The U.K. took a small step forward in its efforts to spur development of new antibiotics, announcing on Tuesday a plan to pay Pfizer and Shionogi roughly $13 million a year over the next decade in exchange for a guaranteed supply of two drugs used to treat infections from treatment-resistant bacteria.
England's National Institute for Clinical Excellence, which evaluates new medical technologies for the National Health Service, said the annual fee paid to the two companies represents the country's "fair share" of contributions to help incentivize drugmaker development of new antimicrobial medicines. The agency called on other governments to establish similar plans to help make the development incentives more meaningful.
The momentum for "subscription-style" antibiotic contracts appears to be building, with the Group of 7 countries endorsing plans for similar purchasing incentives and a bill in the U.S. Congress that would establish an $11 billion fund to buy new antimicrobial treatments.
Still, antibiotic developers, which have struggled to stay afloat as their new products haven't found commercial success, argue that subscription-style purchasing might not be enough. In the U.S., they are calling for Medicare and other insurers to provide higher reimbursement to hospitals for administration of new antibiotics, so they're incentivized to use them for treating more patients.
NICE's plan designates cefiderocol from Shionogi and ceftazidime–avibactam from Pfizer for subscription-style purchasing. The former drug is sold as Fetcroja in Europe and Fetroja in the U.S., while the latter is called Zavicefta in Europe and Avycaz in the U.S., where it is sold by AbbVie.
Cefiderocol is used in adults and ceftazidime–avibactam in children as young as 3 for certain bacterial infections with limited treatment options. Ceftazidime–avibactam is also specifically used in complicated abdominal, lung and urinary tract infections, and related bloodstream infections.
The agency estimated use of cefiderocol could improve health in England over 20 years by 16,200 "quality adjusted life years," a measurement of disease burden, while ceftazidime–avibactam could improve it by 8,880 quality adjusted life years over the same period.
While the draft guidance sets a benchmark for reimbursement, payments to Pfizer and Shionogi will be set through commercial contracts with the NHS, which have yet to be negotiated.
NICE said the fee of 10 million pounds, or about $13 million, over 10 years was set at a level that can be "scaled" by other countries based on gross domestic product to provide the necessary incentive to reward drugmakers for research and development of new antibiotics. Worldwide, governments need to promise up to $4.2 billion over a decade to sufficiently entice companies to enter the market, according to Kevin Outterson, executive director of CARB-X, a non-profit focusing on antibiotic resistance.
The Association of the British Pharmaceutical Industry called the draft guideline a "milestone," but urged NICE and the NHS to expand their work on antibiotics.
"We acknowledge the difficulties of generating evidence on the broader public health benefits that antibiotics bring to patients, but it is essential these are fully captured in evaluation frameworks," ABPI chief executive Richard Torbett said in a statement. "Rapid progress is needed to establish a permanent evaluation and reimbursement approach and deliver the incentives needed to develop these important medicines."