Quick and affordable patient access to innovative medicines remains an issue in many countries including the Netherlands, reports a new study.
Rising healthcare spending is often attributed to an ageing population coupled with the high costs of innovative medication. In the Netherlands, where life expectancy has risen to 80.6 years, the healthcare system needs to be prepared to deal with an increase in the incidence of diseases associated with older age.
While innovative medicines can treat these ailments, cost and access factors remain challenging.
While pursuing his PhD with the Erasmus University Rotterdam, Renaud Heine was surprised to find that great differences in access to innovative medicines persist between EU member states.
Heine told Euractiv that “even in high-income EU member states, time to market is increasing. One of the factors impacting access is the pricing of innovative medicines and the resulting negotiations that might lead to managed entry agreements.”
Balancing act
According to Heine, European countries are finding it harder to strike a balance between the benefits and costs of novel cancer drugs.
He highlights that new anticancer drugs have led to a rise in pharma spending in both the EU and the US. One estimate for 2023 was that the global pharmaceutical market would exceed $1.5 trillion – with half of it going towards specialty pharmaceuticals that include oncology pharmaceuticals.
The Netherlands has implemented a more cyclic decision-making process, says Heine, repeatedly using market entry agreements (MEAs) to regulate the costs of expensive oncology pharmaceuticals.
MEAs are usually financial or performance-based. The former aims to manage the uncertainty of the budgetary impact of new drugs, while the latter aims to reduce uncertainty surrounding their effectiveness.
Chimeric antigen receptor (CAR) T-cell therapy, for example, is used to treat certain leukaemias and lymphomas and is among one of the most expensive cancer treatments. In the Netherlands, publicly available data for two types of treatment show that their listed price ranges between €320,000 and €327,000.
Conditional reimbursement
Based on their list price, Heine estimated the expenditure for CAR T-cell therapies for current and certain future indications in different scenarios from 2019 to 2029 to be €1.4 billion in the Netherlands.
For comparison, the figure grew to €6.7 billion in neighbouring Germany.
Heine warns that the price of the therapy is associated with a high degree of uncertainty and that most of the actual prices are confidential.
His best estimate for the price of CAR T-cell therapies for future indications was €323,500 per treatment.
“New expensive treatments such as CAR T-cell therapy can considerably impact health expenditure. Therefore, caution is needed when reimbursing these innovative treatments,” Heine said.
He suggests that reimbursement could be made conditional on certain endpoints being met, ensuring that if the long-term effects are not as predicted, the risk is jointly shared by payers and manufacturers.
In his study, Heine noted that some hospitals are exploring the possibility of creating their own CAR T-cell treatments. In Germany and the Netherlands, this could bring costs down to €80,000 per treatment.
While the Netherlands and Germany are reimbursing CAR T-cell therapies, Eastern Europe is struggling to do the same, with many patients currently lacking access to these promising therapies, Heine said.
Nonetheless, Heine found that even in countries like Germany and the Netherlands, CAR T-cell therapies place a large financial burden on their healthcare systems. Costs for patient care before and after the treatment is given are also reimbursed insufficiently.
“Combined with the expected expansion of indications, the financial burden on health care systems will increase substantially with direct effects on patient access to these new treatment options,” Heine wrote.
International reference pricing
While the Netherlands has managed to keep pharmaceutical spending as a percentage of healthcare spending low, Heine believes the country’s main challenge is to remain attractive as a market for new launches while providing access to patients without crowding out other care.
The researcher pointed out that price confidentiality does hamper research focusing on pricing differences. However, he acknowledged that these market entry agreements also facilitate access to innovative medicines for patients who need them.
“If perfect transparency on pricing is to be achieved, countries would need to stop using international reference pricing or be ready to access uniform prices across EU member states,” Heine told Euractiv.
[Edited by Vasiliki Angouridi, Brian Maguire]
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