Category Archives: PBS
Relating to the Australian Pharmaceutical Benefits Scheme
Public Submissions to the August 2018 PBAC Special Meeting – Part 2
In the second part of this two-part series (Read Part 1 about here) we bring you further insight into opinions from the public submissions to the August 2018 PBAC Special Meeting. Opinions from the Public Submissions Outcomes of the PBAC’s … Continue reading
Public Submissions to the August 2018 PBAC Special Meeting – Part 1
In the first of a two-part series, we provide insights into opinions from 28 public submissions to the August 2018 PBAC Special Meeting held on 17 August 2018 regarding considerations for PD-1 and PD-L1 checkpoint inhibitors for multiple cancer types … Continue reading
Sponsors struggle with Ministerial discretion
The 2017 Medicines Australia Strategic Agreement with the Australian Government extended the existing five-year anniversary statutory price reduction (SPR) of 5% for F1 medicines and introduced new SPRs for drugs that have been listed for ten years and fifteen years … Continue reading
The long road to PBS listing for Orkambi
Orkambi (lumacaftor and ivacaftor), a treatment for cystic fibrosis (CF), will go before the PBAC for a fourth time at the upcoming July 2018 PBAC meeting. So far, the road to reimbursement has been filled with multiple rejections, a strong … Continue reading
Life Saving Drugs Program: new lease on life, or on life support?
Last week saw the release of the final report of the post-market review into the Life Saving Drugs Program (LSDP), including a response to the report released by the Australian Government. The Life Saving Drugs Program currently provides subsidised access … Continue reading
Dr Greg Pearce – Time to support biosimilars
Dr Greg Pearce, from our Regulatory Services team, has written a follow-up article for Pharma in Focus on biosimilars. Dr Pearce’s first article focussed on the challenges biosimilars pose for the Australian medicines industry. This second article looks at the … Continue reading
Pricing uncertainty within the Pharmaceutical Benefits Scheme
Recent years have seen an active attempt to control Pharmaceutical Benefits Scheme (PBS) costs. Price disclosure and mandatory price cuts upon formulary transition have ensured prices of pharmaceuticals (especially generics) continue to tumble. Yet despite the use of these tools, … Continue reading
Defining value in the MBS Review
In May 2015 the Federal Government announced a review of the Medicare Benefits Schedule (MBS) with a view to bringing the MBS up-to-date and increase the value derived from the more than 5,700 listed items. The announcement of this review … Continue reading
Is nothing safe from price reduction?
As of 1 April 2016, all F1 medicines that have been on the PBS for five years will take a 5% price cut. Originator brands will be removed from the weighted average disclosed price (WADP) calculations from the cycle commencing … Continue reading
Is it possible to manage PBS Managed Entry Schemes?
Flash back to 1st January 2011 and the Department of Health introduced a unique market access route for innovative medicines to be listed on the PBS: the Managed Entry Scheme. The original framework for the introduction of a PBS Managed … Continue reading
