September SMC approvals include new gout treatment

The Scottish Medicines Consortium (SMC) has accepted the following drugs for restricted use in NHS Scotland:

• Febuxostat (Adenuric) for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis). Use is restricted to patients in whom treatment with allopurinol is inadequate, not tolerated or contraindicated.
• Dronedarone (Multaq) for clinically stable adults with a history of, or current non-permanent atrial fibrillation (AF) to prevent AF recurrence or to lower ventricular rate. Use is restricted to the prevention of recurrence of AF in patients in whom conventional first-line antiarrhythmics are ineffective, contraindicated or not tolerated. Treatment should be initiated only on specialist advice.
• Esomeprazole 10mg granules for oral solution (Nexium Granules) for the treatment of endoscopically proven erosive reflux oesophagitis and the symptomatic relief of gastro-oesophageal reflux disease (GORD) in children 1 to 11 years old (and for patients having difficulty swallowing dispersed esomeprazole tablets). Use for this indication and age group is restricted to patients in whom licensed doses of a generic proton pump inhibitor have been ineffective.
• Imatinib (Glivec) for the adjuvant treatment of adults who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours. Use is restricted to patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology [AFIP] risk criteria).
• Bivalirudin (Angiox) as an anticoagulant in adults undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction undergoing primary PCI. Bivalirudin should be administered with aspirin and clopidogrel. Use is restricted to patients who would have been considered for treatment with heparin in combination with a glycoprotein IIb/IIIa inhibitor. It should not be used as an alternative to heparin alone.

The SMC rejected the following drugs:

• Agomelatine (Valdoxan) for the treatment of major depressive episodes in adults.
• Trabectedin (Yondelis), in combination with pegylated liposomal doxorubicin, for the treatment of relapsed platinum-sensitive ovarian cancer.

Further information: SMC