T2 Hepatocellular Carcinoma Exception Policies That Prolong Waiting Time Improve the Use of Evidence-based Treatment Practices

Abstract

Background. A United Network for Organ Sharing policy change in 2015 created a 6-mo delay in the receipt of T2 hepatocellular carcinoma exception points. It was hypothesized that the policy changed locoregional therapy (LRT) practices and explant findings because of longer expected waiting time. Methods. Patients transplanted with a first T2 hepatocellular carcinoma exception application between January 1, 2010 and December 31, 2014 (prepolicy; N = 6562), and those between August 10, 2015 and December 2, 2019 (postpolicy; N = 2345), were descriptively compared using data from United Network for Organ Sharing. Results. Median time from first application to transplantation was more homogenous across the US postpolicy, due to greater absolute increases in Regions 3, 6, 10, and 11 (>120 d). During waitlisting, postpolicy candidates received more LRT overall (P < 0.001), with more notable increases in previously short-wait regions. Postpolicy explants were overall more likely to have ≥1 tumor with complete necrosis (23.9 versus 18.4%; P < 0.001) and less likely have ≥1 tumor with no necrosis (32.6% versus 38.5%; P < 0.001). Significant geographic variability in explant treatment response was observed prepolicy with recipients in previously short-wait regions having more frequent tumor viability at transplant. Postpolicy, there were no differences in the prevalence of recipients with ≥1 tumor with 100% or 0% necrosis across regions (P = 0.9 and 0.2, respectively). Conclusions. The 2015 T2 exception policy has led to reduced geographic variability in the use of pretransplant LRT and in less frequent tumor viability on explant for recipients in previously short-waiting times.

Impact of COVID‐19 Pandemic on Liver Transplantation and Alcohol‐Associated Liver Disease in the USA

“…In February 2020, UNOS implemented a policy limiting a candidate’s maximum exception score to each center’s median MELD‐Na at LT minus 3. ( 18 ) This policy was implemented to reduce the inequity in access for LT between patients with and without HCC and would prioritize non‐HCC. This policy may have an increased rate for LT among patients without HCC, including patients with ALD.…”

Acute Alcohol-Associated Hepatitis in the COVID-19 Pandemic — a Structured Review

“…Second, another potential limitation is the variable study periods used in the publications pre-COVID versus COVID and different lockdown policies between US states and countries. Third, the increase of LT for ALD and AH during the pandemic may not have been related to the pandemic but rather reflective of national trends in LT for AH as well as consequence of acuity circle-based allocation and distribution implemented in February 2020 [ 76 ], which prioritize patients without HCC [ 35 •]. Fourth, COVID-19 status in patients presenting with AH was mostly not reported in the reviewed publications, which could have been an effect modification, therefore potentially impacting the severity of AH with direct or indirect liver injury [ 17 ].…”

Early Impact of MMaT-3 Policy on Liver Transplant Waitlist Outcomes for Hepatocellular Carcinoma

“… 8 These exception policies, which artificially increase HCC patients MELD score, inadvertently overprioritized HCC patients for LT compared with non-HCC patients with chronic liver disease. 9 …”

“…An extension was submitted every 3 mo, which would increase an additional 3 points and cap at 34. Despite the 6-mo wait period, HCC patients continue to benefit from over prioritization for LT. 7 , 9 , 11 To reduce this disparity in access to LT, OPTN/UNOS implemented a new exception policy on May 15, 2019, which capped the first HCC exception score received to the median MELD at transplant within the donor service area minus 3 points (MMaT-3) after the 6-mo wait period, with an increase every 3 mo similar to prior policy. 2 There are no published data to confirm whether this goal has been achieved.…”

“…8 These exception policies, which artificially increase HCC patients MELD score, inadvertently overprioritized HCC patients for LT compared with non-HCC patients with chronic liver disease. 9 In 2015, the HCC exception policy implemented a 6-mo delay from listing to receive HCC exception points and capped the MELD exception score granted to 34. 10 As a result, an initial exception score of 28 was given 6 mo after listing as it equates to 35% waitlist mortality at 3 mo.…”