The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Empagliflozin (Jardiance®) has been accepted for use in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. It is noted that empagliflozin offers an additional treatment choice in the therapeutic class of sodium glucose co-transporter 2 inhibitors in this indication.
Liraglutide (Saxenda®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:
- ≥30kg/m² (obese), or
- ≥27kg/m² to <30kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea
It is noted that 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 economic analysis to gain acceptance by SMC.
Bempedoic acid / ezetimibe (Nustendi®) 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
The SMC restriction limits use to patients who are:
- statin intolerant or for whom a statin is contra-indicated
- where ezetimibe alone does not appropriately control LDL-C
- where proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitors are not appropriate
It is also noted that this advice only applies in the context of an approved NHSScotland Patient Access Scheme (PAS).
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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