Formulary Group Decisions December 2008
Approved for use in NHS Grampian
Bivalirudin injection (Angiox®)
Parenteral anticoagulants BNF 2.8.1
Bivalirudin injection (Angiox®) was approved for inclusion in the Grampian Joint Formulary for restricted use, for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction) planned for urgent or early intervention. It is restricted to use in patients who would otherwise have been considered for heparin in combination with a glycoprotein IIb/IIIa antagonist. In these patients bivalirudin monotherapy may be a suitable alternative. It should not be used as an alternative to heparin alone. Bivalirudin should be administered with aspirin and clopidogrel [
SMC 516/08]. Available for restricted use under specialist supervision and recommended for hospital use only.
Parenteral anticoagulants BNF 2.8.1
Bivalirudin injection (Angiox®)
was approved for inclusion in the Grampian Joint Formulary for restricted use, for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction) planned for urgent or early intervention. It is restricted to use in patients who would otherwise have been considered for heparin in combination with a glycoprotein IIb/IIIa antagonist. In these patients bivalirudin monotherapy may be a suitable alternative. It should not be used as an alternative to heparin alone. Bivalirudin should be administered with aspirin and clopidogrel [
SMC 516/08]. Available for restricted use under specialist supervision and recommended for hospital use only.Flecainide m/r capsules (Tambocor XL®)
Drugs for arrhythmias BNF 2.3.2
Flecainide m/r capsules (Tambocor XL®) was approved for inclusion in the Grampian Joint Formulary for restricted use, for: the treatment of AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways; paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction. Arrhythmias of recent onset will respond more readily. The capsules can be used for the maintenance of normal rhythm following conversion by other means.
Patients for whom the use of flecainide is appropriate and who are controlled on 200mg daily using the immediate release formulation may be transferred to one 200mg XL capsule with the benefit of once-daily rather than twice-daily dosing at reduced cost [SMC 521/08]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
Drugs for arrhythmias BNF 2.3.2
Flecainide m/r capsules (Tambocor XL®) was approved for inclusion in the Grampian Joint Formulary for restricted use, for: the treatment of AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways; paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction. Arrhythmias of recent onset will respond more readily. The capsules can be used for the maintenance of normal rhythm following conversion by other means.
Patients for whom the use of flecainide is appropriate and who are controlled on 200mg daily using the immediate release formulation may be transferred to one 200mg XL capsule with the benefit of once-daily rather than twice-daily dosing at reduced cost [
SMC 521/08]. Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.Methylnaltrexone solution for injection (Relistor®)
Laxatives 1.6
Methylnaltrexone solution for injection (Relistor®) was approved for inclusion in the Grampian Joint Formulary for restricted use, for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient [
SMC 518/08]. Available for restricted use under specialist supervision and for hospital use only. It is restricted to use by physicians with expertise in palliative care and for the treatment of opioid-induced constipation in advanced illness patients receiving palliative care and unresponsive to usual laxative therapy.
Methylnaltrexone solution for injection (Relistor®)
was approved for inclusion in the Grampian Joint Formulary for restricted use, for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient [
SMC 518/08]. Available for restricted use under specialist supervision and for hospital use only. It is restricted to use by physicians with expertise in palliative care and for the treatment of opioid-induced constipation in advanced illness patients receiving palliative care and unresponsive to usual laxative therapy.Rivaroxaban 10mg tablets (Xarelto®)
Oral anticoagulants BNF 2.8.2
Rivaroxaban 10mg tablets (Xarelto®) were approved for inclusion in the Grampian Joint Formulary for restricted use, as per
SMC 519/08, for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Available for restricted use under specialist supervision and recommended for hospital use only.
Oral anticoagulants BNF 2.8.2
Rivaroxaban 10mg tablets (Xarelto®)
were approved for inclusion in the Grampian Joint Formulary for restricted use, as per
SMC 519/08, for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Available for restricted use under specialist supervision and recommended for hospital use only.Thymoglobuline® 25 mg powder for solution for infusion
Drugs affecting the immune response BNF 8.2
Rabbit anti-human thymocyte immunoglobulin (Thymoglobuline® 25 mg powder for solution for infusion) was approved for restricted use under strict medical supervision, prescribed by physicians with experience in using immunosuppressive agents for the treatment of steroid resistant graft rejection in renal transplantation. Approved for restricted use in particular circumstances and recommended for hospital use only.
Drugs affecting the immune response BNF 8.2
Rabbit anti-human thymocyte immunoglobulin (Thymoglobuline® 25 mg powder for solution for infusion) was approved for restricted use under strict medical supervision, prescribed by physicians with experience in using immunosuppressive agents for the treatment of steroid resistant graft rejection in renal transplantation. Approved for restricted use in particular circumstances and recommended for hospital use only.
Not approved for use in NHS Grampian
Aliskiren tablets (Rasilez®)
Renin inhibitors BNF 2.5.5.3
Aliskiren tablets (Rasilez®) is not recommended for use within NHS Scotland for the treatment of essential hypertension [
SMC 462/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Renin inhibitors BNF 2.5.5.3
Aliskiren tablets (Rasilez®)
is not recommended for use within NHS Scotland for the treatment of essential hypertension [
SMC 462/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Buprenorphine transdermal patches (Butrans®)
Opioid analgesics BNF 4.7.2
ADVICE: following a third re-submission
Buprenorphine transdermal patches (Butrans®) are not recommended for use within NHS Scotland for the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics. In the patient population considered in this submission, severe osteoarthritis pain in elderly patients whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, buprenorphine transdermal 7-day patch was superior to placebo and similar in efficacy to World Health Organisation (WHO) 'Step 2' analgesic comparator agents.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by the SMC [SMC 234/07].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Opioid analgesics BNF 4.7.2
ADVICE: following a third re-submission
Buprenorphine transdermal patches (Butrans®) are not recommended for use within NHS Scotland for the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics. In the patient population considered in this submission, severe osteoarthritis pain in elderly patients whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, buprenorphine transdermal 7-day patch was superior to placebo and similar in efficacy to World Health Organisation (WHO) 'Step 2' analgesic comparator agents.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by the SMC [
SMC 234/07].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler®)
Corticosteroids BNF 3.2
ADVICE: following a re-submission
Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler®) is not recommended for use within NHS Scotland for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% to <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
While there were improvements in lung function tests and reductions in moderate exacerbations with the salmeterol/fluticasone combination compared to placebo and to salmeterol alone, there were no significant differences in mortality rates over 3 years. In addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC [SMC 450/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication. Note: The SMC advice is consistent with the NHSG integrated care pathway for COPD [intranet]; inhaled steroids are only recommended for patients with moderate or severe COPD i.e. those with a FEV1/FVC <0.7 and FEV1 <50% predicted.
Corticosteroids BNF 3.2
ADVICE: following a re-submission
Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler®) is not recommended for use within NHS Scotland for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% to <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
While there were improvements in lung function tests and reductions in moderate exacerbations with the salmeterol/fluticasone combination compared to placebo and to salmeterol alone, there were no significant differences in mortality rates over 3 years. In addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC [
SMC 450/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication. Note: The SMC advice is consistent with the NHSG integrated care pathway for COPD [intranet]; inhaled steroids are only recommended for patients with moderate or severe COPD i.e. those with a FEV1/FVC <0.7 and FEV1 <50% predicted.
Stiripentol capsules, powder (Diacomit®)
Control of epilepsy BNF 4.8.1
Stiripentol capsules, powder (Diacomit®) is not recommended for use within NHS Scotland for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
The number of responders with >50% reduction in the number of clonic (or tonic-clonic) seizures was significantly greater in SMEI patients receiving adjunctive stiripentol than in patients receiving placebo.
The product did not gain acceptance by SMC as the manufacturer did not present a formal economic evaluation [SMC 524/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication. However, to ensure that the management of patients already receiving stiripentol (Diacomit) is not jeopardised, SMC advises that patients continue to receive treatment and are not switched to alternative therapies if it is currently proving clinically effective. SMC advice does not override the individual responsibility of health professionals to make decisions using their clinical judgement and in this case good prescribing practice in epilepsy patients would hold over SMC advice on cost-effectiveness.
Control of epilepsy BNF 4.8.1
Stiripentol capsules, powder (Diacomit®) is not recommended for use within NHS Scotland for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.
The number of responders with >50% reduction in the number of clonic (or tonic-clonic) seizures was significantly greater in SMEI patients receiving adjunctive stiripentol than in patients receiving placebo.
The product did not gain acceptance by SMC as the manufacturer did not present a formal economic evaluation [
SMC 524/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication. However, to ensure that the management of patients already receiving stiripentol (Diacomit) is not jeopardised, SMC advises that patients continue to receive treatment and are not switched to alternative therapies if it is currently proving clinically effective. SMC advice does not override the individual responsibility of health professionals to make decisions using their clinical judgement and in this case good prescribing practice in epilepsy patients would hold over SMC advice on cost-effectiveness.
Zoledronic acid 5mg intravenous infusion (Aclasta®)
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Zoledronic acid 5mg intravenous infusion (Aclasta®) is not recommended for use within NHSScotland for the treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture. 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 535/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Zoledronic acid 5mg intravenous infusion (Aclasta®)
is not recommended for use within NHSScotland for the treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture. 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 535/08].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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