This means that from the start of 2018, eligible people with cystic fibrosis who are taking Pulmozyme® (dornase alfa), another CF (cystic fibrosis) medication, will be able to add reimbursed Bronchitol to their treatment regime.
Cystic fibrosis is a genetic condition affecting one in every 2500 Australian babies.
People with the condition develop an abnormal amount of excessively thick and sticky mucus within their lungs, airways and the digestive system.
What is Bronchitol
Bronchitol has an active ingredient in mannitol, which is delivered as an inhalable dry powder to restore the airway surface liquid.
Other benefits include enhanced mucus clearance, improved lung function while reducing incidence of lung infections.
Bronchitol has been studied in more than 1000 clinical trial patients4 and is indicated for appropriate CF patients over six years of age.
Pharmaxis plans for a Bronchitol FDA re-submission by Chiesi in 2018.
Chiesi is the distributor for the major EU markets.
Importance of the listing on PBS
This new listing will allow clinicians treating cystic fibrosis to use two agents that work differently, and are proven to work together in the CF lung, to improve mucus clearance.
PBS reimbursement of this combined treatment approach will also significantly reduce paperwork for CF treating teams and improve access for patients.
Gary Phillips, chief executive officer for Pharmaxis, commented:
"We are delighted that more Australians with cystic fibrosis will now have access to treatment with Bronchitol under this expanded listing.
"We are proud that a locally developed and manufactured product is helping people living with this incurable disease."
An expanded PBS listing for Bronchitol was supported by the CF community, healthcare professionals and Cystic Fibrosis Australia in submissions to the government committee advising on medicine reimbursement.