“Astonishing mismatch”: Market potential of AMR tools vs. patient needs

The report is the output from a 3-year project in which the AMR Hub’s Expert Advisory Group undertook exhaustive modeling of the therapeutic and diagnostic markets. Here are the links you need:

• The webpage for the report
• The report itself
• A 3-page policy brief focused on therapeutics
• A 3-page policy brief focused on diagnostics

Here are a few excerpts from the analysis of therapeutics. As expected, the problem for therapeutics that reimbursement based on usage does not cover the costs of developing and maintaining a new antibiotic:

• “… there were an estimated 3.7 million cases of MDR BSI (bloodstream infection) and 1.7 million cases of MDR pneumonia attributable to Gram-negative pathogens worldwide in 2020.
  • “In the absence of any intervention, patient numbers are forecast to rise to 5.5 million cases of MDR BSI and 2.8 million cases of MDR pneumonia by 2040.
• “… therapeutics for the treatment of BSI and pneumonia were estimated to generate less than $200 million ($184 million for BSI and $127 million for pneumonia) in sales revenue at their market peak in 2036, following a first launch in the US in 2025.
• “These estimates are broadly in line with similar estimates previously carried out and confirm a now solid body of evidence –from studies and anecdotally – that antibiotic markets are unattractive investments for private companies and investors, both in absolute terms and relative to other therapeutic areas.
• “… at the apex of the public health need (the products modelled here), the market may be failing most acutely and therefore struggle to deliver these most needed products to society.”

The messages are equally dark for diagnostics, but here the problem is due to limited uptake because of the way that use of a diagnostic currently creates costs that may be higher (at least from the perspective of the patient and provider) than the cost of treating empirically:

• Two rapid, near-patient diagnostics were modeled: one that separates bacterial from non-bacterial causes and one that predicts the presence of (and species of) a highly resistant Gram-negative pathogen.
• Due to the way that the cost of using a diagnostic drives clinicians to treat empirically, especially in Low- and Middle-Income Countries, the diagnostic separating bacterial from non-bacterial was predicted to reach only 2% of its target patients or 17 million patient-diagnoses out of ~800m who could benefit.
• The diagnostic predicting species and resistance improves only slightly on this: it reaches about 10% of the 30m who could benefit and it does this mainly in Upper- and Middle-Income Countries.

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Strong stuff! Here are the report’s top 3 recommendations:

1. That widespread and immediate use of existing policy levers i.e., national-level reform of pricing and reimbursement (ideally backed by broader value-assessment frameworks) are required, as current sales revenues from AMR technologies are insufficient to support private investment. This intra-country action would leave individual health systems to discriminate and value individual AMR technologies according to their own needs, priorities and available policy-levers.
2. That such national efforts should be supplemented with additional pull support measures in order to reach the scale of return on investment to be attractive to private developers and investors and ensure critically important new products are both sustainably developed and also licensed in a broad number of countries with accompanying stewardship measures to ensure their longevity.
3. To substantially progress the dialogue on possible global access, distribution, and supply chain efficiency mechanisms due to the growing reliance on smaller developers and the geographic location of the projected future AMR burden – outside HICs.

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I know that I sound like a broken record, but it really, really, really is time for concerted global action on the AMR problem.

• For therapeutics, we need Pull incentives of a sufficient size to create and maintain an adequate antibiotic ecosystem.
  • As the Hub states in its summary: “The specific features of these markets (the stewardship imperative, slow uptake, low and fragmented global volumes and cheap and plentiful older antibiotics) suggest that additional support and/or implementation of new models will be required in addition to the use of traditional policy levers.”
  • The UK (NHS England) subscription pilot and the PASTEUR Act in the US are both good starts, but the rest of the G20 needs to get into the game: a new report of this type is great to have as confirmation, but the outcomes from YAS or YAM (yet-another-study, yet-another-model) would really be a foregone conclusion.
  • As DRIVE-AB showed so very clearly, volume-delinked rewards are the tool that will break the logjam for therapeutics.
• The best solutions for diagnostics are still evolving (we eagerly await outputs from the IMI-sponsored VALUE-DX project), but the Hub’s policy report (and common sense) would suggest that the key is policy and reimbursement adjustments such that use of good diagnostics is not seen as a cost/obstacle at the local level.
  • As the Hub’s summary states: “Broader value-frameworks – such as those being explored within ValueDx – that capture and incorporate longer-term health and economic impacts on the whole health system would improve the flow and rate of innovation.”

Let’s make it happen!  All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.