The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Patiromer sorbitex calcium (Veltassa®) has been accepted for restricted use in the treatment of hyperkalaemia in adults. The restriction limits use to patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease (CKD) stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level (normokalaemia).
Inclisiran (Leqvio®) has been accepted for restricted use in the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid lowering therapies in patients who are unable to reach 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 contraindicated
The restriction limits use to patients at high cardiovascular risk as follows:
- patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥ 5.0mmol/L, for primary prevention of cardiovascular events or,
- patients with HeFH and LDL-C ≥ 3.5mmol/L, for secondary prevention of cardiovascular events or,
- patients with high risk due to previous cardiovascular events and LDL-C ≥ 4.0mmol/L or,
- patients with recurrent/polyvascular disease and LDL-C ≥ 3.5mmol/L.
It should also be noted that this recommendation applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower. It is therefore expected that this medication would be supplied through secondary care.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.