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Update National Liver Review Board Guidance Documents and Policy Clarification

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eye iconAt a glance

Current policy

The National Liver Review Board (NLRB) reviews requests from transplant programs for candidates whose model for end-stage liver disease (MELD) score or pediatric end-stage liver disease (PELD) score does not reflect their medical urgency for transplant.

The NLRB uses policy and guidance documents to inform their decision to approve or deny a request for an exception score.

Supporting media

Presentation

View presentation slides

Proposed changes

  • Include one additional diagnostic criteria for a candidate to receive an automatic exception for cholangiocarcinoma (CCA) in OPTN policy.
  • Update NLRB guidance documents for pediatric exceptions, candidates with a neuroendocrine tumor (NET), and candidates with primary (PSC) or secondary sclerosing cholangitis (SSC).

Anticipated impact

  • What it's expected to do
    • Provide NLRB members with updated guidance to use when reviewing exception score requests for specific candidates
    • Provide transplant programs with an updated list of diagnostic criteria when submitting a standardized exception request for a candidate with CCA
  • What it won't do
    • Will not impact how liver candidates are prioritized on a match run

Themes

  • National Liver Review Board (NLRB) improvements

Terms to know

  • 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
  • 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 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‚Äôs medical urgency for transplant.
  • Standardized exception: A exception with criteria outlined in policy that is automatically approved when submitted and is not reviewed by the NLRB
  • Cholangiocarcinoma (CCA): Bile duct cancer
  • Neuroendocrine Tumor (NET): A tumor that forms in the liver
  • Primary Sclerosing Cholangitis (PSC): A rare disease that causes scarring in the bile ducts
  • Secondary Sclerosing Cholangitis (SSC): A chronic disease similar to PSC caused by a known condition
  • Click here to search the OPTN glossary

eye iconComments

Amber Breuer | 02/01/2021

My husband was diagnosed with PSC when he was in his early twenties. He was fortunate to have a living donor transplant on June 20, 2016. At that time, he was not on the waitlist and we were told that he would likely die before his MELD would be high enough to get a donor liver. Thankfully his mom was accepted as a living donor, and we have cherished the milestones we've experienced since then (marriage and the birth of our first child). Unfortunately, PSC has returned in his new liver, and now we find ourselves at the beginning of his second transplant journey. PSC does a terrible number on the body, and MELD scores rarely indicate how sick the patient actually is. Unlike many liver diseases, the MELD score can fluctuate from week to week. In the last two months, my husband's MELD has been as high as 30 and as low as 14, despite the fact that he is deteriorating rapidly. Because of this, I believe that PSC patients should qualify for exception points. Patients who have PSC did nothing to bring on the disease, and spend their lives fighting this horrible monster. They deserve exception points that will help their MELD score accurately reflect how sick they truly are.

Region 4 | 02/04/2021

Region 4 sentiment: 5 strongly support; 12 support; 2 neutral/abstain; 0 oppose; 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One attendee suggested changing requirement for PSC/SSC to 2 hospitalizations within 6 months instead of 1 year. Another attendee suggested providing better guidance on exceptions for ischemic cholangiopathy after DCD transplantation.

Region 3 | 02/18/2021

Region 3 sentiment: Strongly Support-2, Support-14, Neutral/abstain- 6, Oppose -0, Strongly oppose- 0. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. A member commented that the use of a grandfather clause has been inconsistent across changes to status exception policies.

Region 5 | 02/19/2021

Region 5 sentiment: 7 strongly support, 18 support, 10 neutral/abstain, 0 oppose, 0 strongly oppose. During the meeting there were comments voiced during the discussion, submitted online and submitted as comments from the OPTN representatives. Overall, there was general agreement and support for this proposal. One member stated they were confused about the 3-cm criteria for cholangiocarcinoma, stating it used to be an exclusion, and now it is a criterion for inclusion. There is a need for clear language for what constitutes a hilar mass. It is important to be clear for listing and exception. The member asked how would it be defined and are there imagining requirements? The member commented that the language should be clearer and that is one thing that has kept so many exception requests at bay is a need for tissue. The member stated that criteria was fairly strict and kept requests low.

Stephen Enderton | 02/26/2021

How will this affect other people on the list? Does it just change who will die in a subjective way? Exceptions are important but I don't know enough to know if PCS needs an exception. Isn't this really the kind of issue that should be discussed and decided by doctors and not by a petition?

Lezlee Peterzell-Bellanich | 02/27/2021

Thank you to UNOS for really taking a look at how some changes in the liver allocation affect certain groups of people and trying to "even the playing field." If we had more donors, we would not be scrambling to distribute precious organs. While many people, including myself, feel that the MELD score does not always indicate how sick someone is from their liver disease, this is the accepted barometer. People living with PSC and (please include PBC) often suffer years, sometimes decades, with fatigue, itching, jaundice, etc. before they qualify for transplant. The current policy for doctors to obtain exception points for their patients is way too restrictive. This proposed policy is an important step in the right direction. Instead of having to be admitted to the ICU twice in three months with sepsis to obtain exception points, if patients are admitted to the hospital twice in one year they would qualify. This is more realistically obtainable so I support this.

Stephen Enderton | 02/27/2021

I was questioned about my comment by a supporter so let me clarify. Advocating for research that will better identify the people that are in the greatest need of a transplant is one thing but to advocate for a special exemption for everybody with a certain disease is simply splitting the liver transplant community. I agree that the MELD score leaves some people out but giving special consideration to a subgroup of people simply because they have PSC does not address the real issue. It simply provides a subjective advantage to some while excluding others. What is needed is better objective testing to determine need for a liver that addresses need across all subgroups

Julie Duncan | 02/28/2021

I fully support the proposed changes to exception points for PSC and CCA patients. My husband was diagnosed with PSC in 2015 at age 30. By the time of diagnosis, he had cirrhosis and other complications that required him to go straight to transplant evaluations. Like most patients with PSC, he was advised to find a living donor due to having a relatively low MELD and the risks associated with waiting for a high enough score to get a deceased donor transplant. My husband was lucky to find a living donor, but unfortunately needed a second transplant less than eighteen months later due to cholestatic graft failure. The PSC community has long heard the argument against providing exception points for PSC patients due to them having a lower waitlist mortality, but I have always wondered what those numbers would be if PSC patients weren't driven down the path of LDLT. Would their waitlist mortality be higher? I think the staggering numbers provided in your literature about waitlist dropout suggests that there could be something to this theory. The proposed changes to the exception points for PSC would help these patients obtain the scores needed to get a full liver from a deceased donor-- and a full liver with a full biliary tree logically seems like a better choice for patients with a bile duct disease that carries a significant recurrence rate. I also support the expansion of the criteria for the automatic allocation of exception points for patients with hilar CCA. These patients already face limited access to transplant due to the relatively small number of centers that are willing to treat them. Additionally, their transplants need to happen in a timely manner and within the parameters of their treatment protocols. Giving them a clearer path to exception points could improve their odds at getting a transplant and give them a better shot at beating their horrid cancer. I am so thankful the NLRB is considering these important changes. My husband has been doing amazingly well for the past three and a half years, but on his last ERCP and MRCP, there were findings suggestive that his PSC is returning. I hate this disease. No one asks for it to come into their home or for the destruction it causes. These patients (often very young) need a shot at living full and healthy lives. Better access to deceased donor transplant through exception points would be a huge step in the right direction.