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Journey towards a better antimicrobial pipeline; is there light at the end of the tunnel?
– by Colm Leonard & Tracy Parker


Journey towards a better antimicrobial pipeline; is there light at the end of the tunnel?
– by Colm Leonard & Tracy Parker

The Global Action Plan on antimicrobial resistance (AMR), endorsed at the World Health Assembly in May 2015, recognised the need for sustainable and increased investment in new medicines, diagnostic tools, vaccines and other interventions. In 2016, the global facing independent review on AMR, led by Lord O’Neill, recommended a global system of market entry rewards. This was also recognised by the G20 leaders’ statement in 2017 which committed to exploring practical market incentive options. Many other governments and international organisations have since been focusing on how to make this happen.

At the same time, the Independent AMR Review called on governments to make changes at the national level by considering possible changes to their purchase and distribution systems for antibiotics, to find ways to support better rewards for innovation while helping to avoid over-use of a new product.

It is now widely recognised that, while funding that has been provided for early drug development has been much needed and welcomed; investment at other stages in the pipeline is also needed, together with purchasing mechanisms that make new drugs more commercially viable.

Innovative evaluation and purchasing models

In the UK we are committed to testing innovative evaluation and purchasing models that will support good antimicrobial stewardship and we have made significant progress, formally launching our project on July 9th 2019. Two antimicrobial products will be selected for evaluation in the project. The aim is to demonstrate the feasibility of innovative models that pay companies for antimicrobials based primarily on a health technology assessment (HTA) of their value to the National Health Service (NHS) as opposed to the volumes used. The benefit of this new model is that companies would be paid based on an assessment of the drug’s value to the NHS. The NHS will have new drugs to call on when needed, while companies, in turn, will be able to reliably forecast the return on their investment.

It is now widely recognised that, while funding that has been provided for early drug development has been much needed and welcomed; investment at other stages in the pipeline is also needed, together with purchasing mechanisms that make new drugs more commercially viable.

The proposed model would forecast the value of health benefits provided by a new antibiotic at the time of launch. The value forecast would be used in commercial negotiations leading to payments to the company, potentially in instalments and not related to volumes used; though other innovative approaches are being considered and the precise commercial arrangements will require negotiation with the companies concerned.

Health technology assessment of new antimicrobials

HTA of antimicrobials presents many challenges. Our value assessment will attempt to go beyond standard HTA and try and model as many additional attributes of value such as transmission effect, insurance, diversity, enablement and spectrum values in addition to modelling in the development of resistance to the new antimicrobial and existing comparators. Formal expert elicitation will be used to deal with areas of significant uncertainty. The output from the value assessment will then be considered by a National Institute for Health and Care Excellence (NICE) assessment committee, which will add additional commentary around stewardship, and any clinical scenarios and/or attributes of value not included in the economic model. The output from the NICE committee will inform the NHS England & Improvement commercial negotiation with the companies whose products have gone through the evaluation.

A number of reimbursement models are being considered (fixed fee, fixed fee with renegotiation, cap and collar payments, condition and outcome-based payment arrangements), but we recognise that a ‘one size fits all’ model is unlikely to be possible, and the model may need to be tailored to suit particular medicines, pathogens, and settings.

Aiming for global market incentives solutions

The UK represents only a small part of the global market for these drugs and we want to send a signal to the rest of the world that there are workable models to achieve the right sort of pull incentives for these vital medicines, and we applaud the recent announcement from the Centers for Medicare & Medicaid Services (CMS) in the United States of enhanced reimbursement mechanisms for novel antimicrobials addressing resistant organisms. We want to engage with other countries and share the learning from our UK project to encourage them to offer similar incentives in their own domestic markets, alongside regional or global market incentives solutions.

For this reason, we were pleased that invitees from across Europe and North America participated in our first project stakeholder forum on 31st July 2019 and we can report interest from Japan, Brazil and Mexico in this UK project.

Our next steps are to identify two products through a NICE led topic selection process in the autumn with the novel value assessment taking place through 2020. The aim is to have two antimicrobials with commercial agreements linked with NICE guidance in place in 2021.

Following undergraduate training in Dublin, and post-graduate experience in Dublin, London and California, Professor Colm Leonard was appointed as a Consultant Thoracic Physician in Manchester in October 2000, and is an Honorary Professor of Respiratory Medicine at Manchester Academic Health Sciences Centre. Since 2008 Colm spends part of his week in the Centre for Health Technology Evaluation at NICE, which involves assessing which novel pharmaceutical and MedTech products will benefit from a NICE value assessment.
A significant amount of Colm’s time over the past 3 years has been spent with colleagues in NICE, DHSC and NHS England working towards a novel value assessment and reimbursement of new antimicrobials.

Tracy Parker is Head of policy for antimicrobial resistance, healthcare associated infections and sepsis in the Emergency and Public Health Directorate of the Department of Health and Social Care. Tracy has worked in several Government Departments before joining the Department of Health in 1999. After working in corporate roles, including risk management, she moved to a clinical policy team in 2004 working to implement the Cancer Plan for England. In April 2013, Tracy moved to coordinate the programme to implement the UK Antimicrobial Resistance (AMR) Strategy 2013-2018. As head of policy for AMR since the start of 2017, she has worked across UK government departments and agencies to coordinate the development of the UK vision for AMR in 2040 and the five-year national action plan published in January 2019.

The views and opinions expressed in this blog are solely those of the original author(s) and do not necessarily represent those of GARDP, their donors and partners, or other collaborators and contributors. GARDP is not responsible for the content of external sites.

2019-09-02T07:32:41+00:00

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