Limited patient access to new antibacterials in high-income countries

Limited patient access to new antibacterials in high-income countries

  • 23/08/2021

A group of experts has shown in an analysis that also in high-income countries patient access to new antibacterials is currently very limited.

Authors: Kevin Outterson,  Ebiowei S F Orubu,  John Rex,  Christine Årdal,  Muhammad H Zaman

Abstract
Background of the paper
Inaccessibility of medicines in low- and middle-income countries 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 new antibacterials, which are saved as a last resort in order to prevent the development of resistance, resulting in insufficient revenues to offset costs. Prior studies report only regulatory approval, missing the important lag that occurs between approval and commercial launch, although some antibiotics never launch in some countries.

Methods
We identified all antibacterials approved and launched in the G7 and 7 other high-income countries in Europe for the decade beginning 1 January 2010, using quantitative methods to explore associations.

Results
Eighteen new antibacterials were identified. The majority were accessible in only 3 countries (United States, United Kingdom, and Sweden), with the remaining 11 high-income countries having access to less than half of them. European marketing authorization did not lead to automatic European access, as 14 of the antibacterials were approved by the European Medicines Agency but many fewer were commercially launched. There was no significant difference in access between “innovative” and “noninnovative” antibacterials. Median annual sales in the first launched market (generally the United States) for these 18 antibiotics were low, $16.2M.

Conclusions
Patient access to new antibacterials is limited in some high-income countries including Canada, Japan, France, Germany, Italy, and Spain. With low expected sales, companies may have decided to delay or forego commercialization due to expectations of insufficient profitability.

See here the full paper, published in Clinical Infectious Diseases: https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciab612/6319400