Patient Access in Fourteen High-Income Countries to New Antibacterials Approved by the FDA, EMA, PMDA, or Health Canada, 2010-2020

Abstract

Background: Inaccessibility of patented medicines in low- and middle-income countries (LMICs) is a frequent challenge. Yet it is typically assumed that high-income countries have complete access to the full arsenal of medicines. This study tests this assumption for patented antibacterials, a class widely acknowledged as having a broken business model. New antibiotics are saved as a last resort in order to prevent the development of resistance, resulting in insufficient revenues to offset costs. Methods: We identified all antibacterials approved in Canada, Europe, Japan, and the USA for the decade beginning January 1, 2010 and evaluated differences in marketing authorizations and commercial launches in fourteen high-income countries. Delays in access were described as launch lags – the time in days between approvals and commercial launch. Associations between several factors including “innovativeness” were explored. Findings: Eighteen new antibacterials were identified. The majority were accessible in the US (n=17, 94%), the United Kingdom (n=11, 61%), and Sweden (n=10, 56%), with the remaining eleven countries having access to less than half of them. European marketing authorization did not lead to widespread European access, as fourteen of the antibacterials were approved by EMA, but many fewer were commercially launched. Five antibacterials were deemed as “innovative”, but there was no significant difference in access between “innovative” and “non-innovative” antibacterials. Surprisingly, antibacterials not listed on the EML had shorter launch lags. Japan had the longest median launch lags. Canada had the fewest drugs commercially available (n=2, 11%). Interpretation: Patient access to new antibacterials is limited not just in LMICs, as previously reported, but also in high-income countries such as Canada, Japan, France, Germany, Italy, and Spain. The major driver of delayed access appears to be poor commercial prospects for reimbursement, leading to company decisions to delay or forego commercialization in many high-income countries due to expectations of insufficient profitability. Funding Information: No funding received. Declaration of Interests: John H. Rex, MD is Chief Medical Officer & Director, F2G, Ltd., Editor-in-Chief, AMR.Solutions, Operating Partner & Consultant, Advent Life Sciences, and Adjunct Professor of Medicine, McGovern Medical School, Houston, TX; He has received grant support from Wellcome Trust; He sits on the scientific advisory boards of Bugworks Research, Inc., Basilea Pharmaceutica, Forge Therapeutics, Inc., Novo Holdings, and Roche Pharma Research & Early Development; He has received consulting fees from Phico Therapeutics, ABAC Therapeutics, Polyphor, Ltd., Heptares Therapeutics, Ltd., Gangagen, Ltd., Meiji Seika Pharma, Basilea Pharmaceutica International Ltd., Allecra Therapeutics GmbH, Forge Therapeutics, Inc., SinSa Labs, AtoxBio, Peptilogics, F. Hoffmann-LaRoche, Ltd., Novo Holdings, Innocoll, Vedanta, Progenity, Nosopharm SA, Roivant Sciences, Shionogi Inc., GlaxoSmithKline, and Pfizer Pharmaceuticals; He is a shareholder in AstraZeneca Pharmaceuticals, F2G, Ltd, Advent Life Sciences, Zikani Therapeutis, and Bugworks Research, Inc. The opinions expressed are his own and do not necessarily reflect the opinion of any of the groups with which he works. All others have nothing to disclose.