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Obesity: France reimburses new treatments for severely affected patients; Italia opens the debate

The Italian Obesity Society has sent a letter to political and health authorities, scientists and patients: the drugs work; let’s eliminate inequalities

by Ernesto Diffidenti

Closeup view of pharmacist hand taking medicine box from the shelf in drug store. Pharmacy and health care. littlewolf1989 - stock.adobe.com

3' min read

Translated by AI
Versione italiana

Key points

  • The dispensing system in France

3' min read

Translated by AI
Versione italiana

From 15 June, the French National Health Service will cover the costs of Mounjaro (tirzepatide) and Wegovy (semaglutide) for the treatment of obesity, but only for a limited group of patients and via a dedicated prescription pathway. The new policy introduces a two-tier system for accessing the two anti-obesity drugs: on the one hand, reimbursable prescriptions for the most severe cases; on the other, prescriptions to be paid for by the patient in accordance with the indications authorised at the time of marketing authorisation.

Sio: Italia should launch a debate on sustainable access

The decision in Paris has reignited the European debate on the management of obesity and comes just a few months after another significant step taken by Italia: the passing of Law 149/2025, which recognised obesity as a chronic, progressive and recurrent condition. For this reason, the Italian Society for the Study of Obesity (SIO) has sent a letter to the country’s leading political and health authorities, scientific societies and patient associations, calling for an institutional review of how to ensure appropriate and sustainable access to innovative treatments in Italia as well.

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“France’s decision deserves close attention because it recognises the value of new treatments for patients with the most severe obesity and incorporates them into a structured specialist care pathway,” says Silvio Buscemi, president of the SIO. Today, drug treatment is an essential component of obesity care, alongside nutritional interventions, lifestyle changes, psychological support and, where necessary, bariatric surgery. We therefore believe it is appropriate to initiate a discussion in Italia as well on the most appropriate and sustainable ways to ensure access to innovative therapies for patients with the most severe forms of the disease and the highest risk of complications.”

The dispensing system in France

Tirzepatide and semaglutide will be reimbursed only for adults with a body mass index (BMI) of 35 kg/m² or higher, accompanied by at least one weight-related comorbidity, or with a BMI of 40 kg/m² or higher. In both cases, treatment must be accompanied by a low-calorie diet and an appropriate exercise programme.

The initial prescription will also be subject to specific restrictions. It may only be issued by doctors working in Specialised Obesity Centres (CSOs), University Hospital Centres (CHUs), or medical and rehabilitation facilities (SMRs) specialising in gastroenterology, endocrinology, diabetology or nutrition, as well as by endocrinologists affiliated with a CSO. Subsequent renewals, however, may be carried out by any doctor.

At the same time, the two medicines will remain available without reimbursement for their authorised indications. In this case, the prescription may be issued by either a general practitioner or a specialist for patients with a BMI of 27 kg/m² or higher associated with a weight-related comorbidity, or with a BMI of 30 kg/m² or higher, always in conjunction with lifestyle changes.

Scientific evidence on new medicines

In recent years, the introduction of new drug therapies has radically changed the treatment outlook for a condition that affects millions of Italians. “Scientific evidence demonstrates unequivocally,” explains Buscemi, “that these treatments not only enable a significant reduction in body weight, but also help to improve numerous complications associated with obesity, including type 2 diabetes, cardiovascular disease, kidney and liver disease, obstructive sleep apnoea syndrome and other conditions that have a significant impact on quality of life and life expectancy.”

All too many patients today meet the clinical criteria for treatment but are unable to access the available therapies solely for financial reasons. This situation risks creating inequalities for the most vulnerable members of society. “For this reason, as the Italian Society for Obesity, we have drawn up a technical document for national institutions, proposing a set of useful criteria that are essentially identical to those adopted in France to assess a progressive pathway to access innovative drug therapies for people with severe obesity and a high risk of complications.”

The SIO confirms its willingness “to work with the Government, Parliament, the Regions, AIFA, the National Institute of Health and the Higher Health Council to identify the most appropriate and sustainable ways of implementing these care pathways”.

In Italia, a prescription is always required

In Italia, all new medicines for diabetes and obesity require a prescription and have different therapeutic indications. For the treatment of type 2 diabetes mellitus, AIFA notes that it has published a guide on use and risks; medicines such as Ozempic and Rybelsus (semaglutide), Mounjaro (tirzepatide), Victoza (liraglutide), Trulicity (dulaglutide) and Byetta/Bydureon (exenatide) are reimbursed by the National Health Service (Class A/PHT), according to AIFA Note 100. They may be prescribed by general practitioners and specialists.

For the management of body weight (obesity and overweight with comorbidities), medicines such as Wegovy (semaglutide), Saxenda (liraglutide) and Mounjaro (tirzepatide, prescribed for this specific indication) are not reimbursed by the NHS and are classified as Class C, with costs borne by the patient.

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