After an initial favorable opinion for the reimbursement of Mounjaro (tirzepatide) in obesity in September 2024, the High Authority for Health (HAS) reassessed the file in the light of new data provided by the manufacturer, on weight loss and the benefit on weight-related complications. This December 9, 2025, it confirms its green light for the reimbursement of Mounjaro in obesity, but this time, by changing the specialty from an ASMR (for improvement of the medical benefit) 5 (non-existent) to 4 (minor). Or the same ASMR level as Wegovy (semaglutide), also obtained after re-evaluation.
“It is a criterion that enters into the price-setting negotiation” which should start “in the coming months” with the Economic Committee for Health Products, a spokesperson for Eli Lilly France told AFP. To date, Mounjaro, indicated for both diabetes and obesity, is not refundable in any of its indications.
The new HAS opinion confirms the reimbursement scope of this double GIP/GLP-1 analogue defined in 2024, namely a second-line prescription – in the event of failure of healthy-dietary management and well-conducted physical activity over 6 months (weight loss of < 5%) - in obese adults with an initial BMI ≥ 35 kg/m², and in addition to a low-calorie diet and increased physical activity. That is, an identical reimbursement indication to that of Wegovy (semaglutide).
In its new opinion, the HAS Transparency Commission insists on “the fundamental importance of non-pharmacological interventions for the management of obesity” before and during drug treatment. She recalls the need to re-evaluate the treatment after 6 months and “to consider a possible cessation in the event of weight loss less than 5%”. Finally, although the first prescription (and renewal) is now open to all doctorsthe HAS recommends a prescription for Mounjaro on the advice of a specialist in the management of obesity.
Data on the cardiovascular benefit to come
The re-evaluation of the HAS focused in particular on the results of several phase 3 studies which showed that Mounjaro, compared to the placebo, led to an improvement in sleep apnea syndrome in obese patients, a reduction in the risk of the onset of diabetes and a reduction in events linked to heart failure (in the case of heart failure with preserved LVEF). These data come respectively from studies Surmount-OSA, Surmount-1 and Summit. Concerning a possible cardiovascular benefit, the Commission indicates that it is waiting for data for Mounjaro (Surmount-MMO study), “Wegovy having demonstrated a modest cardiovascular benefit on 3P-MACE, however without demonstrated effect on the reduction of deaths from cardiovascular causes”.
Finally, the HAS states that it has not determined which of Wegovy or Mounjaro to favor, “in the absence of robust comparative data”. On this subject, experts from the Consultation and Coordination Group of Specialized Obesity Centers (GCC-CSO) and the Force network (French Obesity Research Center of Excellence, F-CRIN) recently published a position paper on medical treatments for obesity (MMT). “The demonstrated effects on the complications of obesity contribute to the choice of an OMT, according to the shared medical objective. The working group suggests favoring the prescription of certain TMOs depending on the patient’s phenotype” (see figure 6 of the recommendations), they indicate.