Pharmaxis gets simplified PBS listing for Bronchitol

Pharmaxis (ASX:PXS) has successfully applied to simplify the criteria by which cystic fibrosis patients can qualify for PBS reimbursement for its Bronchitol treatment.

The Pharmaceutical Benefits Advisory Committee (PBAC) has agreed to change the wording of Bronchitol’s PBS listing, Pharmaxis announced.

The new listing will remove a requirement for patients to demonstrate a 10% increase in a spirometric measure of lung function to qualify for continued PBS reimbursement and replace it with a more flexible set of clinician and patient-determined criteria for improvement.

The new listing “simplifies the process for patients and allows clinicians more flexibility in managing people being treated with Bronchitol”, Pharmaxis CEO Gary Phillips said.

Cystic Fibrosis Australia CEO David Jack welcomed the news as a “positive step for CF patients in Australia, providing more appropriate access for some patients - especially people in rural areas and younger patients”.

Bronchitol is a spray-dried formulation of mannitol, delivered to the lungs through a portable inhaler. In Australia, it is approved for cystic fibrosis patients aged over six years, as an add-on treatment to dornase alfa, or in patients intolerant of or inadequately responsive to dornase alfa.

Pharmaxis first secured its PBS listing for Bronchitol in early 2012. The company secured EU approval in adult patients in April that year.

The company is also developing Bronchitol for bronchiectasis, but a recent phase III trial failed to meet its primary endpoint of a statistically significant reduction in pulmonary exacerbation rates compared to the control.

Pharmaxis shares were trading 5.41% lower at $0.175 as of around 1 pm on Thursday.