Last-resort antibiotic excluded from Belgian system, testing EU pharma reforms
The problem goes far beyond Belgium. The inability to secure access to cefiderocol reflects a broader European market failure in valuing and funding last-resort antibiotics.
'The fight against antimicrobial resistance (AMR) is a spearhead of your policy and was a priority during the recent Belgian EU presidency,' MP Irina De Knop (Open VLD) told Health Minister Frank Vandenbroucke in the Belgian Parliament on 15 July, addressing the issue.
'The challenge lies not only in preventing resistance but also in ensuring access to scarce, new antibiotics that serve as last-resort treatments.' First-in-class antibiotic Cefiderocol is not a generic antibiotic. It is a first-in-class, patented siderophore cephalosporin developed by Shionogi, approved in the EU in 2020 under the name Fetcroja®.
Specifically engineered to treat carbapenem-resistant Gram-negative bacteria such as Acinetobacter baumannii and Pseudomonas aeruginosa , it penetrates bacterial defences by hijacking iron uptake pathways.
Its novel mechanism and limited target population make it difficult to assess using traditional volume-based pricing and reimbursement models designed for high-volume generics.
Cefiderocol targets 'superbugs' identified by the World Health Organisation (WHO) as priority pathogens and is intended for an estimated 200 patients per year in Belgium, typically those with no remaining treatment options.
'Precisely because of this limited target group, it is hardly commercially viable,' said De Knop. 'The societal value of reserve antibiotics lies not in frequent use, but in their availability. This leads to a 'broken market' that threatens innovation and sustainable access.' Cost and safety criteria Minister Vandenbroucke confirmed that Belgium's reimbursement process for cefiderocol ended without a deal.
'We went far to reach an agreement, especially for those 55 patients,' he said.
'But apparently, even with far-reaching proposals, we could not meet the company's demands. The requested price is more than double that of the most expensive reimbursed late-line antibiotic.'
Citing limited clinical evidence and safety concerns from one comparative trial, the minister explained that the antibiotic is classified as a true last-line option and must be kept outside the hospital's regular reimbursement system due to its high cost.
'In the absence of strict prescription controls, there's a risk it would be used too broadly, potentially accelerating resistance to this last-resort treatment,' he warned.
While Belgium is monitoring EU-level initiatives, including push and pull incentives and alternative financing mechanisms, the minister acknowledged: 'There are currently no concrete plans to introduce a subscription financing model like in the United Kingdom.' Company calls for pan-European rethink The product's manufacturer, Shionogi, told Euractiv that Belgium's decision reflects a systemic issue across Europe.
'Reserve antibiotics play a vital role in treating infections caused by multidrug-resistant (MDR) pathogens, often when no other options remain,' the company said.
'Although used in very small patient populations, these antibiotics offer immense public health value, yet current reimbursement systems are not designed for low-volume, high-importance medicines.'
The company cited remarks made by Minister Vandenbroucke during an AMR conference held under the Belgian Presidency of the Council in June 2024:
'Look at antibiotics: they should not be used too much. However, some of them have to be ready as soon as you need them. For that, you need a different kind of financing, almost like a subscription to a streaming service.'
'These initiatives, including the 'streaming service' model referenced by Minister Vandenbroucke, are aligned with G7 health priorities and show how sustainable innovation and access can go hand in hand,' the company said.
Shionogi confirmed participation in delinked funding pilots:
'Yes. Shionogi is actively participating in the UK's NHS AMR Subscription Model, which pays for antibiotics based on their value to the health system, not the volume used. We were also involved in Sweden's national pilot and are engaged in discussions with HERA on similar approaches.'
'We recognise that European countries have unique needs. In Belgium, as across Europe, we're always open to solutions that deliver timely access for patients, reward responsible use, and make continued innovation in antibiotics possible,' the company's CEO Huw Tippett told Euractiv. A test case for the EU's Pharmaceutical Package Despite Belgium's efforts to strike a deal, MP De Knop warned that the lack of reimbursement leaves patients at risk.
'The result remains that this antibiotic, which is particularly important for a small group of people, is currently not reimbursed,' she said. 'You also did not present an immediate solution,' pointing to the minister.
Belgium plans to introduce 'early and fast access' procedures by 2026, but currently lacks a dedicated funding stream for reserve antimicrobials. With no viable market and limited public procurement tools, cefiderocol has become a test case for Europe's broader pharmaceutical policy agenda.
Antibiotic incentives are central to the EU's Pharmaceutical Package, currently under negotiation. The European Commission has proposed transferable exclusivity vouchers and pull incentives to stimulate antimicrobial innovation, though these remain politically contentious.
Under the Belgian Council Presidency in June 2024, EU health ministers adopted Council conclusions calling on the European Commission and Member States to 'explore alternative reimbursement models, such as subscription-based schemes,' and to strengthen 'EU-level coordination to ensure sustainable access to critical antimicrobials.' These conclusions were part of the strategy paper 'The Future of the European Health Union: a Europe that cares, prepares and protects.'
While often associated with generic shortages, the proposed Critical Medicines Act also introduces tools such as joint procurement, strategic stockpiling, and EU-wide demand coordination, all of which could be applicable to patented, last-resort antibiotics like cefiderocol.
[Edited by Vasiliki Angouridi]
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A critical antibiotic designed to treat infections caused by multidrug-resistant bacteria will remain unavailable through Belgium's reimbursement system after negotiations between the government and the manufacturer failed. The problem goes far beyond Belgium. The inability to secure access to cefiderocol reflects a broader European market failure in valuing and funding last-resort antibiotics. 'The fight against antimicrobial resistance (AMR) is a spearhead of your policy and was a priority during the recent Belgian EU presidency,' MP Irina De Knop (Open VLD) told Health Minister Frank Vandenbroucke in the Belgian Parliament on 15 July, addressing the issue. 'The challenge lies not only in preventing resistance but also in ensuring access to scarce, new antibiotics that serve as last-resort treatments.' First-in-class antibiotic Cefiderocol is not a generic antibiotic. It is a first-in-class, patented siderophore cephalosporin developed by Shionogi, approved in the EU in 2020 under the name Fetcroja®. Specifically engineered to treat carbapenem-resistant Gram-negative bacteria such as Acinetobacter baumannii and Pseudomonas aeruginosa , it penetrates bacterial defences by hijacking iron uptake pathways. Its novel mechanism and limited target population make it difficult to assess using traditional volume-based pricing and reimbursement models designed for high-volume generics. Cefiderocol targets 'superbugs' identified by the World Health Organisation (WHO) as priority pathogens and is intended for an estimated 200 patients per year in Belgium, typically those with no remaining treatment options. 'Precisely because of this limited target group, it is hardly commercially viable,' said De Knop. 'The societal value of reserve antibiotics lies not in frequent use, but in their availability. This leads to a 'broken market' that threatens innovation and sustainable access.' Cost and safety criteria Minister Vandenbroucke confirmed that Belgium's reimbursement process for cefiderocol ended without a deal. 'We went far to reach an agreement, especially for those 55 patients,' he said. 'But apparently, even with far-reaching proposals, we could not meet the company's demands. The requested price is more than double that of the most expensive reimbursed late-line antibiotic.' Citing limited clinical evidence and safety concerns from one comparative trial, the minister explained that the antibiotic is classified as a true last-line option and must be kept outside the hospital's regular reimbursement system due to its high cost. 'In the absence of strict prescription controls, there's a risk it would be used too broadly, potentially accelerating resistance to this last-resort treatment,' he warned. While Belgium is monitoring EU-level initiatives, including push and pull incentives and alternative financing mechanisms, the minister acknowledged: 'There are currently no concrete plans to introduce a subscription financing model like in the United Kingdom.' Company calls for pan-European rethink The product's manufacturer, Shionogi, told Euractiv that Belgium's decision reflects a systemic issue across Europe. 'Reserve antibiotics play a vital role in treating infections caused by multidrug-resistant (MDR) pathogens, often when no other options remain,' the company said. 'Although used in very small patient populations, these antibiotics offer immense public health value, yet current reimbursement systems are not designed for low-volume, high-importance medicines.' The company cited remarks made by Minister Vandenbroucke during an AMR conference held under the Belgian Presidency of the Council in June 2024: 'Look at antibiotics: they should not be used too much. However, some of them have to be ready as soon as you need them. For that, you need a different kind of financing, almost like a subscription to a streaming service.' 'These initiatives, including the 'streaming service' model referenced by Minister Vandenbroucke, are aligned with G7 health priorities and show how sustainable innovation and access can go hand in hand,' the company said. Shionogi confirmed participation in delinked funding pilots: 'Yes. Shionogi is actively participating in the UK's NHS AMR Subscription Model, which pays for antibiotics based on their value to the health system, not the volume used. We were also involved in Sweden's national pilot and are engaged in discussions with HERA on similar approaches.' 'We recognise that European countries have unique needs. In Belgium, as across Europe, we're always open to solutions that deliver timely access for patients, reward responsible use, and make continued innovation in antibiotics possible,' the company's CEO Huw Tippett told Euractiv. A test case for the EU's Pharmaceutical Package Despite Belgium's efforts to strike a deal, MP De Knop warned that the lack of reimbursement leaves patients at risk. 'The result remains that this antibiotic, which is particularly important for a small group of people, is currently not reimbursed,' she said. 'You also did not present an immediate solution,' pointing to the minister. Belgium plans to introduce 'early and fast access' procedures by 2026, but currently lacks a dedicated funding stream for reserve antimicrobials. With no viable market and limited public procurement tools, cefiderocol has become a test case for Europe's broader pharmaceutical policy agenda. Antibiotic incentives are central to the EU's Pharmaceutical Package, currently under negotiation. The European Commission has proposed transferable exclusivity vouchers and pull incentives to stimulate antimicrobial innovation, though these remain politically contentious. Under the Belgian Council Presidency in June 2024, EU health ministers adopted Council conclusions calling on the European Commission and Member States to 'explore alternative reimbursement models, such as subscription-based schemes,' and to strengthen 'EU-level coordination to ensure sustainable access to critical antimicrobials.' These conclusions were part of the strategy paper 'The Future of the European Health Union: a Europe that cares, prepares and protects.' While often associated with generic shortages, the proposed Critical Medicines Act also introduces tools such as joint procurement, strategic stockpiling, and EU-wide demand coordination, all of which could be applicable to patented, last-resort antibiotics like cefiderocol. [Edited by Vasiliki Angouridi]
