In Europe, healthcare has always been a national responsibility, but with the arrival of gene therapies and other advanced therapy medicinal products (ATMPs), the boundaries of our systems are tested. Or they will be crossed. Literally.
Due to the small patient numbers and the complicated delivery of ATMPs, treatment centers may only be available in some countries. This implies that patients will have to cross borders to get treatment in a treatment center abroad. In Belgium, a change in law was recently adopted, making it possible for ATMPs to be reimbursed and unavailable on the Belgian market. This opens the road for planned cross-border delivery of ATMPs. Are we ready to get our Belgian patients abroad and provide them fair access to ATMP treatment?
“We should start by making a detailed overview of the existing legislative routes arranging planned cross-border healthcare that could be relevant for ATMPs.” I looked behind me, as I was pretty sure my colleague was not talking to me. No one else was in the room then, so okay, no sooner said than done, I started reading legislation and tried to make sense of never-ending sentences in which parenthetical phrases seemed to be the greater good. With the support of legal experts within and outside of Hict, we slowly but surely started finding ends of sentences.
We made an overview of all existing authorization and reimbursement routes and needed to recognize that the maze of the current legislation creates a complex reality. Not only for payers, healthcare providers, and industry but, most disturbingly, also for patients. None of the routes can provide access to ATMP treatment abroad without introducing issues and barriers along the way. If you realize that it often takes years to correctly diagnose patients with a rare disease, the last thing these patients need is to turn around the corner to find another waiting line — this time, the one to get access to treatment. Long story short, we leveraged our overview of existing legislation to reach out to all relevant stakeholders involved: government, patients, sickness funds, pharmaceutical companies, hospitals, and legal representatives.
By bringing all those people together in a room, we wanted to agree at least that there *is* a real problem and that it will occur soon. With the new Belgian law in place, ATMPs for which treatment will not be provided in Belgium will be reimbursed sooner or later. As a society, we should be able to guarantee access to ATMPs that our national government approves for reimbursement, shouldn’t we?
Our real ambition, however, with this roundtable, was to find starting points for practical solutions: Which issues are solvable on a national level? Who is responsible, and who should be involved in tackling the problems?
They say preparation is the key to success. And to that extent, organizing roundtable discussions is like managing a party. When the evening arrives, there’s nothing else you can do other than just let it all happen, hope for the best, and try to enjoy the moment.
The roundtable discussion began, people started talking, and we realized that this discussion went quite well. All participants recognized that real issues were to be solved and thought along within our defined scope. Everyone spoke their mind and did not hold back from challenging each other constructively.
After the agony that followed in writing a report that required us to translate a naturally flowing discussion into a well-designed structure, we managed to take several crucial steps in the right direction. All participants agreed that there are issues to solve and that we need a robust solution tailored to this specific context of ATMPs, where we should focus on uniformity of authorization decisions and affordability for patient and payer. Moreover, our participants saw opportunities to tackle the existing issues, although this might require a new legislative framework.
But we’re not done yet. We cannot wait to continue our efforts and aim to improve access to ATMPs that require Belgian patients to cross borders. Meanwhile, I realize this is one of those projects that make me feel like we’re doing the right thing. That give meaning to the words “optimising healthcare.” That makes me love my job.
Amber Werbrouck is a consultant at Hict where she focuses on HEMAR and Policy projects.
In addition, she works at the Vrije Universiteit Brussel (VUB) as a teaching assistant for the Health Economics course in several master programmes.
Amber attained her PhD in health economics and preventive healthcare policy in 2021 at Ghent University and KU Leuven.
Please find below our summary and the full report.
You can read our reference case here: Cross-border healthcare in ATMPs.