Bronchitol mannitol regulatory update

Pharmaxis said it was verbally notified that Australia's Pharmaceutical Benefits Advisory Committee (PBAC) recommended including cystic fibrosis (CF) drug Bronchitol mannitol for reimbursement on the Australian Pharmaceutical Benefits Scheme (PBS). Pharmaxis said Bronchitol will go before the Australian Pharmaceutical Benefits Pricing Authority (PBPA) to finalize the reimbursement. Pharmaxis filed a minor resubmission for reimbursement with PBAC for Bronchitol last year (see BioCentury, Jan. 2).

Last November, Pharmaxis said it was verbally notified that PBAC recommended against including Bronchitol for reimbursement (see BioCentury, Nov. 14, 2011). The committee had previously recommended against reimbursement due to "uncertainties in where Bronchitol will fit in clinical practice and consequent difficulties in identifying the right comparator in one clinical setting that leads to uncertain cost-effectiveness" (see BioCentury, April 25, 2011 & July 18, 2011). ...