Analyses

The costs associated with cancer care keep on rising¹. As cancer represents the second most important cause of death and morbidity in the European region², the financial sustainability of its care can be a significant challenge to all health systems, even in the most affluent countries. Overall, the OECD estimates that cancer care-related health expenditure per capita will rise by 59% until 2040³, making rethinking cancer care financing in Europe a priority.

Although the cost increase in cancer care is multifactorial, for example linked to the increase in the number of people affected by cancer, the rise in the price of oncology medicines has been considered the most significant factor¹. It is estimated that between 2005 and 2018, the cost of cancer care medicines has increased by 220%, with other healthcare costs representing a 4% increase¹. It is also the cause of significant disparities in Europe with, for example, Germany reporting coverage for all approved cancer medicines with a high clinical benefit, while Cyprus and Latvia report coverage for only a third of these same medicines².

These increasing financial burdens can come at heavy opportunity costs for already strained healthcare systems. Simultaneously, they can also exacerbate financial hardship in people affected by cancer⁴; not only can this lead to poorer adherence to treatment, but can also lead to an overall negative impact on the health of people affected by cancer and their families. 

Reimbursement mechanisms for cancer medicines vary widely in the region, causing significant disparities in access across Europe not just in terms of which medicines are available or not and at what cost, but also in terms of timeliness. A commonly used indicator is to look at the time between obtaining the European marketing authorization and public reimbursement at the national level. Although this is not a comprehensive measure that enables perfectly accurate comparisons of timely access to medicines across countries, it provides an important basis for discussion. According to the EFPIA WAIT Indicator Survey, it takes on average 1.6 years for oncology medicines to go from EU marketing authorization to being available in national reimbursement lists, but this number also ranges from 3.6 months in Germany to 2.6 years in Lithuania⁵.

Hence, gaining a better understanding of reimbursement mechanisms is crucial to effectively address the cancer burden on the population’s health, while also mitigating the rise of health expenditure and ensuring the health system’s financial sustainability. In this deep dive article we explore how Belgium and Slovakia revisited existing reimbursement mechanisms to improve access to cancer medicines: i) in Belgium improving reimbursement procedures for childhood cancer medicines was deemed a priority, ii) while Slovakia tried to increase the timely access to innovative cancer care medicines.

Belgium guaranteed public coverage for over 50 essential childhood off-label cancer medicines

It is widely known that paediatric cancer medicine development often falls behind adult cancer treatments, with international recommendations relying frequently on adult guidelines⁶. Some factors associated with this are the overall low number of potential users alongside the need to develop medicines carefully taking into account age and stage of children’s development. 

As a result, a study in Belgium found that one-fourth of all children affected with cancer are treated with off-label medicines, meaning with medicines indicated for adults, but with an adapted paediatric dosage still not approved⁷. Off-label medicines are not reimbursed in Belgium, which leads to an extra financial burden on families of children affected with cancer that can represent up to EUR 1.12 million per year in the country. This extra financial burden can lead to unequal access to essential cancer care and to a widening of pre-existing health inequalities across families.

To address this gap, a multistakeholder collaboration launched by a non-governmental organization (Kickcancer) took place in Belgium. In 2024, all relevant stakeholders including representatives of the Ministry of Health, the national health insurance, paediatric oncologists, industry representatives, and civil society actors got together to discuss the reimbursement of off-label ongology medicines for children. This event and its successive discussions, led to the establishment of a list of 50 essential childhood cancer medicines to be included for public coverage, with the aim of alleviating the financial burden of families.

Kickcancer acting as a bridging voice between the critical needs for patients, families, and health professionals, and the concerns on resource sustainability from policy-makers and the health insurance system, was key to successful discussions. Another key component of this initiative has been the establishment of a monitoring committee to oversee its implementation and uphold its quality and efficiency. In addition, only accredited cancer centres have been able to access this funding. The national health insurance (INAMI/RIZIV) is dedicating a budget of EUR 3.2 million per year for this initiative that is running for a temporary period of three years (2024–2026)⁸.

Beyond the national reimbursement of off-label cancer medicines, other initiatives at the EU level are ongoing to encourage the development and submission for regulatory approval of paediatric formulations, such as the mandatory development of paediatric investigation plan (PIP) for any new medicine or indication in the European Economic Area⁹. Nonetheless, these initiatives show mix results, with too many medicines still lacking approved paediatric indications¹⁰, and some experts raising concerns on the feasibility of such initiative¹¹. 

Slovakia made the most of legislative amendments to streamline innovative cancer medicines reimbursement

Barriers to the use of innovative cancer care medicines have been identified for several years as an issue in Slovakia, with studies calculating an average of five to seven years of delay in innovation compared to the EU average^12,13. The reimbursement mechanism was often mentioned as inefficient, with an inflexible QALY threshold for evaluating new medicines in addition to being a long and bureaucratic process.

To address this gap, Slovakia created stakeholder consulting groups to support the preparation of legislations, which aimed at streamlining the reimbursement decision-making process and transforming it into a more adaptable and fit for purpose process. This was thought as a key step to make innovative cancer medicines more widely available in a timely manner throughout the country. 

Beyond a strong political commitment, consultations with all stakeholders and transparent decision-making was key, especially to ensure the success of the extensive negotiations that were required to align stakeholders’ diverse interests.

The legislation was passed in August 2022 and included the collection of data on costs to continue the monitorization and evaluation of the sustainability of future decisions. Since then, this national approach has been considered a success with relevant stakeholders claiming it has contributed to greater accountability and transparency in reimbursement mechanisms, as well as more frequent use of innovative cancer medicines, more tailored to patients’ needs, with an increased number of innovative cancer medicines now in the reimbursement scheme (14 new medicines reimbursed in 2024 compared to 1 in 2021, for example). This more streamlined and transparent approach also helped to shorten waiting times for patients to receive medication (medium time to availability went from 706 to 413 days), decreasing inequalities in access to treatment as well¹⁴. 

Nonetheless, concerns linked to the financial sustainability of public reimbursement in Slovakia remain, particularly in regards to the rising cost of innovation. These concerns are shared by many countries across the EU, and cost-related inequalities across the region are further challenged by a general lack of transparency in medicines’ pricing^15,16. 

An evidence-based approach to reimbursing cancer care medicines is crucial to decrease opportunity costs

Deciding which medicines are publicly covered must take into account patients needs and the cancer burden across its population, but also needs to balance health systems’ resource limitation through the use of thorough analysis on added clinical benefits and cost-effectiveness. The development of new cancer treatments do not always represent cost-effectiveness and added benefits for the population^1,17. The benefits of a new medicine can indeed be marginal, but for a dramatically higher price, especially in a market as lucrative as oncology treatments where there are significant incluences from the private sector¹⁸. In Slovakia, for example, consultation of stakeholders led to well-balanced improvements of the amendments proposed to lawmakers, to better take into account patients’ needs in the decision process. In Belgium, gathering all stakeholders on the topic of coverage of childhood cancer treatments was key to ensure a strong political commitment and enable collaboration towards concrete solutions for patients and their families. 

In both country examples, monitoring and evaluation systems have been implemented to address the needed balance between affordability for the health system (and overall country budget) and the needs of people affected by cancer. This will most likely prove to be a difficult balance as cancer-care related health expenditure is estimated to keep on rising, leading to a constant need to address and think about the long-term financial sustainability of these measures. 

One answer could lie at the EU level, by fostering cooperation and regulatory/purchasing processes at a larger scale. An example of this coordinated approach has been the EU-wide COVID-19 vaccine joint procurement strategy in 2020 that led to the purchase of several billion doses, ensuring security of supply and more negotiating power for member states. Another example of such an approach is the EU HTA Network, which aims to streamline health technology assessment processes across the EU to promote informed decisions on pricing and reimbursement for Member States.

Civil society can play a significant role, and its participation in decision-making is impactful 

Whether initiatives are top-down (i.e. Slovakia) or bottom-up (i.e. Belgium) approaches, the involvement of all stakeholders, including the civil society, in the decision-making process is a strong asset to effective change. 

The initiative to address paediatric cancer care gaps in Belgium was started by a non-governmental organization, representing the needs and voices of patients and families affected by childhood cancer. The success of this initiative illustrate how a greater inclusion of the voices of people affected by cancer in decision-making processes can be a strong enabler to gathering different stakeholders to the table, while also highlighting unmet needs to policymakers. The concept of a patient’s voice in this context relates to the notion that the citizen is actively involved with the healthcare system and is an active stakeholder in decision-making. As such, how citizens/patients interact with the overall healthcare system and are involved in the delivery and quality assurance of their own care is at the heart of the concept of co-production in health. In the case of Belgium, this was key to represent the unequal access to treatment and financial impact in families and kickstart such a wide collaboration across state, commercial and healthcare sector actors. 

Co-production in healthcare goes beyond the inclusion of people affected by cancer. It also holds space for different professionals across healthcare and other sectors and the collaboration of wider communities, emphasizing the importance of including different perspectives and expertise as well as acknowledging that for impactful measures often there is the need for input and support of different stakeholders^21,22. In Slovakia, the establishment of consulting groups involving the voices and expertise of many different stakeholders was crucial to achieving an ambitious and robust reform of legislation.

The examples from both countries show that initiatives require the input and collaboration of different stakeholders in an active effort, but representativeness from state, to private sector, to civil society, can lead to not just more ambitious changes, but also to successful initiatives. 

Conclusions 

Both examples showcased in this article highlight an increasingly more difficult challenge: cancer care medicines are notoriously getting more expensive, all while cancer burden keeps on rising in the European region. Revisiting cancer care reimbursement mechanisms can be an important component of the wider national strategies to address cancer care costs. Making these mechanisms more transparent and suited to population needs and to innovative medicines is key as cancer care is a rapidly evolving field.

Evidence-based decision-making, which relies on transparent monitoring and evaluation mechanisms, is key to success. While there is not one single way for co-production of new policies, many European countries are successfully experimenting and implementing new approaches to policy change, showing that there is a strong argument for cross-country learning and sharing of lessons learnt.