Impact of major hepatocellular carcinoma policy changes on liver transplantation for hepatocellular carcinoma in the United States

Abstract

Since its inception in 2002, Model for End-Stage Liver Disease (MELD)based allocation has undergone a series of revisions, especially with respect to exception points. Hepatocellular carcinoma (HCC) is the most common indication for MELD exceptions, and as a result of higher transplant proportions and lower waitlist mortality, a series of policy changes have been implemented to deprioritize HCC transplants. We examined the impact of HCC exception policy changes on transplant and waitlist mortality rates. We evaluated Organ Procurement and Transplantation Network/United Network for Organ Sharing data on adult patients from January 1, 2005, to June 4, 2021, focusing on waitlist mortality and deceased donor liver transplantation (DDLT) proportions. The data were divided into four policy eras: (1) MELD 22 points at waitlisting with an increase in points every 3 months (i.e., elevator) (January 2005-October 2015), (2) delay and cap at MELD 34 points (October 2015-May 2019), (3) delay and fixed exceptions based on donor service area (DSA) median MELD at transplantation minus three (MMaT-3; May 2019-February 2020), and (4) delay and fixed exceptions based on the MMaT-3 of centers within 250 nautical miles (i.e., acuity circles; February 2020-June 2021). We evaluated (a) changes in the proportions of DDLTs for patients with HCC exceptions within each era nationally and by DSA and (b) waitlist mortality in the three recent policy eras, focusing on mortality in the 6 months after the 6-month delay period. The percentage of adult DDLT with HCC exceptions decreased through the four eras: 22.9% (n = 14,049), 17.9% (n = 4598), 14.3% (n = 851), and 12.4% (n = 1425), respectively. Of the 51 DSAs analyzed, the annual percent change in DDLTs for patients with HCC exceptions was negative (i.e., decreased) in 47 (92.2%). Waitlist mortality remained stable. All HCC policy implementations led to a decrease in the SEE EDITORIAL ON PAGE 1821How to cite this article: Shah RH, Chyou D, Goldberg DS. Impact of major hepatocellular carcinoma policy changes on liver transplantation for hepatocellular carcinoma in the United States.

Living Donor Liver Transplantation (LDLT) for Hepatocellular Carcinoma (HCC) within and Outside Traditional Selection Criteria

“…Organ scarcity has led to several policy changes in the United States since the early 2000s to improve equity for patients without HCC in access to transplantation. 24 These changes have included a mandatory 6-month delay in receipt of exception points for candidates with HCC for transplantation. 25 The result of these policies has been a deprioritization of patients with HCC for transplantation, with a reduction in the percentage of transplantations performed for HCC.…”

Optimizing liver transplant prioritization for hepatocellular carcinoma through risk stratification

“…This artificial prioritization has been controversial, as early iterations overprioritized HCC patients, leading to higher transplant rates compared to non-HCC patients [6 ▪ ]. The United Network for Organ Sharing (UNOS) classifies stage T1 HCC as a single tumor ≤2 cm, and Stage T2 HCC as either a single 2–5 cm tumor or 2–3 lesions all between 1 and 3 cm, and alpha-fetoprotein (AFP) ≤ 1000 ng/ml [7].…”

“…As a result, UNOS has since enacted multiple policy changes, including cap-and-delay in 2015, which set a maximum to MELD exception points accrued over time and mandated a 6-month waiting period prior to receipt of exception points. In 2019, with implementation of the National Liver Review Board to address geographic variability, exception points transitioned from a fixed number of exception points to a score based on the median transplant score (MMaT -3) of a geographic unit – initially the donor service area, then the transplant center, and most recently as of 2022, the donor hospital [6 ▪ ]. With implementation of these policies, transplant rates for HCC and non-HCC patients have equalized, and the proportion of transplants via HCC exception in the United States has decreased from 23.8% in 2010 to 16.5% in 2020 [2,8 ▪ ].…”

“…With implementation of these policies, transplant rates for HCC and non-HCC patients have equalized, and the proportion of transplants via HCC exception in the United States has decreased from 23.8% in 2010 to 16.5% in 2020 [2,8 ▪ ]. Patients listed for HCC now experience longer wait times, with a 16.8% waitlist dropout rate under the MMaT-3 system, compared to 12.2% under cap-and-delay [6 ▪ ].…”

Liver allocation policies for hepatocellular carcinoma have leveled the playing field—But who should be playing?

“…In this issue of Liver Transplantation , Shah et al [ 3 ] describe the impact of these policy changes on liver transplantation and waitlist mortality rates for HCC from 2005 to 2021. The study design is mindful of the time course and intent of each policy change, with eras defined to capture system‐level outcomes during each policy era and minimize overlap.…”