Health authorities have opened the way for reimbursement in France of the anti-obesity drug Wegovy only for patients suffering from severe obesity. Wednesday, December 4, the High Authority of Health (HAS) maintained a favorable opinion after taking into account new data, which reduces cardiovascular risks. It now authorizes reimbursement “only for adults with an initial body mass index (BMI) ≥ 35 kilos/m²”. This corresponds to so-called severe obesity. This treatment should be taken “in addition to a low-calorie diet and an increase in physical activity for weight management, including weight loss and weight maintenance”, specifies the HAS opinion.
HAS expands the target population
The target population of Wegovy is estimated between 1 and 2.1 million patients, according to HAS. “With this new opinion, our objective is to obtain a reimbursement from Wegovy as soon as possible” in the cases defined by the HAS, reacted the Danish manufacturer Novo Nordisk in a press release. Until now, access to the drug is reserved for patients who can finance their treatment themselves, even though obesity mainly affects the most vulnerable populations. It is also very expensive: 9 and 12 euros per day, depending on the margins applied by wholesalers and pharmacists, or between 274 and 365 euros per month. Less than in the United States (around 1,300 euros per month), but very far from being accessible to everyone.
On paper, reimbursement was in theory possible since December 2022. A first positive decision was then made by the HAS. The latter, however, considered at the time that the product did not provide “any improvement in the medical benefit provided”. A poor rating which placed the company in a delicate position to then negotiate the price of its product with the State, via the Economic Committee for Health Products (CEPS). Novo Nordisk therefore preferred to postpone this discussion until better days. In May, the laboratory finally provided new data to HAS. Result: while a positive opinion from 2022 concerned “for obese adults aged under 65”, in its second evaluation, the HAS lifted the restriction on age.
Weight loss of approximately 17%
This medication, which consists of a weekly injection with progressive dosage, was authorized by the European Medicines Agency in early 2022 for the management of obesity in adults and since 2023 for adolescents over 12 years old. The results arouse enthusiasm since the weight loss is, according to the HAS, around 17%. But its use is accompanied by undesirable effects such as nausea, diarrhea or even vomiting.
As a precaution, it is also proposed by the HAS “that the initial prescription be reserved for professionals and structures involved in the management of obesity”, that is to say “the doctor specializing in obesity ( nutritionist doctor) and working in partnership with other professionals concerned with obesity, SSR specialized in gastroenterology, endocrinology, diabetology, nutrition”, or specialized obesity centers (CSO) or university hospital centers (CHU ).