Acetylcysteine - Part 3 and still no answer

Unfortunately I've had this ongoing saga dragging out for more than a year now, where I've been waiting for a replacement nebuliser medication named Acetylcysteine to be added to the PBS.

Introduction
Part One
Part Two

Prior to March 2011, the PBAC were responsible for approving medicines under $10 Million per annum. For products over $10 Million the PBAC referred to the Federal Cabinet for approval. 

From March 2011, Nicola Roxon decided to change the rules and make the Federal Cabinet responsible for the review and approval of all PBAC recommendations, further delaying the approval of Acetylcysteine.


I wrote to Ms Roxon (Federal Health Minister) and Mr Peter Dutton (Oppsition Health Minister) in early March 2011. As yet, I have had zero response.


My sister also wrote to Ms Roxon, but apparently she may have used much stronger language than me, as today, she actually finally received a response (after six weeks).

So this letter doesn't tell me anything that I don't already know, and doesn't direct me to do anything that I haven't already done.

At this stage I'm still wasting an entire day every four weeks driving an 80 kilometre round trip to a major city public hospital to wait at a specialist clinic in order to get an approved hospital prescription to take to the hospital pharmacy where I sit and wait for another hour for it to be filled....

Some days I really feel like tearing my hair out.... it's no wonder I'm going grey!

Acetylcysteine

Totally non-craft related post, so you may want to move on....

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!

To cut a long story short

Have you ever thought about what would happen if you needed a certain type of medication and it just wasn't available anymore? Unfortunately, this is the scenario that I've been dealing with lately. The one and only supplier decided to stop manufacturing without any warning, leaving patients like me with absolutely no equivalent alternative.


I've been without it for a couple of months now, which has led to a further decline in my lung function. After some online research, I finally managed to find some details on a new Australian manufacturer just this week (which my pharmacist and doctors didn't even know about). The drug has not yet been added to the PBS, but I was able to order it in. From the information that I found, it is scheduled to be listed from July 1st 2010.

The good news is that I'm looking forward to being back on track again after my slight hiccup..... and I can finally start to breathe again.

My advice to everyone is to always do your own research. Doctors will never be able to know everything about the latest and the greatest treatments, or the manufacturing plans of the various drug companies, and your health is far too important to just leave it to someone else to manage.

I'm adding some keywords to the bottom of this post just in case someone out there is googling looking for help just as I was Monday night, when I stumbled across just what I needed..... thankyou to the WWW.

Mucomyst alternative
Acetylcysteine Solution
Omegapharm
Mucolytic Agent
Bronchiectasis