Ken, many thanks for your response and for the clarifications,...

Ken, many thanks for your response and for the clarifications, which have been most helpful.

I had mistakenly thought that the IRA had the potential to impact pricing of both Medicare and Medicaid covered drugs as it is the Centers for Medicare & Medicaid Services (CMS) which has the responsibility for drug price negotiation under the IRA.

I have checked US Government site information on the IRA and see that, indeed, it only applies to Medicare covered drugs (reminder for Australian readers that in the US, Medicare is federal government provided health insurance for those aged 65+ and some younger people with disabilities. Medicaid is a joint federal and state program which, together with the Children’s Health Insurance Program, covers mainly low income families.

Acadia has estimated that ~60% of DayBue patients are covered by Medicaid and ~30% by private health insurance. Medicaid does have some drug pricing control in place but it’s important to note that the US$375,000 average price of DayBue per patient quoted by Acadia has been calculated after Medicaid’s 23.1% rebate on list price has already been taken into account.

While the breakdown in insurance coverage for patients in any other orphan indications in which NNZ-2591 might be approved is still unknown, it is likely to be similar to that for DayBue.

Which all means that not only should NNZ-2591 in multiple paediatric orphan diseases not be impacted by IRA price negotiation, but that NNZ-2591 should become an even more attractive/lucrative asset in the eyes of pharma precisely because it isn't impacted.

To use Aussie lingo, that’s bloody fantastic!