Proposal to Delay the HCC Exception Score Assignment
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Proposal to Delay the HCC Exception Score Assignment
Liver and Intestinal Organ Transplantation Committee Spring 2014
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Candidates with HCC exceptions receive high priority on the waiting list Scores may increase automatically every three
months Most patients treated (90%), many with stable tumors
HCC: Significantly lower dropout rates than non-HCC
How to even out transplant rates for HCC vs non-HCC?
The Problem
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Overall Dropout Rates for HCC and Non-HCC Candidates: Listed 4/14/04-12/31/07
0
5
10
15
20
25
0 100 200 300
% D
rop
ou
t
Days after Listing/Initial Application
HCC Non-HCC (MELD < 21) Non-HCC (all)N=14,839N=5002 N=20,923
p < 0.0001
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% Dropout within 12 Months: HCC and Non-HCC Candidates by RegionCandidates Added 7/1/08 – 6/30/11
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The Final Rule: 42 CFR Part 121October 20, 1999
§121.8 of the Final Rule states that allocation policy should be based on “objective and measurable medical criteria, for patients or categories of patients who are medically suitable candidates for transplantation to receive transplants”
Waiting time should be de-emphasized
Patients should be rank ordered according to severity of disease and predicted mortality on the liver list
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The proposed solution will address the disparities in transplant/drop-out rates between patients with HCC exceptions and those without by delaying the HCC score assignment
Goal of the Proposal
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Current Schedule
Proposed Schedule
Initial Score 22 Calculated MELD Score
First Extension (3 months) 25 Calculated MELD Score
Second Extn. (6 months) 28 28Remainder of schedule the same (29, 31, 33, etc.)
Proposed Solution
Currently, as long as the candidate meets criteria, the initial score assignment is 22, followed by increases every 3 months
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LSAM modeling: delay led to similar transplant rates between HCC and non-HCCAt least in regions with lower waiting times
Study by Halazun, et al: Recipients with HCC exceptions have worse outcomes in regions with shorter waiting times “Biologic test” not met due to rapid transplantation
Supporting Evidence
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Transplant Rates by HCC StatusLSAM Modeling Results
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Understand changes in the score assignment
For HCC cases submitted as “Other, specify”: will be monitored by the Committee
What Members will Need to Do
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David C. Mulligan, MD Committee Chair
Name Region # Representative Email
Committee Liaison
Questions?