There are 3 stages.
1) Marketing approval by the TGA (similar to the FDA) which will generate a report like this (for Sofosbuvir) www.tga.gov.au/auspar/auspar-sofosbuvir
- and does not currently exist for velpatasvir.
2) Once that hurdle has been negotiated it will need to go to the PBAC for consideration of a subsidised listing on the PBS. Last time that took 2 years, but given that the PBAC only meet 3 times a year (+ 1 special meeting on average) www.pbs.gov.au/info/industry/listing/ele...etings/pbac-outcomes
, and first applications are often knocked back, and they take months to report back, even a rails run here is 6 months.
3) Once the PBAC provide a positive recommendation it still has to get approved by the cabinet and medications like Viagra and Nicotine Replacement Therapy both got PBAC approval but fell over at cabinet.
So looking to history for guidance...
Sovaldi was approved by the FDA on 6th December 2013 and it took 2 years and 4 months to reach availability on the PBS in Australia.
In short think years, not months.
Actually there are 4 stages - first it needs to be listed on the poisons schedule www.legislation.gov.au/Details/F2016L00849
and currently it is not, so curious as it may seem, currently in Australia you could import velpatasvir and it is not even classified as a medication!