UK Plans Upfront Payment Scheme To Spur Antimicrobial Development
Executive Summary
A new UK project will look at the potential of upfront payments to encourage companies to invest in the development of new antimicrobial drugs. The scheme, developed by NICE and NHS England, will use a tailored health technology assessment approach and is seen as a possible model for other countries to emulate in the fight against antimicrobial resistance.
The UK government is planning to test a new scheme aimed at fostering the development of new antimicrobials whereby companies will be paid upfront for new drugs on the basis of their expected value to the national health service, rather than on the volume of products actually used on the NHS.
The trial, involving what the government describes as "the world's first 'subscription' style” payment scheme, is intended to help tackle the growing problem of antimicrobial resistance (AMR) and will be developed and run by the health technology assessment (HTA) body NICE, NHS England and NHS Improvement.
It will initially be tested using two antimicrobial drugs and will be in two phases. The first phase – developing an evaluation framework and identifying the two products – is expected to be completed by the end of this year. The second phase, including value assessments of the products and the implementation of payments, should be finished by the end of 2020.
NICE and NHS England are calling on companies to identify products they would like to be considered for the initial phase of the project. A stakeholder advisory group will shortly be set up with representatives of industry, experts in public health and the clinical and health economic evaluations of vaccines, as well as a “wide range of national and international representatives”.
The group will be used to support a period of targeted engagement that will begin shortly in order to “secure stakeholder input into the development of key areas of the project, including the proposed approach for topic selection, the approach to evaluation, and the outline commercial model,” the organizations said.
The scheme will “make it more attractive for companies to invest the estimated £1 billion it costs to develop a new drug” – UK Department of Health and Social Care
It is widely accepted that companies see investment in novel antibiotics as commercially unattractive because of the high cost of R&D and the low returns on investment. The Department of Health and Social Care said the new scheme would “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.”
The project was welcomed by the Association of the British Pharmaceutical Industry, which described it as a “big step forward” that could have “a big impact on the future of health and research by making it sustainable for companies to keep investing.”
Dr Sheuli Porkess, the ABPI’s executive director of research, medical and innovation, said the announcement was “an example of how the UK can lead the world in this fight and hopefully brings us closer to fixing the problems that have hampered investment in antibiotics research for so long.” She said ABPI members were “ready to get started, and the sooner we get this pilot up and running, the sooner we can apply what we find to other antimicrobials in development.”
The scheme is also seen by the government as a model for other countries to emulate. Health Minister Nicola Blackwood said: “This project is an important step but it will only address global market failure if other countries do the same, which is why we want to involve as many countries as we can and share our learning from this work. Today we are sending a strong signal to the rest of the world that there are workable models to stimulate investment in these vital medicines and that together we can tackle AMR.”
The New Payment Model
The announcement of the trial follows the publication in January of the government’s “20-year vision” and five-year “action plan” for containing and controlling AMR. The plans outlined in those documents included cutting the number of drug-resistant infections by 10% by 2025, and reducing the use of antibiotics in humans by 15%. They also said that NICE and NHS England would explore a new payment model for antibiotics.
A key part of the new approach will be to use revamped HTA methods to assess the likely value of new drugs. NICE and NHS England said that research conducted by EEPRU (Economic Methods of Evaluation in Health & Care Interventions), which is funded by the National Institute for Health Research, had confirmed that “capturing the full value of a new antimicrobial is complex” and that a robust evaluation of benefits “may not always be feasible or practical.”
The research did, however, conclude that “an adapted HTA framework, informed by health economic modelling and expert opinion, could be developed to capture the full value of novel antimicrobials.” NICE, NHS England and NHS Improvement have now established a jointly led project supported by EEPRU to “develop and test innovative models for the evaluation and purchase of antimicrobials.”
The Two Phases
The two organizations said they were working closely with the DHSC and stakeholders including industry, and that they had set up a central project team to lead the work and facilitate input from experts and stakeholders.
The first phase of the project, which is expected to be completed by the end of this year, will focus on possible adaptations to the current HTA framework, the development of an outline reimbursement and payment model, and the selection of two products to undergo trial assessment and commercial discussions.
“It is therefore important that companies have notified the project team if they have a product which could be considered through this process,” according to the two organizations. If not, companies should get in touch with [email protected].
The reimbursement and payment model would include “a strong emphasis on companies needing to ensure that optimal stewardship arrangements are maintained through the introduction of the product and that they are making efforts to keep environmental contamination of antimicrobials to a minimum.”
The second phase, expected to last until the end of next year, will involve an assessment of the two selected products, including the development of NICE guidance by a special committee to be convened for the project. It will also see commercial discussions on the two products, the implementation of payments, and monitoring of the use of the products.
“Evaluation and communication will be ongoing throughout the project and the evaluation will be critical in shaping UK policy on the wider application of the model,” the organizations said.