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!