Is Europe Set Up for Equitable Access to Cancer Drugs?

BARCELONA, Spain — The challenges of accessing oncology drugs are not limited to low- and middle-income countries but also affect high-income nations. This was highlighted here by experts at the annual congress of the European Society for Medical Oncology (ESMO). The session, part of the patient advocacy track, aimed to help doctors and patients understand the obstacles that often block the path between the discovery of a new therapy and the patient’s bedside.

Early Access vs Data Robustness

Finding a balance between early access to drugs and robust data is a significant challenge for European regulatory bodies. The issue has been widely debated internationally.

Juan Garcia Burgos, MD, head public and stakeholder engagement at the European Medicines Agency (EMA), discussed this with Univadis Italy, a Medscape Network platform. “Today, the EMA invests heavily in supporting the development of new drugs and in creating a connection between stakeholders,” he explained.

The EMA’s role does not end with the approval of a medicine. It closely collaborates with regional and national health technology assessment bodies from the early stages of drug development to ensure robust data generation. It also supports expediting national approval processes and market entry.

In some cases, the regulatory process can be accelerated. For example, in a disease with significant unmet clinical needs, it may be acceptable to have a greater degree of uncertainty in the data necessary for authorization. In this case, real-world patient experience data (PED), like patient-reported outcomes (PRO), can aid the decision-making process.

“The agency encourages the collection and use of these data, but it is crucial that they are of high quality,” said Garcia Burgos, adding that patients play a fundamental role in all EMA activities. Guidelines on how to generate PED, including PROs, are available, and European Union (EU) regulatory authorities encourage careful planning of this type of data collection. For this reason, the EMA recommends that drug developers engage, through scientific advice, with regulatory authorities from the early stages of their development plans.

Centers of Expertise for Advanced Drugs

Despite stringent requirements, the number of new oncology therapies approved by the EMA each year has significantly increased over the last two decades, from five in 2004 to 15 in 2022, totaling 152 drugs approved during this period. But there has also been a corresponding rise in access inequalities in Europe.

Liora Bowers, MPH, MBA, health policy analyst from the Health Division of the Organisation for Economic Cooperation and Development (OECD), presented data drawn from a working paper titled, “Access to oncology medicines in EU and OECD countries,” which examined various aspects of inequalities in access to oncology drugs, from authorization to market entry to reimbursement decisions and adoption in clinical practice.

As the working paper reveals, the authorization of new drugs or new indications for existing therapies is challenging the reimbursement system in many countries for several reasons, including high costs and the increasing number of new therapeutic options and of cancer patients. The paper’s analysis of 13 indicators for 10 medicines highlights significant differences among OECD countries in terms of reimbursement, from 100% in Germany to 31% in Latvia and Cyprus.

“The fact that a drug has been reimbursed does not imply that it is accessible to the patient,” Bowers said. She also noted differences in the time from EMA approval to reimbursement. In some cases, this ranges from a few days or months in countries like Germany and Sweden, to periods longer than a year.

At the root of these differences are many other factors, such as the timing of reimbursement requests by pharmaceutical companies, which tend to be shorter in countries with higher gross domestic product. Additionally, some countries modify EMA drug indications, sometimes restricting them to reduce the number of patients eligible for treatment and consequently the cost impact. Even conveying information and drugs within medical settings is not straightforward: Each hospital has its budget to adhere to and doctors must be updated on usage guidelines.

In this scenario, how is real equity in access to drugs possible?

“One direction taken in Europe and generally is that of centers of expertise, the only places where some drugs can be prescribed,” Bowers told Univadis Italy, noting that in centers with large patient volumes, expertise can be achieved more quickly, and doctors are often more receptive to new guidelines.

Bowers added that to increase access to the latest drugs, the “cancer system” must be organized in such a way as to prioritize, in the approval processes, drugs that have high value. Enrollment in clinical trials and early access programs are two other possibilities for improving access to new therapies in OECD countries.

Garcia Burgos and Bowers declared no conflicts of interest in relation to the topic discussed.

Cristina Ferrario is a molecular biologist and former researcher in molecular oncology at three institutes in Milan. She has a master’s degree in communication and health from the University of Milan, Milan, Italy, and a master’s degree in cancer genetics from the University of Pavia, Pavia, Italy. She has worked as a science journalist for more than 20 years.

This story was translated, with slight adaptation, from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.