UK selects Shionogi’s Fetcroja for antimicrobial reimbursement scheme

Shionogi’s novel antibiotic Fetcroja has been selected for inclusion in a pilot subscription reimbursement scheme, launched by the UK’s National Institute for Health and Care Excellence (NICE) and NHS England and Improvement (NHSE&I).

The scheme – first announced by Health Secretary Matt Hancock in 2019 – will pilot a model that reimburses pharma companies for antimicrobials based on a health technology value assessment of their value to the NHS, as opposed to the volumes of the drug used.

This pilot is intended to encourage drug developers to resume and increase research and development into new antibiotic medications, given that this area is lacking in innovation due to the economic challenges associated with it.

This is due in large part to the fact that the newest antibiotic drugs are reserved as last-line treatments, and are often only used when all other treatment options have been exhausted.

“Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research,” Shionogi said in a statement.

“Shionogi strongly supports the introduction of new incentives, funding and value assessment models for reimbursement to restore a viable commercial environment to address the economic challenge faced in bringing novel antibiotics to market,” the company added.

Fetcroja was launched in the UK in September and treats infections caused by aerobic Gram-negative bacteria in adults.

In the UK, over 5,000 deaths per year are attributed to antimicrobial resistance (AMR), with over 25,000 deaths per year attributed to AMR in the EU. AMR is a major health burden wherein bacteria, fungi, viruses and parasites become resistant to a range of antimicrobial drugs, such as antibiotics, antifungals and antivirals.

Prior to the launch of Shionogi's Fetcroja (cefiderocol) in the UK, the drug had already gained European Commission approval earlier this year, and it is the first treatment which protects against all Gram-negative pathogens considered to be of 'critical priority' by the World Health Organization (WHO).

This includes carbapenem-resistant strains of Enterobacterales, P. aeruginosa and A. baumannii, all of which have been highlighted as the top priority in the research and development of new antibiotics.

Shionogi’s novel antibiotic is designed to use the bacteria’s own iron uptake system to gain entry into the cell and inhibit cell wall synthesis.

The use of Fectroja in a range of infections is supported by data from three clinical studies, APEKS-cUTI, APEKS-NP, and CREDIBLE-CR. In these studies, the drug demonstrated efficacy against complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) and blood stream infections (BSI).

In the US, Shionogi’s drug is approved under the name Fetroja for the treatment of adult patients with cUTI who have limited or no alternative treatment options.

The US Food and Drug Administration (FDA) approval of Fetroja was based on results from the APEKS-cUTI study, in which the novel antibiotic demonstrated significantly higher response rates compared to the older antibiotic imipenem/cilastatin.