The Danish laboratory Novo Nordisk announced on October 8, 2024 the commercial launch in France of its flagship drug against obesity, Wegovy, on prescription but without reimbursement and within a framework restricted by the National Agency for the Safety of Medicines (ANSM).
An explosion in demand
The launch comes amid exploding demand for a new generation of effective weight loss treatments: GLP-1 analogues (aGLP-1), which include Wegovy.
This class of drugs mimics an intestinal hormone that stimulates insulin secretion and produces a feeling of satiety.
In a message sent to AFP, the general director of the French subsidiary of Novo Nordisk, Etienne Tichit, "hopes that this arrival will allow many French patients to enter a course of care including a low-calorie diet and increased physical activity which remains essential."
But the ANSM indicates in a separate press release "restrict the conditions of prescription and dispensing of all aGLP-1 indicated in the treatment of obesity".
Thus, prescriptions for initiating treatment must be provided by specialists in endocrinology-diabetology-nutrition. Renewals can, however, be carried out by general practitioners.
The agency also asks doctors to comply with the care pathway of the High Authority for Health, that is to say to "prescribe aGLP-1 indicated in the treatment of obesity to patients with an initial body mass index (BMI) greater than or equal to 35 kg/m2, aged under 65".
This medication should only be used after failure of nutritional support and in combination with a low-calorie diet and physical activity.
For the drug police, this is about "to secure the use of aGLP-1 indicated in the treatment of obesity, in a context of potential misuse of these products", You can also find out more about "diversion for aesthetic purposes" by people who do not have weight-related health problems.
“Between 9 and 12 euros per day”
Wegovy is not, to date, registered for reimbursement and its price is therefore freely set, as in most of the fifteen countries where it is already marketed.
Based on its other anti-obesity drug marketed in France, Saxenda (liraglutide), which has not yet been evaluated for reimbursement, the French subsidiary of Novo Nordisk has estimated the price of the Wegovy treatment at "between 9 and 12 euros per day".
Up to 10,000 obese patients have had access to Wegovy ahead of schedule in France, according to the manufacturer, as part of early access which allows them to benefit from innovative treatments more than a year before their official marketing.
This access authorized between July 2022 and September 2023 allowed them to have free use of it until the end of October 2024. The laboratory will extend this measure "until the end of January 2025" in such a way as "not to be left unsolved" the approximately 7,000 patients still receiving treatment.
But it is highly unlikely that by that date, the price negotiations with the Economic Committee for Health Products (CEPS) will have been concluded, since Wegovy must be revalued. "by the end of the year" by the HAS taking into account the results of a new study (Select) which showed a reduction in the risk of major adverse cardiovascular events with this treatment.
Read alsoGLP-1 hormone, the “miracle” molecule: it all starts in the intestine
Wegovy: weight loss around 17%
This drug, which consists of a weekly injection with a 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 are causing enthusiasm since the weight loss is, according to the HAS, around 17%, but its use is accompanied by side effects such as nausea, diarrhea and vomiting.
Its active substance, semaglutide, is the same as that of the antidiabetic Ozempic also manufactured by Novo Nordisk, but in obesity it is used at higher doses.
These two products are making the Danish laboratory's fortune. The leading European capitalization is investing billions to strengthen its global production.
Obesity now affects more than a billion people worldwide, according to a study published in March in the British medical journal The Lancet.
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