tablets (Tredaptive®) was approved for inclusion in the Grampian Joint Formulary for restricted use as monotherapy for the treatment of dyslipidaemia in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDLcholesterol) in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Available for general use and recommended treatment may be initiated in the either hospital or community.
2.12 Lipid-regulating drugs
Extended release nicotinic acid/laropiprant tablets (Tredaptive®) was approved for inclusion in the Grampian Joint Formulary for restricted use as monotherapy for the treatment of dyslipidaemia in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDLcholesterol) in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Available for general use and recommended treatment may be initiated in the either hospital or community.
Teriparatide injection (Forsteo®)
Affecting bone metabolism, BNF 6.6 Drugs
Teriparatide injection (Forsteo®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of established severe osteoporosis in men over 65 years of age. It should be restricted to initiation by specialists experienced in the treatment of osteoporosis following assessment of fracture risk who, according to the FRAX algorithm, have >30% risk of any fracture in the next 10 years, and >25% risk of hip fracture. Available for restricted use under specialist supervision and recommended for recommended hospital use only.
Affecting bone metabolism, BNF 6.6 Drugs
Teriparatide injection (Forsteo®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of established severe osteoporosis in men over 65 years of age. It should be restricted to initiation by specialists experienced in the treatment of osteoporosis following assessment of fracture risk who, according to the FRAX algorithm, have >30% risk of any fracture in the next 10 years, and >25% risk of hip fracture. Available for restricted use under specialist supervision and recommended for recommended hospital use only.
Oxycodone hydrochloride 50mg/mL injection (OxyNorm®)
Opioid analgesics, BNF 4.7.2
Oxycodone hydrochloride 50mg/mL injection (OxyNorm®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of moderate to severe pain in patients with cancer. Use is restricted to patients who have difficulty in tolerating morphine or diamorphine therapy and who require a high dose of oxycodone delivered via syringe pump which necessitates the daily preparation of an additional syringe pump if oxycodone 10mg/mL is used. Available for general use and recommended treatment may be initiated in the either hospital or community.
Opioid analgesics, BNF 4.7.2
Oxycodone hydrochloride 50mg/mL injection (OxyNorm®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of moderate to severe pain in patients with cancer. Use is restricted to patients who have difficulty in tolerating morphine or diamorphine therapy and who require a high dose of oxycodone delivered via syringe pump which necessitates the daily preparation of an additional syringe pump if oxycodone 10mg/mL is used. Available for general use and recommended treatment may be initiated in the either hospital or community.
Not approved for use in NHS Grampian
In the absence of a submission from the holder of the marketing authorisation
Denosumab injection (Prolia®)
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab injection (Prolia®) is not recommended for use within NHS Scotland.
Indication under review: bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
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 [
SMC 670/10].
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab injection (Prolia®)
is not recommended for use within NHS Scotland.
Indication under review: bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.
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 [
SMC 670/10]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Dexamethasone intravitreal implant (Ozurdex®)
Corticosteroids and other anti-inflammatory preparations BNF 11.4
Dexamethasone intravitreal implant (Ozurdex®)
is not recommended for use within NHS Scotland.
Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of ≥ 15 letters. Longer-term effectiveness of treatment is uncertain.
Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit [SMC 652/10].
is not recommended for use within NHS Scotland.
Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of ≥ 15 letters. Longer-term effectiveness of treatment is uncertain.
Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit [
SMC 652/10]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation
Diclofenac 4% spray gel (Mobigel®)
Rubefacients, topical NSAIDs, capsaicin, and poultices, topical NSAIDs BNF 10.3.2
Diclofenac 4% spray gel (Mobigel®) is not recommended for use within NHS Scotland.
Indication under review: for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.
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 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 [SMC 667/10].
Rubefacients, topical NSAIDs, capsaicin, and poultices, topical NSAIDs BNF 10.3.2
Diclofenac 4% spray gel (Mobigel®) is not recommended for use within NHS Scotland.
Indication under review: for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.
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 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 [
SMC 667/10]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
In the absence of a submission from the holder of the marketing authorisation
Fondaparinux sodium 1.5mg/0.3mL injection (Arixtra®)
Parenteral anticoagulants BNF 2.8.1
Fondaparinux sodium 1.5mg/0.3mL injection (Arixtra®)
is not recommended for use within NHS Scotland.
Indication under review: treatment of acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
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 [SMC 668/10].
is not recommended for use within NHS Scotland.
Indication under review: treatment of acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
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 [
SMC 668/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Gefitinib tablets (Iressa®)
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Gefitinib tablets (Iressa®)
is not recommended for use within NHS Scotland.
Indication under review: the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
In a comparative study in previously untreated patients, gefitinib was superior to a platinumbased doublet chemotherapy regimen in terms of progression-free survival; subgroup analysis supported this finding in patients with activating mutations of EGFR-TK.
However, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient and the economic case was not sufficiently robust to gain acceptance by SMC [SMC 615/10].
is not recommended for use within NHS Scotland.
Indication under review: the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
In a comparative study in previously untreated patients, gefitinib was superior to a platinumbased doublet chemotherapy regimen in terms of progression-free survival; subgroup analysis supported this finding in patients with activating mutations of EGFR-TK.
However, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient and the economic case was not sufficiently robust to gain acceptance by SMC [
SMC 615/10]. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Prucalopride tablets (Resolor®)
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Prucalopride tablets (Resolor®)
is not recommended for use within NHS Scotland.
Indication under review: symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
There were weaknesses in the clinical data as in the pivotal studies the majority of patients did not achieve the primary or secondary outcome measures and the exclusion criteria applied limit the ability to assess the likely clinical effectiveness of prucalopride in the target treatment population. In addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC [SMC 653/10]. The licence holder has indicated their intention to resubmit.
is not recommended for use within NHS Scotland.
Indication under review: symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
There were weaknesses in the clinical data as in the pivotal studies the majority of patients did not achieve the primary or secondary outcome measures and the exclusion criteria applied limit the ability to assess the likely clinical effectiveness of prucalopride in the target treatment population. In addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC [
SMC 653/10]. 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.
Ranolazine tablets (Ranexa®)
Other antianginal drugs BNF 2.6.3
Ranolazine tablets (Ranexa®) is not recommended for use within NHS Scotland.
Indication under review: as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta blockers and/or calcium antagonists).
When added to standard doses of antianginal drugs, ranolazine increased exercise duration at trough drug levels compared with placebo after 12 weeks treatment. Although significant the effect size was modest.
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 565/09].
Other antianginal drugs BNF 2.6.3
Ranolazine tablets (Ranexa®)
is not recommended for use within NHS Scotland.
Indication under review: as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta blockers and/or calcium antagonists).
When added to standard doses of antianginal drugs, ranolazine increased exercise duration at trough drug levels compared with placebo after 12 weeks treatment. Although significant the effect size was modest.
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 565/09].Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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