A important antibiotic designed to deal with infections attributable to multidrug-resistant micro organism will stay unavailable by Belgium’s reimbursement system after negotiations between the federal government and the producer failed.
The issue goes far past Belgium. The shortcoming to safe entry to cefiderocol displays a broader European market failure in valuing and funding last-resort antibiotics.
“The struggle towards antimicrobial resistance (AMR) is a spearhead of your coverage and was a precedence in the course of the latest Belgian EU presidency,” MP Irina De Knop (Open VLD) instructed Well being Minister Frank Vandenbroucke within the Belgian Parliament on 15 July, addressing the problem.
“The problem lies not solely in stopping resistance but additionally in making certain entry to scarce, new antibiotics that function last-resort remedies.”
First-in-class antibiotic
Cefiderocol is just not a generic antibiotic. It’s a first-in-class, patented siderophore cephalosporin developed by Shionogi, accepted within the EU in 2020 underneath the identify Fetcroja®.
Particularly engineered to deal with carbapenem-resistant Gram-negative micro organism resembling Acinetobacter baumannii and Pseudomonas aeruginosa, it penetrates bacterial defences by hijacking iron uptake pathways.
Its novel mechanism and restricted goal inhabitants make it tough to evaluate utilizing conventional volume-based pricing and reimbursement fashions designed for high-volume generics.
Cefiderocol targets “superbugs” recognized by the World Well being Organisation (WHO) as precedence pathogens and is meant for an estimated 200 sufferers per yr in Belgium, usually these with no remaining remedy choices.
“Exactly due to this restricted goal group, it’s hardly commercially viable,” mentioned De Knop. “The societal worth of reserve antibiotics lies not in frequent use, however of their availability. This results in a ‘damaged market’ that threatens innovation and sustainable entry.”
Price and security standards
Minister Vandenbroucke confirmed that Belgium’s reimbursement course of for cefiderocol ended with out a deal.
“We went far to achieve an settlement, particularly for these 55 sufferers,” he mentioned.
“However apparently, even with far-reaching proposals, we couldn’t meet the corporate’s calls for. The requested value is greater than double that of the costliest reimbursed late-line antibiotic.”
Citing restricted scientific proof and security considerations from one comparative trial, the minister defined that the antibiotic is assessed as a real last-line possibility and should be saved exterior the hospital’s common reimbursement system on account of its excessive price.
“Within the absence of strict prescription controls, there’s a danger it will be used too broadly, doubtlessly accelerating resistance to this last-resort remedy,” he warned.
Whereas Belgium is monitoring EU-level initiatives, together with push and pull incentives and different financing mechanisms, the minister acknowledged: “There are at the moment no concrete plans to introduce a subscription financing mannequin like in the UK.”
Firm requires pan-European rethink
The product’s producer, Shionogi, instructed Euractiv that Belgium’s resolution displays a systemic concern throughout Europe.
“Reserve antibiotics play an important position in treating infections attributable to multidrug-resistant (MDR) pathogens, typically when no different choices stay,” the corporate mentioned.
“Though utilized in very small affected person populations, these antibiotics provide immense public well being worth, but present reimbursement programs are usually not designed for low-volume, high-importance medicines.”
The corporate cited remarks made by Minister Vandenbroucke throughout an AMR convention held underneath the Belgian Presidency of the Council in June 2024:
“Have a look at antibiotics: they shouldn’t be used an excessive amount of. Nonetheless, a few of them must be prepared as quickly as you want them. For that, you want a unique sort of financing, nearly like a subscription to a streaming service.”
“These initiatives, together with the ‘streaming service’ mannequin referenced by Minister Vandenbroucke, are aligned with G7 well being priorities and present how sustainable innovation and entry can go hand in hand,” the corporate mentioned.
Shionogi confirmed participation in delinked funding pilots:
“Sure. Shionogi is actively taking part within the UK’s NHS AMR Subscription Mannequin, which pays for antibiotics based mostly on their worth to the well being system, not the amount used. We had been additionally concerned in Sweden’s nationwide pilot and are engaged in discussions with HERA on comparable approaches.”
“We recognise that European nations have distinctive wants. In Belgium, as throughout Europe, we’re all the time open to options that ship well timed entry for sufferers, reward accountable use, and make continued innovation in antibiotics attainable,” the corporate’s CEO Huw Tippett instructed Euractiv.
A take a look at case for the EU’s Pharmaceutical Bundle
Regardless of Belgium’s efforts to strike a deal, MP De Knop warned that the shortage of reimbursement leaves sufferers in danger.
“The outcome stays that this antibiotic, which is especially vital for a small group of individuals, is at the moment not reimbursed,” she mentioned. “You additionally didn’t current an instantaneous answer,” pointing to the minister.
Belgium plans to introduce “early and quick entry” procedures by 2026, however at the moment lacks a devoted funding stream for reserve antimicrobials. With no viable market and restricted public procurement instruments, cefiderocol has turn out to be a take a look at case for Europe’s broader pharmaceutical coverage agenda.
Antibiotic incentives are central to the EU’s Pharmaceutical Bundle, at the moment underneath negotiation. The European Fee has proposed transferable exclusivity vouchers and pull incentives to stimulate antimicrobial innovation, although these stay politically contentious.
Below the Belgian Council Presidency in June 2024, EU well being ministers adopted Council conclusions calling on the European Fee and Member States to “discover different reimbursement fashions, resembling subscription-based schemes,” and to strengthen “EU-level coordination to make sure sustainable entry to important antimicrobials.” These conclusions had been a part of the technique paper “The Way forward for the European Well being Union: a Europe that cares, prepares and protects.”
Whereas typically related to generic shortages, the proposed Crucial Medicines Act additionally introduces instruments resembling joint procurement, strategic stockpiling, and EU-wide demand coordination, all of which may very well be relevant to patented, last-resort antibiotics like cefiderocol.
[Edited by Vasiliki Angouridi]
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