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).
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Substantial
The Committee deems that 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).
Insufficient
The Committee deems that the clinical benefit of MOUNJARO (tirzepatide) is insufficient to justify public funding cover in view of the available alternatives in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
the evidence of superiority of tirzepatide versus placebo on weight loss endpoints in four phase 3 clinical studies:
with a mean weight loss change after 72 weeks of treatment (co-primary efficacy endpoint), of approximately 3% in the placebo groups, and -13 to -24% in the tirzepatide groups, depending on the doses and the studies,
with a percentage of patients achieving weight loss of > 5% after 72 weeks of treatment (co-primary efficacy endpoint), of 11 to 30% in the placebo groups and approximately 95% in the tirzepatide groups all doses combined in the SURMOUNT 1 to 3 studies,
with a mean weight change between week 36 and 88, ranging from +14% in the placebo group to – 6% in the tirzepatide group all doses combined in the SURMOUNT-4 study,
the absence of data demonstrating a clinical benefit of MOUNJARO (tirzepatide) on clinically relevant endpoints such as cardiovascular morbidity and mortality,
the safety profile of tirzepatide, which appears to be favourable with limited follow-up in clinical trials, characterised by gastrointestinal events, like GLP-1 analogues,
uncertainties regarding the long-term safety of tirzepatide, particularly related to its GIP receptor agonist component, monitoring for the development of medullary or pancreatic cancers, complications of diabetic retinopathy,
indirect comparisons with a low level of evidence, meaning that it is not possible to determine the role of MOUNJARO (tirzepatide) compared to semaglutide (WEGOVY), and the absence of comparative data versus SAXENDA (liraglutide),
the Transparency Committee deems that, based on the data currently available, MOUNJARO (tirzepatide) provides no clinical added value (CAV V) in the current 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 six months) and as an adjunct to a reduced-calorie diet and physical activity.
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