LONDON – The U.K.'s National Health Service (NHS) is to set up to test the world's first subscription-style payment system for antibiotics that treat drug-resistant infections, in which the amount paid will be de-linked from the volume sold.
In the scheme, pharmaceutical companies will be paid up front for access to the drugs, rather than being paid for drugs they sell, at a time when health care systems everywhere are attempting to limit use of antibiotics to prevent the development of antimicrobial resistance (AMR).
"This will make it more attractive for companies to invest the estimated £1 billion it costs to develop a new drug, as they can be reassured they will still be paid for the drug, even though it may be stored for reserves," said John Rex, AMR campaigner and chief medical officer at antifungal specialist F2G Ltd., of Manchester.
The trial will be led by the health technology assessment body, the National Institute of Health and Care Excellence (NICE), which is calling on companies to nominate products for it to consider.
The Department of Health said it wants to send a signal that there are workable models to stimulate investment in antibiotics. The scheme will be evaluated and findings shared so that other health care systems can test similar models.
Matt Hancock, health minister, said the NHS is in a unique position to take the first steps in testing new payment models. "We will take the lead, but this is a global problem and we cannot succeed alone," he said. The government did not say how much money it will spend on the trial.
It has been more than 30 years since the last new class of antibiotics was discovered and came into routine use. Across 30 companies whose pipelines were analyzed in the AMR Benchmark last year, there are 276 programs in place, but only 28 of those antibiotics are in the late stages of clinical development. (See BioWorld, Jan. 25, 2018.)
There are now only three large pharmas left with an interest in the area, and although initiatives to promote antibiotic discovery are bearing fruit, there are few homes for programs to go when drugs complete phase II.
Meanwhile, many common diseases, including tuberculosis (TB), sexually transmitted infections, pneumonia, sepsis and food poisoning can already resist a wide range of antimicrobial drugs. Some strains of TB and gonorrhea can resist last line antibiotics, making them effectively untreatable.
"Our members are ready to get started," said Sheuli Porkess, executive director of research at the Association of the British Pharmaceutical Industries. "The sooner we get this pilot up and running, the sooner we can apply what we find to other antimicrobials in development."
Spreading the costs
Ensuring the development of new therapeutics means finding a way to bridge the large gap that exists between the commercial returns of developing a new antibiotic, which are low relative to most other drugs, and their value to society, which is high.
"All approaches to solving this problem have trade-offs, but a substantial market entry award granted on approval of a high value new antibiotic is the mechanism that has the best chance of working in the real world," F2G's Rex said.
It is not possible for the U.K. to solve market failures alone, but the government said it will catalyze efforts to address the problems at an international level, and work to change the incentives in order to improve the rewards for investment in the domestic market.
The use of up-front rewards was first suggested to fix the market failure by Jim O'Neill, former chief economist at Goldman Sachs and former government treasury minister, in his government-commissioned report on the problem of AMR in 2016.
Another route to shifting the risk/reward balance suggested by O'Neill was for pharma to "pay to play," in which companies that do not develop antibiotics would pay a levy to fund research by companies that do. That suggestion has not been taken up.
O'Neill has also said pharma companies should change their business models to reflect the value of antibiotics to the rest of their business. Many of the drugs developed by the industry depend on antibiotics being available and to carry on working. If there are high levels of hospital-acquired infections, there is not a safe environment for other therapies to be used effectively.
Cancer treatments, for example, are failing not because oncology drugs do not work, but because patients with weakened immune systems succumb to antibiotic-resistant infections.
Given that, pharma companies should think about spreading the costs of producing antibiotics across their business lines, because they need them to underpin other products, O'Neill said.
The launch of the subscription model is part of a 20-year AMR action plan, published in January, in which the government said its aim is to ensure that in the future all decisions to use antimicrobials are informed by a diagnostic test, a clinical decision support tool or relevant data. (See BioWorld, Jan 25, 2019.)