Prioritizing funding decisions can accelerate access to oncology innovation

Access to innovative treatment methods is one of the main unresolved problems in oncology. For this reason, as part of the CANCER NOW Initiative’s Annual Patient Meeting, participants in the roundtable on “Access to Innovation and Equity in Treatment” sought to analyze the current scenario and possible formulas for reducing time to treatment. availability.

Pedro Pérez Segura, Secretary of the IVF Foundation and Head of the Medical Oncology Service at the San Carlos Clinical Hospital (Madrid), was responsible for moderating this part of the day. To put the debate into perspective, he noted that “currently available treatments are becoming increasingly effective, and therefore the ability to access these medications has a major impact on patients’ life expectancy and quality of life.” “This is the axis that drives us, given the situation we are in,” agreed Begoña Barragán, president of the Spanish Group of Patients with Cancer (GEPAC). For this reason, participants in this table considered areas that could be improved to ensure access and equity.

Delays in availability

According to the latest data from the WAIT Report, which analyzes availability in the European Union, 57 percent of approved oncology drugs are available in Spain, and the time to availability was 611 days, an increase compared to the previous year. “This is unacceptable because cancer cannot wait, patients die; For those diagnosed with cancer, if a drug is proven to be effective and safe, it should be available immediately,” Barragán said. Likewise, the GEPAC President noted that “there must be a sustainable system, but the economic figure that reflects the value of a drug cannot be subordinated to people’s lives.” For this reason, he suggested that “another thing would be that after the drug is approved, there will be a review or economic analysis.” But Barragán was blunt, saying that “if the EMA approves the drug, it should be funded for all indications.”

Regarding approvals and sustainability of the National Health System (SNS), Xavier Badia, health economist and director of the journal Economía de la Salud-EDS, explained that one of the keys to speeding up this process is to prioritize funding decisions. “Cancer should be a priority primarily because of unmet survival needs,” he noted. On the other hand, he stressed that “in addition to prioritizing cases, it is necessary to have more resources and more people involved in assessment so that the process moves faster.”

Pilar Fernandez, President of the Spanish Association of Metastatic Breast Cancer (AECMM), spoke about therapeutic positioning (IPT) reports. “We get IPTs and file charges, but it lengthens the timeline because there is no specific period for these reports; IPT assessment resources should be better managed,” he said.

And, as Luis Miguel de la Fuente, President of EUROPACOLON, has shown, these delays in access mean that some patients are “open”. “We met with AEMPS to discuss treatments for mutations such as BRAF V600E, which affects 6 to 8 percent of patients with metastatic colorectal cancer, and without this option they are defenseless,” he noted. “If the European Commission approves a treatment, and there are reports of evidence from neighboring countries such as France or Italy that the medicine is more effective compared to an alternative treatment, what reason could there be for rejecting this option?” , stated. For this reason, he pointed out that “if it is about money, we will have to increase the percentage of GDP that is allocated in our country.” In this regard, he stated that “cancer treatment is very expensive, and there are many people with various neoplasms, but there will be more and more of them, because the increase is expected until there is a third of people over 65 years of age.” you have been diagnosed with cancer.”

Inequality between territories

From the public, Alfredo Carrato (IVF Foundation) called for “reducing the time, as is happening in countries like Germany.” But Javier Badia reminded that on a practical level, “no country innovates immediately.” Despite this, he emphasized that “Germany implements the innovation within 10-20 days and evaluates in the meantime until a year later they make a decision based on the information provided about the drug.” But he said that “there is no European country that does not have barriers.”

“To change times, you need to change the way you do things; We should have more evaluators who can analyze the problem faster. We must remember that conducting IPT cannot take six months because we need to save time and this is if the time of IPT was limited to two months and if the meeting takes place after six months, the drugs will be available sooner,” Badia explained. In short, Badia concluded that “regulators must look for ways to build a system that reduces time.”

Alicia Gil of Omakase Consulting said another challenge could be information gathering. “We have to look at what is recorded in patient records because one autonomous community may record the impact of treatment on quality of life and another may not,” he said.

Revaluation

“There are a lot of bureaucratic barriers to accessing innovation,” lamented de la Fuente. And he said that “it is necessary to break down barriers and obstacles.” “If the EMA approves, AEMPS will make its decision…there will be no need for subsequent assessments; If efficacy and safety have been demonstrated, pricing and reimbursement formulas must be sought directly,” he said. “In addition, after the European, national and regional decision, we will have to wait until it reaches the hospital and its management makes a decision,” he added.

For his part, Badia emphasized that “in Spain, when a medicine is approved by the central administration, there are different deadlines depending on the Autonomous Community.” So, in his view, part of the solution would be to “try to reach an agreement between the parties and do it as quickly as possible.”

“In January 2025, the implementation of the new European Health Technology Regulation (HTAR) will begin and this could help speed up access to medicines, since, as planned, patients and professionals will have something to say,” recalled Pilar Fernandez. Here, the AECMM President emphasized that “this will avoid repetitive and ineffective assessments at the national, regional and local levels.”

Diagnostics and clinical trials

Another thing Fernandez mentioned is diagnosis. “When we talk about access, we are talking not only about drugs, but also about molecular diagnostics, identifying mutations or overexpression of certain proteins,” he clarified. In this regard, he estimated that “precision medicine in general is not developed in Spain, to achieve this goal it is necessary to create a network of precision oncology centers, because from the point of view of biomarkers there is no regulation that would support their evaluation, financing and implementation.” In this regard, Pedro Perez Segura recalled that “there is already a document from the Ministry of Health so that there are minimums in terms of diagnostics, which means that there will be regions that will do even more tests. But here, according to him, the question arises “to see.” how is this adaptation financed, because there may be autonomous communities that will have to buy equipment from scratch.” To highlight the importance of these tests, De la Fuente noted that “doing a biomarker test could mean finding a treatment that will save patients’ lives or reduce numerous side effects effects.”

On the other hand, Fernandez mentioned another aspect of cancer treatment. “Beyond equal access to innovation, we have another unresolved issue: access to clinical trials.” Regarding them, he emphasized that “they have undergone great evolution and have provided great help, especially in patients with metastatic disease, where time and treatment options are limited.” From his point of view, “they are too centralized”, and although he believes that “they cannot be in all hospitals, they should cover all autonomous communities or at least make logistics easier for patients.” On this point, Pérez Segura believes that “it is very important to facilitate access to clinical trials, because although the promoters usually cover the costs, the cases are becoming more complex and require highly targeted drugs, so many clinical trials are being carried out. different treatment methods.”

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