Kidney disease affects 4 million people in Italy: the paradox of a test that exists but ‘cannot be seen’

Chronic kidney disease, whether diagnosed or as yet undiagnosed, affects between 3.5 and 4 million adults in Italia. A veritable ‘army’ of people who suffer from diagnoses that are all too often made too late, by which time the condition is already at an advanced stage and has caused damage to the body that may even be irreversible. The picture becomes more complicated when we consider the close correlation between the kidneys and the heart: when one of these organs ‘falls ill’. It therefore becomes all the more important to have diagnostic tools capable of overcoming organisational and bureaucratic barriers to detect chronic kidney disease at an early stage and identify cardiovascular risk, particularly when it comes to non-invasive and cost-effective tests.
As is often the case, the crux of the matter lies in aligning national and regional strategies, as well as introducing a new reimbursement code and laboratory standards. It is a puzzle that requires a harmonious solution, and one from which Italia is still a long way off, whilst the solution for the early identification of cardio-renal risk is on the table, waiting to be implemented. Luca Pinto, Head of Engagement Solutions Italy &Greece at IQVIA, who coordinated a multi-stakeholder working group on the role of the uACR (urinary albumin-to-creatinine ratio) test in enabling timely management, once cardio-renal risk has been identified at an early stage in patients with hypertension or type 2 diabetes.

The independent survey, carried out by a board led by IQVIA, was presented in Rome at an event organised by Boehringer Ingelheim as part of the first EU Screening Week (28 September–4 October), launched by the European Commission to raise awareness amongst citizens and institutions of the importance of prevention and early diagnosis, as part of the ‘Safe Hearts Plan’, which aims to reduce premature cardiovascular deaths by 25 per cent by 2035 by tackling the main risk factors. The figures today are truly alarming: in the European Union, around 62 million people live with cardiovascular disease – equivalent to roughly one in seven people – and in Italia, too, heart disease is the leading cause of death, with such a high social and economic cost that the impact on the healthcare system here exceeds 40 billion a year.

“The picture that emerges from the survey,” explains Pinto, “is that of a clinically recognised test which is technically simple and already available, but which has not yet been incorporated in a uniform and systematic manner into Italian care pathways, and which shows significant regional variation. The issue is not one of technical unavailability, but rather of recognition, standardisation and organisational integration. The uACR can already be carried out, but it is not yet consistently prescribed, identified, performed and utilised in a uniform manner.” In other words: ‘The fragmentation of care pathways and the absence of a uniform coding system complicates laboratory management,’ he summarises. Different PDTA protocols, a lack of standardised coding and inconsistent laboratory practices are the obstacles to the early diagnosis of albuminuria. Meanwhile, the Roadmap drawn up by the experts points in a completely different direction: systematic integration of the test into the PDTA, clear and unambiguous identification of uACR, and shared laboratory management to promote the standardisation and implementation of this test.

In particular, the absence of a specific code in the Tariff Schedule makes it extremely difficult for GPs to issue a referral, even where a suspected diagnosis exists. For this reason, Gaetano Piccinocchi, a general practitioner and head of the Kidney Diseases Section at the SIMG Scientific Society, identifies as a priority objective ‘the inclusion of uACR in the PDTA and the allocation of a dedicated, standardised and easily recognisable code, with a view to incorporating the test into the Essential Levels of Care’.
Things might start to ‘move’ with an amendment to the Mulè Bill, which aims to introduce a diagnostic programme to identify chronic kidney disease in the adult population (AC 1761), but the process is still in its early stages, with the bill currently undergoing its first reading in the Chamber of Deputies’ Social Affairs Committee, and it is unlikely that the law will be passed during this parliamentary term.

Yet, as Giuseppe Grandaliano, Professor of Nephrology at the Catholic University and Head of Nephrology at Gemelli Hospital, explained – ‘uACR indicates organ damage; it is the first sign that the renal filter – that is, the glomerulus – is failing to retain albumin, which should never be present in the urine. When this happens, it means that renal filtration capacity is compromised, so there is a problem that needs to be investigated. The KDIGO Guidelines (on chronic kidney disease, ed.) have recommended the use of the uACR test for at least a decade, and nephrologists follow these guidelines; they also advise combining the uACR with the eGFR, which allows for an even more precise stratification of both kidney damage and cardiovascular risk.”
“Until a few years ago, we had no treatments for kidney failure apart from diet and antihypertensives; now the situation has completely changed – we have drugs capable of significantly slowing the progression of kidney disease, or even halting it if intervention occurs at a very early stage. This is why it is of fundamental importance to carry out regular tests capable of detecting kidney disease at a very early stage, and the uACR is one such test – it is extremely sensitive and accurate,’ continues Massimo Morosetti, president of the Italian Kidney Foundation (FIR ETS) and emeritus head of Nephrology and Dialysis at ASL Roma 3. However, for the uACR test to truly guide clinical decisions, its results must be reliable. ‘We need to ensure that measurements are comparable across different laboratories, both in terms of the result and the way it is expressed, for example in units of measurement,’ explains Michele Mussap, Director of Laboratory Medicine at Villa Salus Hospital Foundation and IRCCS San Camillo in Venice – “Equally important is the choice of method to ensure maximum reliability of the results; immunological methods are the most reliable and are based on international calibration standards for albuminuria, to which all kit manufacturers must adhere.”
‘We need to move towards a more holistic approach, one that is less specialised and specific: the heart and kidneys cannot be managed separately,’ summarises Leonardo De Luca, Director of Cardiology at the IRCCS Policlinico San Matteo Foundation in Pavia and Vice-President of the HCF ANMCO Foundation for Your Heart ETS. “The aim is not merely to diagnose kidney disease, but to identify at-risk patients promptly and intervene immediately with strategies that can slow the progression of kidney disease and, consequently, reduce the risk of cardiovascular events.”