Formulary Group Decisions November 2010
Approved for use in NHS Grampian
Certolizumab pegol injection (Cimzia®)
Drugs that suppress the rheumatic disease process, cytokine modulator BNF 10.1.3
Certolizumab pegol injection (Cimzia®)
was approved for inclusion in the Grampian Joint Formulary for restricted use:
Drugs that suppress the rheumatic disease process, cytokine modulator BNF 10.1.3
Certolizumab pegol injection (Cimzia®)
was approved for inclusion in the Grampian Joint Formulary for restricted use:- in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate
- monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate
This advice takes account of the benefits of, and is dependent upon the continuing availability of a Patient Access Scheme (PAS) that improves the cost-effectiveness of certolizumab pegol. Available for restricted use under specialist supervision and recommended for hospital use only.
Eltrombopag tablets (Revolade)®
Drugs used in platelet disorders BNF 9.1.4
Eltrombopag tablets (Revolade)® was approved for inclusion in the Grampian Joint Formulary for restricted use for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Eltrombopag may be considered as second-line treatment for adult non splenectomised patients where surgery is contraindicated.
Restriction: in both the splenectomised and non-splenectomised patient populations, restricted to use in patients with severe symptomatic ITP or a high risk of bleeding. Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Available for restricted use under specialist supervision and recommended for hospital use only.
Drugs used in platelet disorders BNF 9.1.4
Eltrombopag tablets (Revolade)®
was approved for inclusion in the Grampian Joint Formulary for restricted use for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Eltrombopag may be considered as second-line treatment for adult non splenectomised patients where surgery is contraindicated.
Restriction: in both the splenectomised and non-splenectomised patient populations, restricted to use in patients with severe symptomatic ITP or a high risk of bleeding. Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Available for restricted use under specialist supervision and recommended for hospital use only.
Esomeprazole 10mg granules for oral solution (Nexium®)
Proton pump inhibitors BNF 1.3.5
Esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium®) was approved for inclusion in the Grampian Joint Formulary for restricted use for children (1 to 11 years old) who have nasogastric/PEG tubes and are unable to take medicines orally. Use is limited to the paediatric service. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a specialist.
Proton pump inhibitors BNF 1.3.5
Esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium®) was approved for inclusion in the Grampian Joint Formulary for restricted use for children (1 to 11 years old) who have nasogastric/PEG tubes and are unable to take medicines orally. Use is limited to the paediatric service. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a specialist.
Paclitaxel albumin intravenous infusion (Abraxane®)
Other antineoplastic drugs BNF 8.1.5
Paclitaxel albumin intravenous infusion (Abraxane®) was approved for restricted use for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated.
Restriction: Use is restricted to patients who would otherwise receive docetaxel or 3-weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer.
Note that paclitaxel albumin may have substantially different pharmacological properties compared to other formulations of paclitaxel and is licensed for use in a 3-weekly dosage schedule.
Available for restricted use under specialist supervision and recommended for hospital use only.
Other antineoplastic drugs BNF 8.1.5
Paclitaxel albumin intravenous infusion (Abraxane®) was approved for restricted use for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated.
Restriction: Use is restricted to patients who would otherwise receive docetaxel or 3-weekly solvent-based paclitaxel as second-line treatment for metastatic breast cancer.
Note that paclitaxel albumin may have substantially different pharmacological properties compared to other formulations of paclitaxel and is licensed for use in a 3-weekly dosage schedule.
Available for restricted use under specialist supervision and recommended for hospital use only.
Not approved for use in NHS Grampian
In the absence of a submission from the holder of the marketing authorisation
Denosumab 60mg solution for injection in pre-filled syringe (Prolia®)
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab 60mg solution for injection in pre-filled syringe (Prolia®): Is not recommended for use in NHSScotland.
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 NHSScotland [
SMC 670/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Denosumab 60mg solution for injection in pre-filled syringe (Prolia®)
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab 60mg solution for injection in pre-filled syringe (Prolia®)
: Is not recommended for use in NHSScotland.
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 NHSScotland [
SMC 670/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Dexamethasone 700 microgram intravitreal implant (Ozurdex®)
Eye BNF 11
Dexamethasone 700 microgram intravitreal implant (Ozurdex®): is not recommended for use in NHSScotland. 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 [SMC 652/10].
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.
Eye BNF 11
Dexamethasone 700 microgram intravitreal implant (Ozurdex®)
: is not recommended for use in NHSScotland. 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 [
SMC 652/10].
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.
In the absence of a submission from the holder of the marketing authorisation
Diclofenac 4% spray gel (Mobigel Spray ®):
Diclofenac 4% spray gel (Mobigel Spray ®):
Rubefacients and other topical antirheumatics, topical NSAIDs BNF 10.3.2
Diclofenac 4% spray gel (Mobigel Spray ®): is not recommended for use in NHSScotland.
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 NHSScotland [SMC 667/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Diclofenac 4% spray gel (Mobigel Spray ®): is not recommended for use in NHSScotland.
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 NHSScotland [
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 solution for injection, pre-filled syringe (Arixtra ®)
Parenteral anticoagulants BNF 2.8.1
Fondaparinux sodium 1.5mg/0.3mL solution for injection, pre-filled syringe (Arixtra®) : is not recommended for use in NHSScotland.
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 NHSScotland [SMC 668/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Fondaparinux sodium 1.5mg/0.3mL solution for injection, pre-filled syringe (Arixtra ®)
Parenteral anticoagulants BNF 2.8.1
Fondaparinux sodium 1.5mg/0.3mL solution for injection, pre-filled syringe (Arixtra®) : is not recommended for use in NHSScotland.
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 NHSScotland [
SMC 668/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Gefitinib 250mg film-coated tablets (Iressa)
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Gefitinib 250mg film-coated tablets (Iressa®) is not recommended for use in NHSScotland.
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 platinum-based 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.
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Gefitinib 250mg film-coated tablets (Iressa®)
is not recommended for use in NHSScotland.
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 platinum-based 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 1mg and 2mg tablet (Resolor®)
Laxative BNF 1.6
Prucalopride 1mg and 2mg tablet (Resolor®) is not recommended for use in 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].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Laxative BNF 1.6
Prucalopride 1mg and 2mg tablet (Resolor®)
is not recommended for use in 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].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Ranolazine prolonged-release tablets (Ranexa®)
Other antianginal drugs BNF 2.6.3
Ranolazine 375mg, 500mg and 750mg prolonged-release tablets (Ranexa®) is not recommended for use in NHSScotland.
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 [SMC 565/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Other antianginal drugs BNF 2.6.3
Ranolazine 375mg, 500mg and 750mg prolonged-release tablets (Ranexa®)
is not recommended for use in NHSScotland.
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 [
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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