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January 17, 2023
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Fifty years later, ESKD patient population is heading for a (lower) steady state

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In October 2022, the United States marked 50 years since the passage of Social Security Act amendments that created the Medicare entitlement for end-stage kidney disease.

By the end of 2019, nearly 3.4 million people had registered as being diagnosed with ESKD.

Eric D. Weinhandl

That count increases annually, and throughout the 1990s and 2000s, it seemed as if the rate of increase was accelerating like a rocket, portending a public health disaster that would overwhelm the Medicare coffers.

The dialysis population seems a little different than perhaps what some had predicted 10 or 15 years ago. Have we reached a long-awaited “steady state” of dialysis patients in America? If so, what will the coming decade hold, considering the 2019 executive order on Advancing American Kidney Health?

Patient population

As a starting point, it is helpful to consider the patient population at three different times: the years 1980, 2000 and 2020. Back in 1980, only 18,000 people in the United States were diagnosed with ESKD. In contrast, 94,500 were diagnosed in 2000 and 130,500 were diagnosed in 2020. The decadal rate of increase in the sheer number of diagnosed cases of ESKD has slowed greatly.

What about those patients? In 1980, only 29% were aged 65 years or older. In 2000 and again in 2020, about 50% were in that age range. Thus, although newly diagnosed patients with ESKD grew older during the 1980s and 1990s, there has been little aging since 2000.

Enlarge 
Figure. Average treatments per day at DaVita Inc. and Fresenius Medical Care North America, from fourth quarter of 2019 to third quarter of 2022 (U.S. patients only; Form 10-Q, Form 6-K filings).

The racial distribution of new patients has shifted modestly, with a progressively smaller share of patients who are considered non-Hispanic white, but not because there are more Black people. Instead, Hispanic and Asian people represent a larger share of patients newly diagnosed with ESKD in 2020 than in 2000.

Causes of ESKD

Another important point of evolution is the primary cause of ESKD. In 1980, 15% of newly diagnosed cases were due to diabetes. By 2000, that share was 45%, and by 2020, 46%. Like diabetes, the comorbidity profile of newly diagnosed patients with ESKD seems to have evolved little between 2000 and 2020. In 2000, 32% of patients presented with heart failure, whereas between 2018 and 2020, 28% did so. CVD was present in 9% of patients in both 2000 and 2018 to 2020.

In sum, although old age and diabetes proliferated among new patients with ESKD before the turn of the century, further evolution has been unremarkable, with only a shift in race and ethnicity that seems to track the growing diversity of the United States.

Dialysis treatments

The overall number of patients undergoing dialysis is a deceptively complex quantity to understand, as it reflects the number of people diagnosed with ESKD each year, the survival of patients on dialysis and the number of patients who receive a transplant each year, which is largely governed by the organ supply.

This number followed an upward straight line before the start of the COVID-19 pandemic: 282,500 patients in 2000; 419,400 patients in 2010; and 569,300 in 2019. However, the pandemic quickly put the brakes on growth. For the first time in the history of the Medicare entitlement, the number of patients on dialysis began to decline. After almost 3 years of COVID-19, it is unclear that growth has yet resumed, as financial reports from DaVita Inc. and Fresenius Medical Care North America continue to suggest steadily declining treatment volume (see Figure).

Questions about growth

Will growth of the dialysis population resume in 2023? On one hand, it seems safe to answer “yes,” as COVID-19 clearly lacks the punch that it did in 2020 due to the combination of infection history and repeated vaccination.

However, excess all-cause mortality in the general population remains, according to the CDC, and just as COVID-19 recedes, influenza stands ready to reprise its usual wintertime impact in the United States.

Furthermore, the preliminary number of newly diagnosed patients with ESKD in 2021 was just 0.6% higher than the corresponding count in 2019. With more deaths and more transplants than in the past, such a paltry increase in incidence is unlikely to support growth in the overall number of patients on dialysis.

All this flux is occurring concurrently with a growing collection of pharmacologic interventions to slow the progression of chronic kidney disease, if not lower the risk of developing CKD in the first place. These interventions include the following:

  • SGLT2 inhibitors (“flozins”) that appear to be effective in both diabetic and non-diabetic CKD, when albuminuria is present;
  • finerenone, a nonsteroidal mineralocorticoid receptor antagonist, which is newly indicated to slow CKD progression in those with diabetes; and
  • GLP-1 receptor agonists semaglutide and tirzepatide, which are poised to deliver substantial weight loss effects, probably leading to lower population-level risk of CKD.

These interventions will improve health only if the interventions are accessible and affordable. In the case of flozins, enthusiasm to prescribe is often met with considerable barriers imposed by payers. This conflict may be the most likely (and pitiful) path to a rapidly growing dialysis population in the future.

An important issue for planning is required capacity for dialysis, especially for in-center hemodialysis. In light of flat ESKD incidence, a multi-year impact from COVID-19, an array of forces drumming up kidney transplants and the decidedly steady growth of home dialysis, it is reasonable to conclude that the number of dialysis centers per 100,000 people has hit its limit. Whether we see a wave of closures is unclear, but a new era of center construction across America seems unlikely.

Patient survival

Where do we go from here? In my opinion, a focus on patient survival, and tackling the problems that lead to death, is of paramount importance. Even a steady-state population can generate treatment volume growth if survival is improving. Controlling fluid volume, blood pressure and infection is likely to extend life. Medication management and vaccination are also likely to improve clinical outcomes. Quality measures should incentivize attention to these domains and avoid the chase for biochemical targets of uncertain value.

Ultimately, the likely end of growth in the dialysis population is not only a win for public health, but also an opportunity to concentrate resources to improve the health of a well-defined population before us.