News & Events
Submissions and Advocacy Activities
Position Statement: Targeted Therapies And Predictive Markers
Please find below a selection of the submissions MOGA tabled in 2013 to various regulatory bodies.
September 2013: Transparency Model Consultation and Discussion Paper
October 2013: Access to Cancer Medicines in Australia
A Joint Submission to the Senate Standing Committees on Community Affairs on the Supply of Chemotherapy Drugs such as Docetaxel submitted by MOGA and the PCPA.
Please find below a selection of the submissions MOGA tabled in 2012 to various regulatory bodies.
1st August: Destriction of Taxanes
12th November: 1313 Consultation decision analytic protocol (DAP) to guide the assessment of bone mineral density analyses using Dual Energy X-Ray Absorptiometry (DXA) in breast cancer patients receiving aromatase inhibitor treatment
9th November: Decision Analytic Protocol (DAP) 1293 to guide the assessment of Epidermal Growth Factor Receptor (EGFR) gene mutation testing for eligibility for afatinib treatment in patients with stage IIIB or stage IV non-small cell lung cancer (NSCLC)
13th June: Submission pertaining to the melanoma drugs vemurafenib and ipilumumab as well as co-dependant approval for the vemurafenib and cobas 4800 BRAF V600 mutation test.
31st October: Submission to PBAC on vemurafenib and ipilumumab.
2nd November: Follow up on vemurafenib and ipilumumab in response to NICE recommendation. (The NICE press release can be read here).
METASTATIC RENAL CELL CARCINOMA:
17th February: Sunitinib and pazopanib
APPROVAL FOR PROSTATE DRUGS, NOVEMBER 2011
MOGA submission to support approval for prostate cancer drugs (including aberaterone and carbazitaxel) considered at the November Meeting of the Pharmaceutical Benefits Advisory Committee. The Association thanks Dr Mustafa Khasraw for his assistance in developing the MOGA submission.
On receipt of advice that at its November meeting the PBAC were to consider submissions pertaining to new prostate cancer drugs, including aberaterone and carbazitaxel the Association wrote to support and endorse the approval of this class of drugs by the PBAC. Click here to view.
DRAFT INFORMATION REQUESTS FOR ASSESSING CO-DEPENDANT TECHNOLOGIES
In mid December 2010 MOGA endorsed and contributed to a joint submission to the Australian Department of Health and Ageing (DOHA), the Medical Services Advisory Committee and the Pharmaceutical Benefits Advisory Committee on the DRAFT INFORMATION REQUESTS FOR ASSESSING CO-DEPENDANT TECHNOLOGIES. The submission can be viewed here and represents the views of MOGA, the Clinical Oncological Society of Australia, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiation Oncologists, Cancer Council Australia and Cancer Voices Australia.
MOGA welcomes this timely initiative to promote discussion and feedback on the co-dependent and hybrid technologies with the aim of providing comprehensive Ministerial advice.The focus of the draft is on a single pairing of a proposed test with a proposed drug as the first test in formulating a framework to manage the evidence and process issues involved in dealing with co-dependant technologies. This is a viable starting point for the management of co-dependent technologies, however it is acknowledged that more comprehensive guidelines capable of addressing a wide diversity of complex co-dependent scenarios needs to be developed at the next stage in this process. For instance, the development lag between drug approval and subsidisation and the subsequent emergence of related new tests and extending the linkage principles to encompass other issues such as PET and drugs, surgical techniques and radiological testing.
Given the absence of appropriate legislation and monitoring, the Draft paper and consultation process also highlights the need for the DOHA, regulatory organisations and clinicians to address the growing number of unregulated technologies, tests and treatments in the Australian marketplace.The Association particularly acknowledges the contribution of A/Prof Paul Craft from The Canberra Hospital who provided a detailed analysis to assist with the MOGA submission.
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