WEGOVY (sémaglutide) - Obésité

Key points

Approval of reimbursement of the proprietary medicinal product WEGOVY (semaglutide) indicated alongside a low-calorie diet and increased exercise for weight management, including weight loss and weight maintenance, only for adults with an initial body mass index (BMI) ≥ 35 kg/m² and aged ≤ 65 in cases of failure of well-conducted nutritional management (< 5% weight loss at six months).

The retention of this opinion is conditional on the reassessment of WEGOVY (semaglutide) within not more than 2 years on the basis of the findings of the SELECT phase III study assessing the risk of cardiovascular events in overweight or obese patients who have previously presented with cardiovascular events (findings available in the first quarter of 2024).

Disapproval of reimbursement of the proprietary medicinal product WEGOVY (semaglutide) indicated alongside a low-calorie diet and increased exercise for weight management, including weight loss and weight maintenance for adult patients with an initial BMI < 35 kg/m².

Therapeutic improvement?

No therapeutic improvement, based on the data available.

Role in therapeutic strategy?

he first-line medical treatment of overweight and obesity in adults is based on active multidisciplinary management with at least two years of long-term regular follow-up, therapeutic education of the patient, dietary support, exercise, and psychological support. It involves lifestyle changes (diet and exercise). Medicinal treatment in obesity comes after introducing lifestyle changes and tailored nutritional management, when the patient’s weight has still not reduced. In cases of failure of well-conducted nutritional management (< 5% weight loss at six months), particularly on dietary behaviour and subject to the patient’s involvement in care, a medicinal treatment may be proposed using a GLP1 analogue which has been granted a marketing authorisation in the indication of obesity of patients of obese status falling under levels 2 and 3 (patients with BMI ≥ 35 kg/m²). It may be prescribed from the outset for patients whose obesity compromises their autonomy and is causing severe impairment of an organ function, and for whom lifestyle changes are limited.

Surgical treatment of obesity is only proposed as a second-line approach, after failure of well-managed medical treatment, for adult subjects with a body mass index (BMI) > 40 kg/m² or with a BMI > 35 kg/m² associated with comorbidities. Therefore, the surgical treatment of obesity is proposed as a last resort and is designed in line with the coordinated care pathway, with patient follow-up pre- and post-surgery. Regardless of the procedure used, this treatment is effective, with a weight loss of between 20 and 40%   maintained in the long term, but burdensome and invasive. Indeed, these procedures may be associated with surgical and functional complications and with nutritional deficiencies. In fact, bariatric surgery is not indicated for all patients on account of its risk (based on risk, physical or mental health) and outcomes vary significantly from one patient to another, with long-term failure observed in approximately one-third of patients.

Role of the medicinal product

In view of the current therapeutic strategy recommended by HAS and the medical need for obesity treatment in adults, WEGOVY (semaglutide) is a second-line treatment in association with a low-calorie diet and exercise, to be reserved only for adult patients with an initial body mass index (BMI) ≥ 35 kg/m² and aged ≤ 65 years in cases of failure of well-conducted nutritional management (< 5% weight loss at six months), the cohort at the highest risk of obesity-related complications for whom HAS has recommended medicinal treatment with a GLP1 analogue which has been granted a marketing authorisation in the obesity indication.

The Committee recommends that semaglutide (WEGOVY) only be prescribed after review by an obesity management specialist.

Beyond 2 years of treatment, the efficacy and safety data are limited, entailing a systematic reassessment of continued treatment beyond this period.

Special recommendations

In view of the specific characteristics of the product and in order to ensure correct use of WEGOVY (semaglutide) (subcutaneous injection, position in the therapeutic strategy as a second-line approach in association with lifestyle and dietary measures, uncertainties in respect to a rebound effect when treatment is discontinued), the Committee requests that initial prescription be reserved for practitioners and establishments involved in level 2 and 3 obesity management, namely:

• Medical obesity specialist (nutritionist doctor) practising in partnership with other practitioners involved in obesity, follow-up and convalescence care specialised in “gastroenterology, endocrinology, diabetes care, nutrition”,

Obesity specialist centres or university hospital centres.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 13/12/2022.

L’avis économique porte sur une indication supperposable à celle demandée au remboursement, à savoir le traitement par semaglutide en complément d’un régime hypocalorique et d’une augmentation de l’activité physique pour la gestion du poids, incluant la perte de poids et le maintien du poids chez l’adulte ayant un indice de masse corporelle (IMC) ≥30 kg/m² (obésité) et, un âge ≤ 65 ans et, non diabétiques et en échec d’un traitement non médicamenteux seul bien conduit pendant 6 à 12 mois.

La CEESP n’a pas été en mesure de conclure sur le niveau d’efficience du produit versus régime et exercice en raison de l’incertitude globale majeure qui entoure le résultat.

L’analyse d’impact budgétaire n’est pas recevable en raison d’une réserve méthodologique majeure sur l’estimation de l’incidence de la gonarthrose, engendrant des proportions de patients ayant subi une pose de prothèse de genou qui est bien au-delà de la prévalence moyenne retrouvée dans cette population.

WEGOVY - Avis économique (pdf)