How can we assess the value of new antibiotics?

Adrian's slides from his ISPOR Glasgow issues panel on assessing the value of new antibiotics.

1. How can we assess the value of new antibiotics?

2. Taken from OHE-AIM publication, May 2017 This Briefing, from OHE and the Academy of Infection Management, 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. Free download from https:// www.ohe.org/publications/additional-elements-value-health-technology-assessment-decisions Or from https:// www.aiminfection.org/article/bad-bugs-undervalued-drugs-time-to-change-the-way-we-value-antibiotics

3. HTA challenges for antibiotics Concerns that current HTA/payer methods may not capture the full range of benefits of antibiotics, including value of tackling AMR Two key challenges: Clinical trials typically designed to demonstrate non-inferiority, whereas HTA bodies generally require demonstration of clinical superiority HTA bodies/payers generally do not have a mechanism to assess the broader public health benefits of antibiotics, including tackling rise in AMR

4. Additional Elements of Value Relevant to Antibiotics Relevant benefits included in traditional HTA Other types of benefit of possible relevance to antibiotics Health gain Insurance value Unmet need Diversity value Cost offsets Diagnostic value Productivity benefits Uniqueness or innovation value Enablement value Spectrum value Need also to focus on the evidence requirements for new elements of value

5. Relevant benefits included in traditional HTA Health gain Includes both life extension and quality of life gains Generally accepted as key criterion for positive HTA recommendation Evidence typically required by HTA bodies often unachievable for antibiotics (superiority trials) Unmet need Includes both severity of disease and current availability of alternative treatments Could include use of priority pathogen lists

6. Relevant benefits included in traditional HTA Cost offsets Reduction in costs in other areas that come from use of new medicine Use of modelling studies and/or evidence from clinical trials Productivity benefits Gains or losses related to value of patient’s time, receiving medical care or out of work Use of modelling studies and/or evidence from clinical trials / observational studies

7. Other types of benefit of possible relevance to antibiotics Insurance value Value of having treatment available in case of catastrophic health event, e.g. outbreak of MDR infections which cannot be contained by existing ‘last-line’ antibiotics Analogous to availability of a fire engine (Rex and Outterson, 2016 ) Also need to add in the “precautionary principle” – maybe we have two fire engines Use of modelling studies Diversity value Selection pressure: Antibiotic able to eradicate susceptible species of bacteria but not other resistant pathogen so r esistant pathogens survive and multiply and the antibiotic becomes ineffective Evidence that reducing selection pressure by withdrawing antibiotic for period of time may lead to restoration of susceptibilities Use of modelling studies

8. Other types of benefit of possible relevance to antibiotics Diagnostic value If infection is accurately and speedily diagnosed then appropriate antibiotic therapy can be started earlier Need evidence of test accuracy Uniqueness or innovation value Potential value associated with new or unique mechanism of action (MOA) antibiotics with novel MOA may avoid problems of cross-resistance seen amongst existing classes Discovery of new MOA antibiotic makes it easier for “follow on” products to enter market Evidence of new or unique mechanism of action

9. Other types of benefit of possible relevance to antibiotics Enablement value Availability of effective antibiotics underpins many surgical procedures and treatments for people with compromised immune systems Use of modelling studies Spectrum value Narrow spectrum antibiotics may be more valuable than broad spectrum antibiotics as could reduce spread of AMR by preventing ‘collateral damage’ to the microbiome Depends on the antibiotic

10. Innovation in Payment Mechanisms Good stewardship requires the use of new antibiotics to be limited to delay the build up of resistance. Volumes will be too low to give a return on investment – even at prices that recognise all of the value. Partial d elinkage is needed between drug volumes / use and revenue with some revenues coming via a separate payment mechanism. Could be an insurance policy, or a per-member-per-month fee.

11. Insights gained from the Value Forum S ome of the additional elements of value not typically considered in traditional HTA are not unique to antibiotics Transmission value is important in assessing the value of a vaccine Surrogate end-points are used in a number of disease areas M easurement of some elements likely to require modelling studies, evidence on decision-makers and/or the public’s attitudes towards risk New elements of value should be seen as additional elements within current HTA frameworks rather than requiring a completely new assessment framework for antibiotics . Need for collaboration and/or engagement with international and global organisations such the OECD and EUnetHTA . Need for different contractual arrangements to complement the value assessment – cannot be delivered through a “high” price.

12. Adrian Towse The Office of Health Economics The Office of Health Economics is a charity (registration number 1170829 ) and a company limited by guarantee (registered number 09848965) Southside , 7 th Floor, 105 Victoria Street, London SW1E 6QT Website: www.ohe.org   Blog: http://news.ohe.org Email: [email protected] THANK YOU FOR YOUR ATTEN TION