Guest blog: World Antimicrobial Awareness Week
Deborah O’Neil, CEO of NovaBiotics, discusses antimicrobial resistance for World Antimicrobial Awareness Week (WAAW).
Antimicrobial resistance – where are we now?
As the world continues to respond to the COVID-19 pandemic, another public health threat looms – the ‘silent pandemic’ of antimicrobial resistance (AMR). Over 700,000 people already die each year from drug-resistant infections, and research suggests that without action to address AMR, this figure could rise to over 10 million people by 2050.
This week is World Antimicrobial Awareness Week (WAAW), and the theme for 2021 is ‘Spread Awareness, Stop Resistance’. Despite recent progress on tackling AMR, so much more still needs to be done. Combatting this global challenge needs a one-health multi-pronged approach to restrict the use of, more accurately prescribe, and protect wherever possible, the world’s antimicrobial agents. Crucially, it also requires innovation to increase the number of effective antimicrobial drugs. At present, most national purchase and distribution systems fail to provide sufficient incentives for companies to invest in innovative antimicrobials, as there have traditionally been high costs and low returns associated with their R&D. Most systems also link company revenues to volume of usage and sales, which risks undermining antimicrobial stewardship by encouraging the overuse of drugs. As Lord O’Neill recommended in his UK Government-commissioned report on AMR in 2016, better incentives are needed to promote investment in new antimicrobials.
Impact of the pandemic
The COVID-19 pandemic has had both positive and negative effects on the global fight against AMR. The pandemic has shone a new and very bright spotlight on infectious diseases for the past two years and the catastrophic global impact of being unprepared (without treatments or vaccines) for an infectious pandemic. Meanwhile, the global response to the pandemic, including the rapid development of vaccines, has demonstrated how much can be achieved when governments and industry prioritise a public health issue. On the downside, data suggests that the pandemic has exacerbated AMR, including from antibiotic use among hospitalised COVID-19 patients and increased prescribing of antimicrobials in community medicine. The need for innovation in AMR is therefore greater than ever and changes to reimbursement and funding models are crucial in providing commercial incentives for this innovation.
Rethinking reimbursement models
Existing reimbursement models for drug development fail to encourage investment in developing new antimicrobials which would only be used as a last resort for treating infections in order to avoid the emergence of further resistance. New economic models are needed which de-link the price paid for antimicrobials from the volumes sold to incentivise investment.
The UK is leading the way in this area, as it prepares for the final phase of its pilot scheme for a subscription-based payment model for antimicrobial drugs. The National Institute for Health and Care Excellence (NICE) is currently evaluating two antimicrobials – Cefiderocol (Fetcroja) manufactured by Shionogi and ceftazidime with avibactam (Zavicefta) manufactured by Pfizer – which will inform the subscription payment price each company will receive for its products. The products are expected to be made available to patients from early 2022. This will be the world’s first subscription-based payment model for antimicrobials and the international AMR community will be watching very closely.
Other countries are also considering changes to their reimbursement schemes. In the USA, Congress is considering the PASTEUR Act which would allocate $11 million for subscription contracts for antimicrobial drugs. In Europe, Sweden will offer guaranteed payments to companies with innovative new antimicrobials, even if they are not used and Germany is offering to pay companies high prices for innovative antibiotics when prescribed to patients.
The need to strengthen incentives for antimicrobial drug development has also been recognised by the G7 throughout the UK’s presidency. At a meeting in June 2021, G7 finance and health officials agreed to work together to “overcome the economic barriers to an endurable supply of antimicrobial products and to ensure sustainable innovation in antimicrobial R&D”.
Some antimicrobial drugs (antibacterials and antifungals), including Avycaz, Dificid and Cresemba, have made significant revenues in recent years, outpacing expectations. Avycaz is an antibiotic therapy which currently generates revenue at a $500 million annual run rate and could be on a trajectory to become a blockbuster drug. Although such high revenues have not been typical for antimicrobials, the performance of these drugs provides a counter-argument to the widespread belief that no new antimicrobials will sell well.
Meanwhile, some progress has been made in developing the funding landscape for R&D into novel antimicrobials. In 2020, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) launched the $1 billion AMR Action Fund, which will invest in smaller biotech companies to support the clinical development of novel antimicrobials. It aims to bring 2-4 new antibiotics to patients by 2030 and is expected to make its first investment(s) by the end of 2021.
We have seen some recent significant investments in, and licensing deals for, antimicrobial companies such as Spero’s $40 m (investment and licensing) from Pfizer and Pulmocide’s £64.4m Series C (for an inhaled antifungal) in March this year. Investments in earlier stage antibacterial companies and assets continue to remain much thinner on the ground than for oncology assets as a comparison.
The AMR landscape report card would read, ‘some improvement, but still needs to do much better’. The BIA is keeping its finger on the pulse of continuing developments, both in the UK and globally as an associate Board member of the AMR Industry Alliance and through its links with organisations including the BEAM Alliance. Hopefully, as further changes to AMR reimbursement and funding models take effect, we will see a trickle-down effect with more funds flowing into antimicrobial companies and more start-ups in the AMR space, aided by some key positive clinical trial results toward new product launches (especially from our home-grown UK antimicrobials companies) in the near future.