The delay that the Government has accumulated when it comes to authorising new medicines that reach the European market is hitting patients hard. As this newspaper has already reported, the latest available data reveals that these drugs take an average of 661 days to receive the green light for marketing in Spain, one month more than in 2022.
In cancer, the situation is getting drastically worse, with the average waiting time reaching 725 days in 2023, 256 more than a year earlier. To these delays must be added those arising from the obstacles that regional health services themselves impose to ensure that drugs reach patients, with cases being recorded in which the average waiting time far exceeds 1,000 days.
Yesterday, a group of women with metastatic breast cancer went to the Ministry of Health to deliver more than 80,000 signatures collected through “Change.org” to request that the public system finance two cutting-edge drugs: “Enhertu” and “Trodelvy”.
The promoter of this initiative and a patient with metastatic breast cancer, Victoria Rodrigo, said at the doors of the department headed by Mónica García that she would like to ask the minister “how much a life is worth to her,” reports Ep. “We need to continue living and be with our relatives, our children, our friends. How much is a life worth to you?” she emphasized. This group of patients began collecting signatures on June 25, after the Interministerial Commission on Drug Prices decided not to approve the authorization of financing for the treatments at its meeting held on the 19th.
Three rejections
«Enhertu» (trastuzumab deruxtecan) is indicated for metastatic breast cancer with positive hormone receptors (HR) and negative HER2. This is the third time that a rejection has occurred, something that patients do not understand, especially considering that the drug has the approval of the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). In addition, it is already funded in 16 European countries. Rodrigo pointed out that «it is what prolongs our life and gives us quality of life. We need these drugs to live». For her part, Nuria Perea, who was diagnosed with metastatic breast cancer when she was 37 years old, stressed, in statements collected by Ep, that this initiative allows them to begin to be visible to civil society. “80,000 signatures, which is 80,000 people, shows that we are supported, that we are not alone in this,” she said.
The delay in the incorporation of medicines into the system is, together with the waiting lists for specialist consultations and for surgical interventions, one of the best tools to measure the real state of health of a health system. In both cases, Spain is at record levels, which has led many experts to warn of the deterioration that the system is experiencing. For some, this deterioration is already irreversible, in view of the financial insufficiency that plagues the system and the zero prospects of the Government deciding to inject more funds into Health.
Another patient, Mari Ángeles Martín, explained that “many of her colleagues are selling even their second homes, leaving their families with almost no assets to pay for this treatment,” in statements also collected by Ep. According to her data, the medication “costs around 5,500 euros and they need it every 21 days.”
According to Ep, Martín also pointed out that patients with metastatic breast cancer represent around 25% of breast cancer patients, and that another 20% of primary cancer patients develop metastatic breast cancer over the years. In this regard, he highlighted the number of deaths from this pathology that could be avoided with the help of treatment and that, however, continue to occur while public bodies and pharmaceutical companies agree on aspects such as indications or prices. “Every day, we lose 18 colleagues, 6,500 a year, due to metastatic breast cancer.”
The latest analysis commissioned by the European pharmaceutical industry (Efpia) reveals that new medicines are taking 276 days longer to arrive than when Pedro Sánchez came to power after the motion of censure against Mariano Rajoy.
The European report also reveals that more than half of the drugs that obtain funding in Spain do so with restrictions regarding the indications for which they can be prescribed. A percentage that has also increased in the last two years and that leaves us in a bad position compared to countries such as Germany, where 99% of drugs are funded, Italy (80%) or France (65%).