Advice

following a full submission:

alirocumab (Praluent®) is accepted for restricted use within NHS Scotland.

Indication under review:  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.

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 at 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 a large phase III clinical study program, alirocumab significantly reduced LDL-C from baseline to week 24 versus active and placebo comparators in patients with hypercholesterolaemia unable to reach lipid goals with currently available therapies.

SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of alirocumab and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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Medicine details

Medicine name:
alirocumab (Praluent)
SMC ID:
1147/16
Indication:
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.
Pharmaceutical company
Sanofi-Aventis
BNF chapter
Cardiovascular system
Submission type
Full
Status
Restricted
Date advice published:
08 August 2016
Additional notes

The ‘For specialist use only’ restriction was not intended to restrict use to specialist prescribing only. Initiation in secondary care with prescribing transferred to primary care thereafter is in line with SMC advice.