Antimicrobial resistance (AMR) occurs when microorganisms such as bacteria, viruses, fungi and parasites change in ways that render the medications used to cure the infections they cause ineffective.
Without new antibiotics, more patients will die from previously treatable infections.
However, a key issue is how antibiotics can be appropriately assessed, particularly by payers and/or health technology assessment (HTA) bodies, to take account of AMR and reflect the full benefit they provide to patients and society.
There are several reasons why we need additional elements of value for antibiotics
- AMR is a public health priority. The rise of AMR is recognised as a serious global and urgent threat, and tackling this threat is a priority for leading national and international organisations. Current HTA methods, in general, do not explicitly account for the value of reducing this public health threat, for example of the “insurance” value of having a treatment available in case of a future major or rapidly escalating problem of resistance.
- A diverse set of non-inferior antibiotics are valuable to society. Because of the rise of AMR, there is value in developing a new antibiotic for MDR pathogens, even if it is no more effective than existing antibiotics in treating susceptible (non-resistant) pathogens, since it enables diverse prescribing patterns. This concept is unique to antibiotics and is not explicitly considered by HTA bodies.
- Non-clinical and microbiology data are important for demonstrating the value of antibiotics. For antibiotics, non-clinical and microbiology data can be important predictors of outcomes. Difficulties in conducting clinical trials for antibiotics for MDR pathogens has led regulators to accept these alternative types of evidence as part of the approval process in areas of high unmet need
- Antibiotics have benefits that go beyond the patient treated. When one patient is treated with an antibiotic, this reduces the spread of the infectious disease, leading to population-wide benefits.
- Antibiotics enable other types of treatment and procedures. As well as treating infections, antibiotics reduce the risk associated with other types of treatment such as surgery and chemotherapy.
A new Briefing, authored by OHE’s Professor Adrian Towse and colleagues together with Professor Robert Masterton and Peter West from The Academy of Infection Management (AIM), discusses 10 elements of value which can be split into two groups: four relevant benefits typically included in HTA, and six other types of benefits not traditionally included. These were discussed at a multi-country, multi-disciplinary, multi-stakeholder Value Forum.
Overall, there was broad agreement at the Forum that these additional elements of value were potentially relevant for HTA of new antibiotics. Participants offered a number of valuable insights into how further work could be approached in order to maximise both its practicality and its potential policy impact. These are summarised in the Briefing.
The Forum and the report result from a joint collaboration between OHE and AIM, who brought together leading experts from HTA bodies, payer organisations, industry and regulatory bodies, with economists and clinical experts across Europe to discuss the valuation of antibiotics.
Access the briefing here.
A two page summary of the briefing, written by Dr Chris Henshall and Professor Adrian Towse is available here.
Posted in Countering AMR, Drug Development/R&D, Health Care Systems, Innovation, Research | Tagged Briefing