Spain Prioritizes Clinical Benefit Over Efficiency in Funding New Cancer Drugs

Funding for new cancer drugs in Spain is primarily guided by the substantial clinical benefit they demonstrate and the inclusion of data on patient quality of life, while efficiency (cost-utility) and the degree of innovation do not appear to be determining factors. This was the main conclusion of the empirical research presented at the virtual conference organized by Funcas on Thursday, November 27th, 2025, dedicated to discussing the timeliness with which innovative drugs reach Spanish patients .

The meeting, moderated by Félix Lobo , professor emeritus at Carlos III University of Madrid and director of Health Economics and Policy at Funcas , served as a platform to highlight that the debate on access to innovative medicines is a recurring theme in Spain and Europe. Lobo himself pointed out that, despite the “very intriguing” differences in funding between European countries, the response to whether innovative medicines are made available to patients in Spain is “quite positive.” However, he admitted that the average time in Spain until public funding is decided is “undoubtedly quite long,” estimated at 452 days for the period 2020-2023.

The economist also highlighted that the differences in the time it takes for drugs to be incorporated into the market are partly explained by the fact that not all medicines authorized by the European Medicines Agency (EMA) are strictly innovative, which, he said, can generate “confusion.” He further explained that the system in Spain is conditioned by the economic constraints operating in international pharmaceutical markets, where price reference mechanisms make it difficult for companies to differentiate prices, which particularly impacts lower-income countries.

The quality of the evidence is crucial

The session continued with presentations of research conducted by Celia Castaño Amores and Pelayo Nieto Gómez , specialists in Hospital Pharmacy at hospitals within the Castilla-La Mancha Health Service ( Sescam ). Castaño Amores presented the conclusions of a study analyzing “the factors influencing the decision to fund cancer drugs in Spain” and concluded that substantial clinical benefit increases the likelihood of a cancer drug receiving funding. The researcher clarified, however, that “more than two-thirds of the indications that did not have substantial clinical benefit were funded.” This included funding for 24 indications considered to have “insignificant” clinical benefit, whose average incremental cost amounted to almost €115,000 per quality-adjusted life year.

In addition to the clinical benefit, the study found that the lack of quality-of-life data in clinical trials decreases the likelihood of funding by approximately 15 percentage points. The expert lamented that, despite quality of life being an important factor for cancer patients, this data was only presented in 46 percent of the trials.

The researchers also revealed that funding decisions have changed over time in Spain. While between 2010 and 2015, 100 percent of indications were funded, in the 2020-2023 period , only slightly more than 68 percent received a positive decision. This change was largely attributed to the fact that in the latter period there has been a very high number of authorizations with a significant budgetary impact , which could be delaying the decision-making process.

Efficiency and Cost-Utility in Spain

Regarding efficiency, measured through cost-utility analysis, the research determined that this factor does not appear to have a clear relationship with financing decisions. According to Castaño Amores , this finding suggests that in Spain, efficiency is not a priority guiding decision-making, unlike in other countries such as the United Kingdom or Canada.

Regarding the timelines, Pelayo Nieto Gómez presented the conclusions of his study, which demonstrated that drugs with more robust evidence , such as those with Phase III trials and data on quality of life and overall survival , resulted in faster decisions. This suggests that the quality of evidence is a factor that directly influences access times. Nieto Gómez explained that the lack of publicly available information on the initial price requested by companies or on funding proposals hinders the analysis, indicating that, since this information is not available, “estimating the budgetary impact of so many indications is quite a complex task, so we could not include it ” in the study.

Ana Ortega’s Ten Commandments

The event included remarks from Ana Ortega, president of the Advisory Committee for Pharmaceutical Benefits Financing (CAPF), although she clarified that her participation was in a personal capacity. Ortega stated that the fundamental challenge is ensuring that, within a reasonable timeframe, “medicines that provide value reach patients,” a process that requires sound decision-making and sufficient time . The expert criticized the fact that financing medicines with the same resources but offering fewer benefits than other alternatives incurs an opportunity cost, which translates into “loss of health for patients.”

To improve this situation, Ortega proposed a series of actions. First, she explained, it is essential to try to reach a consensus on the definitions of concepts and criteria such as additional clinical benefit, innovation, therapeutic alternatives, and unmet need, as well as to determine how all funding criteria are considered in decision-making.

Furthermore, the establishment of a provisional accelerated funding system should be considered for those medications that meet the criteria for high clinical benefit. On the other hand, the CAPF advocated for creating spaces for dialogue among all stakeholders (patients, professionals, industry, and government) and promoting studies that analyze this data to determine the current direction.

Finally, Ortega defended the need to allocate resources for better evaluation and legislative changes to incorporate improvements, and expressed support for considering opportunity cost and efficiency more broadly, not only when deciding whether to fund something, but also when deciding whether to defund it. In her view, greater coordination should also be sought between evidence generation and responses to the needs of decision-makers and patients.

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(Featured image by Marek Studzinski via Unsplash)

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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