Update Multi-Organ Allocation for Continuous Distribution of Lungs At a glance Background The OPTN Board of Directors approved the proposal Establish Continuous Distribution of Lungs in December 2021. This proposal included an update to allocation of multi-organ transplants with lungs, using a candidate’s composite allocation score to rank them on a match. The score chosen was meant to cover 95% of lung multi-organ transplants currently happening. After receiving additional data, the Committee found that the score initially selected would not maintain access for as many patients as expected. Supporting media Presentation View presentation Proposed changes Update composite allocation score to qualify for a multi-organ transplant involving lungs from 28 to 25 Goal is to maintain access for lung multi-organ transplant patients in the new continuous distribution system for 95% of the transplants that are currently done Anticipated impact What it's expected to do Make sure that current patient access to lung multi-organ transplants is kept about the same as it is now What it won't do Does not change original intent of multi-organ transplant in the continuous distribution of lungs policy Terms to know Continuous Distribution: A new system of organ allocation that considers individual patient and donor attributes as part of a composite allocation score. This score is then used to rank candidates for every organ offer. Composite Allocation Score: The total number of points assigned to a candidate on the waiting list, which would determine their rank on a match run. Multi-organ candidate: A patient who needs to receive more than one organ transplant at one time. Click here to search the OPTN glossary Comments UC San Diego Health Center for Transplantation | 09/29/2022 The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Update Multi-Organ Allocation for Continuous Distribution of Lungs. We commend the Committee for their proactive approach to ensuring that the newly designed allocation and distribution system is fair and equitable, and reconsidering the impact on multi-organ candidates even prior to implementation in light of updated modeling. We strongly support updating the composite allocation score to from 28 to 25 for required multi-organ offers appears to strike a balance that fairly maintains access but does not permit undue prioritization for candidates under the new continuous distribution system. We appreciate the Committee’s commitment to re-examining the very real impact of policy changes on patients. With regards to the feedback specifically requested: • Does the score threshold of 25 appropriately balance access to transplant between lung multi-organ candidates and kidney, liver, and heart single-organ candidates? A threshold of 25 does appear to more appropriately balance access for each of the lung multi-organ combinations. It also appears probable that a threshold of 25 will more likely capture those candidates whose severity of illness the other organ is driving, and who might otherwise have to wait until offers are being made to that respective organ match run, effectively reducing the time to placement. • Once all organs are in continuous distribution, how might the Committee update lung multi-organ allocation across a continuous spectrum? The Committee will need to consider triple plus organ combinations and how those candidates should be prioritized for organ placement. For those combinations currently not covered in policy, it is left to the discretion of the allocating OPO whether or not to offer a center all organs they are listed for. As we move toward continuous distribution a more complex algorithm and refined sharing rules may be needed to ensure those candidates are not unintentionally disadvantaged based on an individual OPOs preferred practice and/or in instances where a cardiothoracic organ is not driving the patient’s severity of illness. Attachment OPTN Transplant Coordinators Committee | 09/29/2022 The OPTN Transplant Coordinators Committee thanks the Lung Transplantation Committee for their work and for the opportunity to comment on this proposal. One member asked and received clarification that this proposal addresses not just heart-lung combinations, but also lung-liver and lung-kidney combinations. Another member noted that the challenge with heart-lung combinations is that the lung allocation score (LAS) might be high but the heart status is lower, therefore preventing the candidates from receiving the lungs. The member added support for the change in order to capture 95% of that population of patients. One member asked about the status of multi-organ allocation for more than two organs since there are currently no policies addressing them. Another member noted the challenge with those candidates within the framework of broader distribution is that they might be farther down on the match run and other organs may have already been placed. Region 6 | 09/28/2022 Sentiment: 3 strongly support, 13 support, 7 neutral/abstain, 1 oppose, 0 strongly oppose Region 10 | 09/28/2022 Sentiment: 2 strongly support, 4 support, 9 neutral/abstain, 0 oppose, 0 strongly oppose HonorBridge | 09/28/2022 HonorBridge supports the Lung Transplantation Committee recommendation to update multi-organ allocation for continuous distribution of lungs. We recognize the results of the updated analysis performed by the committee and agrees that it is appropriate to update the lung composite allocation score threshold for multi-organ candidates from 28 to 25 to ensure qualifying candidates remain eligible for required multi-organ shares. OPTN Operations and Safety Committee | 09/28/2022 The Operations and Safety Committee (OSC) thanks the Lung Committee for their work on the proposal, Update Multi-Organ Allocation for Continuous Distribution of Lungs. The Committee supports the proposal and anticipates this change will improve lung allocation; it was also noted to increase equity in organ transplantation. NATCO | 09/28/2022 NATCO would like to thank the Lung Transplant Committee for the opportunity to review and reply to the public comment on their proposal for changing the CAS score from 28 to 25. We strongly support this change as the current CAS of 28 is not maintaining access to those patients that require multiple organ offers. As the original score was intended to allow 95% of the dual listed patients who receive an offer, we applaud the committee for recognizing that this was not happening. Ongoing data collection and revision is needed for all policy changes, and by reducing the CAS score to 25, we will be able to provide increased equity to patients that are listed. We propose that if this effect takes change, that we continue to assess and redefine the criteria needed to better serve our patient population. Region 8 | 09/27/2022 Sentiment: 0 strongly support, 12 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose Association of Organ Procurement Organizations | 09/27/2022 Please see the attached comment from the Association of Organ Procurement Organizations Attachment Region 7 | 09/27/2022 Sentiment: 3 strongly support, 10 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member noted that multi-organ allocation, in general, is not equitable for pediatric candidates. Another member expressed support for lowering the threshold to capture a greater percentage of patients. If implemented, this should be monitored closely to ensure it accomplishes the intent. More research will need to be done to understand how to allocate multi-organ transplants within the continuous distribution framework. This is a very complex question and needs careful thought and analysis for incorporation. American Society of Transplantation | 09/27/2022 The American Society of Transplantation (AST) offers the following comments for consideration in response to the proposal “Update Multi-Organ Allocation for Continuous Distribution of Lungs:” •There has been a dramatic increase in multi-organ transplants including kidneys over the past 10 years, including lung-kidney multi-organ transplants, typically utilizing high-quality kidneys in patients that often have very limited life expectancy and that could otherwise provide great life expectancy benefit to young, kidney-only candidates with long waiting times. The AST recommends the final proposal also include monitoring the usage and outcomes of lung-kidney transplants to assess whether medical eligibility criteria should be developed in the future, similarly to what has been done with liver-kidney. •More recent data presented by UNOS reflect that the score threshold of 28 only captured 75% of lung multi-organ candidates. With these updated data, the score of 25 did increase this to 95% of transplants currently being performed and this was the intent of the Lung Committee. It also appears probable that a threshold of 25 will more likely capture those candidates whose severity of illness the other organ is driving, and who might otherwise have to wait until offers are being made to that respective organ match run, effectively reducing the time to placement. The AST supports and agrees with this adjustment as it will maintain this access at the same rate as in the LAS for these candidates. •In lung, as in all other organs, multi-organ combinations are often challenging. Often, this is because of different protocols between organs and different scoring systems. We believe that when continuous distribution is implemented across all organs, it may be less complicated and more efficient as the strategy will be similar. When creating the composite allocation score for solid organs after the lung composite allocation score is accepted and implemented, it will be beneficial to align each organ with the same process as much as possible. The OPTN will also need to consider triple plus organ combinations and how those should be prioritized in allocation, particularly considering that it may not be the heart or lung driving the patient’s severity of illness but the liver. A more complex algorithm may be needed to ensure those candidates are not unintentionally disadvantaged. Attachment American Society of Transplant Surgeons | 09/27/2022 The American Society of Transplant Surgeons provides the following feedback to the OPTN Lung Transplantation Committee. Does the score threshold of 25 appropriately balance access to transplant between lung multi-organ candidates and kidney, liver, and heart single-organ candidates? Decreasing the Composite Allocation Score (CAS) threshold of 28 to 25 would increase access to multi-organ lung transplants which the training organ would often be at a disadvantage in the non-CAS era. Based on the modeling, the decrease would increase access for MOT (based on Table 1 and 2). Once all organs are in continuous distribution, how might the Committee update lung multiorgan allocation across a continuous spectrum? This is difficult to determine as the modeling attempts, though does not account for, differences in practice, expertise, and aggressiveness between and within centers. ASTS does not feel that this impacts patients dramatically in either a positive or negative way; we are unsure if this would be beneficial, since it is a relatively small percentage of patients compared to the overall transplant patient population. Attachment Region 11 | 09/26/2022 Sentiment: 2 strongly support, 7 support, 11 neutral/abstain, 0 oppose, 0 strongly oppose Comments: An attendee commented that equity in access is important for multi-organ recipients; they are often young candidates who have potential for long life and have no other options for life-saving treatments. Region 1 | 09/21/2022 Sentiment: 2 strongly support, 0 support, 7 neutral/abstain, 0 oppose, 0 strongly oppose Region 3 | 09/20/2022 Sentiment: 2 strongly support, 10 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: The region generally supported the proposal. One attendee commented that this criteria expansion is not accompanied by safeguards to ensure appropriate use of lung-kidney multi-organ listing, and provides no data regarding whether historic lung-kidney multi-organ transplantation was appropriate. They added that there has been a dramatic increase in multi-organ transplants including kidneys over the past 10 years, including lung-kidney multi-organ transplants, typically utilizing high-quality kidneys in patients that often have very limited life expectancy and that could otherwise provide great life expectancy benefit to young kidney-only candidates with long waiting times. They went on to comment that no new policy should expand access to multi-organ transplantation that includes kidneys without also taking steps to mitigate any potential deleterious impact of inappropriate use of multi-organ transplant on kidney-only candidates. Region 2 | 09/13/2022 Sentiment: 4 strongly support, 11 support, 9 neutral/abstain, 1 oppose, 0 strongly oppose This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. There was noted opposition to all extensions of multi-organ allocation until such time as the negative impact of multi-organ on kidney candidates is appropriately weighed and addressed. To date and for many years, the issue has been ignored by the community to the detriment of kidney recipients. There are highly sensitized candidates who have waited years for an offer see their chance at transplant disappear because multi-organ candidates take uniform and total precedence without any counterweight which is offensive to kidney candidates and deeply unfair. Region 9 | 09/12/2022 Sentiment: 0 strongly support, 6 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose Region 5 | 09/08/2022 Sentiment: 6 strongly support, 15 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose Region 4 | 08/26/2022 Sentiment: 1 strongly support, 15 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Nicole Seefeldt | 08/08/2022 I am for any change that will help lessen the struggle of those who have to be dual or multiply listed for organs, esp because when lung function depletes it’s very hard not to be bedridden from it. Ones quality of life suffers greatly and then to compound that with more organ failure is incredibly difficult. This group has been talked about frequently but something needs to be done to bring them to the level of parity with others who struggle with organ failure, especially the lungs.