The Spanish Medicines Agency, dependent on the Ministry of Health, has positioned itself in favor of the use of semaglutide for the treatment of obesity. However, public health cannot cover the cost of treatment for the more than ten million people for whom it is indicated in Spain. Given this limitation, obesity doctors advocate that semaglutide be initially funded only for the most serious cases, with the perspective of expanding funding to more patients in the future.
Semaglutide is the first of a new generation of drugs that “will represent a revolution in the treatment of obesity,” reports Andreea Ciudin, coordinator of the obesity unit at the Vall d’Hebron hospital in Barcelona. It is an analogue of the hormone GLP-1, which is like a Swiss army knife with multiple functions: among others, it enhances the action of insulin, slows down the emptying of the stomach and increases the feeling of satiety and reduces appetite in the brain.
After semaglutide, tirzepatide is expected to arrive, for which the company Eli Lilly has already requested authorization from the European Medicines Agency after demonstrating its effectiveness and safety in phase 3 clinical trials. And drugs are being studied for later similar that have not yet completed phase 3 clinical trials.
They are all based on the hormone GLP-1. Some complement this action with other hormones that the human body produces naturally after eating food, called incretins. In clinical trials they have achieved average weight losses ranging between 17% and 25% after treatments lasting between one and two years. These weight losses are similar to those usually achieved with bariatric surgery.
Semaglutide is now available in Spain for the treatment of diabetes in people with obesity under the trade name Ozempic. And it is authorized, but not yet available, for the treatment of obesity in people without diabetes, as well as for the treatment of some cases of overweight without becoming obese, under the commercial name Wegovy.
The appropriate dose for the treatment of obesity is different than for diabetes, which is why Ozempic is not indicated for obesity. Even so, some people have turned to Ozempic to lose weight, which has led to shortages of the drug for the treatment of diabetes, both in Spain and in other countries.
The Novo Nordisk company, which has developed and markets semaglutide, will begin the distribution of Wegovy in Spain “as soon as possible,” a company spokeswoman reported on Friday. Among doctors specializing in obesity treatment, it is expected to be in the first half of 2024. It has not yet been decided what the price of the treatment will be.
According to the Therapeutic Positioning Report on Wegowy published on August 25 by the Spanish Agency for Medicines and Health Products (AEMPS), the drug should not be considered the first option to lose weight, but rather “it is considered an alternative treatment for the control weight loss after failure of attempts based on the modification of dietary habits and exercise.
The Wegowy is indicated, according to the AEMPS, for all those people with a body mass index (BMI) greater than 30, which is the threshold from which a person is considered obese. And also for people with a BMI between 27 and 30, which is not defined as obesity but as overweight, if they have at least one weight-related disorder, such as diabetes, prediabetes, hypertension or sleep apnea, among others.
These indications are in line with those of the European Medicines Agency (EMA), which in 2022 authorized Wegovy for the treatment of obesity in adults and adolescents over 12 years of age.
22.8% of men and 20.5% of women between 25 and 64 years old are obese in Spain, the AEMPS points out in its report on Wegovy. Another 39.3% of the adult population is overweight, although there is no estimate of how many overweight people would benefit from treatment with Wegovy.
As is usual in the pharmaceutical industry, the price of Wegovy will vary depending on each country, as it will be negotiated between Novo Nordisk and each government. In Spain, it will probably be similar to that of other European countries. For now, the treatment has a price of about 310 euros per month in Germany, an amount significantly lower than the $1,300 per month it costs in the United States, CNBC reported.
Given that public health does not have the capacity to cover the cost of treatment for all the people who would benefit from it, and that the Novo Nordisk company does not have the capacity to produce the necessary doses for the entire obese population, “we must prioritize the patients who need it most,” declares Andreea Ciudin, from Vall d’Hebron, who is also a member of the board of directors of the Spanish Society for the Study of Obesity (SEEDO) and co-president of the Working Group on Treatment of Obesity. the European Obesity Society.
From SEEDO, “we defend that the financing of these drugs be covered first for patients for whom bariatric surgery is indicated” because pharmacological treatment has fewer risks than surgery. This includes all people between 18 and 60 years old with a BMI greater than 40, and those with a BMI of 35 to 40 with serious diseases associated with obesity.
According to Ciudin, “if the financing of semaglutide for these patients is not covered, we will find ourselves in a situation in which people who can afford it will access the drug and we will only be able to offer bariatric surgery to those who cannot afford it, even knowing that it is not the best option from a medical point of view.”
