For those who may remember my post last year.
The manufacturer of one of the nebulised medications that I use three times a day, stopped manufacture early in 2010 without any warning to patients, leaving no equivalent alternative.
After doing my own research, I found a company who was working on getting TGA and PBS approval in Australia. Unfortunately, having gone without it for so long, I ended up in hospital on three separate occasions.
At the moment (while it's still not on the PBS), I've been lucky enough to obtain a month by month supply which is being funded through the Respiratory Department at the Alfred Hospital.
I've been in contact with the new manufacturer throughout the approval process, so I was overjoyed to receive this email tonight:
I am writing to update you on the TGA and PBS listing for Omegapharm Acetylcysteine.
As many of you are aware the Omegapharm product is the only version of Acetylcysteine Solution available in Australia. The molecule is the generic equivalent of the Bristol-Myers Squibb's (BMS) Mucomyst 20% 5mL which was discontinued from the Australian market in late 2009.
Omegapharm via the Therapeutic Goods Administration (TGA) was able to secure a 'Section 19a' listing that enables pharmaceuticals registered in the USA to be supplied into Australia. In April 2010 Omegapharm Acetylcysteine received an approval by the Pharmaceutical Benefits Advisory Committee (PBAC). However the product could only be PBS reimbursed once the molecule received full TGA approval.
Therefore, I am extremely pleased to announce that we have (finally!) secured TGA registration. This registration will see the product PBS listed from the 1st May 2011 and will guarantee patients pay no more than $5.40 (concession) or $33.30.
I would like to thank you for supporting our company and acetylcysteine over the last twelve months. I understand that the process has been very frustrating. However I feel extreamly satisfied that we have been able to secure the best possible outcome for all patients guaranteeing affordable access to this vital product.
I would also like mention that our company has provided over 2,300 packs at no charge under our compassionate use program. The program has helped those patients that could not afford the product to have access. I would like to thank Symbion and the Pharmacists who helped distributed the stock to patients on our behalf.
It's taken twelve months longer than I expected it to.... but at least it's finally happened - hallelujah!
34 comments:
Oh Cam! This is just fantastic. Happy dances and high fives!!!!
Hooray!
That is fan-freaken-tastic Cam! Thanks for sharing the great news.
That's fabulous. Don't they waffle on until the third or fourth para before they get to the good news?
The PBS is a God-send when medication is listed on it. So glad you're benefitting!!
That's nice to read the drug company provided medicatuon at no charge under their 'compassionate use' programme.
"Thank goodness" doesn't seem to cut it, but I will say it anyway with added emphasis..
Thank-frickin-goodness.
Great news! Hope this means you'll be able to stay out of hospital!
Wonderful news! I hope 2011 is a year with many less hospital stays for you.
Fantastic news for you Cam! Good things must come in fours!!
x
HOORAY!!!! Great news, Cam.
Abso-bloody-lutely fantastic Cam. What a relief.
This is such wonderful news! I think I may have a litle cry! (for joy!!)
awesome news... ihope this will make your life healthier for you
That is just wonderful news.
xxx
yay! you must be so relieved x
Brilliant news, Cam - awesome for you and others!
woohoo! great news Cam! it must be such a relief for you.
x
I'm delighted for you Cam! You must be bursting with relief.
Woohoo! Great News!
Fabulous news Cam, hope this year sees a lot less hospital visits for you. What a relief!
Woo-fucking-hoo!!!!!!
And not a moment too soon!!!
Absolutely fantastic news! So happy for you Cam! What a great company too for providing the drugs free under compassionate use.
Yeay!!
Oh Cam you must be so relieved!
Congratulations and let's hope now you can breathe easier for a long time to come. X
That is WONDERFUL news! Hooray!
this is great news Cam, Hopefully less time in hospital.
I am so thrilled for you. How immoral and unethical to have taken it off the market with no warning. I hope this supply last forever!
OH Cam, this is WONDERFUL!! Phew eh?
xo
So happy for you and everyone else who will benefit. Cherrie
Oh...Cam, I am doing one very big hip hip hooray for you!!! We had to get a high level of funding for finnys formula at one stage and if he didn't respond to the very last batch we were in no mans land and he would not have survived. So I am sitting here over the bloody moon for you and wishing you much better heath. Leonie xx
Oh- you've redecorated, much prettier than reading in google reader. Cam, that is BRILLIANT news, hooray for you for such a great outcome, even if overdue. three cheers for the activist!
such a frustrating battle through a ton of red tape. a greta outcome. well done, you must feel very relieved
Cam, that is fabulous news!
This is wonderful news!
As someone who works in generic pharmaceutical manufacturing I found this post really interesting!
Brilliant news Cam, so glad to hear it.
Post a Comment