Carlo Montagner of Specialised Therapeutics has delivered a stinging critique of decision-making at the parliamentary inquiry into approval processes for new drugs and novel model technologies.
Mr Montagner appeared at the hearing a short time ago with Michael Graham of ViiV Healthcare and CSL Behring's Loretta Croker.
Mr Graham said Australia faces an "insidious decline" in access to new medicines because of the current decision-making framework. He referred to Australia as a "technology taker" globally and asked the committee what future did it want for health care.
Ms Croker said there is an opportunity to enhance access to blood products. She said the funding system through the National Blood Authority should be updated to provide more timely decision-making and access, including a six-month timeline from the decision to funding.
In a very direct opening statement, Mr Montagner outlined his experiences of Australia's decision-making processes with the OncotypeDX breast cancer diagnostic and raised concerns over the government's plan to strip confidentiality protections for sponsors of submissions to the Pharmaceutical Benefits Advisory Committee (PBAC).
"A key step towards achieving this is for MSAC [Medical Services Advisory Committee] and PBAC to disclose to the applicant all details of the deliberations that result in a decision, instead of delivering a summary of the evaluation.
"This is especially important when an application for reimbursement has been rejected multiple times…and when a company seeks a greater understanding of all the issues discussed by committee members during a meeting."
He continued, "I have a recent example I would like to share that illustrates this issue. Our company provides a breast cancer genomic test called OncotypeDX. In Australia, this test costs women $5,000. This test is highly recommended and listed as best practice by every breast cancer peer-reviewed treatment guideline in the world.
"Not surprisingly, it is widely reimbursed in countries with a health system like Australia - such as the UK, Canada, Germany and Italy…but also in less affluent countries including Lebanon, Greece and South Africa.
"Our company has submitted six applications to MSAC seeking to have this test reimbursed for the thousands of Australian women who would potentially benefit - by allowing many of them to safely avoid six months of very arduous and unnecessary chemotherapy.
"All six applications have been strongly supported by local breast cancer specialists and Australia’s peak breast cancer patient advocacy group - the BCNA.
"The last time we were rejected we didn’t even receive any explanation until I submitted an FOI request - some 6 months after the MSAC hearing.
"The minutes we eventually received stated that MSAC wanted evidence from a different type of trial. But breast cancer experts tell us that the sort of trial MSAC is requesting would be unethical to conduct and would take at least a decade to deliver results.
"The documents we did receive under FOI were so heavily redacted that we remain completely in the dark as to the reasoning behind this strange request for a trial that no oncologist would recruit patients to."
Mr Montagner said the company was not asking for the "nuclear codes" just information on the reasons for the rejection. He also challenged the Department of Health's administration of Freedom of Information requests.
He continued, "Being denied access to presentations made to MSAC/PBAC and their subsequent deliberations only erodes trust in the process and hampers our ability to submit future applications that appropriately address relevant issues.
"To have no real visibility around these decisions is extremely frustrating, especially when we have paid many hundreds of thousands of dollars to make these applications."
On the government's move to strip PBAC submission sponsors of confidentiality submissions, Mr Montager said, "Ironically, the Government has recently introduced a Bill that has the potential to fully reveal commercially sensitive information such as unpublished clinical data and special negotiated pricing. This places even greater onus on the industry to be completely transparent but with no requirement for PBAC or MSAC to reciprocate and be transparent in their deliberations. This could jeopardise access to new medicines in this country. I have written to the Minister seeking greater consultation with key stakeholders before this Bill is considered by Parliament."
He said the Bill is a "real issue" that will negatively impact access to medicines in Australia.
Mr Montagner also said the fees for submissions and the risk of failure is high to the extent he is rejecting potential deals to bring new medicines to Australia.
In response to questions, Mr Montagner described Australia as a global 'laughing stock' over its refusal to fund OncotypeDX and that the company will not make another submission to MSAC given the demand it conducts an 'unethical' clinical trial.
"It is like I am saying to MSAC the earth is round and they are saying it is flat - we have nowhere to go," he said.
