MAP Insights

insights-3

NICE Models for the evaluation and purchase of antimicrobials – what next?

In response to the challenges associated with discovering, developing and bringing new antimicrobial drugs to market, the National Institute for Health and Care Excellence (NICE) and NHS England and NHS Improvement (NHSE&I) developed a project to create a world-first pull incentive.[1]  The NICE/NHSE&I project has had numerous twists and turns and has taken years to come to fruition.  However, yesterday, the project leapt forward as NICE published the draft guidance for cefiderocol and ceftazidime with avibactam (https://www.nice.org.uk/about/what-we-do/life-sciences/scientific-advice/models-for-the-evaluation-and-purchase-of-antimicrobials).

The guidance is unlike other NICE guidance – instead of a yes/no decision, it provides an estimate of the value to the NHS expressed as quality-adjusted life years2 (QALYs) over 20 years, and the consequent value of each year of a 10-year contract, also expressed as QALYs.  These values will now be used as the basis for a negotiation with NHSE over the value of a 3-year contract, which will be extendable up to a maximum of 10 years.  NHSE&I has set a maximum contract value of £10m per year for each of the antimicrobials.

The NICE committee has taken into account numerous sources of data, including clinical trials, complex economic models, qualitative data and expert judgment to arrive at their most plausible QALY/year values (970 QALYs/year for cefiderocol and 530 QALYs/year for ceftazidime with avibactam). This can be read that, even at the lowest end of the usual cost per QALY range of £20–30k, the NICE committee has assigned more value to both antimicrobials than the £10m cap that NHSE&I determined for each contract.

This is exciting news for several reasons. The first is that, pending negotiations with NHSE&I, contracts for significant sums should be available for two antimicrobials irrespective of volume used.  This sends a signal both to industry and to other governments that this is a viable, implementable strategy that offers a true reward for market entry.

Secondly, it is possible, if extremely difficult, to place a quantified value on a new antimicrobial.  As can be seen from the guidance documents, the economic models developed by the Policy Research Unit in Economic Evaluation of Health and Care Interventions (EEPRU) at the University of York were considered a starting point by the committee.  In their considerations, they included various additional modifiers and qualitative judgments to come to an agreed value. This suggests that while a quantitative health technology appraisal (HTA) can be used to assess the value of a new antimicrobial, it is neither absolutely necessary nor completely sufficient in practice.  Instead, a more pragmatic approach of blending the quantitative value of a new antimicrobial, as determined by population size and Gross Domestic Product (GDP), with qualitative judgments of its value, could be an option for countries lacking the UK’s HTA infrastructure.

The third reason this is exciting is that it shows that true policy shifts in tackling antimicrobial resistance (AMR) are possible, when there is political, industrial, academic and public backing. This has been a protracted process, but it has at last arrived at an answer that provides hope for the future.  There is growing awareness of the existential threat that AMR poses globally, and the need for the development of new antimicrobials.  This project could serve as a model for how multiple sectors can come together to deliver a solution to a challenge that has, until now, seemed insurmountable.

In its Call to Action document, MAP outlined how the NICE/NHSE&I project could be the inspiration for further global action, and the steps that governments, industry, academia and the public should take to create a sustainable future for antimicrobial development. Following feedback from stakeholders, including pharmaceutical companies involved in antibiotic research and development, it is clear that the views expressed in the document have industry support and should appeal to a wider audience.

The time is right for change. The Health and Care Bill has completed its stages in both Houses of Parliament and will shortly become an Act of Parliament. The new NHS structures are being formalised and the Integrated Care Systems (ICSs) are being embedded in our health and social care system. These changes align with the NHS Long Term Plan’s AMR commitments, including system-wide improvements in the development of new antimicrobials, ensuring access to old and new treatments and support for diagnostics and electronic prescribing-systems in all health settings (Para 2.22 - https://www.longtermplan.nhs.uk/online-version/chapter-2-more-nhs-action-on-prevention-and-health-inequalities/antimicrobial-resistance/ ). There are some ongoing issues around resilience in the UK manufacturing and supply chain and the updating of local formularies that need to be dealt with, but the UK is closer to enabling the fair and economically sustainable introduction of new antimicrobials.

We are now in a unique position to become a world leader in tackling AMR with the draft NICE guidance coupled with the recent Infection Management Coalition Whitepaper https://theimc.org/. MAP invites you to support its Call to Action and join the fight against AMR.

[1] A pull incentive aims to provide assurance that there is a viable market that is ready and able to pay for a new antimicrobial, which in this case takes the form of an assured payment regardless of volume used. This breaks the link between drug profitability being linked to the volume sold, which has significant implications for the stewardship of antimicrobials.

[2]QALYs are defined by NICE as ‘a measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One quality-adjusted life year (QALY) is equal to 1 year of life in perfect health’

1 / 13
Next Insight
Arrow Vector-Quotes