Health campaigners hope a move by the UK to introduce a fixed-price model for funding the development of new antibiotics will boost global efforts to tackle the growing problem of resistance to existing drugs.
The UK is to launch the world’s first “subscription” incentive program for antibiotics, which will pay manufacturers a flat rate for making new drugs available to the NHS, regardless of their quantity or low usage.
The pilot program announced on Tuesday will initially offer Pfizer of the United States and Shionogi of Japan contracts capped at £10 million 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 1.2 million people a year according to the latest estimate. The causes of antimicrobial resistance are the overuse of antibiotics in medicine and agriculture, and the failure of industry to invest in new products.
How will the subscription system promote 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 get a new antibiotic through clinical trials and gain regulatory approval.
“When we looked at the antibiotics market, we found that recently introduced drugs were only selling in the tens of millions of dollars a year globally,” 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 the revenues of antibiotic producers are relatively low. Antibiotics do not have high prices, with many cheap old drugs on the market; patients receive only short-term treatments; and ‘stewardship’ rules to prevent inappropriate use mean doctors are subject to strict controls when prescribing.
Under the subscription model, companies are guaranteed a higher level of revenue than they would likely make from conventional sales, Knox said, and would justify more R&D investment.
Is a contract worth £10m a year enough to drive more pharmaceutical investment in antibiotics?
The NHS program is just a start that other governments should follow, leading to global action to address antibiotics market failure, said Thomas Cueni, director of IFPMA, the international health body. pharmaceutical manufacturers in Geneva.
He said the UK’s National Institute for Health and Care Excellence (Nice) had led the way with an assessment showing that the two pilot drugs – Zavicefta from Pfizer and Fetcroja from Shionogi – offered sufficient value to justify payments of £10 million a year.
Nick Crabb, who led the Nice assessment, pointed out that the UK only accounted for 3% of the global antibiotics market. If extended globally, the payout would amount to £300million a year.
“We are sharing learnings from this project with international stakeholders and encouraging other countries to offer similar incentives in their own national markets, so that we can collectively gain meaningful incentive for global investment in antimicrobials,” said said Crabb.
Dame Sally Davies, UK Special Envoy on RAM and former Chief Medical Officer for England, said she was encouraged by the growing interest from G7 and G20 countries in funding incentives to the market for new antibiotics. The biggest program will be in the United States if Congress passes the bipartisan Pasteur Act, which could make more than $1 billion in federal funding available per antibiotic.
How will the new regimen affect patients?
Charities and patient groups, such as doctors and pharmaceutical companies, have come out in favor 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,” Knox said. “But we don’t want doctors to prescribe the drugs more frequently because they’re considered 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 drugs to consumers who need them. “They will make a real difference to patients, in a positive way. No one will be deprived of a medicine 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 pharmaceutical industry can develop them.”
The NHS and Nice will closely monitor prescribing patterns after subscription contracts come into effect.
What else is needed to fight antimicrobial resistance?
In addition to incentives, such as Britain’s subscription scheme, experts say more funding is needed to seed the discovery of new antibiotics in university labs and biotech companies.
“Cancer gets 20 times more money than RAM, even in the early stages of research,” Garner said. “We need to stop antibiotic resistance from being a Cinderella zone.”
A drive to reduce over-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 rapid tests and accurate in telling doctors if bacteria sensitive to antibiotic treatment are causing an infection.
“We’ve seen during the pandemic how quickly diagnostic tests have been developed for Covid,” Garner said. “We need to take a similar approach for RAM. If a company introduces a new antibiotic, there should be an accompanying test.