The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Delafloxacin (Quofenix®) has been rejected for use in the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. The manufacturer failed to make a submission for this indication. The SMC advised that consideration should be given to official guidance on the appropriate use of antibacterial agents.
Bempedoic acid (Nilemdo®) has been accepted for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- In combination with a statin, or a statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or
- Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated
The restriction limits use, in combination with ezetimibe, in patients who are:
- statin intolerant or for whom a statin is contra-indicated, and
- where ezetimibe alone does not appropriately control LDL-C, and
- where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate
Furthermore, this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) similar to existing NICE guidance that applies in England and Wales.
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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