Recognizing the Full Value of Novel Antibiotics: Identifying Value Elements in the Context of Antimicrobial Resistance
Author(s)
Roberto Di Virgilio, MD1, Maria Gheorghe, PhD2, Claudio Jommi, MSc3, Rosanna Tarricone, PhD4, Oriana Ciani, BSc, MSc, PhD5, Edward Ivor Broughton, BSc, MPH, PhD6, Brittany Darrow, MSc7, Priscila Radu, MSc7, Hannah Hussain, MSc, PhD7, Grace Hampson, MSc7.
1Pfizer, Rome, Italy, 2Pfizer, Bucharest, Romania, 3Universita del Piemonte Orientale, Milano, Italy, 4Bocconi University, ROMA, Italy, 5SDA Bocconi, Milan, Italy, 6Pfizer, New York, NY, USA, 7Office of Health Economics, London, United Kingdom.
1Pfizer, Rome, Italy, 2Pfizer, Bucharest, Romania, 3Universita del Piemonte Orientale, Milano, Italy, 4Bocconi University, ROMA, Italy, 5SDA Bocconi, Milan, Italy, 6Pfizer, New York, NY, USA, 7Office of Health Economics, London, United Kingdom.
OBJECTIVES: Antimicrobial resistance (AMR) is an urgent global health problem. Novel antibiotics are essential to addressing AMR however the World Health Organisation notes current development remains insufficient. Appropriate Health Technology Assessment (HTA) processes can incentivise development by creating confidence that future antibiotics can be reimbursed according to their full value in the context of AMR. The literature suggests a range of relevant value elements, but their priority and feasibility of measurement are not clear. We aimed to identify a set of value elements for novel antibiotics that are high-priority and feasible to consider for the HTA process in Italy.
METHODS: We recruited 10 Italian experts, including microbiologists, infectious disease specialists, health economists, and payer representatives for a Delphi-process consisting of an online survey and semi-structured focus groups. The survey involved rating the priority and feasibility (high/medium/low) of 25 candidate value elements identified via literature review. Afterwards, experts received their individual and the group’s aggregated ratings. In focus group 1, they discussed value elements rated as high priority and high feasibility, considered additional elements, and worked toward consensus on a core set of value elements. In focus group 2, they defined 2-3 performance levels for each core element to distinguish better from worse outcomes.
RESULTS: Stakeholders reached consensus on a core set of 6 elements to capture patient and population benefits of novel antibiotics: activity against resistance mechanisms; activity against priority pathogens; evidence of efficacy; health system costs; penetration to anatomical sites of infection; and risk-severity of adverse events.
CONCLUSIONS: Some of the consensus-derived value elements identified here are not typically considered in HTA, signalling that current methods may undervalue novel antibiotics and disincentivise development. Italian and other HTA processes around the world could consider broadening their value assessment criteria for novel antibiotics to reflect AMR development.
METHODS: We recruited 10 Italian experts, including microbiologists, infectious disease specialists, health economists, and payer representatives for a Delphi-process consisting of an online survey and semi-structured focus groups. The survey involved rating the priority and feasibility (high/medium/low) of 25 candidate value elements identified via literature review. Afterwards, experts received their individual and the group’s aggregated ratings. In focus group 1, they discussed value elements rated as high priority and high feasibility, considered additional elements, and worked toward consensus on a core set of value elements. In focus group 2, they defined 2-3 performance levels for each core element to distinguish better from worse outcomes.
RESULTS: Stakeholders reached consensus on a core set of 6 elements to capture patient and population benefits of novel antibiotics: activity against resistance mechanisms; activity against priority pathogens; evidence of efficacy; health system costs; penetration to anatomical sites of infection; and risk-severity of adverse events.
CONCLUSIONS: Some of the consensus-derived value elements identified here are not typically considered in HTA, signalling that current methods may undervalue novel antibiotics and disincentivise development. Italian and other HTA processes around the world could consider broadening their value assessment criteria for novel antibiotics to reflect AMR development.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA282
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
Infectious Disease (non-vaccine)