FRAMEWORK FOR VALUE ASSESSMENT OF NEW ANTIMICROBIALS: Implications of alternative funding arrangements for NICE Appraisal

Antimicrobial resistance (AMR) is a complex issue of major global concern, and infectious organisms are now becoming increasingly resistant to the array of existing antimicrobials (AMs) available. At the same time, the pharmaceutical and biotechnology industry is becoming reluctant

to develop novel AMs because of their expected limited return on investment. The problem is compounded further by public health and conservation goals that require AMs to be used judiciously and, in some cases, only as last resort therapies, in an effort to curb the rise in AMR.

This is increasingly difficult for multi-drug resistant (MDR) pathogens where the number of available AMs is decreasing at an alarming rate, to the point that more patients will eventually die from previously treatable infections.

The O’Neill report on tackling drug-resistant infections globally recommended a range of policy responses to the international challenge of AMR and research and development in this area, including a global system of market entry rewards for new products [1]. It also urged national governments to find new ways of rewarding industry to help avoid over-use of new products. One policy that is being considered in the UK is an insurance-based delinked model, where a one-off or series of ‘insurance’ payments is made to reward innovation and to delink revenue from volume of antimicrobials sold. This model would be based on a payment that reflects the expected value of a new product to the National Health Service (NHS) over a specified period, and with the possible addition of ‘cap and collar’ arrangements to meet an agreed maximum and minimum payment, respectively, in order to share risk and unexpected variations in use. The precise specification of the UK insurance-based delinked model is yet to be determined, but it is likely to be specific to the profile of risk for particular AMs and their expected patterns of resistance over time.

Central to the proposed alternative funding arrangements of new AMs is the necessary prerequisite to characterise the expected value of a new product over an appropriate time horizon. This involves taking into account the same values as other health technologies; namely, the health benefits accruing at a population level, the expected costs borne by the payer, and the opportunity costs associated with expenditure on the new intervention; but also to reflect the additional elements of value for AMs, including diversity value (benefits of having a range of treatments available to reduce selection pressure and preserve the efficacy of existing AMs); transmission value (benefits of avoiding the spread of infection in the population); enablement value (benefits of enabling surgical and medical procedures to take place); spectrum value (benefits of replacing broad spectrum with narrow spectrum AMs that target specific pathogens); and, potentially, insurance value (benefits of having treatments available in case of sudden, or major, increase in prevalence of infections) [2], [3].