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PJ Online homeThe Pharmaceutical Journal
Vol 276 No 7388 p193
18 February 2006

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SMC accepts six medicines for Scotland — four medicines rejected

Two antiretroviral medicines, emtricitabine (Emtriva) and emtricitabine/tenofovir (Truvada) have been approved by the Scottish Medicines Consortium (SMC) for use within NHS Scotland. The medicines have been accepted for use in HIV-1 infected individuals in combination with other antiretrovirals, prescribed only by HIV specialist doctors.

The SMC reviewed 10 medicines in total and offered advice to the NHS boards and area drug and therapeutics committees.

Long-acting beta-2 agonist formoterol has also been accepted in the form of Atimos Modulite 12µg metered dose inhaler, for the treatment of persistent moderate to severe asthma in patients requiring regular bronchodilator therapy in combination with long-term anti-inflammatory therapy.

Ibandronic acid (Bonviva), taken once a month, has been shown to reduce significantly the risk of vertebral fractures in postmenopausal women. The SMC has approved its use in the treatment of osteoporosis in this patient group.

Another medicine approved by the consortium is ibuprofen intravenous injection (Pedea) for the treatment of severe patent ductus arteriosus in preterm babies born at less than 34 weeks’ gestation. Ibuprofen — and similarly indometacin, used for many years for this indication — helps to close the ductus arteriosus through the inhibition of prostaglandin, which is responsible for keeping the duct open in utero.

The proton pump inhibitor rabeprazole (Pariet) has been approved by the SMC for use in patients with Zollinger-Ellison syndrome, a condition in which over-production of the hormone gastrin results in excessive gastric acidity.

The other four medicines under consideration were rejected by the consortium.

The BuTrans buprenorphine patch was rejected for lack of evidence of comparative efficacy with a relevant treatment for chronic pain already available in the UK [amended text].

A clarithromycin oral suspension gran-ules product (ClaroSip), which uses sip technology — where granules are contained inside a drinking straw — was rejected because of its higher cost compared with conventional clarithromycin products, without evidence of improved compliance.

A combination product containing paracetamol and tramadol (Tramacet) was shown to have similar efficacy to other combination analgesics. But because the amount of paracetamol in each tablet (325mg) is lower than the 500mg strength considered appropriate in the UK, and due to the significantly higher cost of the combination product compared with the individual ingredients alone, the SMC has not recommended its use within NHS Scotland.

Modified release nicotinic acid (Niaspan) was rejected because of a lack of evidence for its use in dyslipidaemia. The SMC issued advice on Niaspan in 2004, stating that the product could not be endorsed for the treatment of hypercholesterolaemia and mixed dyslipidaemia within NHS Scotland (PJ, 24 April 2004, p500).

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