Great news Pat…so very happy for you

But I must say, the Gilead response was a bit thin.

“A spokeswoman for Gilead said the company would negotiate on price if asked. ‘We remain ready and willing to continue discussions with the government and NHS England in the public interest and in a constructive manner,’ she told Good Health.”

This is a significant change in attitude. Prior to this the Gilead party line was:

Gilead defended the price. “We believe the price of Harvoni reflects the value of the medicine,” it said in a statement. “Unlike long-term or indefinite treatments for other chronic diseases, Harvoni offers a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant health care savings to the health care system over the long term.”

http://www.nytimes.com/2014/10/11/business/harvoni-a-hepatitis-c-drug-from-gilead-wins-fda-approval.html?_r=0

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) https://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) http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/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 https://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!

The St Vincent’s one does not count, so you may not be out of credits yet, in fact you should have 2 qualitative tests left, although they may have got a billing failure for a quantitative and quietly converted it to a qualitative.

As far as I know there is no lookup tool to see if you are out of qualitative/quantitative credits. What happens is that the lab tries to bulk bill it and if that fails they send you the bill.

Here are the items: http://www9.health.gov.au/mbs/search.cfm?q=hcv+rna&Submit=&sopt=S

I have just called Medicare on 132150 – option 1 – and according to them you have had 4 quants on May 2015, Dec 2015, Jan 2016 and Feb 2016 and NO qualitative tests. The May test has now fallen off so you have 3 official MBS tests leaving at least 1 qualitative available to be bulk billed.

PS: Sent you a form.

The licensing agreements between the manufacturers and Gilead constrain sales to within certain territories, including India, but not including the west.

With the recent patent law change Gilead now has more power and may well seek to enforce their rights.

The REDEMPTION process of seeing a doctor in India, getting an Indian script, etc means that the medication transaction occurs within the assigned territory.

It is entirely possible that the situation as it currently stands will change, in fact it’s probably almost inevitable it will. Access is available now, but can not be guaranteed into the future.

Here is the list of the Gilead 91 – those countries classified sufficiently poor to be allowed to buy Generics:

http://www.gilead.com/~/media/Files/pdfs/other/HCV%20Generic%20Agreement%20Fast%20Facts%20-%20February%202015.pdf

Countries like Thailand are not included and with 1.2 million patients with HCV the bill to treat them would be $120 billion or over 25% of their GDP ($400 billion) and 8 times their entire annual health budget.

http://www.tradingeconomics.com/thailand/gdp