In order to make new drugs available to patients in Australia, a successful interaction with the PBAC – the Australian HTA body is needed. Alan Brnabic lives in Australia and collected a lot of experience with these submissions over the years.
In this episode, we cover:
- the basics of understanding how the PBAC works,
- why a successful PBAC submission is important,
- what evidence is needed to have a successful PBAC submission,
- how much work is needed from the statistician’s side for the PBAC interactions,
- what are the typical challenges from the PBAC,
- when is a good start to get prepared for the PBAC work, and
- how is the data submitted to PBAC publicly available
Finally, we’ll also cover an upcoming one-day PSI workshop on RWE in which such evidence needs are discussed besides other approaches, that are available and emerging?
You can register for the one-day event at http://www.psiweb.org/events/psi-events.
Mr. Brnabic is currently Principal Research Scientist at Eli Lilly working in Real World evidence (RWE) with a focus on specialized analysis that supports this area. Prior to this he was the Asia Pacific Director of the Health Outcomes and Health Economics, Life Sciences for OPTUM.
Whilst at Eli Lilly he has been the Health Outcomes and Statistics Asia Pacific statistical sciences group leader and manager. His work has included: leading and managing staff, designing/reviewing concepts and studies (Phase IIIb & IV observational studies), analyzing/reviewing studies, presenting & writing/reviewing results in peer review publications, leading and reviewing external methodologies/ guidelines for use within the company as well as consulting/coordinating strategy for analysis on Reimbursement dossiers & other related Health Outcome activities for countries like Australia, Canada & Korea.
Mr. Brnabic received a BA Dip Ed in mathematics and statistics and a MA in applied statistics from Macquarie University, Sydney. He has worked for SPSS Australasia as a Technical Support and Training Consultant; at Macquarie University Practical Demonstrator/Tutor in statistics.
In 1994 he worked as a Consultant Biostatistician for 5 years in Public Health NSW Health Department. Following that he was a Senior Biostatistician at the George Institute which is affiliated with UNSW where he worked on epidemiological studies and RCTs. Before joining Eli Lilly in 2002 he also took a position at the NSW Department of Corrective Services as Deputy Director of the Research & Statistics, Sydney.
Mr. Brnabic’s interests are in the design and analysis of observational studies with a focus on methodologies related to subgroup identification as well as selection bias adjustment tools including matching, propensity score analysis and local control. He is also interested in Health Outcomes and statistical approaches used to help support the reimbursement of medicines like matched adjusted indirect comparisons as well as mixed treatment comparisons.
He has A-STAT Professional Accreditation with the Statistical Society of Australia (SSAI). He is an active member and previous Chair for the Australian Pharmaceutical Biostatistics Group (APBG) and on the Australian Bipolar Comprehensive Outcomes Study Steering Committee. He is also a member of ISPOR and the SSAI.