UK courts antibiotic developers with 'subscription-style' incentive to combat superbug scourge
As antibiotic developers languish, and superbugs flourish, the United Kingdom is taking a key step to invigorate antimicrobial development by wooing manufacturers with the incentive of a ‘subscription’ style payment: the drugs will be paid for, even if they’re just stored in reserves.
It is no secret that the industry players contributing to the arsenal of antimicrobials are fast dwindling. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments must be priced cheaply, and often lose potency over time as microbes grow resistant to them. Consequently, there has been no new class of antibiotics approved since the 1980s — and today, roughly 700,000 deaths annually are attributed to drug resistant bacteria, according to the WHO.
For one of the biggest threats to global health, the lion’s share of antibiotic development is taking place in a handful of labs of small biopharma companies as their larger counterparts focus on more lucrative endeavors. In recent months, a handful of antibiotic developers — including Achaogen and Tetraphase — have seen their value go up in smoke as feeble sales frustrate growth.
Existing incentives to entice antibiotic R&D are too weak to fix this broken system, drugmakers, public health organizations and doctors have asserted, asking policymakers to take a fresh approach to stimulate drug development by enacting policy measures to increase the value of a marketed antibiotic.
In the United States, incentives are already in place to push drugmakers to develop antibiotics — but the industry is clamoring for the passage of “pull incentives,” or policy measures to increase the value of a marketed antibiotic by rewarding drugmakers only after their antibiotic is approved. The initiative by the UK, first broadly discussed in a five-year action plan published by the government in January, is such a “pull incentive”.
The project, led by NICE and NHS England, involves developing and testing a model that pays companies for antimicrobials based primarily on their expected value to the National Health Service (NHS), as opposed to the actual volume used.
In the first phase of the project — expected to be completed by the end of the year — the agencies will structure a reimbursement and payment model, and select two products to undergo the trial assessment and commercial discussions. By the end 2020, the evaluation of the two products is expected to conclude, and the authorities will determine whether the current system of deploying antimicrobials should be amended, NICE said.
Findings will be shared across the world, so other healthcare systems can test similar models, the UK department of health and social care added on Tuesday.
“Imagine a world in which a papercut can lead to infection that can’t be controlled…Tackling superbugs needs global leadership and peoples’ lives depend on us finding a new way forward,” UK Health and Social Care Secretary Matt Hancock said in a statement.
Drug-resistant infections in humans increased by 35% from 2013 to 2017 in England, according to estimates by Public Health England. The UK government has set the lofty goal of containing and controlling antimicrobial resistance by 2040.
Joan Butterton, associate VP of clinical research, infectious diseases at Merck — one of the remaining large drugmakers in the antimicrobial space — suggested that the UK’s ‘pull incentive’ proposal was encouraging, in an interview with Endpoints News earlier this month.
What the UK is doing “is exactly what we need — we need to think of multiple ways of incentivizing companies in the space and to be able to ensure that they have a guaranteed and predictable income,” she said.
Last year, former FDA commissioner Scott Gottlieb suggested a “licensing model” in which acute care institutions that prescribe antimicrobial medicines would pay a fixed licensing fee for access to these drugs, granting them the right to use a certain number of annual doses.