Encourage development of new antimicrobials

Antimicrobial resistance (AMR) is a global threat, particularly given the modest activity in the pipeline of new antimicrobials in development, and emerging resistance to existing antibiotics. In 2016, Lord Jim O’Neill published a globally-focused review on AMR, which highlighted the lack of incentives for new antimicrobial development and encouraged a worldwide system of ‘push’ and ‘pull’ incentives to stimulate new drug development.

Push incentives have gathered pace with combatting antibiotic-resistant bacteria via biopharmaceutical accelerator (CARB-X), global AMR innovation fund (GAMRIF), and other public/private investors funding early-stage research. However, effective pull incentives are still needed. The UK government, in response to the O’Neill report, started working with the Association of the British Pharmaceutical Industry (ABPI), NICE, and NHS England to investigate a novel approach to value assessment of new antimicrobials, which would inform a scheme to pay companies primarily based on their value to the NHS as opposed to the volumes used.

NICE recognised that current health technology assessment (HTA) methods generally do not fully assess the specific value of new antimicrobials beyond the benefit of curing a given patient’s infection. It has been argued that the value assessment needs to address additional attributes, such as the impact on transmission, spectrum effect, enablement, and diversity values, while also factoring in the impact of development of resistance to the new and existing antimicrobials. NICE and the Department of Health and Social Care (DHSC) commissioned an academic group at the University of York that carried out an 18-month study researching how to design a new HTA approach using these principles, in order to facilitate such a payment scheme.

Following on from the methodological research, the UK is now planning to test two antimicrobials with the novel HTA value assessment. This will be considered alongside a test of an innovative reimbursement approach that provides proportionate incentives to invest in research and development while supporting antimicrobial stewardship. By testing the feasibility of evaluating and reimbursing antimicrobials in a different way, the UK is sending a clear signal to the rest of the world that workable models can achieve the right sort of pull incentives for these vital medicines. To have a more significant impact on AMR globally, other countries will need to respond to this signal by developing similar incentives in their own domestic markets.

I would like to acknowledge my co-authors Dr Nick Crabb, National Institute for Health and Care Excellence, UK, and Tracy Parker, Health Protection Policy, Head of AMR, HCAI, and Sepsis policy at Department of Health and Social Care, UK, for their contribution.

Dr Colm Leonard is a Consultant Thoracic Physician at University Hospital of South Manchester NHS Foundation Trust since October 2000 and, since 2008, spends 50% of his time as clinical adviser to the Centre for Health Technology Evaluation at NICE. He leads the clinical input on the AMR work in NICE. A Graduate of the Medical School at the University of Dublin, Trinity College, Dr Leonard has a very broad experience in clinical care of immune-suppressed patients, basic science research, animal model work, and clinical trials, and his horizon-scanning work with NICE spans across all clinical specialties.

First published in European Biotechnology, Spring 2019 Edition.