Inappropriate prescription rates and overuse of antimicrobials have led to resistance that has created a major global health challenge. It has been estimated that by 2050, 10 million worldwide deaths could result from antimicrobial resistance, making it deadlier than cancer.
The draft guidance published by NICE is a part of a project with NHS England, NHS England and the Department of Health and Social Care that aims to incentivise the research and development of antimicrobials by testing new approaches to evaluating and paying for them.
The guidance recommends that cefiderocol and ceftazidime/avibactam should only be used to treat patients with severe drug-resistant infections who would otherwise have limited treatment options.
Further informationView cefiderocol drug record
New payment model
Investment in new antimicrobials, especially those that target multi-drug-resistant pathogens, is not commercially attractive since they are subject to strict controls to restrict their use to slow the development of resistance, leading to low sales. In 2020, only 41 new antimicrobial drugs were in clinical trials compared to approximately 1800 immuno-oncology drugs.
The new subscription-style payment model has been designed to overcome this issue and encourage pharmaceutical companies to develop new antimicrobials by ensuring they receive a fixed annual payment that will depend on the benefits the drug offers to patients and to the NHS, not the volume supplied.
The draft guidance on cefiderocol and ceftazidime/avibactam provides an estimate of their benefits to the health of the overall population in England measured in quality-adjusted life years (QALYs).
The guidance will be used to inform commercial discussions between the NHS and pharmaceutical companies to agree an annual payment in a 3-year contract, with an option to extend the contract up to 10 years.
NICE has acknowledged the complexity behind estimating the full benefit of new antimicrobials, and therefore what the annual fee should be, and has said it requires a different economic modelling approach which considers the wider benefits to public health. For example, effective antimicrobials are essential in ensuring that chemotherapy, surgery, and other medical procedures can go ahead; in reducing the spread of infection; and in providing treatment options to reduce the risk of resistance developing.
Nick Crabb, programme director in NICE’s Science, Evidence and Analytics Directorate, said: 'This draft guidance represents an important milestone in the UK project. Its ultimate goal is to ensure the NHS has access to effective new antimicrobials to call on when needed and patients aren’t left without treatment options in the face of growing antimicrobial resistance.'
'But we cannot address the global threat of antimicrobial resistance alone, since the UK represents only about 3% of the global market for antimicrobials. We are sharing our learning from this project with international stakeholders and encourage other countries to offer similar incentives in their own domestic markets, so that collectively we can achieve a meaningful incentive for global investment in antimicrobials,' he added.
NICE will issue final guidance once the commercial discussions between NHS England and NHS Improvement and pharmaceutical companies have concluded.