Final report for the technology evaluation of ceftazidime with avibactam for treating severe aerobic Gram-negative bacterial infections

Background

The National Institute for Health and Care Excellence (NICE), National Health Service England (NHSE) and NHS Improvement are currently undertaking a project to assess the feasibility of innovative models that pay for antimicrobials (AMs) based on an evaluation of their value to the NHS as opposed to the volumes used. Following the selection of two products considered to be of high public health importance, this project involves evaluation of the selected products to inform commercial discussions regarding contract value for a period of up to 10 years. The selection process was a formal procurement exercise and aimed to identify one new AM and one existing but “nearly new” AM. The products selected by this process are, respectively, Cefiderocol (Fetcroja) which is manufactured by Shionogi; and ceftazidime with avibactam (Zavicefta), which is manufactured by Pfizer.

This report details the evaluation phase of this project for ceftazidime with avibactam (CAZ-AVI).

CAZ-AVI received a marketing authorisation in June 2016 for treatment in adults and paediatric patients (>3 months) for complicated intra-abdominal infections (cIAI), complicated UTI (cUTI), hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP), bacteraemia (adults only) associated with the aforementioned infections and treatment of infections caused by aerobic gram-negative organisms with limited treatment options.

Aim and objectives

The aim of this evaluation is to assess the value of CAZ-AVI to the NHS in England, for the treatment of severe aerobic Gram-negative bacterial infections when used within its licensed indications.

Specific objectives are:

i. To identify two high value clinical scenarios (HVCSs), within its broad licensed indications, for which CAZ-AVI is expected to have a significant impact on patients’ outcomes in terms of reducing mortality risks and improving health-related quality of life.

ii. To undertake an ‘evidence mapping’ exercise and relevant systematic literature reviews to characterise the available clinical effectiveness evidence for the use of CAZ-AVI in the HVCSs.

iii. To establish an appropriate decision-analytic model to quantify the costs and health benefits of the use of CAZ-AVI under various usage scenarios compared with alternative treatments and management strategies (usage scenarios of other available AMs) in the HVCSs. The decisionanalytic model was required to estimate costs and health effects at both the individual level and also at the aggregate population level, providing population incremental net health effects (INHEs).

iv. Drawing on the systematic reviews and evidence synthesis, national-level data on health-care associated infections, and other sources as needed, identify evidence to populate the decisionanalytic models.

v. To use structured expert elicitation as necessary to supplement the available evidence to populate the decision-analytic models at the levels of both the individual patients and populations.

vi. To use available evidence and where necessary expert opinion to quantitatively extrapolate estimated population INHEs associated with CAZ-AVI in the HVCSs to other expected uses for the product beyond the HVCSs and within the product’s licensed indications.