Favourable opinion for reimbursement only “as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial body mass index (BMI) ≥ 35 kg/m² in the event of failure of well-conducted nutritional management (< 5% weight loss after six months)”.
Clinical Benefit
Substantial
The clinical benefit of WEGOVY (semaglutide) is substantial only as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in patients with an initial body mass index (BMI) ≥ 35 kg/m² in the event of failure of well-conducted nutritional management (< 5% weight loss after six months).
Insufficient
The clinical benefit of WEGOVY (semaglutide) is insufficient to justify public funding in the other MA situations.
Clinical Added Value
minor
Considering:
evidence in the phase 3 SELECT study of the superiority of semaglutide compared to placebo, for a clinically relevant cardiovascular endpoint, i.e. the reduction in events in the 3P-MACE composite endpoint, including cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, with an HR=0.80; 95% CI [0.72; 0.90]; p<0.0001), in non-diabetic patients with obesity and a history of at least one cardiovascular disease,
evidence in the phase 3 STEP HFpEF study of the superiority of semaglutide compared to placebo, for two co-primary endpoints, i.e. a quality of life endpoint assessed using the CSS score of the KCCQ-23 questionnaire and weight loss, after 52 weeks of treatment in patients with obesity and heart failure with preserved ejection fraction,
the safety profile of semaglutide, primarily marked by gastrointestinal adverse events, characteristic of GLP-1 analogues,
but taking into account:
the lack of evidence of a superiority of semaglutide versus placebo in the SELECT study for the first ranked secondary endpoint, which was cardiovascular death, interrupting the analysis of the other cardiovascular endpoints,
the modest reduction in cardiovascular risk in the SELECT study (with, in particular, a reduction in the relative risk of one of the major cardiovascular events of the 3P-MACE composite endpoint of 20% compared to placebo),
the absence of cardiovascular results in patients with a BMI of under 30 kg/m2, as well as the absence of primary prevention data in patients,
the to date unmet medical need to have access to medicinal products to treat obesity showing evidence of a reduction in cardiovascular morbidity and mortality,
the Committee deems that WEGOVY (semaglutide) provides a minor clinical added value (CAV IV) in the care pathway for adult patients with an initial body mass index (BMI) > 35 kg/m² in the event of failure of well-conducted nutritional management (< 5% weight loss after 6 months) and as an adjunct to a reduced-calorie diet and physical activity.
Listen
