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Blog posted by: James Love-Koh, Scientific Adviser – Science Policy & Research Programme, NICE, 21 November 2022.

James Love-Koh talks about the next steps for the 3-year project to develop a routine framework for evaluating and paying for new antimicrobials.

Paying the right amount for an antimicrobial is an important but challenging task. It should reward clinical value, encourage companies to develop new products and support appropriate use in the real world.

NICE, NHS England and the Department of Health and Social Care are developing a new approach to evaluating antimicrobials that balances these key objectives in a robust and efficient way.

What happened in the pilot antimicrobial evaluations?

In August 2022, we published ground-breaking guidance on two new antimicrobials, cefiderocol and ceftazidime–avibactam. NICE is the first health technology assessment organisation anywhere in the world to attempt to estimate the full value of an antimicrobial – capturing public health benefits that go beyond the direct benefits for the people who receive the drug – to inform payments delinked from sales volume.

This was the culmination of a 3-year project to assess antimicrobials targeting difficult-to-treat drug-resistant pathogens designated as a global priority by the World Health Organisation (WHO) and take account of unmet need in the UK.

The project aimed to address the urgent global need for a supply of new products able to treat types of infections that have become resistant to existing drugs.

By using subscription contracts instead of paying for each dose used, the new NHS payment model aims to incentivise antimicrobial companies to develop new products, while also upholding the important principles of antimicrobial stewardship - an approach that seeks to limit the growth of resistant infections caused by an overuse of antimicrobials.

The pilot evaluations used innovative methods to estimate the health benefits and costs of cefiderocol and ceftazidime–avibactam. In the absence of any relevant randomised or observational studies, they combined laboratory evidence showing how well an antimicrobial slows a pathogen’s growth, with expert opinion and other published evidence on how laboratory outcomes might predict clinical outcomes in order to estimate health benefits and resource-use savings. This allowed the NICE committee to assess the effectiveness of the products in terms of how much they contribute to length and quality of life relative to their cost, as is done for many NICE technology evaluations.

What is happening now?

During the summer, NICE and NHS England held stakeholder workshops to capture the lessons learnt from the antimicrobial pilot – the output from those workshops has been published today.

The next phase of the project is to use that experience to develop a routine framework for evaluating other new antimicrobials and paying for them using the same subscription contract approach. While the pilot evaluations were an important advance in the evaluation of antimicrobials, NICE and its stakeholders agreed that the methods for economic analysis need to be further developed. Combined with the need for improved surveillance data on antimicrobial usage and the resource-intensive nature of the pilot, it was neither practical nor feasible to replicate the approach used in the pilot evaluations on a routine basis.

In its place are plans to adopt a more pragmatic approach to determine the value of the contract payments for qualifying products. We see this as being a clinical points-based scoring system that will allow aspects of value that are unique to antimicrobials to be captured.

We are developing these plans as we continue to work with key stakeholders over the coming months, with an engagement exercise planned in early 2023.