Yearly Archives: 2018
Are you ready for the mandatory transition to eCTD for prescription medicines?
In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading
November 2018 PBAC Meeting Agenda
The November 2018 PBAC Meeting is scheduled to conclude today. Here, the Commercial Eyes Market Access team provides an analysis of the meeting agenda, including Sponsors with multiple submissions and the nature of requested listings by type. The … Continue reading
Patient programs for improved patient outcomes
In the digital age of present, patients have never been better equipped with the devices and technologies to take control of their own healthcare needs and outcomes. With the ease of online access to tools such as patient forums, advocacy … Continue reading
PBAC Meeting Outcomes – July 2018
The July 2018 PBAC Meeting Outcomes were published on 17th August 2018. With 64 outcomes in total, the Commercial Eyes Market Access team provides an overview of PBAC decision making, including additional analysis conducted on biosimilar and oncology submissions. … Continue reading
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
PBAC Special Meeting – August 2018
The August 2018 PBAC special meeting is scheduled for 17 August 2018 to consider options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple tumours (pan-tumour indications) on the PBS. Here, the Commercial Eyes Market Access team … Continue reading
Making the most of complementary medicines reforms
In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms. One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications. All … 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
