In early October, a law was approved in Italy, which was the first to recognize obesity as a chronic disease. The news was widely reported and commented on in newspapers, even abroad, but less than two months later the limitations regarding its implementation became increasingly apparent.
In fact, the law cannot rely on much funding and most importantly, it cannot be fully implemented until the Level of Essential Assistance (LEA) is established, namely the services that the National Health Service must guarantee to everyone. The text of the law does not define the services that will be guaranteed so it is not yet known what will be included, including surgical interventions to reduce the size of the stomach, local treatment activities and administration of new generation drugs such as Ozempic.
Work on a draft law declaring obesity a “chronic, progressive and relapsing disease” began three years ago on the initiative of Forza Italia MP Roberto Pella, president of the parliamentary intergroup “Obesity, diabetes and chronic non-communicable diseases”. After going through various processes in parliament, the law was approved in early October, and made headlines for being the first law in the world to provide a formal definition of obesity as a disease in the legal system.
But currently, the biggest issue reported in recent months by various experts is regarding the updating of critical aid levels and their management. Legislating that health services against obesity fall within LEAs does not mean this will happen automatically and quickly. The administrative path to doing this is long and often winding, especially when compared with economic resources. Introducing a new chronic disease implies costs that must be managed in the long term for each patient and therefore there are doubts about the resources estimated so far to do this.
The discussion regarding LEA is linked to the discussion regarding drugs: in recent years, the new drugs mentioned above have been shown to be very effective against obesity, despite their cost of hundreds of euros per month per patient. The agency that in Italy decides whether a drug is reimbursable by the National Health Service is the Italian Medicines Agency (AIFA), whose president Roberto Nisticò has said that for now there are no plans to make the drug reimbursable for all obese people. The goal is to determine priority groups by risk category to calibrate reimbursement criteria.
Like other medicines, AIFA must move forward by striking a balance between clinical effectiveness and economic sustainability. If the government decides to reimburse the majority of the population for anti-obesity drugs, the costs borne by the National Health Service will become unsustainable. However, patient associations ask that the aspect of reimbursement for people at risk, with other health problems, not be underestimated, and this is why AIFA is working to determine priorities. This is time-consuming work and will inevitably impact the application of legal assumptions.
In addition to the recognition of this disease and the use of LEA, the new law establishes a national program for the prevention and treatment of obesity, the creation of a national observatory on these issues and awareness-raising activities to reduce the stigma associated with obesity and communications that in the past have sometimes blamed people who are obese. The law provides national funding for treatment and prevention activities, but the annual allocation will be less than one million euros for the first few years: according to many observers, this amount is insufficient.
In short, the process before achieving concrete change is still long. The Ministry of Health must now update the LEA with a decision, which technically defines performance and criteria. The Ministry of Economy must then verify that these costs can actually be covered and that there is stable funding over the years. We will then go through a technical body that will evaluate the proposal and the economic sustainability of the Region. The process will continue with discussions at the State-Territory Conference and then the issuance of a definitive decision. Another provision will indicate the national level tariff that will be the basis for Regions to reimburse the costs of health facilities in their area.
Obesity has long been identified as one of the fastest increasing chronic diseases, with substantial risks for those affected and high costs to the healthcare system. According to the World Health Organization (WHO), since 1990 the number of obese adults in the world has more than doubled, while among teenagers it has quadrupled. WHO estimates that among the 2.5 billion people who are overweight, at least 890 million people are obese with a high risk of health problems, especially cardiovascular problems, and lower life expectancy.
In most cases, obesity is caused by excessive food intake compared to needs, family tendencies, and environmental factors. It is difficult to treat and even among those who successfully lose weight and change lifestyle habits, there are cases of relapse causing people to return to their original condition. These difficulties result in large social costs, most of which are due to the public health costs of trying to address the problem.
