Acetylcysteine - Part Two - How Government red tape ruins everything

Just when I thought everything was sorted, Government red tape has ruined it:

Following my correspondence to you last week regarding the 1st May 2011 PBS listing of Omegapharm Acetylcysteine Solution. 

I received notification on Friday from the Pharmaceutical Benefits Advisory Committee (PBAC) that our submission will now require Federal Government 'Cabinet' approval. This decision was made without any consultation or warning from the Minister for Health and Ageing, Nicola Roxon and has come as a great surprise to both myself and the PBAC.

Prior to last week, the PBAC were responsible for approving medicines under $10 Million per annum. For products over $10 Million the PBAC refers to the Federal Cabinet for approval. The Federal Cabinet will now be responsible for the review and approval of all PBAC recommendations.

Even though Omegapharm Acetylcysteine is well below the $10 Million level (and the product was recommended for listing in April 2010 by the PBAC and was accepted for a May 1st 2011 listing last week) the product will require Federal Government 'Cabinet' approval. 

The decision by the Federal Government will affect the May 2011 listing of Acetylcysteine. The Federal Government confirmed that it will 'put the needs of patients with serious conditions and limited treatment options first', so hopefully they uphold this statement and finalise the PBS listing of Acetylcysteine quickly.

So what does this all mean right now. We urgently need you help!

As part of the new 'Cabinet' review process, I have been asked by the Lung Foundation, Thoracic Society and the PBAC to seek feedback from Prescribers/ Specialists on the effectiveness of Acetylcysteine in patients that have the following lung conditions:

·         chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung);

·         acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis);

·         pulmonary complications of cystic fibrosis;

·         pulmonary complications associated with surgery;

·         post-traumatic chest conditions;

·         atelectasis due to mucus obstruction.

·         lung cancer;

·         tracheostomy care;

·         anaesthesia.

Therefore, we URGENTLY require the following information;

Name of your Specialist

Location of your Specialist

Telephone Number of your Specialist

The Lung Foundation and the Thoracic Society require this information with the next 48 hours and will be writing to the Federal Government and PBAC.

If you feel uncomfortable providing us with this information, please send the details through to the CEO of the Lung Foundation Mr William Darbishire @ Williamd@lungfoundation.com.au

To date our company has done everything it can to provide affordable access to this important medicine. While the delay with the TGA and now the Federal Government is well beyond our control, our company is committed to ensuring Acetylcysteine Solution receives the PBS listing.


I think I might need to head down to Julia's office with a letter of complaint on Wednesday.