Novel Antimicrobials and AMR Diagnostics 2019


Pull incentives to happen during 116th congress?

US stakeholders active in AMR have sent a letter to US congress representatives urging the need for pull incentives.

The letter was published in early February and signed by a broad coalition of stakeholders including SMEs, big pharma, and other organisations. It has been sent to all the relevant legislative committees: the Senate Committee on Health, Education, Labor & Pensions (HELP), the Senate Committee on Finance, the House Committee on Ways & Means, and the House Committee on Energy & Commerce.

After explaining the background and the need for a fundamental fix via a package of incentives, the letter highlights that:

  • Incentives should be paid after FDA approval, rewarding only successful development of novel antibiotics that address the greatest public health need.
  • A package of incentives should aim both to stabilize today’s novel antibiotic market and to ensure the viability of future development – meaning they must be substantial and viewed as highly valuable to private markets.
  • Economic incentives should provide predictability for drug developers – assurance that the company can commit R&D funds today, knowing that the economic incentive will be available if the new drug meets eligibility criteria.
  • Incentives must be aligned with appropriate antibiotic stewardship and surveillance.

In addition, the authors say: "We commit to working with Congress and the Administration to further develop and advance a package of antibiotic incentives, at least some of which must be enacted in 2019 to meet growing patient needs and help mitigate a public health crisis. Such a package could, for example, include a mix of tax incentives, novel pull incentives, reimbursement changes, and even a low-interest loan program, along with continued investment in NIAID and BARDA."

According to experts, there is an active progress on a bipartisan bill that would be introduced to the House and Senate simultaneously in which a fundamental DRG fix is proposed as an initial step. Now, the stakeholders hope that a delinked reward model could follow in the future as well.

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