Pharmaxis has announced that it “filed a minor resubmission with the Pharmaceutical Benefits Advisory Committee (PBAC)” for its Bronchitol mannitol dry powder inhaler for the treatment of cystic fibrosis. According to the company, the committee’s next scheduled meeting is in March 2012, at which time it will consider the submission. Bronchitol received marketing approval in Australia in February 2011, and the PBAC’s recommendation would be necessary for listing on the Australian Pharmaceutical Benefits Scheme (PBS).
After its November meeting, the PBAC did not recommend listing the drug on the PBS. At the time, Pharmaxis CEO Alan Robertson responded that the decision “highlights the fact that Australia is one of the most challenging reimbursement
environments in the world” and vowed to “continue to work with the PBAC to understand what further information it still requires in order to make Bronchitol available on a subsidised basis for Australians living with cystic fibrosis.”
Commenting on the resubmission, Robertson said, “We are pleased to file our resubmission to PBAC following a constructive discussion with its recently appointed Chair. We remain committed to securing satisfactory reimbursement for Bronchitol to assist patients with cystic fibrosis.”
After multiple negative opinions, the CHMP issued a positive opinion recommending approval of the marketing authorization application for Bronchitol in October 2011.
Read the Pharmaxis press release.
