The Rock Just Below the Water: Market Access Risk and Early-stage Biotechs


  • Ed Saltzman, Executive Chairman, Cello Health BioConsulting, previously Defined Health


The pharmaceutical landscape is littered with the market-access failures of recent biotech launches – the reason investors now often “sell on the launch” — innovative science and a biotechs’ vision of “unmet medical need” are often irrelevant or meaningless to payers. Even the earliest target product profile needs to reflect “unmet need” from the payer’s point of view – using an objective, broad and forward-looking understanding of competition — and create a medical and economic roadmap for minimizing payer restrictions. Certainly, by Phase I, biotech companies need to be considering payer-relevant clinical development plans – checking off the standard regulatory boxes is far from sufficient. As investors focus more attention on access, biotechs will need to show them progress, at each standard value-inflection point, on proving value to payers on a variety of fronts — with highly credible pharmacoeconomic evidence, for example, and clinical and other markers that will support a pragmatic contracting program. Defining financeable contracting strategies (by Ph II) and the pre-identified clinical/economic markers they rely on will be even more important for more complex therapeutics (e.g., cell and gene therapies, orphan diseases) about which payers are increasingly concerned.

You are invited to join Ed Saltzman, Cello Health BioConsulting, (previously Defined Health), Roger Longman and Jeffrey Berkowitz, Real Endpoints, and Dennis Purcell, Aisling Capital for a collegial, in-depth discussion on this important topic.