The new drugs to treat obesity have been designated by Science magazine as the most important scientific advance of 2023. Novo Nordisk CEO Lars Fruergaard Jørgensen, who has led the development of the first of these drugs, has been named Person of the Year by the Financial Times after having turned the Danish company into the most valuable in Europe. In 2024, after scientific and economic success, comes the social challenge of ensuring that these drugs reach the enormous volume of the population that can benefit from them.
This year, Novo Nordisk’s semaglutide, already approved by the European Medicines Agency (EMA) for the treatment of obesity, is expected to arrive in Spain. The EMA is also expected to authorize Eli Lilly’s tirzepatide, also as an anti-obesity therapy. Both drugs simulate the action of the hormone GLP-1, which the human body produces naturally and acts in the brain by inhibiting appetite. In addition to reducing obesity, GLP-1 agonists are effective for type 2 diabetes – an indication for which they are already approved -, they reduce cardiovascular mortality and kidney disease, and research is underway to see if they can be useful for the treatment of addictions and Alzheimer’s.
But weekly injections of semaglutide for obesity, marketed as Wegovy, cost around €300 a month in the first European countries where the drug is available, which include Germany, Denmark, Norway and the United Kingdom. With 17% of the adult population with obesity in the European Union, and 16% in Spain, no health system has the resources to pay for treatment for all the people who would benefit from it, and even less so if we take into account that The majority of those affected will have to take medication for years, because they gain weight again when treatment is stopped.
The prohibitive prices that limit access to treatments do not only affect obesity drugs. They are a structural problem in the relationship between health systems and the pharmaceutical industry that affects almost all innovative therapies.
Recent examples include antibodies against the beta-amyloid protein for Alzheimer’s. Lecanemab, which has slowed cognitive decline by 27% in the initial stages of the disease in a clinical study, is priced at $26,500 per year (about 24,000 euros) in the US, where the drug has been approved in 2023. The treatment would be indicated for 5.4 million people in the European Union, where it is expected to be approved this year. If the price were the same as in the US, it would consume half of the entire pharmaceutical budget of EU countries, according to a study by the European Alzheimer’s Disease Consortium published in The Lancet Regional Health-Europe.
“These treatments will not be able to reach all the patients for whom they will be indicated; It would not be sustainable,” warns neurologist Mercè Boada, medical director of the ACE Foundation and co-author of the study. “Patients will have to be evaluated individually with appropriate tests to prioritize cases in which these drugs can provide the most benefit.”
In the cardiovascular field, this November inclisiran arrived in Spain, an innovative RNA drug that reduces cholesterol by acting on the PCSK9 protein. It is indicated for 10% of the Spanish adult population but, with a cost of 2,300 euros per year per patient, public health will only cover its use for a minority of cases.
And in the field of oncology, new molecular therapies designed against the vulnerable points of cancer cells, as well as immunotherapies that make it easier for the immune system to attack tumors, have led to a continued increase in survival rates in the last two decades, but also an increase in the cost of treatments.
The high cost of some of these therapies means that negotiations between governments and pharmaceutical companies to set prices in each country are prolonged, which prevents patients from accessing effective treatments already approved by the EMA on which their health may depend. survival. The time that elapses between the approval of a new oncological treatment in Europe and its arrival in Spanish hospitals is, on average, around a year and a half.
With the development of increasingly sophisticated and more effective treatments, such as those based on gene editing or stem cells, the most advanced therapies remain out of reach of the majority of citizens and their large-scale use may be unaffordable for health systems.
This situation has been reached for a number of reasons, none of them easy to correct. To begin with, medical research and innovation are expensive. They require a huge investment in spaces, instruments, materials and personnel. Although much of the basic research that leads to medical advances is paid for with public funds, it is the industry that finances the expensive clinical trials that evaluate the effectiveness and safety of new treatments, and that ends up producing and marketing the drugs.
Some of these clinical trials also fail after large investments have been made, as has recently happened with gantenerumab against Alzheimer’s beta-amyloid protein, which has an impact on the price of treatments that do prove to be effective and safe.
On the other hand, the trend towards increasingly personalized therapies increases costs. A drug that is produced in the same way for millions of people does not have the same price as a treatment adapted to the genomic profile of each patient. An extreme example is that of the Hemgenix gene therapy to cure hemophilia, the most expensive in history with a price of 3.5 million dollars (about 3.1 million euros), which was administered for the first time in 2023. to a patient from the United States.
An additional, and decisive, factor is that the pharmaceutical industry follows the logic of large companies, where economic criteria prevail over social criteria, which are not ignored but are secondary. With few exceptions, drug prices are set prioritizing profitability, even if it is at the cost of not reaching all patients.
Associations of doctors and patients have denounced the situation and, although they have achieved specific successes, such as accelerating access to some treatments, they do not have enough strength to change the status quo. According to Aleix Prat, director of the Cancer Institute at the Hospital Clínic in Barcelona, ??it would be useful to promote academic clinical trials, led by doctors and not by industry, and financed with public funds and philanthropy, to answer questions that pharmaceutical companies do not address. and that have a direct impact on patients. Prat has opted for this type of study during the five years that he has been president of the Solti research group, which now has more than 450 research partners and has 77 clinical trials in the field of breast cancer.
Administrations have also begun to move, without great results for now. In November 2020, the European Union adopted the new European Pharmaceutical Strategy with the hardly compatible objectives of improving access to treatments, promoting innovation and protecting the sustainability of health systems. Three years later, during which the industry has been reluctant to change, the new strategy has still not translated into a reform of European pharmaceutical legislation – although the European Commission presented a proposal to reform it in April.
In the United States, the Biden Administration warned pharmaceutical companies in December that it will annul patents on treatments developed with the help of public funds unless they lower prices, although it has not specified which treatments or which companies it was referring to. “President Biden believes that health care should be a right, not a privilege,” the White House said in the statement announcing the measure. “For too long, … Big Pharma has made record profits, while millions of Americans struggle to pay for health care and prescription drugs to treat common and chronic diseases.”
The industry, for its part, has shown little interest in changing the situation. A first step has been taken by Novo Nordisk, which is an atypical company because it depends on a foundation that reinvests its profits in research and social actions. The Danish company has agreed to make the price of semaglutide more flexible so that health systems can pay for it. According to the Novo Nordisk proposal that emerged in November, the price will not be reduced, but payment can be deferred for several years until cost savings are achieved from the treatment of obesity. No government has yet commented on the proposal.
