Shionogi’s Novel Antibiotic, Fetcroja® (Cefiderocol), Has Been Selected By UK’s NICE / NHS&I as Part of an Antimicrobial Subscription Style Reimbursement Model

OSAKA, Japan, AMSTERDAM, NL – December 21, 2020 - Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announce that NICE and NHSE&I have selected its innovative antibiotic, cefiderocol, for inclusion in a pilot subscription reimbursement model in the UK which ‘de-links’ payment from volume of use, thereby recognising its potential in treating multidrug resistant Gram-negative bacterial infections and its benefits to society and healthcare systems. This scheme is called the UK Project for developing and testing an innovative model for the evaluation and purchase of antimicrobials. Pull incentives such as this are an important step to help bring urgently needed new antibiotics to market.

The aim of this scheme, which was officially announced by Matt Hancock, Secretary of State for Health, at the World Economic Forum in January 2019, is to pilot a model that reimburses companies for antimicrobials based on a health technology assessment of their value to the NHS, rather than the volumes used.4 The selection process by NICE and NHSE&I was designed to favour products which meet a key need in the UK while also addressing disease areas of international importance, in particular those drugs which treat serious infections including blood stream infection (BSI), sepsis and hospital or ventilator acquired pneumonia (HAP & VAP). A range of factors, including degree of novelty, activity against the WHO critical priority pathogen list, surety of supply, the supplier’s demonstrated commitment to antimicrobial and environmental stewardship and commitment to support surveillance were considered. As a next step, NICE will further assess cefiderocol in 2021, and implementation of the subscription-based payment is due to commence in April 2022

We are delighted that NICE and NHSE&I have recognised the important role of Shionogi and our novel antibiotic, cefiderocol, in the fight against antimicrobial resistance. Our bid was assessed according to a rigorous selection process, including novelty, activity against the most difficult to treat pathogens and serious infection, surety of supply and antimicrobial stewardship, and our company and our medicine met all these criteria,” said Dr Mark Hill, MB, BS, MRCP, Global Head of Market Access, Shionogi. “We look forward to working closely with NICE next year, and hope that their new value assessment methodology will allow the full the value of cefiderocol to be reflected.”
While developing antibiotics is a long, risky and costly process, commercialisation is also challenging.  Once launched, there is often a low frequency of use driven by the need for stewardship to prevent resistance development. Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialisation of antibiotics, and several smaller biotech companies have filed for bankruptcy. 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 UK has demonstrated its leadership position with the introduction of this pilot subscription reimbursement model, which aims to recognise the benefit of new antibiotics to society,” commented Takuko Sawada, Executive Vice President, Shionogi. “Shionogi feels this is an important step in making the market for new antibiotics more predictable and sustainable. We hope that it will set a positive precedent for further innovative payment mechanisms in the future.

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