Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - May 2016

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide (Genvoya®) has been accepted for use in the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Ivacaftor (Kalydeco®) has been rejected for use in the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25kg who have a specified gating mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Lumacaftor and ivacaftor (Orkambi®) has been rejected for use in the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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