announces improved listing of bronchitol

PHARMAXIS ANNOUNCES IMPROVED PBS LISTING OF BRONCHITOL
Pharmaceutical company Pharmaxis (ASX: PXS) today announced it has received approval for simplified access to Bronchitol® for the treatment of cystic fibrosis (CF) under the Australian government’s Pharmaceutical Benefits Scheme (PBS) in a decision that brings criteria for reimbursement in line with current clinical practice.
Pharmaxis has been advised of a positive decision on its application to the Pharmaceutical Benefits Advisory Committee (PBAC) to change the wording of the PBS listing for Bronchitol, removing a requirement for patients to demonstrate a 10% increase in a spirometric measure of lung function in order to secure continued PBS reimbursement.
The new listing will see the “10% Continuation Rule” removed and replaced with a new set of clinician and patient-determined criteria which are intended to allow flexibility in clinical decision-making.
Under the improved listing arrangement lung health will continue to be measured objectively to ensure patients are continuing to receive treatment benefit. Furthermore, it will be measured at 3 months, a time better aligned with clinical decision-making in keeping with routine patient visits to clinics.
Pharmaxis CEO Mr Gary Phillips said, “This is welcome news for cystic fibrosis patients in Australia. It simplifies the process for patients and allows clinicians more flexibility in managing people being treated with Bronchitol. The PBAC decision recognises the fact that Bronchitol patients in Australia are well managed by a team of CF specialists who provide close and ongoing assessment of their treatment.”
Mr David Jack, CEO of Cystic Fibrosis Australia, the peak patient body representing CF patients in Australia said: “This is 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 precision spray-dried form of mannitol, delivered to the lungs by a portable inhaler. Bronchitol® is approved in Australia for the treatment of cystic fibrosis in adults and paediatric patients aged over six years as either an add-on therapy to dornase alfa, or in patients intolerant of, or inadequately responsive to, dornase alfa.