Health campaigners hope that a move by the UK to introduce a fixed-fee model to finance the development of new antibiotics will boost worldwide efforts to combat the growing problem of resistance to existing drugs.
The UK is to launch the world’s first “subscription” incentive scheme for antibiotics, which will pay manufacturers a flat rate for making new drugs available to the NHS, regardless of how much or how little they are used.
The pilot scheme announced on Tuesday will initially offer Pfizer of the US and Shionogi of Japan contracts capped at £10mn a year each, to supply a new antibiotic for up to 10 years.
Antimicrobial resistance is a global public health crisis, with drug-resistant bacteria killing more than 1.2mn people a year according to the latest estimate. The causes of AMR are overuse of antibiotics in medicine and agriculture, and the industry’s failure to invest in new products.
How will the subscription scheme encourage the development of new antibiotics?
Existing drug reimbursement systems, which depend on volumes sold, provide little incentive for companies to invest the hundreds of millions of dollars needed to bring a novel antibiotic through clinical trials and achieve regulatory approval.
“When we looked at the antibiotics market, we found that recently introduced drugs were only selling a few tens of millions of dollars a year worldwide,” said Jeremy Knox, head of infectious disease policy at Wellcome, the medical charity. “That’s not enough to justify their R&D spending.”
There are several reasons why revenues for antibiotic producers are relatively low. Antibiotics do not command high prices, with many cheap old drugs on the market; patients are only given short courses of medication; and “stewardship” rules to prevent inappropriate use mean that doctors are subject to strict controls when prescribing.
Under the subscription model, companies are guaranteed a level of income above what they would probably make from conventional sales, said Knox, and would justify more R&D investment.
Is a contract worth £10mn a year enough to drive more pharmaceutical investment into antibiotics?
The NHS scheme is just a start that other governments should follow, leading to global action to address the antibiotic market failure, said Thomas Cueni, director of IFPMA, the international pharmaceutical manufacturers body in Geneva.
He said that the UK National Institute for Health and Care Excellence (Nice) had led the way with an assessment showing that both drugs in the pilot — Pfizer’s Zavicefta and Shionogi’s Fetcroja — provided sufficient value to justify payments of £10mn a year.
Nick Crabb, who led Nice’s evaluation, pointed out that the UK represented only 3 per cent of the global market for antibiotics. If scaled up across the world, the payment would be equivalent to £300mn a year.
“We are sharing our learning from this project with international stakeholders and encouraging other countries to offer similar incentives in their own domestic markets, so that collectively we can achieve a meaningful incentive for global investment in antimicrobials,” Crabb said.
Dame Sally Davies, UK special envoy on AMR and former chief medical officer for England, said she was encouraged by growing interest by G7 and G20 countries in funding incentives to pull new antibiotics on to the market. The biggest scheme will be in the US if Congress passes the bipartisan Pasteur Act, which could make more than $1bn in federal funding available per antibiotic.
How will the new scheme affect patients?
Charities and patient groups, like doctors and drug companies, have spoken out in favour of subscription contracts.
“Companies will no longer have a financial incentive to push sales as high as they can — and stewardship guidelines should mean prescribing is very tightly controlled,” said Knox. “But we don’t want doctors to prescribe the drugs more frequently because they are seen as effectively free at the point of use.”
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Many medical experts insist that the new model will not limit the supply of medicine to consumers who need it. “They will make a real difference to patients, in a positive way. No one will be deprived of a drug they need,” said Professor Colin Garner, chief executive of Antibiotic Research UK.
“Patients with drug-resistant infections are desperate for new treatments — and only the pharma industry can develop them.”
The NHS and Nice will be watching prescribing patterns closely after the subscription contracts take effect.
What else is needed to fight antimicrobial resistance?
As well as incentives, such as the UK subscription scheme, experts say more funding is needed to seed the discovery of new antibiotics in university laboratories and biotechnology companies.
“Cancer receives 20 times more money than AMR even at the earlier stages of research,” said Garner. “We need to stop antibiotic resistance being a Cinderella area.”
A drive to cut excessive prescribing of antibiotics by GPs is having some effect in the UK, he added, but it would be helped by more incentives for the diagnostics industry to develop fast and accurate tests to tell doctors whether bacteria susceptible to antibiotic treatment are causing an infection.
“We’ve seen during the pandemic how quickly diagnostic tests were developed for Covid,” Garner said. “We need to have a similar approach for AMR. If a company introduces a new antibiotic, there should be an accompanying test.”