The Pharmaceutical Journal
Vol 277 No 7422 p441
14 October 2006

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New hepatitis B treatment approved for Scotland

Entecavir (Baraclude), a new treatment for hepatitis B infection, has been approved by the Scottish Medicines Consortium in its latest round of appraisals. It was launched in the UK last month (PJ, 23 September, p359) and is accepted for use within NHS Scotland for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation or fibrosis.

The SMC has also accepted lercanidipine (Zanidip) tablets 20mg for the treatment of patients with mild to moderate essential hypertension. The SMC says that “this new strength allows a reduction in the number of tablets administered at the maximum dose, at reduced cost compared with the formulation available previously”.

Choriogonadotropin alfa pre-filled syr-inge (Ovitrelle) has been accepted for the treatment of anovulatory or oligo-ovulatory women and for use in women undergoing superovulation before assisted reproduction techniques such as in vitro fertilisation.

The following products have also been approved by the SMC for use in NHS Scotland:

· Carglumic acid (Carbaglu) dispersible tablets for hyperammonaemia due to N-acetylglutamate synthase deficiency (restricted to use by experts providing the supraregional specialist service for this condition)

· Zoledronic acid (Aclasta) solution for infusion for treatment of Paget’s disease of bone

· Bimatoprost with timolol (Ganfort) eye drops for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues alone

· Etoricoxib (Arcoxia) tablets for the symptomatic relief of osteoarthritis, rheumatoid arthritis and the pain and signs of inflammation associated with gouty arthritis (taking into account current advice on the use of specific cyclo-oxygenase-2 inhibitors)

· Levetiracetam (Keppra) concentrate for infusion as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy, when oral administration is temporarily not feasible

The SMC has rejected co-careldopa (Duodopa) intestinal gel and ivabradine (Procoralan) tablets. Sunitinib (Sutent) capsules were not approved for use for treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour after failure of imatinib due to resistance or intolerance.