Despite the thriving life sciences ecosystem that has made Belgium one of the top European destinations for clinical trials, the country continues to grapple with considerable access challenges and remains behind many of its European counterparts. In a recent roadmap, the minister of health set out to improve the country’s drug reimbursement system and speed up access to innovation. While local industry stakeholders are optimistic about the reform and how it aims to take into account RWE and the patient voice when making reimbursement decisions, they remain cautious about its implementation.
A European Pharma Bastion … but not for Access
Belgium, one of Europe’s leading clinical trials destinations, boasts a strong life sciences and innovation ecosystem. However, there is a surprising lack of correlation between the country’s place at the forefront of European R&D and its access scenario. “Belgium boasts a strong healthcare system with a good reputation, but access to innovation remains a concern. The bridge from having a fantastic portfolio to ensuring patient access is not a given in Belgium, says Marie-José Borst, GM, BeLux at Roche.
Belgium boasts a strong healthcare system with a good reputation, but access to innovation remains a concern.
Marie-José Borst, GM, BeLux, Roche
While the biopharmaceutical industry has a solid presence in Belgium and the country is home to a network of quality research centres and hospitals along with researchers and regulatory authorities of the highest standard, industry executives feel that the country’s expertise is not reflected when it comes to access to innovative therapies. “Although university centres and physicians have access to research and development through the large number of clinical trials conducted in the country, this is not reflected in the final access for patients,” claims Frederic Clais, country manager at Eli Lilly Belgium.
Behind its European Counterparts
It is a well-known fact that disparities in the time it takes for patients to access new medicines in different EU member states exist, but as one of Europe’s high-income countries, it surprises many that Belgium does not rank higher on the EFPIA’s “WAIT” Indicator survey. “Belgian patients must wait longer than their equivalents in other high-income European countries to access medicines following EMA approval, waiting over 500 days on average and 638 days for orphan drugs,” states Michael Nesrallah, GM at Takeda Belgium.
Belgian patients must wait longer than their equivalents in other high-income European countries to access medicines following EMA approval
Michael Nesrallah, GM, Takeda Belgium
“The harsh reality in Belgium is that only 50 percent of EMA-approved medicines are eventually reimbursed on the market. This percentage is close to 90 percent in Germany. Moreover, the average time to get to this reimbursement is longer than a year, whereas it is a matter of weeks in Germany. [This] leads to the unacceptable situation of patients in Belgium not having the same level of access as their counterparts in other European countries,” confirms Federico Mambretti, country president at Novartis Belgium & Luxembourg.
Reimbursement Challenges and Inefficiencies
Pharma leaders pinpoint Belgium’s drug reimbursement procedure, which for an innovative medicine currently takes 180 days to complete, claiming that it is not only slow, but also complicated. “The evaluation methodology is not always clear,” claims Caroline Ven, CEO of pharma.be, the association of the Belgian R&D-based pharmaceutical industry.
The current product launch experience in Belgium is challenging due to the lengthy reimbursement process
Frederic Clais, country manager, Eli Lilly Belgium
“Overall, the launch of new products in Belgium is heavily dependent on reimbursement. The current product launch experience in Belgium is challenging due to the lengthy reimbursement process,” says Clais.
Industry stakeholders concur that the Belgian system is rigorous, yet remains inefficient. “While the fact that a rigorous efficacy, safety, and quality assessment process exists is a positive – there is significant room for improvement,” states Nesrallah.
Part of the problem is that medicines are not always analysed based on their specific virtues, but on purely budgetary grounds, in Nesrallah’s view. “Belgian healthcare has a fixed budget, and regulators and payers must review medicines both on their individual merits as well as in the context of total spend. There is always a tension between the willingness/ability to pay for a new treatment against existing budget constraints,” he maintains.
Positive Reactions to Reform
The system’s deficiencies have been recognized by the Minister of Health, Frank Vandenbroucke, who last year commissioned the National Institute for Health and Disability Insurance (INAMI) to begin a consultation process with a number of stakeholders, including the pharmaceutical industry. The consultation process took some 20 months and resulted in a series of measures recently presented by the minister and the INAMI’s deputy general administrator, Pedro Facon.
There will be much more external expertise in the evaluation of medicines, greater use of real-world evidence (RWE), and a move towards a value-based evaluation rather than a narrow focus on price alone
Caroline Ven, CEO, pharma.be
Pharma leaders have applauded the government’s willingness to rethink reimbursement and involve the industry. “We have held discussions with the current government on this issue and are convinced that our objectives are aligned. There is a common recognition that a future-proof reimbursement system that can support the introduction of the increasingly complex treatments coming to market, would be highly beneficial. The government has recently released a roadmap with a series of proposals regarding early and fast access as well as a reformatting of the reimbursement system, which we hope will crystalise our shared goals,” Borst affirmed.
Local industry stakeholders also commended the willingness to consider external expertise when evaluating medicines for reimbursement. “The new framework for medicinal policy that the MoH is preparing should lead to a big improvement. There will be much more external expertise in the evaluation of medicines, greater use of real-world evidence (RWE), and a move towards a value-based evaluation rather than a narrow focus on price alone,” claims Ven.
Moreover, the creation of a Health Data Agency will also support the use of RWE by granting companies access to data that was previously siloed. “The current low levels of RWE utilisation lead to greater uncertainty and the requirement for companies to pay higher rebates. Greater RWE use will make it possible for promising medicines to prove their value,” Ven added.
“Hopefully, [the reform] can address the biggest gaps in medical evaluation, which needs to be approached more from a value perspective rather than a cost perspective,” says Clais.
Patient Voice
Apart from taking into account RWE, local pharma leaders have also demonstrated their approval of the reform’s aim to include patients in the reimbursement decision-making process through the creation of a Patient Council. “We are pleased to see positive elements in the roadmap regarding the patient voice that will be better integrated in the reimbursement decision-making process through the set-up of a Patient Council made of different patient groups that the CRM will consult in a regular and structured manner,” Borst maintains.
Cautious Optimism
While the Belgian pharma industry sees the new roadmap as a positive step towards improving access, many stakeholders, including Clais from Eli Lilly, remain somewhat sceptical about how it will be put in place. “The government has committed to improving the evaluation of the value of medical innovation, but it remains to be seen how this will work in practice. This new reform needs to be a commitment from both sides, giving new opportunities to deliver innovation in the Belgian environment,” he says.
We believe this access roadmap is extremely relevant to the future of healthcare in Belgium. However, we will have to wait and see whether this intention becomes a reality
Federico Mambretti, country president, Novartis Belgium & Luxembourg
Mambretti agrees that although the reforms are encouraging, how they will be implemented is still an unknown. “We believe this access roadmap is extremely relevant to the future of healthcare in Belgium. There are some positive signals contained within it. However, we will have to wait and see whether this intention becomes a reality, as there are already several options that exist, but are not currently being converted into practice,” he states.
In addition, in Mambretti’s view, the reform needs to go one step further and recognize the industry for the value it brings. “The pharmaceutical industry and healthcare in general need to be seen for the investments they are. Healthcare is not a cost but rather a driver of economic and health value in society. It cannot be approached solely with the mindset of cost minimization because this will lead to fewer opportunities for patients here to access the medicines they need,” he claims.
