Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
One out of 4 experts was familiar with or had used this technology before.
Level of innovation
Three of the experts agreed that the technology is novel compared with standard care and is expected to be used in addition to established tests such as estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (uACR). The other expert stated that PromarkerD offers an incremental advancement of current biomarkers used to predict renal dysfunction but is unlikely to significantly alter efficacy or safety. One of the experts highlighted that there has been a long-standing search for biomarkers that better predict the development of diabetic kidney disease (DKD) in people with type 2 diabetes. However, before PromarkerD, no established biomarker has been developed that provides more information than the uACR, a test which demonstrates ongoing damage rather than predicting DKD.
Potential patient impact
Two of the clinical experts commented that PromarkerD has the potential to allow earlier identification of people with type 2 diabetes who are at high risk of developing cardiovascular and renal complications. This could allow a more intensive approach to reduce risk of both cardiovascular and kidney damage early on after diagnosis of type 2 diabetes. Another expert stated that PromarkerD could allow for 1 test to be taken instead of the blood and urine tests done in current practice. The expert highlighted that urine tests tend to score poorly in the national diabetes audit. One expert said that diabetes is the most common cause of end-stage renal disease. People from high-risk family backgrounds are at particular risk of developing DKD, so PromarkerD may prove to be an effective option for these people.
Potential system impact
All of the experts agreed that the technology would cost significantly more than standard care, while the effect on long-term outcomes is unclear. Two of the clinical experts explained that PromarkerD may allow the identification of high-risk patients earlier, which would alter the treatment they receive. So, this could lead to a decrease in the number of people developing end-stage renal disease, reducing hospitalisation and need for dialysis. One expert outlined that long-term cost savings depend on the ability of the test to alter management strategies, such that fewer people need end-stage renal failure treatments. Three of the experts added that a training programme would need to be introduced alongside the technology, so healthcare professionals understand how to use the tests and respond to test results. This would mitigate the risk of further increased costs from unnecessary testing, and provide clinicians and patients with clarity on test outcomes.
General comments
One expert stated that the test carries a false positive rate, which could mean that some people who are not at risk of developing DKD are treated. The false negative rate also means that some people who are at risk are not treated. Two experts highlighted that the key efficacy outcome must be a reduction in the incidence of people with advanced kidney disease in the context of diabetes, otherwise the technology will not provide any significant advantage. Three of the experts felt that more evidence is needed on the technology using larger cohorts to confirm its efficacy before adoption across the healthcare system.