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News & Trends - MedTech & Diagnostics

Medtronic, Stryker and Edwards scrutinise approval processes for novel medical technologies at Inquiry hearing

Health Industry Hub | March 15, 2021 |

MedTech News: On Friday 12 March 2021 the House of Representatives Standing Committee on Health, Aged Care and Sport held its second day of the public hearings in Sydney as part of the Committee’s ongoing Inquiry into approval processes for novel medical technologies and new drugs in Australia.

The Chair of the Committee, Mr Trent Zimmerman MP, said that “the Inquiry has received a lot of interest with 185 submissions to date. The Committee is hearing from stakeholders to find out how Australia’s approval systems and funding for novel medical technologies and new medicines will provide the best possible outcomes for all Australians now and into the future.”

In addressing the Committee, Maurice Ben-Mayor, President of Stryker, Australia and New Zealand noted “The timing for this committee meeting is very appropriate because I see that medtech innovation is at an inflection point. The advancements over the last 10 years in robotics, 3D printing, imaging and AI means that we are on the cusp of a significant increase in new technologies coming over the next decade.

“Our current regulatory and reimbursement funding models, access and processes are struggling with the existing demands. Today we see delays like never before and it’s not a single area or a singular issue.

“Firstly, all regulatory and funding agencies and departments need to significantly increase and speed up the process without compromising patient safety. Secondly, we need a fit-for-purpose novel medtech process. We cannot simply transplant the pharma processes into medtech. It just won’t work. Thirdly, we need to view the entire access process as a singular system rather than independent components including the TGA, MSAC and Prostheses List,” he added.

Jan Ewert, Managing Director of Biotronik Australia said “Innovations take on a different shape than they have in the past. Innovation happens in the digital space or in a combination of services, devices and drugs, and they are currently not adequately catered for.”

Mr Ewert provided an example of Biotronik’s drug coated balloons where the company is struggling to find reimbursement pathways in the private sector in Australia because the technology is not a drug nor a prostheses.

“The idea is to create a platform for the government to support bringing stakeholders together, including payers who often are not part of the initial conversations, manufacturers, innovators and the respective providers. They need to collectively look at these technologies and innovations and figure out how they can be implemented in creating benefits for patients in addition to health economic benefits in the Australian marketplace,” added Mr Ewert.

Nicola Leavold, Commercial Director of BXTAccelyon Australia said “We feel that MSAC should offer a consultation period or opportunity to discuss the applications. This could be with nominated clinical experts involved in the applications, if not, with industry itself. Maybe a governing body similar to the PBAC in the PBS would help reduce MSAC’s isolation and dependence. The review committee could have specialists who are directly involved in the treatments, especially with more complex treatment options. Also, greater significance should be placed on international guidelines and recommendations with regard to medical device approvals, especially when treatment protocols within Australia are guided by these international standards.”

Liz Carnabuci, Vice President and Managing Director of Medtronic, Australia and New Zealand said “We support the work of the regulator in ensuring safety and efficacy and we particularly note the efforts they’ve made to improve the way they work with sponsors in recent years.

“However, there are still some areas where more streamlined regulatory processes could improve access to novel medical technology. This includes enabling the TGA to have market entry discussions and better alignment to accept US Food and Drug Administration (FDA) breakthrough designations, extending the use of managed entry agreements and non-drug technologies and permitting coverage with evidence development and real world evidence in approval arrangements.

“The Prostheses List (PL) is also a core component of how patients access novel medical technology in this country. Any discussion about access needs to acknowledge the role the PL plays. We work with the PL every day and acknowledge it can be improved, but it might be worth considering what would happen without the PL. The range and diversity of life-saving technology would reduce and clinicians would have less clinical choice. Both of these outcomes would lead to less patient access to these innovative therapies.

“We need clear, transparent and effective regulatory and reimbursement frameworks providing access to novel medical technology,” she added.

Pat Williams, Managing Director of Edwards Lifesciences Australia, New Zealand and Korea said “If we can align our regulatory processes with our funding mechanisms, patients in Australia will benefit from these innovative technologies. I’m optimistic about the future because we have a real opportunity to deliver better patient outcomes and importantly to save the Commonwealth money.”


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