The UK is expected to become the first country in the world to pay pharmaceutical companies a fixed fee for the supply of antibiotics in a bid to deal with the growing global crisis of resistance to the drugs.
The aim is to give companies a better incentive to develop new antibioticswho would be held back to treat patients who really need them, while curbing overprescribing that is causing microbes to develop drug resistance.
Health experts appreciate that Antimicrobial Resistance (AMR) kills more than a million people worldwide every year and is putting pressure on the medical profession to reduce the use of antibiotics in all but the most severe cases.
Under the deal the NHS has with US-based Pfizer and Japan’s Shionogi, the drug companies will receive a fixed fee of £10million a year. The current volume-based compensation system often does not provide sufficient revenue to justify R&D expenditure.
The value of the contract was set in such a way that international companies would have an incentive to invest in antibiotics research and development if other countries paid proportionate amounts according to their gross domestic product.
Thomas Cueni, Director General of IFPMA, the International Trade Association of Pharmaceutical Manufacturers, agreed: “We urge other leading governments to make every effort to advance their own incentive schemes to achieve sufficient global reach to attract the necessary investments R&D.”
Two new antibiotics from Pfizer and Shionogi have already passed an important price-performance evaluation by the National Institute for Health and Care Excellence (Nice). NHS England is aiming to launch innovative ‘subscription-style’ deals with manufacturers this summer.
Nick Crabb, Nice’s program director, said: “The ultimate aim is to ensure the NHS has access to effective new antimicrobials to fall back on when it needs them and that patients are not left without treatment options in the face of growing antimicrobial resistance. “
Pfizer and Shionogi submitted their drugs for evaluation when the government announced a main plan in 2020, in which two antibiotics would be selected for subscription contracts capped at £10m per year for 10 years.
Several European nations and the US are considering similar schemes that separate payment from prescription volume, either through an upfront payment to enter the market or through annual subscriptions like the NHS England model.
“This is an important step in our world-leading approach to spurring innovation in antimicrobial medicines and the fight against drug-resistant infections,” said Blake Dark, Director of Commercial Medicines at the NHS.
Dame Sally Davies, UK Special Envoy for Antimicrobial Resistance and former Chief Medical Officer for England, said: “I am delighted that Nice has demonstrated the value of innovative antibodies in a subscription-style payment model. I urge the NHS to continue this pilot for years to come. Ideally, we need to add two innovative and needed antibiotics every year.”
Pfizer’s Zavicefta and Shionogi’s Fetcroja are used to treat severe infections of the abdomen, lungs and urinary tract caused by bacteria that are resistant to other antibiotics. Both are administered by intravenous infusion.
Nice worked with the Policy Research Unit in Economic Methods of Evaluation in Health and Care Interventions at the Universities of York and Sheffield to evaluate the two drugs.
Universities used a complex process that recognized their value in allowing other medical practices, reducing the spread of infection to other people and ensuring the NHS had a range of antibiotics available to treat resistant bacteria.
Taking all these factors into account, Nice estimated that for NHS patients over 20 years of age, Fetcroja would be worth 16,200 quality-adjusted life-years (Qalys), while Zavicefta’s was estimated to be worth 8,880 Qalys. Using the Nice standard that a treatment is justified if it costs £20,000 per Qaly, both would justify a £10m-a-year subscription.
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https://www.ft.com/content/c7cbebe4-8597-4340-8c55-56c4b423c1d1 The UK introduces the world’s first ‘subscription’ model for the supply of antibiotics