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Review of National Liver Review Board (NLRB) Diagnoses and Update to Alcohol-Associated Diagnoses

eye iconAt a glance

Current policy

This proposal includes two distinct pieces intended to improve the liver allocation system:

National Liver Review Board

When a liver transplant program believes that a candidate’s calculated model for end-stage liver disease (MELD) or pediatric end-stage liver disease (PELD) score does not accurately reflect their medical urgency for transplant, they can submit a request for a MELD or PELD exception score. The National Liver Review Board (NLRB) reviews requests from transplant programs these exception scores. The NLRB uses policy and guidance documents to decide whether to approve or deny exception score requests.

Alcohol-Associated Diagnoses

The transplant candidate registration form (TCR) is the form completed and submitted by the transplant program when a candidate is added to the waiting list. The transplant recipient registration form (TRR) is the form completed and submitted by the transplant center after a recipient is transplanted. Alcohol-associated liver diseases (ALD) is the leading indication for liver transplantation, however, the current diagnoses on the TCR and TRR are outdated leading to inconsistent data entry.

Supporting media

Presentation

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Proposed changes

  • Two changes to NLRB guidance for patients with hepatocellular carcinoma (HCC)
    • Provides a way for candidates treated with immunotherapy to get an exception score.
    • Clarifies the language for candidates whose HCC was previously resected but has since recurred so that they do not need to wait six months to receive a full exception score.
  • Updates guidance for patients with hepatic encephalopathy with clearer language and more recent references.
  • Clarifies that OPTN policy only requires a chest CT for candidates with HCC prior to the initial exception.
  • Updates the list of ALD diagnoses on the TCR and TRR to allow for more accurate data entry.

Anticipated impact

  • What it's expected to do
    • Provide NLRB reviewers and transplant programs updated guidance to use when reviewing and submitting exception score requests
    • Collect accurate information on liver patients with ALD so there is more complete data collection
  • What it won't do
    • Will not impact how patients are prioritized on a match run

Themes

  • National Liver Review Board (NLRB)
  • Data collection

Terms to know

  • Alcohol-associated liver diseases (ALD): A spectrum of liver diseases resulting from alcohol use.
  • Candidate: An individual on the organ transplant waiting list.
  • Transplant program: An organ specific facility within a transplant hospital.
  • Guidance Documents: Documents that provide more information to transplant programs and NLRB members to use when making decisions on exception requests.
  • Hepatocellular Carcinoma (HCC): The most common type of primary liver cancer, occurring most often in people with chronic liver diseases such as cirrhosis caused by hepatitis B or C infection.
  • Hepatic Encepholopathy:  Brain disfunction often caused by liver disease
  • Model for End-Stage Liver Disease (MELD): The scoring system used in allocation of livers to patients who are at least 12 years old.
  • Pediatric End-Stage Liver Disease (PELD): The scoring system used in allocation of livers to patients who are under 12 years old.
  • National Liver Review Board (NLRB): A review board of members drawn from a nationwide pool of liver transplant physicians and surgeons, who review exception requests from transplant programs for candidates whose automatically calculated model for end-stage liver disease (MELD) score or pediatric end-stage liver disease (PELD) score does not accurately reflect the candidate's medical urgency for transplant.
  • Transplant candidate registration form (TCR): The form completed and submitted by the transplant program when a candidate is added to the waiting list. The form contains information on patient demographics, previous transplants, payment, clinical information at time of listing and organ specific medical factors.
  • Transplant recipient registration form (TRR):The form completed and submitted by the transplant program when a candidate is transplanted. The form contains patient status, pre-transplant clinical measures, transplant procedure, post-transplant clinical measures, graft status, treatment and immunosuppression.

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eye iconComments

Region 11 | 09/30/2021

Region 11 sentiment: 5 strongly support, 9 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Region 11 supported the proposal with no comments.

NATCO | 09/29/2021

NATCO is in support of the proposed changes to clarify language and update guidance documents for patients with HCC and hepatic encephalopathy. The proposed changes could give these patients improved access to transplants especially for those with hepatic encephalopathy, which currently does not factor into the MELD score. NATCO also supports updating the TCR and TRR to improve data collection for those patients with ALD.

American Society of Transplant Surgeons | 09/29/2021

The American Society of Transplant Surgeons (ASTS) strongly supports this proposal and recommends continued study of the area. On balance, this proposal will likely improve both access and equity, while not having a negative impact on any specific population. The expense of implementation, and the burden on transplant centers appears low to minimal. The likelihood of adverse unintended consequences also seems low, and the overall approach of using an iterative and evidence-based process for informing NLRB policy is sound. This well-conceived proposal reflects the work of multiple informed stakeholders and is an example of using evidence-based, iterative review to improve transplant care and regulatory performance.

Attachment

American Society of Transplantation | 09/29/2021

The American Society of Transplantation is broadly supportive of the proposal as written but offers the following comments for consideration. We believe the proposal offers more clarity and would seem to benefit all patients impacted. A specific concern was raised based on the belief that there are not enough data to support the safety of HCC candidates receiving immunotherapy prior to liver transplant. After much discussion, there was agreement that, though this is an ongoing area of investigation, HCC patients within UNOS downstage criteria and effectively downstaged to within Milan criteria (regardless of modality) deserve the opportunity to receive exception points. We recommend explicit monitoring of the outcomes of patients who receive HCC exceptions following immunotherapy for the adverse events of concern (e.g. severe graft rejections, tumor recurrence, or death).

Region 10 | 09/28/2021

Region 10 sentiment: 3 Strongly Support; 8 Support; 8 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The proposal is supported by the region, but it was noted that ongoing communication to NLRB representatives should be occurring to ensure MELD exceptions are granted appropriately. It seems that NLRB members are not enforcing the updates as they are implemented which causes an ongoing need for re-submission for currently-recommended guidance. The need for re-submission places an undue burden on liver programs and delays care/transplantation for patients. Another member noted that is unclear why resection patients should not wait 6 months for exception like all other HCC patients - the purpose of the 6 months is to provide a period of observation of the tumor biology, and to assign appropriate allocation. Resection patients who recur definitely need that same period of observation.

Region 1 | 09/24/2021

Region 1 sentiment: 2 Strongly Support, 4 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: A member commented in support of this proposal, saying it will bring important clarity to this subject.

Region 6 | 09/23/2021

Region 6 sentiment: 2 Strongly Support; 5 Support; 3 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments.

Region 8 | 09/22/2021

Region 8 sentiment: 2 strongly support, 15 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 8 supports this proposal.

Region 7 | 09/15/2021

Region 7 sentiment: 5 strongly support, 6 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: One attendee commented that continuing to update the guidance document ensures that the guidance is representative of current best practice. The commenter further suggested to conduct a webinar and to additionally send out communication to liver programs and the NLRB reviewers, so they are aware of the changes. Another representative commented that the alcohol diagnosis change is also a great idea. Adding that the data on alcohol associate liver disease outcomes can be captured in more detail.

Region 3 | 09/15/2021

Region 3 sentiment: 0 strongly support, 9 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

Region 9 | 09/14/2021

Region 9 sentiment:  2 Strongly Support; 5 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments .

Region 2 | 09/10/2021

• Region 2 sentiment: 9 Strongly Support, 11 Support, 6 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose • Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The proposal was supported by the region and one member commented that there needs to be a universal definition.

Region 5 | 08/30/2021

Region 5 sentiment: 7 strongly support, 16 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose. Region 5 supported the Review of NLRB Diagnoses and Update to Alcohol-Associated Diagnoses proposal. One member requested a consideration for “cirrhosis due to alcohol without acute alcohol-associated hepatitis." Another member stated that this is a significant opportunity to address and standardize listing.

Region 4 | 08/27/2021

3 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported this proposal.