Zavicefta (ceftazidime-avibactam) is one of two antimicrobial products to be selected for NICE technology appraisal and guidance, as part of a novel pilot announced by the Secretary of State for Health and Social Care in the UK 5-year national action plan1 on antimicrobial resistance (AMR).
The NICE antimicrobial health technology evaluation guidance applies to England (but not Scotland, Wales or Northern Ireland) and recommends that Zavicefta should be used appropriately, within its marketing authorisation, as an option for treating severe drug-resistant infections caused by Gram-negative bacteria.2
Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections:
Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.3
The market potential for new antibiotics is limited, due to the steep costs of antimicrobial development, high risk of failure, long lead times, and growing awareness of the need to limit their use.7
No novel class of antibiotic has been discovered for almost 40 years. There are a limited number of antibiotics in clinical development at present, while thousands of potential immuno-oncology therapies are currently being evaluated. The rate of innovation is insufficient to meet current and future needs.8
Challenging economic hurdles mean there are few incentives for venture capital or pharmaceutical companies to invest in antibiotic R&D since it will be difficult to realize a sufficient return. Three antibiotic developers filed for bankruptcy in 2019 alone.9–11
AMR is a significant economic burden, causing an estimated €1.1 billion annual cost to healthcare systems in Europe.12
Pfizer has partnered with NHS England, NICE and the UK government to pilot a world-first innovative reimbursement model for antimicrobials. This initiative is a first step in assessing the broader value that antibiotics bring to people and society . Under this model, NHSE will reimburse the supplier centrally using a subscription-style payment contract that pays a fixed annual fee irrespective of the volumes used by the NHS. This “top-up” is intended to align the financial incentives for the respective pharmaceutical companies and reward companies for bringing new antimicrobial products to market even when the volumes used are low, especially in the years immediately following launch. The intention of this initiative is to start to reinvigorate investment in antibiotics; however other countries would also need to develop and implement initiatives to make this work on a global level.
Local commissioners remain the lead commissioners in line with policy for all antibiotics, and hospital pharmacies should continue to order packs of Zavicefta in the normal way through their procurement systems and pay per pack as they purchase the product.
While funding to NHS Trusts for Zavicefta will continue to be through the relevant Payment by Results (PbR) tariffs and will not require any prior approval, NHS England has made the completion of a Blueteq form a policy requirement. The forms are being used to monitor the use of Zavicefta in a similar approach to that used to monitor the use of COVID-19 treatments.
Drug Usage Monitoring13,14:
A drug usage monitoring form13 (Blueteq form) has been implemented as part of this model. Whilst prior approval is not required for the use of ceftazidime-avibactam, it remains important that prescribing continues to adhere to good stewardship to reduce the risk of resistance developing. The form is designed to capture data on the organism of concern, the suspected resistance mechanism, additional therapy, and site of infection.
It is recognised that this adds administration burden to front line staff but as requested by NHSE, you are encouraged to complete the form to collect the required data as it will help assess and monitor the success of this novel reimbursement model and to understand the types of infections it is being used to treat.
It is important to confirm patient eligibility and should include the use of diagnostic testing to confirm the susceptibility of the pathogen to the agents.
Identifying patients at risk of MDR Gram-negative infections is vital for appropriate selection of adequate, early antimicrobial therapy to reduce the risk of fatal outcomes15.
Access our resources for implementation of an Antimicrobial Stewardship Programme and learn more about Pfizer initiatives to fight AMR
Click here for Zavicefta ® (ceftazidime-avibactam)
ZAVICEFTA has broad spectrum coverage against Gram-negative pathogens including in vitro activity against MDR P.aeruginosa, CRE, including KPC- and OXA-48 producing strains, and ESBL- and AmpC-producing bacteria3-6.
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PP-PFE-GBR-3863. November 2021