Strengthening Australia’s preparedness against emerging superbugs

Nikolaos Komilionis was 66, and on holiday in Greece, when he was admitted to hospital for minor surgery. It should have been a simple procedure, but after picking up a superbug that was resistant to antibiotics, he was soon fighting for his life.

“It was very traumatising,” says his daughter, Noula Settinelli, who went to Greece four times over the next six months as her father underwent multiple operations in three hospitals after rupturing his bowel due to infection. “The doctors said he died 14 times in all the surgeries they did to repair his large intestine, and he came back, they revived him.”

The WHO has warned of the world entering a post-antibiotic era, in which the drugs that we have come to rely on are far less effective. Credit: Pfizer

Finally, Komilionis was stable enough to be airlifted to Australia. But his ordeal was far from over.

He ended up in isolation in Melbourne’s Austin hospital, with numerous abscesses in his abdomen, and superbugs in both his bowel and in the abscesses.

Doctors failed to find a drug that could kill the bugs, so they proposed a cure that dated back to a time before antibiotics: they would remove his large intestine.

The chances of survival were 50-50, doctors told the family. “But if we didn’t do it, he was going to die,” Settinelli says.

Thankfully, the operation was a success. Today, Komilionis is 78 years old and walks 15 kilometres a day.

“He is labelled superman,” Settinelli says. But things could easily have gone the other way. And cases like this are expected to become far more common.

A global threat

Antimicrobial resistance (AMR) – bacteria, viruses, fungi and parasites evolving to become resistant to the antibiotics, antivirals, antifungals and antiparasitics that once killed them – is one of the world’s top health threats, says the World Health Organisation (WHO). It’s estimated that by 2050 it could cause the deaths of up to 10,000 Australians a year – and 10 million people worldwide.

The WHO has warned of the world entering a post-antibiotic era, in which the drugs that we have come to rely on are far less effective.

It’s a prospect that Andrew Bowskill, co-chair of the Australian Antimicrobial Resistance Network (AAMRNet), says would be disastrous for human health.

“It’s like losing 100 years of medical progress...” Bowskill says. “A simple scratch could once again kill you.”

Everything from minor surgeries to giving birth would become riskier, Bowskill says. “Our whole health and medical system basically relies on antibiotics as the backstop to clean up the infection complications that can happen.”

Pipeline running dry

The reason microbes are winning the race against medicine is basically twofold: firstly, we have been using antibiotics too liberally, and secondly, too few new antibiotics are being developed.

Australia, like most developed countries, is taking a One Health approach to tackling AMR by promoting antimicrobial stewardship (the responsible use of antimicrobials) not just in human health, but in animal health and agriculture, and the food and environmental sectors.

But when it comes to the new antibiotics, the cupboard is looking worryingly bare.

The WHO says the clinical pipeline of new antimicrobials is “almost dry”; in 2021 only 27 antibiotics that address WHO bacterial priority pathogens were in clinical development, of which only six were classified as innovative.

Funding model

Anne Harris, the managing director of Pfizer Australia and New Zealand, says the current market for antimicrobials is unsustainable.

“The way antimicrobials are funded is not working for patients or research companies,” Harris says. “It takes on average US$2.6B to progress a medicine or vaccine from early-stage research through clinical trials to a commercialised product. This incorporates the development cost of molecules that are not successful, with only 12 per cent of new molecules that enter clinical trials eventually receiving regulatory approval.”

Antimicrobials are different to other medicines, as they need to be used responsibly in a restricted manner to avoid accelerating the development of resistant bacteria. This leads to an unsustainable return on the research and development (R&D) required to make these treatments.

In its Breakthrough Nation report, Pfizer calls for new funding incentives to make the development of antimicrobials viable.

The UK has shown what’s possible. It recently expanded a program that’s been dubbed a Netflix model for funding antimicrobials: just as Netflix subscribers pay a monthly fee rather than a fee per movie, the UK government paid £10 million per year per drug, based on the value of the drug to the health system, regardless of how many were sold.

Bowskill says the AAMRNet has estimated that a payment of $12.5M per drug per year would be about right if Australia wanted to create a market for antimicrobials and do its fair share in the global battle against AMR.

Australia may be about to adopt something similar. As part of an overhaul of the way Australia conducts Health Technology Assessment (HTA) – the system that is used to determine which medicines are publicly funded and in what circumstances, the HTA Policy and Methods Review, recommended the adoption of a subscription model similar to the UK.

“This is not just for antimicrobials: this is the case for all innovative medicines. The full value of innovative medicines must be recognised in a re-designed system. Australian patients deserve faster access,” Harris says.

“As a nation, we wait three to four times longer to access medicines when compared to people in similar countries – many are not brought to Australia at all. The system needs bold reform and greater investment to continue to meet the needs of Australians - a system that delivers equitable access to the latest medical technologies within 60 days of TGA registration.”

She says that now it is up to the Government to implement changes that will open the door for accelerated and sustainable access to medicines for patients.

To learn more, visit www.pfizer.com.au