MOUNJARO (tirzepatide) - Weight

The clinical benefit of MOUNJARO (tirzepatide) 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 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).

Considering:

• new efficacy data from three placebo-controlled studies conducted in patients with a mean BMI of over 35 kg/m², confirming the substantial efficacy of tirzepatide on weight loss,
• the results of an open-label study that evaluated weight loss with tirzepatide compared to semaglutide, which are difficult to interpret due to methodological limitations,
• results for clinically relevant morbidity endpoints in obese patients, from three studies (SUMMIT, SURMOUNT-OSA, SURMOUNT-1 extension),
• the results of the SUMMIT study concerning patients with heart failure, demonstrating a benefit on a composite endpoint including cardiovascular deaths and worsening of heart failure, which nonetheless did not demonstrate a reduction in cardiovascular deaths,
• the results of the SURMOUNT-OSA study, which demonstrate a benefit for change in apnoea-hypopnoea index,
• the results of the SURMOUNT-1 extension study, which demonstrate a benefit for time to onset of type 2 diabetes in the long term (193 weeks) in patients with prediabetes,
• an improvement of quality of life demonstrated in the SUMMIT study for change in Kansas City Cardiomyopathy Questionnaire Summary Score (KCCQ-CSS),
• the safety profile marked predominantly by gastrointestinal adverse events with, in particular, extensive experience in the SURMOUNT-1 study, with follow-up for up to 193 weeks,

pending the results for the cardiovascular endpoints in the SURMOUNT-MMO study, the Committee deems that MOUNJARO (tirzepatide) provides a minor clinical added value (CAV IV), in the same way as WEGOVY (semaglutide), 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.