Advice

in the absence of a submission from the holder of the marketing authorisation:

alirocumab (Praluent®) is not recommended for use within NHSScotland.

Indication under review: In adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
• in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland in adults with established atherosclerotic cardiovascular disease outwith the restriction specified in SMC advice (1147/16). Note that SMC advice (1147/16) remains valid.

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Medicine details

Medicine name:
alirocumab (Praluent)
SMC ID:
SMC2201
Indication:
In adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors: • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies 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
Non submission
Status
Not recommended
Date advice published:
10 June 2019