inclisiran (Leqvio)

following a full submission:

inclisiran (Leqvio®) is accepted for restricted use within NHSScotland.

Indication under review: for 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.

SMC restriction: for specialist use only in 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.

In three phase III studies, both the percentage reduction in LDL-C to day 510 and the time-adjusted percentage in LDL-C from day 90 to day 540 were significantly larger with inclisiran compared with placebo.

This advice 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.