This new generation drug will not be reimbursed. The National Medicines Safety Agency explained that it would be prescribed only as a second line, in the event of failure of nutritional support.
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An arrival on the French market eagerly awaited by doctors and patients. The Danish pharmaceutical laboratory Novo Nordisk announced on Tuesday October 8 the marketing in France of Wegovy, a flagship drug against obesity, a disease which affects around 14% of French people, according to Public Health France. However, at this stage, this new generation drug is not reimbursed by Health Insurance and will be distributed within a restricted framework by the National Medicines Safety Agency (ANSM).
While obesity affects around 890 million people worldwide, according to the WHO, this marketing comes in a context of exploding demand for this generation of effective weight loss treatments, such as Ozempic, also marketed by Novo Nordisk, or Mounjaro, manufactured by the American laboratory Eli Lilly. Franceinfo takes stock of this new drug in four questions.
1 How does it work ?
Wegovy is one of the treatments called GLP-1 analogues (sometimes referred to as aGLP-1). This class of drugs mimics an intestinal hormone, glucagon-like peptide 1 (GLP-1), which stimulates insulin secretion and provides a feeling of satiety. The active substance in Wegovy, semaglutide, is the same as that used in the antidiabetic drug Ozempic, which is also manufactured by the Novo Nordisk laboratory. But in the case of obesity, it is used in higher dosages.
Initially, this hormone was known “as an important molecule for controlling blood glucose”explains endocrinologist Boris Hansel on France Inter. Scientists have therefore developed this molecule as an antidiabetic drug, by putting more of this hormone in it, so that it “lasts a little longer over time than that which is produced naturally”continues the doctor. The molecule is marketed in the form of an injectable pen, for one injection per week.
2 Who is it intended for?
For the moment, in France, these treatments are intended to combat insufficiently controlled type 2 diabetes and “have no indication in the management of obesity”recalls Health Insurance. This means that these medications are reserved for certain diabetic patients, with the agreement of their doctor.
In addition, Wegovy was tested on just over 7,000 patients suffering from obesity and presenting at least one weight-related comorbidity, such as high blood pressure, dyslipidemia, cardiovascular diseases or sleep apnea syndrome. fitted in July 2022 and September 2023. But for the moment, Health Insurance estimates that only “longer-term monitoring of these patients will make it possible to evaluate the evolution of the different use profiles as part of its marketing”.
With the announcement of the marketing of Wegovy, the National Medicines Safety Agency specified in a press release “restrict the conditions of prescription and delivery of all aGLP-1 indicated in the treatment of obesity”by requiring that treatment initiation prescriptions be provided by specialists in endocrinology-diabetology-nutrition.
On the other hand, renewals can be carried out by general practitioners. The ANSM also asks doctors to comply with the care pathway recommended by the High Authority for Health (HAS), 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 less than 65 years”. This medication should only be used as a second line, in the event of failure of nutritional support and in combination with a low-calorie diet and physical activity, recalls the ANSM.
3 Is it effective?
The results arouse enthusiasm since the weight loss is of the order of 12.4% after 68 weeks of treatment, according to the ANSM (PDF). In addition, taking this drug would lead to a 20% reduction in major cardiovascular events in non-diabetic patients, according to preliminary results communicated by the Novo Nordisk laboratory. A hope shared by doctors, who see it as an effective way to treat obesity.
Before the arrival of GLP-1 analogues, there was no “no drugs of this effectiveness” to help obese patients lose weight, explains nutritionist Pierre Azam on BFMTV. “Before the 2010s, almost all treatments developed failed, mainly because of their serious side effects”underlines researcher Karine Clément in The World. The most commonly reported side effects of Wegovy are gastrointestinal disturbances, such as nausea, diarrhea, constipation, and vomiting. Less commonly, the medication can also cause dizziness, headaches or even hair loss.
The effectiveness of these drugs is touted by celebrities, such as Elon Musk and Oprah Winfrey, providing unexpected publicity to the general public, who see them as a quick and easy way to lose weight. To the point that the ANSM had to warn in June 2023 about the risks linked to improper use, with the appearance of serious adverse effects, such as “pancreatitis, intestinal obstruction [ou] gastroparesis”. And to recall a year later that “aGLP-1 should not be used for weight loss for cosmetic purposes, i.e. for weight loss in people without obesity or in overweight people who do not have problems health related to weight.”
4 How much does it cost?
To date, Wegovy is not reimbursed by Social Security. Which means that its price is set freely, as in most of the fifteen countries where it is already marketed. The French subsidiary of Novo Nordisk has estimated the price of its new anti-obesity treatment at “between 9 and 12 euros per day”.
In pharmacies, pharmacists will buy Wegovy “between 208 and 220 euros for a box of four injections, which corresponds to treatment for one month”says Philippe Besset, president of the Federation of Pharmaceutical Unions of France (FSPF), in The Parisian. Or an estimated resale “between 270 and 330 euros per box, 10% VAT included”he calculates.