Region · 129 analyses
The US is not one payer. It is a commercial market segmented by plan, a Part B buy-and-bill channel, and a Part D pharmacy benefit — and an asset can win in one and lose in another.
Access in the United States is decided by benefit design before it is decided by evidence. An infused specialty product runs through Part B at ASP plus a percentage and is dispensed by the site of care; an oral runs through Part D and a pharmacy benefit manager's formulary. The same molecule can face a step edit in one channel and none in the other, and the difference is worth more than most efficacy margins.
Three forces now shape the picture. Prior authorisation and step therapy gate most specialty categories, with the criteria — not the label — defining who is actually treatable. Cost-effectiveness review by ICER sits outside the coverage decision but anchors the public argument about price. And Inflation Reduction Act negotiation has begun resetting list prices across selected products, with the orphan-drug exclusion shielding some rare-disease assets from it entirely — a distinction that decides whether a franchise faces a price cut at all.
AXLRx US reports are built around those mechanics. They set out the channel an asset will actually be reimbursed through, the prior-authorisation criteria that gate it, the comparator set payers will hold it against, and where the coverage argument is won.