LEQVIO (inclisiran) - Dyslipidaemia

The Committee deems that the clinical benefit of LEQVIO (inclisiran) 284 mg solution for injection in pre-filled syringe is substantial only as primary prevention in the treatment of adults with heterozygous familial hypercholesterolaemia (HeFH), 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;
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Considering: 

• evidence of the superiority of LEQVIO (inclisiran) compared to placebo on LDL-C reduction (at 

D510 and time-adjusted over the [D90 – D540] period; biological co-primary endpoints) in a 
double-blind, randomised comparative study (ORION-9 study);

• the favourable safety profile of inclisiran, comparable to that of placebo;
• the currently partially met medical need; 

but in view of: 

• the absence of morbidity and mortality data in adult subjects with heterozygous familial hypercholesterolaemia;
• the absence of a comparison versus imatinib, an active comparator, despite this being feasible;
• the absence of treatment compliance and quality of life data; 

the Committee considers that LEQVIO (inclisiran) 284 mg solution for injection in a pre-filled syringe provides no clinical added value (CAV V) in the current care pathway as primary prevention in adults with heterozygous familial hypercholesterolaemia.