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Approval timelines in Australia for Velpatasvir 6 years 4 months ago #16912

  • klhilde
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Gilead's Epclusa (Sofosbuvir/Valpatasvir) is scheduled for a decision date of June 28 in the US. It was given an approval recommendation from a panel in the EU on May 26, and (combining two sources I've read) approval will likely be rubber stamped 67 days later, meaning August 1.

So what is the likely result in Australia? When should people in Australia expect a doctor to be legally allowed to prescribe Velpatasvir?
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Approval timelines in Australia for Velpatasvir 6 years 4 months ago #16922

Hi Kevin,

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!
YMMV
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Approval timelines in Australia for Velpatasvir 6 years 4 months ago #16939

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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!


Ummmmmm ..... Wow ..... There are a couple people here that might want to consider running through that door while it remains open ... even if it's just to have it on hand for when a decision is made on what their proper course of action should be.

You've probably already guessed this, but I got a PM from someone that might need it.
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Approval timelines in Australia for Velpatasvir 6 years 4 months ago #16943

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Ty for this thread, as a lobbyist it interests me.
Government pipeline on these meds has been available yes, online I followed it, I even set up a fed gov account (yes you can do that), I was submission number ** at the House of Representatives meeting prior to the Dec1 2015 meetings and the protocol is exactly as James explained.
However I would like to add: re timelines
The release of DAAs from approved by PBAC to PBS was faster than I think it would have been if many of us hadn't lobbied our butts off, then the carrot that caught Minister Ley and forced the issue was this place, FixHepC. And the "roll out" well you know it's a yawn. Not worth revisiting that.

Without mentioning names it's often interesting to see drugs released after being held back for whatever reason when a politician is directly affected; this sounds presumptive but I know of a case which I can't share by citation here for obvious reasons.
I can say it was a long awaited breast cancer drug.
I'm throwing out the factors (and there will be others I haven't thought of just at this moment) that can affect the pipeline moving forward.

Power is always an interesting game isn't it.
Ariel
Gen 1a
Peg/inf/riba 2012(!) stop @ Wk 43 potassium low +issues (rlps week 4 post tx, VL120,000) scnds eg. adenomas.
pre sof/led VL 240,000 Fibsc F0
Day 25 <30
Day 32 UND
Week 10 UND
EOT UND ALT11AST17GGT19
SVR4 UND ALT10 AST16 GGT13
SVR8 UND ALT <9 AST16 GGT15
SVR12 UND ALT14 AST19 GGT12 Bili 5
EOT +18 ALT13 AST20 GGT9 Bili 5
EOT +21 ALT11AST15
Cured SVR12
Dysplasia Adenomas RemvdAug '16
SVR24 UND ALT11AST16
ColonoscopyClear Nov17
LumpectomyClear ‘18
LithotripsyCytoscopyBiopsy 4/18

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