Proteomics International Laboratories’ share price has hit a seven-month high after a United States federal health agency set a national reimbursement price for the company’s predictive “PromarkerD” test for diabetic kidney disease.
Management says the “affordable” US$390.75 (AU$605) price set by the Centres for Medicare & Medicaid Services for the test in the US is a major milestone. The pricing will become effective from January 1 next year after a 30-day public comment period.
But it had an immediate effect on the ASX, with Proteomics’ stock jumping from yesterday’s close of 90 cents, to an intraday high today of $1.15 – almost a 28 per cent jump and the highest mark since February.
CMS is a US federal agency responsible for providing health coverage to more than 100 million Americans and is the single-biggest payer for health care in that nation. It covers 42 per cent of health-care spending in the US.
The PromarkerD payment rate, which was set by the Medicare advisory panel on clinical diagnostic laboratory tests, will be delivered through the company’s business partner Sonic Healthcare USA.
We thank our licence partner, Sonic Healthcare USA for their leading role in attaining this CMS list pricing, which is a key milestone under our agreement. CMS reimbursement will enable affordable access to PromarkerD for millions of Americans and help drive broad adoption of the test. As we prepare for the US launch of PromarkerD, the CMS price is an essential component of the roll-out strategy, both because of the number of people it covers, and because many private payers follow CMS pricing. The CMS pricing … is testament to the clear value the PromarkerD test can deliver to the US health system. Proteomics International Laboratories managing director Dr Richard Lipscombe
The company says the reimbursement price decision comes after the American Medical Association (AMA) approved a unique proprietary laboratory analyses code for PromarkerD earlier this year.
While the pricing is a key step forward in the US, Proteomics has also revealed today that Australia’s Therapeutic Goods Administration (TGA) has decided not to include the PromarkerD test in the Australian Register of Therapeutic Goods. Management says that the while the TGA decision temporarily impacts its ability to sell the test in Australia, it does not affect the company’s activities in the US.
Proteomics says its request for the registration was for the immune-assay version of its PromarkerD test, which was originally manufactured in Australia, but has since been transferred to a manufacturer in Europe.
Management says it remains bullish about the robustness of its published data on PromarkerD and its current immuno-assay manufacturing process and that its immediate focus remains firmly on the major US and European markets.
In the US, an estimated 32 million people – or 11 per cent of the adult population – live with diabetes, while in Europe there are 61 million (7 per cent) and Australia has 1.5 million adults (6.4 per cent) living with the disease. According to the US Renal Data System, the total cost of diabetic kidney disease (DKD) in the US alone is US$130 billion (AU$201.3 billion) per year.
Proteomics says early diagnosis of DKD using PromarkerD can assist doctors’ treatment decisions to improve clinical outcomes for patients. Published research shows early intervention with an SGLT2-inhibitor class, a widely used diabetes drug also indicated for the treatment of DKD, leads to significant reductions in the PromarkerD risk scores for developing the disease.
The company says that reducing or delaying the progression of the disease would reduce the incidence of dialysis and kidney transplant, improving the quality of life for patients and saving healthcare systems millions of dollars.
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