Following a full submission
|Status: Recommended with restrictions
Inclisiran (Leqvio®) is recommended as an option for restricted use within NHS Wales.
Inclisiran (Leqvio®) is licensed for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Inclisiran (Leqvio®) is restricted for use in a subpopulation of the licensed indication who are at high risk of further cardiovascular (CV) events:
Inclisiran (Leqvio®) is not recommended for use within NHS Wales outside of this subpopulation.
This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent to or lower than the WPAS price.
|284 mg solution for injection
In 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 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
|Novartis Pharmaceuticals UK Ltd
|Recommended with restrictions
|NMG meeting date
|AWMSG meeting date
|Date of issue