Proteomics International Laboratories Ltd (ASX: PIQ) has completed the ‘pre-assessment’ phase of Australia’s medical reimbursement system for PromarkerD, the world’s first predictive diagnostic test for diabetic kidney disease.
The application lays the groundwork for the test to be added to the Medicare Benefit Schedule (MBS). Inclusion on the schedule would mean eligible patients receive a Medicare rebate for the PromarkerD test.
In Australia, the suitability of new medical services for public funding is appraised by the Medical Services Advisory Committee (MSAC).
This independent, non-statutory committee advises the government on whether services should attract a Medicare rebate. PromarkerD has cleared the ‘pre-assessment’ stage of the process, which includes a systematic review of clinical evidence and practice, an economic evaluation, and the proposed item descriptor and fee by a specialist sub-committee.
Proteomics International will now submit a full application for the ‘assessment’ stage of the process, which includes evaluation by a second sub-committee and consideration from the full MSAC.
It is expected MSAC will meet in November 2022 to consider the proposal to include PromarkerD on the MBS, and may recommend, defer or reject the test for listing.
The company is also pursuing Therapeutic Goods Administration (TGA) approval for PromarkerD, which is a parallel and independent process, and the Company will provide updates as and when events occur on this front.
Proteomics International managing director Dr Richard Lipscombe said inclusion on the MBS was an important step to bring PromarkerD to the Australian market.
If MSAC recommendation is secured, it will be a key milestone in commercialising PromarkerD in Australia. It means eligible patients are likely to receive Medicare rebate for the test,” he said.
Dr Lipscombe said he was confident in the strong body of evidence for PromarkerD.
“We know the test is safe, it’s effective and it significantly outperforms current standard-of-care tests for diabetic kidney disease. Our studies show PromarkerD will both improve patient quality of life and reduce overall costs to the health system, through fewer patients requiring dialysis and kidney transplants.”
