2016 has been a good year in the battle against Anti-Microbial Resistance (AMR), considered by many to be one of the greatest health threats facing mankind. Among other things:
- the US has launched an accelerator project to bring novel antibiotics through the early stages of R&D and is supporting later-stage development of key antibiotics ;
- the UK Government-sponsored O’Neill review published its final report, highlighting the costs of inaction;
- the WHO received the support of its members to develop a global stewardship framework to ensure that antibiotic resources are not wasted; and
- a group of over 100 companies issued a declaration committing themselves to reduce resistance, increase investment in R&D and improve access to high-quality antibiotics
Many of these actions have been framed under the guiding principle of “one health”, recognising that to combat successfully resistance, we have to tackle it across multiple fronts. The different actions required to make one health a reality have their own specific time-frames: some will yield relatively quick results; others will benefit us in 10-15 years time.
One area in which the results will take time to emerge, is in the revitalisation of the R&D pipeline of new antibiotics. Nevertheless, everything has to start somewhere, and that’s why this week’s announcement from Sweden is very important.
The Government in Sweden has initiated a review of how it reimburses antibiotics. The traditional model works on the principle that companies are reimbursed for every box they sell. Everyone recognises that this is not ideal. Among other things it makes the R&D investment highly dependent on the volume of future sales.
What is needed is something more like an insurance policy for the population. None of us knows when we will contract a resistant infection, but we want the counter measures to be there (available) when we do. Given it takes 10 or more years to develop a new medicine, we need a system that provides that insurance, not only for the population, but also for the companies, so that they know that, if they develop a new important antibiotic, they will be able to earn a return whether or not it is used.
The idea that the Swedes are testing, is that a lump sum payment or payments may be the way forward. This would mean that healthcare systems would be paying for the ability to treat infection, rather than for every treatment episode, which fits very well with societal need and with the need to take a strategic approach to supporting R&D into high-risk infections. Moreover, the “lump sum payment” proposed would be value-based. The value under consideration would be that of having a new tool in the box, rather than the ordinary health economic models that measure the value of exchanging one tool for another.
It may also be worth pointing out that that Swedish government has now given the Public Health Agency the task of examining whether a system based on the specific model developed and suggested by LIF, together with AZ, MSD, GSK and Astellas, including state premiums granted to pharmaceutical companies would be worth trying. The Governmental assignment also states that the investigation should be undertaken in order to decide if the model should be tested on two products evaluated in the health economic model that was developed. The examination will be reported in December.
In 2009, the Swedish Presidency of the EU initiated a debate on new ways of funding antibiotic R&D. Once again, they are in the lead. EFPIA hopes others will follow.0