Something fundamental has shifted in market access over the past decade. When I started working at Hict five years ago, I focused on the development of health economic models as part of reimbursement dossiers for new drugs in Belgium. Sixty projects (and one earring) later, less than half of my time is related to health economics; the rest is focused on the broader context of market access, such as putting our heads together with clinical experts and brainstorming on strategy. This evolution is not only due to a natural career pathway in market access towards more strategically oriented projects; we see this trend company-wide. Next to pure health economics, there is an increasing demand to support pharmaceutical companies from early market access planning through to reimbursement. In this post, I’ll share some personal insights on what drove this evolution, and why we can expect that this evolution will continue in the future.
First, there are more first-time launching companies in Belgium who need local strategic support. The share of first-time market entrants has more than tripled over the past decade and this share is expected to keep growing. It’s impressive to see how teams with only a handful of people succeed at launching a treatment simultaneously in the varied price & reimbursement context across European countries. However, their limited resources may put pressure on country customization and planning. Involving local partners with hands-on experience in managing complex price and reimbursement files and with in-depth knowledge of local policy and guidelines is invaluable to successfully localise a dossier.
Next to limited resources, market access in Belgium hasn’t become easier. The introduction of the joint clinical assessment one year ago was a logical step towards a uniform clinical assessment in Europe but introduces new strategic considerations. Population, comparator and outcome definitions have to be considered earlier on in the drug development pathway to ensure successful patient access, and there is limited experience with the integration of the joint clinical assessment report in the Belgian evaluation procedure. The updated Belgian health economic guidelines were also published last year with an increased focus on indirect treatment comparisons and confidential rebates, which poses new challenges to transparent communication of added value in terms of efficacy, safety and budgets.
Another recent observation: there is more support needed for exit strategies in the context of a managed entry agreement. The rise of orphan drugs and ATMPs in combination with the pressure on budgets and transparency forces NIHDI to consider closely which treatments could be applicable for a managed entry agreement, especially since the number of conventions continues to increase (excl. 2020 and 2021 due to impact COVID-19). Having a clear exit strategy from the very start of the negotiations increases the chances of success and could also result in a higher likelihood of definitive listing after a new evaluation procedure at the end of the contract (which is interesting if we look at the clear decrease in number of definitive listings in the MORSE report).
Let’s start with a certainty: the CRM reform going in effect as of January 2027. The CRM will trim down the number of reimbursements procedures from 10 to 3 to create more clarity and faster patient access. Orphan drugs claiming added value will be most affected, since they will no longer be exempt from providing a cost-effectiveness evaluation as part of the reimbursement dossier. It will be essential for pharmaceutical companies to translate the drug’s added value to proper cost-effectiveness modelling, because orphan drugs are often associated with high incremental cost-effectiveness ratios. This will require different types of evidence packages and shift some of the health-economic work forward in the market access process.
The most favoured nation act took shape last year and was broadly discussed at ISPOR Europe in November 2025, but the real impact on European and Belgian pricing will become visible in the coming year. At the time of writing (January 2026), 16 pharmaceutical companies have reached voluntary agreements with the Trump administration to provide MFN pricing on selected products. However, the entire MFN framework currently rests on an Executive Order rather than Congressional legislation. Without statutory backing, the policy’s durability remains uncertain. Will pharmaceutical companies continue voluntary participation? What happens if enforcement intensifies? And how does this impact pricing throughout a treatment’s lifecycle in Belgium?
Other developments I am personally looking forward to are the structured implementation of AI in clinical study design and market access, new initiatives to support real-world data collection (e.g., NIHDI’s Evidence Platform), and the increasing importance of the patient perspective.
My increasing strategic role on top of providing pure health economics support has let me experience first-hand the dynamic environment of Market Access in Belgium. Shifts in global and local regulations require companies to continuously adapt. With all that is coming our way, it remains clear to me that success in market access will require early strategic thinking, stakeholder engagement and continued transparency.
Some personal advice from my side to market access managers: start planning cost-effectiveness early, anticipate the CRM reform and explore real-world evidence platforms before submission.
Hannes has been a HEMAR consultant at Hict for 5+ years working on Health Economics, Market Access, and Reimbursement projects for different pharmaceutical clients.
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