Ann: Paradigm AGM Presentation, page-47

It’s not so much the previous approvals per se, but rather the opportunity that massive differential pricing by geographies and intended purpose presents for arbitrage and parallel imports.
I know that many on this forum hold the view that insurance companies will willingly pay sky high prices for iPPS on the basis that any price lower than that of a TKR represents a saving, and possibly that is indeed the case in the US, but IMO that’s never going to happen in Australia, as it’s not how the system works. Nor do I think that iPPS will ever go on the PBR at the $2 - $3k per dose that’s being posited here, as the costs involved would break the health budget.
But if people are suffering serious pain because of OA, and can’t afford an available treatment because of the high costs involved, they’re going to look to their options, and get what they need wherever they can.