Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

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My company has a unique scenario playing out in Australia and was curious if anyone has encountered a similar situation or can offer up some much needed advice. As a small EU based IVD manufacturer we're partnering with a third-party to act as our Sponsor.  This same entity is also helping us with reimbursement and is actively engaged with the Medical Services Advisory Committee (MSAC) to obtain funding for our device. In case you're not familiar with MSAC, they are an independent non-statutory committee established by the Australian Government Minister for Health in 1998 to improve health outcomes for patients by ensuring that new and existing medical procedures attracting funding under the Medicare Benefits Schedule are supported by evidence of their safety, clinical effectiveness and cost-effectiveness.

 

The challenge is the MSAC does not allow named proprietary tests to funded by the government and they also need TGA approval to be in place first. The quandary then is how do we go about completing the TGA Declaration of Conformity (DoC) without using our proprietary name, which is obviously part our company branding and which on our labeling, etc. Instead of our proprietary name being on the DoCs, we've been advised it's necessary to use a generic naming conversion that is registered in the MSAC Medicare Benefits Schedule book. These being names such as "characterization of germline gene mutations" or "detection of HLA-B27 by nucleic acid amplification" to name a couple of examples. These generic names would thereby go on the Australian Register of Therapeutic Goods (ARTG). In other words, we'd be using the generic naming conventions established in the MSAC Medicare Benefits Schedule book, instead of our proprietary name.

 

This is Australian Government policy to get funding and reimbursement, which we are not going to change, but how then does it affect my device registration or import/export to Australia if the labeling is different than what's officially listed in the ARTG? I have intentions of reaching out my Sponsor's contact at TGA, but was curious if anyone here had a similar experience or could offer up points of consideration.

 

Thank you in advance and am anxious to hear what the RA community has to say.

Hi,

In order to have your device reimbursed and listed on the prostheses list you need ARTG entry. Without ARTG entry your device will not be listed. Depending on the class of your device and how you want to position it, your brand name will appear on the ARTG certificate.

MSAC application is required when there if medical procedure ​which utilises your device is not on MBS (medicare benefit schedule). Aim of this process is to assess the medical service independently for public funding. In short, this has nothing to do with your specific device as MSAC is not only for your device. By you undergoing MSAC you will open up opportunities for both yourself and your competitors who have similar products or can solve same medical problem with different medical technology.

Hope this helps.

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Romit Singh
Pre Market Team Leader
Belrose
Australia
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Original Message:
Sent: 23-Jan-2019 15:05
From: Anonymous Member
Subject: TGA DoCs & reimbursement challenges in Australia

This message was posted by a user wishing to remain anonymous

​

My company has a unique scenario playing out in Australia and was curious if anyone has encountered a similar situation or can offer up some much needed advice. As a small EU based IVD manufacturer we're partnering with a third-party to act as our Sponsor.  This same entity is also helping us with reimbursement and is actively engaged with the Medical Services Advisory Committee (MSAC) to obtain funding for our device. In case you're not familiar with MSAC, they are an independent non-statutory committee established by the Australian Government Minister for Health in 1998 to improve health outcomes for patients by ensuring that new and existing medical procedures attracting funding under the Medicare Benefits Schedule are supported by evidence of their safety, clinical effectiveness and cost-effectiveness.

 

The challenge is the MSAC does not allow named proprietary tests to funded by the government and they also need TGA approval to be in place first. The quandary then is how do we go about completing the TGA Declaration of Conformity (DoC) without using our proprietary name, which is obviously part our company branding and which on our labeling, etc. Instead of our proprietary name being on the DoCs, we've been advised it's necessary to use a generic naming conversion that is registered in the MSAC Medicare Benefits Schedule book. These being names such as "characterization of germline gene mutations" or "detection of HLA-B27 by nucleic acid amplification" to name a couple of examples. These generic names would thereby go on the Australian Register of Therapeutic Goods (ARTG). In other words, we'd be using the generic naming conventions established in the MSAC Medicare Benefits Schedule book, instead of our proprietary name.

 

This is Australian Government policy to get funding and reimbursement, which we are not going to change, but how then does it affect my device registration or import/export to Australia if the labeling is different than what's officially listed in the ARTG? I have intentions of reaching out my Sponsor's contact at TGA, but was curious if anyone here had a similar experience or could offer up points of consideration.

 

Thank you in advance and am anxious to hear what the RA community has to say.