Industry asks PACCARB to clarify evidence pathways and reimbursement for microbiome therapeutics

Joshua Narrow, speaking for the Microbiome Therapeutics Innovation Group, noted that FDA has approved two products for prevention of recurrent C. difficile but said there is 'no established method for demonstrating the clinical benefit of decolonization' and no approved microbiome therapy for children. He suggested registries and longitudinal follow-up for post-approval evidence and urged PACCARB to study novel reimbursement mechanisms.

Chloe LeBegue-Polley (Nestle) and other commenters emphasized that stewardship and evidence quality must guide clinical management so that cost does not become a barrier to access. Speakers asked PACCARB to consider how reimbursement and diagnostic qualification (e.g., colonization-resistance measures) could support both stewardship and adoption.