Patients with Alpha 1 Antitrypsin Deficiency (AATD), which causes early onset emphysema, will have to wait at least a year for any decision on funding for TGA-listed augmentation treatments, the government says.
A patient petition to fast track funding for alpha I proteinase inhibitor products such as Zemaira and Prolastin-C has a received a response from Federal minister for health Greg Hunt, who said decisions on funding had to go through the usual assessment process for blood-based products overseen by the National Blood Authority.
In a response tabled in parliament, the minister said the augmentation products for AATD were derived from human plasma and therefore would require evaluation by the Jurisdictional Blood Committee, which would then provide advice to the Council of Australian Governments (COAG) Health Council for a decision.
“Based on the timing for consideration of previous submissions, the timeframe for the evaluation and approval processes may take approximately 12 months,” he said.
AATD affects about one in 3000 people and may cause emphysema onset before the age of 40, as well as liver problems.
The two augmentation products have been listed on the Australian Register of Therapeutic Goods (ARTG) for the treatment of AATD since February 2017 and November 2016), respectively
Patients would usually gain subsidised access to such products through hospitals under the national blood arrangements; with funding shared between the Commonwealth and the states and territories.