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Fidaxomicin one of six drugs to gain SMC approval

By News team

Fidaxomicin is one of six drugs newly approved for use within NHS Scotland.

The Scottish Medicines Consortium has restricted the use of Astellas’s Clostridium difficile treatment — launched last month (June 2012) under the brand name Dificlir (PJ 2012;288:702) — to treating first recurrences of infection, and on specialist advice only.

Rufinamide (Inovelon; Eisai) is accepted for restricted use for patients who have failed treatment with, or are intolerant to, other antiepileptic drugs. "The oral suspension is bioequivalent to the tablets and provides an alternative formulation for patients who have difficulty swallowing. Depending on the dose it may be more expensive than the tablets, but any overall budget impact is likely to be small," the SMC says.

Also accepted for restricted use are the pulmonary arterial hypertension drug tadalafil (Adcirca; Eli Lilly) and golimumab (Simponi; Merck Sharp & Dohme) for its psoriatic arthritis indication.

Tadalafil treatment must be initiated by specialists, such as those in the Scottish Pulmonary Vascular Unit, and the drug must be made available under the agreed patient access scheme. Golimumab can only be used at a dose of 50mg and after at least two standard disease-modifying antirheumatic drugs have failed. The economic case was not demonstrated for the 100mg dose of golimumab, the SMC says.

Eplerenone (Inspra; Pfizer) is accepted for the treatment of chronic heart failure and left ventricular systolic dysfunction and pegylated interferon alfa-2b (Viraferon Peg; Merck Sharp & Dohme) for its paediatric indication. Thiotepa (Tepadina; Adienne) is not accepted for use.

Citation: The Pharmaceutical Journal URI: 11103994

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  • Dificlir pack shot

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