The UK is set to implement a single subscription payment model for antibiotics.
The milestone comes in the form of draft guidance on how England’s National Health Service (NHS) should estimate the total value of the two new antibiotics – cefiderocol and ceftazidime-avibactam – which have been selected to make part of the pilot project. The guidance will inform discussions about how much the NHS should pay drugmakers on an annual basis under a subscription plan that aims to decouple the value of antibiotics from the number of units sold.
The guidelines were developed by the UK’s National Institute for Health and Care Excellence (NICE), which assessed the health benefits of medicines to the English population in terms of quality-adjusted life years (QALYs) – a measure used to assess the economic value of a medical intervention.
“These draft guidelines represent an important milestone in the UK project,” Nick Crabb, of NICE’s science, evidence and analysis directorate, said in a press release. “Its ultimate goal is to ensure that the NHS has access to effective new antimicrobials to call upon when needed and that patients are not left without treatment options in the face of growing antimicrobial resistance.”
Assessment of the public health value of antibiotics
The idea behind the subscription-style model, launched by the UK government in 2019, is that the NHS – a state-funded healthcare system that provides free care to English residents – will pay a fixed annual fee for patients have access to cefiderocol and ceftazidime. -avibactam, rather than reimbursing drug manufacturers based on the amount of antibiotics sold. Although these two drugs are essential for patients with drug-resistant bacterial infections, they are used sparingly to avoid the development of resistance, and the number of people who need them is relatively small.
Low sales and lack of return on investment for these and other new antibiotics have led many pharmaceutical companies and investors to abandon antibiotic development, leading to a low pipeline of new products, as has increasing resistance. antimicrobial therapy (AMR) threatens the effectiveness of current treatments. antibiotics. The hope is that guaranteeing companies a fixed annual fee that reflects the true public health value of new antibiotics could help renew interest and spur more investment in antibiotic development to address the growing threat of antimicrobial resistance.
The NHS and NICE selected cefiderocol (made by Shionogi) and ceftazidime-avibactam (Pfizer) to be the first antibiotics purchased under the program in December 2020. Since then, NICE has been working on guidance to assess their value and their cost-effectiveness.
While NICE’s evaluation methods for most drugs focus on the benefits to those who take them, their evaluation for antibiotics takes more into consideration. This also explains their importance in limiting the spread of infections to other people, ensuring that chemotherapy, surgery and other medical procedures can be carried out safely, and providing a range of treatment options that can reduce risk. of resistance.
“It was a very comprehensive review and a much more accurate estimate of the public health value [of these antibiotics]David Hyun, MD, director of the Pew Charitable Trusts Antibiotic Resistance Project, told CIDRAP News that previous research has attempted to demonstrate the economic benefits of treatment therapies.”
For cefiderocol, which is licensed for the treatment of patients with Gram-negative bacterial infections who have limited treatment options, NICE estimated that payment should be based on a value of 970 QALYs per year. For ceftazidime-avibactam, recommended as an option for the treatment of severe drug-resistant infections only when few alternatives are available, NICE estimated a value of 530 QALYs/year.
The next step is for NHS England to negotiate a 3-year contract for the drugs, with an option to extend the contract to 10 years, based on these estimates. The contracts will also require Shionogi and Pfizer to participate in the UK Antimicrobial Register (UKAR), which will provide information on the relationship between antibiotic use patterns and the emergence of resistance in the UK, as well as quantitative data. on clinical and safety outcomes of antibiotics.
“UKAR will support evaluation of the dissociation scheme and provide a basis for considering extending the scheme to other antimicrobials,” said David Jenkins, MBBS, president of the British Society for Antimicrobial Chemotherapy, which developed UKAR. in partnership with the University of Aberdeen, said in a statement.
A “moment of celebration”
Hyun said the draft guidelines are good news for those who have pushed policymakers to adopt policies that respond to difficult antibiotic market conditions and encourage antibiotic development. Pew is among many groups supporting the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act, a bill that would create a similar subscription-style payment model for antibiotics through Medicare.
“This is very encouraging news,” he said. “Many places, including the United States, are watching this pilot project with great interest to see how well it is working and using it as a potential model to replicate or adapt to their own country.”
Writing in the AMR.Solutions newsletter, Advent Life Sciences chief medical officer John Rex, MD, and CARB-X executive director Kevin Outterson, JD, said that while the monetary value of the contracts has yet to be determined , the progress of the pilot project is a “moment of celebration”.
“It is clear that the calculations show that major new antibiotics have real social value that can be estimated and should be rewarded,” they wrote.
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