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Case 2: Amoxicillin/Clavulanic acid (Augmentin™), GSK

This medicine is an older, off-patent widely-used antibiotic. It must continue to be widely available – indeed access needs to increase – yet with multiple competitors in the market, stewardship is particularly complex.

Off-patent antibiotic
  • Multiple companies produce versions of amoxicillin/clavulanic acid
  • Resistance has been noted in a range of pathogens including Klebsiella spp.
  • Placed in WHO EML’s Access group of antibiotics
Increasing access
  • Broad registration, now in 71 low- and middle-income countries
  • Equitable pricing strategy, with different pricing tiers in-country
  • Pricing strategy based on (e.g.,) GNI, burden of disease, health system financing
Stewardship
  • Continuing medical education programmes
  • Marketing materials include information on AMR trends
  • Decoupling of sales staff incentives from sales volume
  • Antibiotic surveillance activitie

Amoxicillin/clavulanic acid (AugmentinTM) is a broad-spectrum antibiotic used to treat mild-to-moderate bacterial infections, including sinusitis, cellulitis, acute otitis media and community-acquired pneumonia. It was first introduced by GSK in 1981, following UK approval. It came off patent in 2002, triggering the arrival of many generic versions on the market. Of the 21 companies with marketed products in the Benchmark’s scope, 13 report marketing at least one formulation of amoxicillin/clavulanic acid. Where there are more versions of a product available, the ability to control resistance decreases.

This broad-spectrum antibiotic is a widely-used treatment for a wide range of infectious diseases. As a result, it has been classified as an Access antibiotic by the WHO in its 2017 WHO Model List of Essential Medicines – meaning that it should be widely available, affordable and quality assured as a first- and second-line treatment for many infectious diseases. However, as it is among the most commonly prescribed antibiotics worldwide, a wide range of different pathogens have developed high resistance rates to this medicine, including Klebsiella spp. (61% of isolates are resistant in Egypt, 33% in Brazil), and Streptococcus pneumoniae (17% resistant isolates in Vietnam). While access remains a priority, the stewardship of this important medicine is also critical to ensure it can continue to be effective. 

Registration: the 1st step to availability
GSK has filed to register amoxicillin/ clavulanic acid in 71 of 106 low- and middle-income countries where access to medicine is likely limited. This makes it the most widely registered product in this group of countries analysed by the Benchmark. GSK has also developed an equitable pricing approach for setting prices at the national level, as well as for populations within countries. When setting prices for this medicine, GSK reports that it considers multiple socio-economic factors, including: a country’s ability to pay, its burden of infectious diseases, how healthcare is financed, and its level of socio-economic inequality. There are many generic versions of amoxicillin/clavulanic acid that are lower in cost than GSK’s version (AugmentinTM). 

Appropriate promotion
In parallel to its measures addressing affordability, GSK also runs stewardship activities for amoxicillin/clavulanic acid. These include the provision of medical education programmes regarding the appropriate use of the medicine. It also undertakes several practices for ensuring the product’s appropriate promotion: it includes AMR-related information and trends in its marketing materials, and has completely separated the remuneration of its sales staff from the sales volume of antibiotics, including amoxicillin/clavulanic acid. GSK has also adapted some of its brochures to facilitate the appropriate use of the product by patients. Looking across the data from the other 13 companies in scope that market amoxicillin/clavulanic acid, GSK performs well in balancing access and stewardship for this product. To maximise the effectiveness of GSK’s actions, and extend the lifespan of this important antibiotic, other producers must meet or exceed the standard GSK sets.

Amoxicillin/clavulanic acid is a widely marketed off-patent product produced by multiple companies, which makes the challenge of expanding access while also protecting the product from resistance-promoting behaviour particularly complex. On the one hand, affordability and availability are easier to achieve due to competition from multiple generic medicine manufacturers. On the other hand, a wider number of producers means more actors that must adopt best practices for stewardship. It is vital that all producers of amoxicillin/ clavulanic acid consider and implement stringent stewardship policies across all healthcare settings. 

For a full list of references, please see the 2018 AMR Benchmark report.



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