how public authorities prepare – L’Express

the spectacular success of appetite suppressant drugs – LExpress

Anne-Sophie Joly “did not choose to be fat”. The president of the National Collective of Obese Associations says this forcefully in a book-manifesto to be published on February 22. Once in an “obesity situation”, she tried everything to get out of it. Lots of diets, then a gastric band. Effective for twenty years, before health concerns forced him to have it removed. The pounds are back, but another operation is ruled out. Her only hope now: the new drugs against obesity, which she impatiently awaits – like many of the patients she represents.

The first to have been authorized in the United States and Europe, Wegovy is already marketed across the Atlantic and in several European countries (Norway, Denmark, Iceland, Germany, United Kingdom and Switzerland). But not in France. A choice from the Novo Nordisk laboratory, which deploys a “responsible” distribution plan on an international level. Understand: constrained by currently insufficient production capacities. Etienne Tichit, the general manager of Novo Nordisk France, indicates, however, that its slimming syringes should be available during the year: “This is what we want. We are waiting for a go of the group’s management, and the French health authorities.” One thing is certain, this arrival will not fail to give rise to numerous debates, both on the price and on the reimbursement conditions of these products. “We can easily anticipate that the expenses linked to these drugs could exceed a billion euros per year in a few years if the products are eligible for reimbursement, so there will inevitably be a subject”, calculates Jean-Marc Aubert, president of the Iqvia France firm and former deputy director of Health Insurance.

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In France, only 10,000 French people already benefit from it thanks to an exceptional procedure called “early access”. But, since September 30, no new patients can be included, and, for the 10,000 people treated, access to injections – provided free of charge by the laboratory – is guaranteed only until October 2024. The rest will depend on negotiations between the manufacturer and the health authorities. And there is hardly any alternative: the direct competitor developed by the American Eli Lilly (Mounjaro) has only just obtained authorization in Europe and is not yet marketed.

The standoff has begun

In the meantime, some do not hesitate to divert Ozempic, Wegovy’s “little brother”, less dosed and normally reserved for diabetics. “This misuse seems to concern people of normal build who simply want to lose a few kilos,” notes a pharmacist. They are prescribed them by careless doctors, or resort to false prescriptions. But, according to the National Medicines Safety Agency (ANSM), only 1.4% of the approximately 270,000 patients taking Ozempic are not diabetic. The phenomenon would therefore remain limited, even if, according to the ANSM, these figures are probably an underestimate.

Will Wegovy be reimbursed? A first examination of the file by the High Authority of Health at the end of 2022 was unsuccessful. At the time, experts considered the data insufficient, particularly on its cardiovascular benefits and its long-term tolerance. They therefore authorized its reimbursement, while judging that it did not bring “any improvement in the medical service rendered”. An assessment which put the laboratory in a bad position to then negotiate the price of its drug with the government. The industrialist then withdrew the file. Additional data having since been published, he is preparing to refile it.

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Novo Nordisk’s massive investment in France (2.1 billion euros announced for its Chartres site) should of course facilitate discussions. But Wegovy is expensive: 1,350 euros for a month of treatment on the American market. Even if prices are traditionally much lower in Europe, the bill will remain heavy. The objective of the authorities is therefore to restrict prescriptions to patients who need it most. “Around 17% of French people are obese, no health system can cover the expenses for such a large part of the population,” recognizes Etienne Tichit. In all likelihood, a “target population” will be defined beyond a certain degree of obesity, yet to be determined.

Who should benefit from it?

The challenge then: to enforce this rule. “It’s more difficult in France, because the public authorities have few means of controlling prescriptions,” notes Jean-Marc Aubert. Another battle is currently being played out: knowing which doctors will be authorized to sign Wegovy prescriptions. With the High Authority for Health, obesity specialists are pleading for the product to be reserved for them. “General practitioners will have enormous pressure from patients, including those who are not obese,” worries Dr Muriel Coupaye, former president of the French Association for the Study and Research of Obesity. Unsurprisingly, the laboratory is campaigning so that all doctors can prescribe it.

Because even more than reimbursement, it is access to treatment which will determine the level of its sales. To their great astonishment, Novo Nordisk managers discovered that, for the first time, patients were willing to pay out of their own pockets for an innovative drug. This is the case in Norway or Denmark, where around 100,000 Danes treat themselves to semaglutide with their own money, according to the Financial Times. In this plan, French patients included in the famous “target population” would see their expenses covered by Social Security, and the others, a little less obese, would finance their medications themselves. A radical change in the economic model, certainly interesting for the laboratory, but which will leave out the most disadvantaged. Precisely those who are most affected by obesity…