In July and September 2017, the NBA received National Blood Supply Change Proposals for purified human alpha1-proteinase inhibitor (A1-PI) for the treatment of A1-PI deficiency, from Grifols (for the product Prolastin-C) and from CSL Behring (for the product Zemaira).
On 1 December 2017, JBC referred the two proposals to MSAC for assessment. The assessment process included the opportunity for input through expert and public consultations.
MSAC considered the proposals on 22-23 November 2018. After considering the strength of available evidence put forward in relation to comparative safety, clinical effectiveness and cost-effectiveness, MSAC did not support A1-PI for the treatment of A1-PI deficiency. Read the basis for MSAC's advice in the Public Summary Document 1530(Opens in a new tab/window).
On 14 March 2019, JBC agreed that, on the basis of the advice received from MSAC in relation to the submitted proposals, A1-PI products should not be funded under the National Blood Agreement at this time.
The advice from MSAC and the JBC decision based on that advice do not preclude resubmission of proposals with further evidence, in accordance with ordinary MSAC processes(Opens in a new tab/window).
Last updated: 14 Mar 2019