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​​National Liver Review Board (NLRB) Updates Related to Transplant Oncology​

eye iconAt a glance

Current policy

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 for these exception scores. The NLRB has three specialty Review Boards: Pediatric, Adult Hepatocellular Carcinoma and Adult Other Diagnosis. The NLRB uses OPTN policy and guidance documents to decide whether to approve or deny exception score requests. The OPTN Liver and Intestinal Organ Transplantation Committee regularly evaluates the NLRB guidance to identify opportunities for improvement.

Supporting media

View presentation PDF link

Proposed changes

  • Guidance for non-standard exception requests will be added for two diagnosis: colorectal liver metastases and intrahepatic cholangiocarcinoma
  • Expands the purview of the current Adult Hepatocellular Carcinoma (HCC) Review Board who review non-standard HCC cases to also review non-standard exception cases related to liver cancers and tumors
    • The current Adult HCC Review Board and guidance document scope is broadened and will be renamed as the Adult Transplant Oncology review board and guidance document
  • Clarify existing policy 9.5.A to align the policy language for Committee review and approval of hilar cholangiocarcinoma (CCA) patient care protocols to current practice and original intent

Anticipated impact

  • What it's expected to do
    • Provide NLRB reviewers and transplant programs with new guidance for reviewing MELD exception requests for candidates with colorectal liver metastases or intrahepatic cholangiocarcinoma
    • Ensure that the appropriate reviewers with expertise are reviewing these cases by broadening the current Adult HCC Review Board to become an Adult Transplant Oncology Review Board
    • Clarify policy to align the policy language to current practice and original intent.
    • Creates a more efficient and equitable system for reviewing MELD and PELD exception requests
  • What it won't do
    • Will not cause any candidates to lose an exception
    • Will not impact pediatric candidates
    • Will not change the review process for the Adult Transplant Oncology Review Board

Terms to know

  • Guidance Documents: Documents that provide information to transplant programs and NLRB members to use when making decisions on exception requests.
  • Model for End-Stage Liver Disease (MELD): The scoring system used in allocation of livers to candidates who are at least 12-years old.
  • Pediatric End-Stage Liver Disease (PELD): The scoring system used in allocation of livers to candidates who are under 12-years old.
  • National Liver Review Board (NLRB): A review board of OPTN 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.
  • Match Run: A computerized ranking of transplant candidates based upon donor and candidate medical compatibility and criteria defined in OPTN policies.

Click here to search the OPTN glossary


Read the full proposal (PDF)

eye iconComments

UC San Diego Health Center for Transplantation | 03/20/2024

UCSD Center for Transplantation (CASD) appreciates the effort the Liver and Intestinal Transplantation Committee continues to put towards improving the processes and guidelines related to the National Liver Review Board. We support this proposal as written with no further recommendations or requests for modification.

Region 10 | 03/19/2024

9 strongly support, 11 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Members of the region are supportive of the proposal. Participants discussed various aspects of liver transplant allocation, focusing on specific medical conditions and exceptions. An attendee noted surprise that neuroendocrine tumors were not included in the discussion. Questions arose about the MELD score of MMaT minus 20 for colorectal cancer and whether a score of 15 would provide more exposure to open offers. The presenter acknowledged the discussion within the committee, emphasizing the challenges in capturing data for colorectal liver metastases patients and the considerations behind the MELD of 15. Some participants questioned the need for mathematical modeling and proposed using a standard exception of 15 for colorectal liver metastases patients. The integration of these exceptions into the Continuous Distribution (CD) system was also considered, with uncertainty about how non-standard indications would fit into the CD framework. Additionally, concerns were raised about the potential increase in exception requests and the burden on the review board. Participants supported the standardization of exceptions for neuroendocrine tumors and emphasized the importance of monitoring the cases for review by the NLRB to ensure adequate expertise and timely responses. Additionally, there was a suggestion to consider liver disease and hepatocellular carcinoma (HCC) secondary to Fontan Heart, expanding the scope of conditions for discussion within the liver transplant allocation system.

Region 9 | 03/19/2024

1 strongly support, 6 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

A member advocated for increasing the score recommendation associated with the colorectal liver metastases NLRB guidance. The member noted that MMaT minus 20 will not result in increased access to deceased donor livers and this population will continue to have to rely on living donation. The member suggested that a set number of cases could be performed at a higher MMaT to gather data, then the Committee could reevaluate criteria and score recommendations. Another member suggested the Committee consider clarifying the process for how transplant programs can resubmit patient care protocols for hilar cholangiocarcinoma. A member stated agreed with the proposal but remained concerned about how outcomes will be monitored in metrics. The member explained that transplant programs can be risk adverse which may impact whether transplant for these candidates occur due to how they are accounted for in the metrics.

UPenn | 03/19/2024

The Hospital of the University of Pennsylvania thanks the OPTN Liver and Intestinal Organ Transplantation Committee for their efforts to evaluate the NLRB updates related to transplant oncology and offers the following comments for consideration. Please note that the overall sentiment of “oppose” on this category does not represent our opinion on several of these topics in which we agree (see detail below). Further, we strongly suggest that in the future this approach of an aggregate sentiment should be abandoned when there are multiple questions within a public comment category.

• Do you agree with the proposed guidance and score recommendation for colorectal liver metastases? If not, please elaborate.
We believe the exception point pathway for metastatic colorectal cancer is in need of further scientific study to better understand patient selection for best outcomes. It also requires a mechanism to tightly ensure implementation of complex selection criteria, and structured prospective data collection to allow a post-hoc review of the policy.

The proposed exception point allocation is additionally problematic: the MMaT-20 proposal as written will effectively result in a fixed MELD exception at 15 in every case, and as such is only nominally related to MMaT. This will result in a geographic disparity in access to transplant for this indication. A relatively low allocation MELD will also force the utilization of marginal organs for this indication which may alter the risk/benefit of this treatment from what is published in the literature.

• Do you agree with the proposed guidance and score recommendation for intrahepatic cholangiocarcinoma? If not, please elaborate.
We agree with the guidance and propose including a clarification for patients with HCC and cholangiocarcinoma occurring in different tumor nodules.

• Do you agree with broadening the Adult HCC Review Board and guidance document to encompass additional liver cancers and tumors? If not, please elaborate.
We agree with this suggestion.

• Do you anticipate that the additional cases that Adult Transplant Oncology Review Board is proposed to review will overburden the reviewers? If so, what is your proposed solution?
We believe the added load will be manageable.

• Do you agree with adding guidance for hepatic adenomas, neuroendocrine tumors, and hepatic epithelioid hemangioendotheliomas to the Adult Transplant Oncology guidance document?
We agree with this suggestion.

• Are there other non-standard exception requests related to liver cancers or tumors that should be addressed by the Adult Transplant Oncology Review Board and associated guidance document?

We would propose allowing patients with a resected or ablated T1 HCC lesion, who develop a second T1 lesion exception points, along the same line as an ablated T2 lesion. The recurrence rate after development of a second lesion within the liver, regardless of whether the original was T1 or T2 is very high, and these patients essentially cannot be cured without transplantation.

Considering this policy adjustment has the added benefit of encouraging centers to ablate or resect T1 lesions – which would then have a relatively high likelihood of cure and not needing transplantation - as opposed to incentivizing a strategy of observing these lesions for growth before delivering definitive therapy.

Further, we suggest that transplant programs planning to ask for exception scores for intrahepatic cholangio and unresectable colorectal metastases also submit their programmatic protocols to the newly formed liver oncology board. If we as a community are taking on newer indications for transplant with potentially inferior outcomes, we need to hold ourselves to a higher standard via the sharing of protocols via UNOS as well as submission of explant path.

Region 6 | 03/19/2024

2 strongly support, 5 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, there is strong support for providing additional guidance, consistency, and access to transplant, but concerns were raised regarding specific criteria, scoring systems, and their impact on different patient populations. While there was wide support for the change to an Adult Oncology Board, one attendee commented that there may be a need to recruit more reviewers if the volume of cases increases. Another attendee added that centers will need to look at their payers related to any new diagnosis for transplant. There were several comments specific to each of the proposed diagnosis:

  • Intrahepatic Cholangiocarcinoma (iCCA)- There was concern raised regarding the poor outcomes for these recipients. Some commented that the score was too high. One attendee recommended doing these transplants as part of a research protocol. There was also concern around the lack of guidance for assessing if the iCCA is resectable. One attendee commented that the primary treatment evaluated for these patients should be resection, with transplant considered only for unresectable cases. They also recommended including the reason for why the iCCA is unresectable in the exception request and noting the treatments used prior to transplant to understand how the treatments affect outcomes. There was also a recommendation to explicitly state in the requirements that this is a single lesion. One attendee was opposed to transplant for iCCA due to the high recurrence rates, adding that more research is necessary. There was also concern about the impact on pediatric patients with lower MELD scores and the consistency of scores approved by the pediatric NLRB as compared to the oncology NLRB.
  • Colorectal Liver Metastases (CRLM)-One attendee raised concern about the guidance for colorectal liver metastases given the high recurrence rates. They commented that in the current environment of organ scarcity, the concern is the use of liver grafts with worse outcomes than for other indications, and to grant exception points with worse outcomes. They did support these patients being transplanted at selected centers under research protocols (similar to how transplants for HIV + patients were started). They added that living donor transplants for metastatic CRLM is another way to continue to investigate and determine consistent inclusion and exclusion criteria and consistent chemoRx regimens and molecular typing to improve the current high recurrence rates seen in liver transplant for metastatic CRC. They also recommended that the expertise required to assess centers' protocols for metastatic CRC should include medical oncologists at the cutting edge of current treatment - immunoRx, systemic chemoRX and should be expanded. They commented that they did not support all centers performing transplants for metastatic CRC given that transplant for this disease is not curative at this stage. They added that data collection to truly learn from this experience is missing as this is guidance and not policy so unless these transplants are studied in a multicenter fashion we won’t learn from the national experience. They recommended templated narratives for NLRB applications and commented that molecular typing of the tumors should be part of the selection process including BRAF mutations and microsatellite instability.  

Region 7 | 03/18/2024

5 strongly support, 7 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose 

Members of the region are supportive of the proposal. One attendee noted concern that the MELD of 15 would limit patients to only receiving living donor transplants, it is unlikely they would receive deceased donor offers with this MELD. The committee may want to consider increasing the MELD to 20 with a more reasonable MELD score for DCD organ offers. Another attendee suggested that there needs to be clarity on the definition for unresectable as this definition varies across programs. Another attendee noted support in recognizing diseases that do not fit well into the current MELD model, but the proposal does not indicate any data related to the expected increase, so it is difficult to speculate what the impacts will be for transplant programs. Lastly, one attendee questioned the validity of MMAT minus 20 as the standard for these exception requests.

Region 1 | 03/18/2024

3 strongly support, 8 support, 1 neutral/abstain, 0 oppose, 1 strongly oppose 

A member stated that a MELD of 15 may limit access for this group of patients. An attendee commented that the data is inconsistent at best.

American Society of Transplant Surgeons | 03/18/2024

Attachment

View attachment from American Society of Transplant Surgeons

Region 5 | 03/15/2024

9 strongly support, 22 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose 

Region 5 supported this update and offered the following feedback. In support of this update an attendee commented that it all sounded reasonable with the minor caveat with the CRLM. He explained that 15 points is difficult. He suggested the committee consider a point increase after a period of time. In regard to oncology review board, he suggested establishing the review board, then see how much they have to review and whether it becomes a burden. He commented that he believes there has been a reduction in HCC review and its mostly cholangiocarcinoma and associated items. He believed the review board would receive nuanced tumors but thinks that its helpful to have all the information in one place for standardization efforts. Several members said they are worried about the workload for this review board after patients are added.  

An attendee strongly supported the idea of transplanting highly selected cases of CRC mets or iCCA. But doesn’t think the proposed MELD point is reasonable. They explained that for both categories, it might make more sense to grant MMaT-10, which will likely be a MELD of ~20-25 in most areas. This way, organs that are not likely used otherwise would be used for these patients who have slightly lower post-LT 5-year survival compared to non-cancer patients. The other suggestion was to clarify the "stability of disease for 6 months" for iCCA cases. They suggested the guidance should specify the absence of a new lesion after the initial lesion has been treated. The development of a new iCCA lesion is consistent with disease progression and more aggressive behavior in the case of cholangiocarcinoma. Another member agreed with the discussion about CRC metz and commented that exception points up to 20 will not make a patient competitive in this region. While another commented that MMAT - 20 for CRC mets seems appropriate, and they should not supersede patients with chronic liver disease or other standard indications for liver transplantation with MELD 15-25. 

Another commented that the committee should collect data on the new diagnoses transplanted with regards to outcomes versus current HCC patients who have been transplanted. A member commented that it will be important to follow up with data on outcomes in the expanded criteria tumor patients. An attendee explained that the field of transplant oncology is growing and with the possibility of the increased availability of liver donors it could help expand the field. An increased utilization of NMP and NRP will likely lead to an increase in liver allograft availability for such endeavors. A member suggested that the OPTN provide additional guidance to transplant centers regarding MELD/PELD exceptions, which could help with the uncertainty surrounding the process. Transplant centers would be able to better identify patients who are likely to be approved for the exception and determine other treatment options for the rest. 

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) generally supports the proposal, “National Liver Review Board (NLRB) Updates Related to Transplant Oncology,” and offers the following comments for consideration:

•The AST supports the reorganization of the NLRB with the creation of the Adult Transplant Oncology Review Board and the proposed guidance document changes to include non-standard MELD exception criteria for both colorectal liver metastases and small (≤3 cm) intrahepatic cholangiocarcinoma. These guidelines could serve to collect additional prospective data on the benefit of transplant in these populations as well as provide a basis for future expansion of indications. Specific comments on each section are provided below:

o Colorectal Liver Metastases

-The proposal recommends MMAT -20 with a MELD of at least 15 for all listed patients. It should be highlighted that candidates with colorectal liver metastases listed at aggressive centers in lower MELD regions may place these candidates in competition with other liver candidates listed for other indications. The AST recommends a minimum MELD of at least 18 to give these patients a reasonable opportunity to receive suitable offers.

-The International Hepato-Pancreato Biliary Association (IHPBA) has documented international consensus for transplanting colorectal liver metastases based on data and expert opinion, some of which is not included in this proposal. For example, primary resection pathology of undifferentiated and signet cell carcinomas are ineligible for transplant and primary resection N2 status is a relative contraindication; the current proposal does not address these topics. The AST recommends including all the guidance from the IHPBA or explaining the rationale for excluding certain aspects.

o Intrahepatic Cholangiocarcinoma

-The proposal recommends MMAT-3 exception for unresectable, liver-limited tumors ≤3 cm in a background of cirrhosis that have demonstrated disease stability for >6 months on locoregional (LRT) or systemic therapy. The AST generally supports these proposed updates; however, there are a few concerns and questions:

*The multicenter studies on which this recommendation was based were exclusively retrospective analyses of data derived from incidental or misdiagnosed intrahepatic cholangiocarcinoma (iCCA) or combined hepatocellular-cholangiocarcinoma (HCC/CCA).1, 2 First, there was no requirement for 6 months of disease stability in these studies. This recommendation seems to have been extrapolated from the current HCC guidance literature and the prospective series on locally advanced iCCA which required disease stability on 6 months of prior chemotherapy.3, 4 For small iCCA or HCC/CCA, there is no data to support 6 months of disease stability prior to exception. The AST does not oppose the initial inclusion of this criteria; however, it must be recognized that the recommendation is not supported by objective data. This also underscores that the OPTN must carefully monitor the impact of these changes and make data-driven adjustments as needed.

*The retrospective multicenter studies serving as the basis for these recommendations1, 2, 5 did not require any pretreatment with LRT, and patients who had received chemotherapy were excluded from analysis. Data for the use of pre-transplant chemotherapy is extrapolated from studies assessing liver transplant in patients with larger or multifocal tumors.3, 4 In contrast, in the multicenter retrospective analysis comparing liver resection and liver transplant for patient with iCCA within Milan with considered tumors from 2-5 cm included 63 percent of patients with pre-transplant LRT. While LRT did not reach significance for tumor recurrence in all patients undergoing either resection or transplant in that study (HR for recurrence 0.41 [95% CI 0.16-1.05], p=0.06),5 the AST believes the inclusion of pre-transplant therapy is reasonable. Again, this underscores the need to carefully monitor the impact of these changes to make data-driven adjustments as needed.

*The AST agrees with increasing the size threshold to at least 3 cm as *Given multicenter data suggesting that tumors with a cumulative diameter of up to 5 cm demonstrate a 5-year recurrence-free survival of 74%, the AST suggests that initial MELD exception consideration should be given to either (1) patients with a cumulative (additive) tumor diameter of up to 5 cm and disease stability for 6 months on chemotherapy or LRT or (2) patients with tumors >3 cm who are downstaged via LRT or chemotherapy to ≤3cm.

-If systemic therapy is used, does a 6 month wait period start from the end of chemotherapy or start of chemotherapy to document the stability of the disease? This consideration would be worthwhile to clarify.

References:

1. Sapisochin G, de Lope CR, Gastaca M, de Urbina JO, Lopez-Andujar R, Palacios F, Ramos E, Fabregat J, Castroagudin JF, Varo E, Pons JA, Parrilla P, Gonzalez-Dieguez ML, Rodriguez M, Otero A, Vazquez MA, Zozaya G, Herrero JI, Antolin GS, Perez B, Ciria R, Rufian S, Fundora Y, Ferron JA, Guiberteau A, Blanco G, Varona MA, Barrera MA, Suarez MA, Santoyo J, Bruix J, Charco R. Intrahepatic cholangiocarcinoma or mixed hepatocellular-cholangiocarcinoma in patients undergoing liver transplantation: a Spanish matched cohort multicenter study. Ann Surg. 2014;259(5):944-52. doi: 10.1097/SLA.0000000000000494. PubMed PMID: 24441817.

2. Sapisochin G, Facciuto M, Rubbia-Brandt L, Marti J, Mehta N, Yao FY, Vibert E, Cherqui D, Grant DR, Hernandez-Alejandro R, Dale CH, Cucchetti A, Pinna A, Hwang S, Lee SG, Agopian VG, Busuttil RW, Rizvi S, Heimbach JK, Montenovo M, Reyes J, Cesaretti M, Soubrane O, Reichman T, Seal J, Kim PT, Klintmalm G, Sposito C, Mazzaferro V, Dutkowski P, Clavien PA, Toso C, Majno P, Kneteman N, Saunders C, Bruix J, i CCAIC. Liver transplantation for "very early" intrahepatic cholangiocarcinoma: International retrospective study supporting a prospective assessment. Hepatology. 2016;64(4):1178-88. doi: 10.1002/hep.28744. PubMed PMID: 27481548.

3. Lunsford KE, Javle M, Heyne K, Shroff RT, Abdel-Wahab R, Gupta N, Mobley CM, Saharia A, Victor DW, Nguyen DT, Graviss EA, Kaseb AO, McFadden RS, Aloia TA, Conrad C, Li XC, Monsour HP, Gaber AO, Vauthey JN, Ghobrial RM, Methodist MDAJCCC. Liver transplantation for locally advanced intrahepatic cholangiocarcinoma treated with neoadjuvant therapy: a prospective case-series. Lancet Gastroenterol Hepatol. 2018;3(5):337-48. Epub 2018/03/20. doi: 10.1016/S2468-1253(18)30045-1. PubMed PMID: 29548617.

4. McMillan RR, Javle M, Kodali S, Saharia A, Mobley C, Heyne K, Hobeika MJ, Lunsford KE, Victor DW, 3rd, Shetty A, McFadden RS, Abdelrahim M, Kaseb A, Divatia M, Yu N, Nolte Fong J, Moore LW, Nguyen DT, Graviss EA, Gaber AO, Vauthey JN, Ghobrial RM. Survival following liver transplantation for locally advanced, unresectable intrahepatic cholangiocarcinoma. Am J Transplant. 2022;22(3):823-32. Epub 20211227. doi: 10.1111/ajt.16906. PubMed PMID: 34856069.

5. De Martin E, Rayar M, Golse N, Dupeux M, Gelli M, Gnemmi V, Allard MA, Cherqui D, Sa Cunha A, Adam R, Coilly A, Antonini TM, Guettier C, Samuel D, Boudjema K, Boleslawski E, Vibert E. Analysis of Liver Resection Versus Liver Transplantation on Outcome of Small Intrahepatic Cholangiocarcinoma and Combined Hepatocellular-Cholangiocarcinoma in the Setting of Cirrhosis. Liver Transpl. 2020;26(6):785-98. doi: 10.1002/lt.25737. PubMed PMID: 32090444.

Anonymous | 03/14/2024

I agree with unifying the NLRB for all Transplant Oncology exceptions, it will probably be challenging at the beginning but should improve over time, making the transplant community more invested in indications other than HCC.

The proposed exception for CRLM -MMAT-20 does not offer a very meaningful access to transplant. This, combined with a broad acceptance criteria may lead to a large number of listed candidates with an expected survival less than optimal for a starting experience. I would prefer to have somewhat stricter criteria but with higher exception MELD to have a more reassuring initial experience.

On the other hand, the exception for iCCA of MMAT-3 gets as much access than HCC, but with stricter acceptance criteria.

Gift of Life Michigan | 03/14/2024

We appreciate the OPTN Liver & Intestinal Organ Transplantation Committee’s review of special cases in which a patient’s medical condition could inadvertently disadvantage or possibly exclude them from consideration for transplantation when transplant might be their only treatment option.

We support the Committee’s objective in this guidance document to provide definition and parameters for patients with colorectal liver metastases or intrahepatic cholangiocarcinoma.

Region 3 | 03/11/2024

3 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 supported the proposal. One attendee raised concern about the workload for the Committee to review and approve patient care protocols for all liver transplant programs and commented that there should be a way to outline guidelines for standard of care requirements prior to request for exception. They added that verification of compliance could be done during program survey during regular regulatory review.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

This proposal is not pertinent to ASHI or its members.

Region 8 | 03/05/2024

2 strongly support, 12 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

A member commented that this affects a small number of patients and is reasonable. An attendee pointed out that that for the metastatic cancer patients, the proposed MELD is too low, and these patients are unlikely to get viable liver offers. 

Region 2 | 02/29/2024

3 strongly support, 13 support, 4 neutral/abstain, 1 oppose, 0 strongly oppose

Overall, members of the region support the proposal. The discussion revolved around consolidating oncology diagnoses in the context of liver transplantation. Concerns were raised about the impact on the waitlist mortality and the appropriateness of the Model for End-Stage Liver Disease (MELD) score for these cases. The committee acknowledges the complexity, especially for intrahepatic cholangiocarcinoma, but the current goal is getting these candidates into consideration with the focus on providing opportunities for candidates with a MELD score of 15 or higher. Another attendee noted the potential handicapping of results by setting MELD exceptions for colorectal metastases too low. They suggested creating a subcommittee within the transplant oncology review board with true expertise in cholangiocarcinoma and colorectal cancers. Enriching the review board with experts in these specific areas is essential, recognizing the limited number of specialists in the U.S. In regard to pediatric oncology there was a suggestion to involve the Pediatric Transplantation Committee and consider pediatric representation on the Liver and Intestinal Organ Transplantation Committee. The need for committee members with expertise in pediatric surgery and various cancers beyond hepatocellular carcinoma (HCC) was emphasized. There were concerns regarding access to experts with sufficient knowledge to guide decisions related to specific cancers, and there is a need for consistency in review board decisions. The importance of ensuring specialty knowledge in non-HCC cancers and monitoring equity in exception requests is essential. Overall, the discussion highlighted the complexity of consolidating oncology diagnoses in transplantation and the need for thorough consideration of various factors, including expertise, equity, and consistency in decision-making.

Anonymous | 02/29/2024

I oppose the suggested CRC hepatic metastasis exception point proposal (but agree with all other elements). Offering MMAT-20, but with a lower threshold of MELD 15, effectively putting everyone in the country to a MELD of 15 will not make a patient competitive for any worthwhile offer and would be pointless in high MELD areas of the country. If we are acknowledging that there are some patients with CRC metastasis that would benefit from receiving a liver transplant with this proposal, we need to consider making these patients a little more competitive for receiving an offer in high MELD regions. As the policy stands, I am concerned it would increase geographical disparity in health care access for transplant, as a MELD of 15 *may* be marginally competitive in some sections of the country (of note, as of the last MMAT report, the MMAT of Puerto Rico is 19). It may be more just to consider a MMAT-6 or -9 to account for these geographical differences.

Region 11 | 02/29/2024

2 strongly support, 8 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose 

The region supports the proposal. An attendee shared support for the oncology review board and that interhepatic cholangiocarcinoma recurrence survival needs to be considered as it is different than first time occurrence. A member requested that the committee clarify that percutaneous biopsy does not exclude intrahepatic cholangiocarcinoma from transplant consideration. 

Anonymous | 02/29/2024

I strongly support the idea of transplanting highly selected cases of CRC mets or iCCA. However, I don't think the proposed MELD point is quite reasonable. For both categories, it might make more sense to grant MMaT-10, which will likely be a MELD of ~20-25 in most areas. This way, organs that are not likely used otherwise would be used for these patients who have slightly lower post-LT 5 year survival compared to non-cancer patients.

The other suggestion is to clarify the "stability of disease for 6 months" for iCCA cases. The guidance should specify the absence of a new lesion after the initial lesion has been treated. The development of a new iCCA lesion is consistent with disease progression and more aggressive behavior in the case of cholangiocarcinoma.

Anonymous | 02/29/2024

Will be a very positive evolution to allow cadaveric livers to go for metastatic colorectal cancer based on Oslo-type criteria

Anonymous | 02/27/2024

I believe that the MMaT - 3 proposed for intrahepatic cholangiocarcinoma is too high. While reviewing the literature for iCCA and mCRC, I believe that we have far more superior data supporting liver transplant for mCRC compared to iCCA. Therefore, suggesting MMaT- 20 for mCRC makes the proposed MMaT - 3 for iCCA even more perplexing. Most of the data on iCCA is flawed and includes patients with mixed CCA and HCC who usually do better than iCCA. iCCA can have good overall survival but it definitely has higher recurrence post-LT compared to HCC so I disagree that iCCA and HCC are comparable. We are also unsure of how best to treat recurrence in iCCA and the role of immunotherapy etc. I propose the score for iCCA be lowered. Can consider a score similar to the one for mCRC.

UAMS | 02/27/2024

After reviewing OPTNs National Liver Review Board updates, we are in support of the proposed changes. If OPTN provides additional guidance to transplant centers regarding MELD/PELD exceptions, there would be less uncertainty surrounding the process. If more information was provided regarding the review/decision process for MELD/PELD exceptions, transplant centers would be able to better identify patients who are likely to be approved for the exception and determine other treatment options for the rest. Changing the purview of the current review boards will lead to expedited decision making and transplant and improved patient outcomes. We are in favor of changing policy language to align with current practices and reduce possible confusion.

Region 4 | 02/26/2024

0 strongly support, 9 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Region 4 supported this proposal. During the discussion one attendee commented that it is a great start for transplant oncology. They added that the only concern is that treatment varies from center to center and even from oncologist to oncologist so the guidance should not be too prescriptive.

Anonymous | 02/21/2024

Strongly Support

Déboralis Ramos | 01/31/2024

Strongly Support