The Evolving Role of Real-world Evidence in Australia – Oncology Industry Taskforce November 2020
This report was prepared by the Oncology Industry Taskforce Real-World Evidence (RWE) Working Group to highlight the unrealised value of real-world data in the assessment of innovative medicines and rapidly advancing health technology in the context of the Australian system.
RWE has gained considerable momentum in the last decade, to a varying degree, depending on the jurisdiction. This report compares Australia’s use of real-world data / evidence with four other comparable countries, via quantitative analysis of public summary documentation combined with qualitative assessment of RWE definitions in guidelines and literature. The analysis was prepared by IQVIA.
Members of the RWE Working Group believe the opportunity exists for Australia to make better use of valuable health information obtained from a range of sources over and above gold-standard randomised clinical trials, such as electronic medical records, claims and billing data, product and disease registries, and data from devices and health apps. However, the report recognises that significant work and collaboration between industry, government, medical experts, patient groups and other stakeholders will be required to standardise definitions, systematise data collection and encourage acceptance of this additional information both in HTAs and in broader decision-making. Critical challenges and a pathway to achieving this are proposed.
Navigating Compassionate Access
The Zero Childhood Cancer program is a ground-breaking program led by the Children’s Cancer Institute and the Sydney Children’s Hospitals Network as well as all major Australian childhood cancer researchers to deliver Australia’s first ever personalised medicine program for children with high-risk cancer.
By using personalised medicine and expert review panels, the Zero Childhood Cancer program or ZCC aims to treat each child’s cancer in the most targeted way possible and hopefully improve their cancer outcomes.
The success of the program is greatly improved if the recommended medicine choice can be accessed and administered as quickly as possible, however, drugs that are unapproved for a particular indication, as is the case for a significant number of ZCC requests, are more challenging to acquire.
When the program clinicians found they weren’t always able to access the medicines they sought in a timely manner, they reached out to industry better understand the issues.
Medicines Australia’s Oncology Industry Taskforce or OIT pulled together medical representatives across their member companies for an open forum with clinicians and researchers to understand how they can better enable timely access to the medicines identified by the ZCC researchers.
A report was prepared to summarise the outcomes from that workshop titled “Navigating (Compassionate) Access to Medicines For Trials” (hyperlink). The participants appreciated the candor and collaborative spirit from across all sectors represented.
This report highlights the need for increased awareness of programs such as ZCC and early engagement and collaboration between industry, trial leaders and clinicians seeking access.
Reports by Michael Wonder – 2016
The Oncology Industry Taskforce commissioned Wonder Drug Consulting Pty Ltd (WDC) to prepare a report on access to new cancer medicines in Australia. WDC conducted an analysis on this issue in 2014. Timely access to new cancer medicines via the Pharmaceutical Benefits Scheme (PBS) remains an important public health care goal. The objective of the project was to update the 2014 analysis of submissions for new medicines for patients with cancer to the Pharmaceutical Benefits Advisory Committee (PBAC) and other comparable health technology assessment (HTA) agencies.
The 2016 reports follows on from Michael Wonder’s report, commisioned in late 2013 by the Oncology Industry Taskforce. This 2013 report comparing Australia’s access to cancer medicines to other countries entitled Reimbursement success rates and timelines for new medicines for cancer; an international comparison can be accessed here
Access to Cancer Medicines 2013
This report was the first comprehensive assessment of stakeholder perspectives into access to new cancer medicines and highlights many challenges within the current system. It includes contribution from various cancer care stakeholders including health consumer organisations, clinicians, researchers, government and payers.
The report was launched at a sponsored symposium at the Medical Oncology Group of Australia’s (MOGA) Annual Scientific Meeting on 31 July 2013. The report can be accessed here
Following the launch of the Access to Cancer Medicines in Australia report on Wednesday 31 July 2013, Medicines Australia through its Oncology Industry Taskforce invited submissions for comments/feedback on the initial findings of the Report.
One of the principal outcomes of the Report is the involvement of the wider community to participate in an informed and collaborative debate to identify how existing processes must progress to meet emerging challenges.
It is Medicine Australia’s preference that all submissions will be made publicly available on the Medicines Australia website; however Medicines Australia will keep a submission in confidence if requested.
Should you require any additional information please send an email to the Oncology Industry Taskforce