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Continuous distribution of lungs concept paper

Proposal Overview

Status: Public Comment

Sponsoring Committee: Thoracic Organ Transplantation Committee

Strategic Goal: Provide equity in access to transplants

Read the concept paper (PDF; 8/2019)

Contact: Betsy Gans

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You may be interested in this concept if

  • You work for a transplant program
  • You work for an OPO
  • You are a transplant candidate or a family member of a transplant candidate

Here’s the purpose of this document

In December 2018 the OPTN Board of Directors approved the continuous distribution framework for all organ allocation systems. Continuous distribution will prioritize waiting list candidates based on a combination of points awarded for factors related to medical severity, expected post-transplant outcome, the efficient management of organ placement, and equity. Continuous distribution will eliminate hard boundaries, which currently preclude a patient from being prioritized ahead of patients on the other side of the boundary.

Why this may matter to you

This model will eliminate hard boundaries and classifications that many people are accustomed to. It will also enable dynamic multi-factor allocation policies.

Tell us what you think

  • Do you understand the advantages of a points-based system versus the current classification-based system?
  • Are there other measures of the efficient management of organ placement that should be taken into account in a points-based framework?
  • What other issues should be considered to convert other organ systems to a points-based framework?
  • What factors should be incorporated into the allocation of lungs within a continuous distribution framework?

Comments

Anonymous | 08/06/2019

as a candidate for almost 3years i feel i hwait longer than the average person due to COPD that should not be a factor.....I have the same issues as all others on the wait list yet the pecking order puts copd at the bottom....I also had lvrs which is not even allowedd to be put into that equasion. very frustrating to say the least

Mark Rolfe | 08/17/2019

This is a very reasonable proposal and would better allocate organs than the current "zone model". The only cautionary point I would offer is the weight of "efficiency" of organ placement in the total calculation not be based on financial concerns. The "cost" of driving across town to acquire an organ should not be an issue/ adjustment that would give preference to a "local recipient" over a recipient where the organ acquisition team is required to helicopter or fly in to acquire the organ, if all other outcome indicators are equal. The continuous distribution of organs scores should be based on need and predicted outcomes and not on financial considerations for the transplant center, the donor center or the OPOs. How much is a life is worth, or how much profit a center, or OPO can make is an area where no one should see this organization attempting to make adjustment in a new allocation system.

OPTN Liver and Intestinal Organ Committee | 08/29/2019

The Liver Committee is interested in the anticipated time frame for implementation. The Liver Committee also asked whether the Thoracic Committee considered incorporating population density, and whether there would be modeling of impact on patients based on whether they were in densely populated versus sparsely populated areas. A Liver Committee member requested that the resulting proposal seek to minimize the difference in impact on patients based on the population density in their area.

OPTN Region 4 | 08/30/2019

Strongly support (10), Support (12), Neutral/Abstain (3), Oppose (0), Strongly Oppose (0) Region 4 overall supports continuous distribution of lungs. Members agree that continuous distribution will allow us to account for various factors involved in allocation, we can separate them out and have discussion and conversation instead of an opaque system with nautical miles. The problem with the current system is the hard boundaries and continuous distribution will alleviate those issues. The committee should consider the following factors when developing the system: o Population density o Highly sensitized • Needs to be clearly defined o What should be included in the term efficiency • Wide variability in costs at OPO  How would those costs add into efficiency score  Example: Single vs double lung • 1 single transplant more efficient however two single lungs are more expensive to travel then 1 double lung • Considering the example above, you can think about efficiency in two very different ways o Identify disadvantaged populations and determine how many points they should be awarded • Pediatrics • High sensitized • Blood group O o Transparency-point descriptions need to be easy to understand for all o Need to get weighting correct • If someone has obstructive lung disease, currently there is no account of quality of life on the current list; variability in the weighing system is very important and we do not want to create a class of patients that are disadvantaged o Outcomes • Example: Ischemic time effect on outcomes o One member suggested that there should be a cap on the number of factors that will be included

OPTN Ethics Committee | 09/03/2019

The OPTN Ethics Committee thanks the OPTN Thoracic Transplantation Committee for its effort in developing this concept paper and presenting a framework for future allocation. The Committee supports the overall concept of a continuous distribution framework. The Committee is highly concerned, however, about how various allocation variables will be weighed to create a total allocation score. The Ethics Committee believes that the weights assigned to allocation variables pertaining to utility will remain the most significant determining factors resulting in a lack of balance between equity and utility. The Committee expresses concern for pediatric patients and would like to ensure that the Thoracic Committee considers the high level of priority accorded to pediatric patients in the creation of this new allocation framework. The Committee members indicated 36% strong support, 43% support and 21% neutral/abstain on the proposal. Those who voted neutral/abstain indicated their sentiments were due to the lack of specific information proposed for variable weights and the general ambiguity about how the future policy proposal for the allocation system would prioritize patients.

OPTN Patient Affairs Committee | 09/03/2019

Below is a summary of the Patient Affairs Committee (PAC) feedback: • The PAC commends the addition of the Proposal at a Glance portion of the proposal. In addition to the current content, PAC recommends adding a history section, to include the proposal timeline, so the reader has some context for the proposal and a glossary of transplant-specific terms • Many things can impact the efficiency management of organ placement, and the phrase “efficient management” of organ placement is broad enough to include virtually every aspect of transplant. If the points-based framework includes all elements affecting medical urgency, outcomes, and patient access in the calculation of the scores of those factors, efficient management becomes merely a question of the allocation and delivery mechanics and related expense. A points-based system can accommodate multiple factors related to efficiency and will more directly connect those factors with these Final Rule provisions. • To facilitate understanding and communication across the transplant community, an idea posed by a Committee member included the points-based system being constructed so that the composite allocation score for each organ would be expressed on a scale format (unique to each organ system). Overall, a transparent points-based system that leads to greater equity in the distribution of organs among those who have been accepted as candidates may result in higher patient and patient family satisfaction • The concept paper discussed the factors that would need to be incorporated. Other factors that should be incorporated include the following: medical urgency, age/size, waiting time, sensitization, patient’s access to a transplanted organ; time on the waitlist; quality of the donor organ; length of time from procurement of organ to implantation; and the utilization of “best practices” throughout the transplant process and aftercare. The group believed adult versus pediatric factors should be also be integrated. • Ultimately, this would impact candidates directly, recipients indirectly, and family members of recipients or donors indirectly. Candidates will have more equity in receiving an organ. Recipients may be negatively or positively impacted, as wait times would play a factor. However, it should be noted that recipients might benefit from less organ rejection due to better organ matching. Family members of recipients or donors may benefit due to their loved one receiving a better organ match (presenting less challenges post-transplant). • From a patient perspective, the group was divided on how they felt about the language used throughout the concept paper. The basics of classification-based framework and points-based framework were clear, but the document as a whole presented confusing material from a patient’s perspective, including the definitions it provided (such as the word “efficiency”). • Some Committee members were concerned about whether there were any safeguards against manipulating the system and how the Thoracic Committee would determine whether a continuous distribution system was effective. • The issue of whether regional review boards would still be needed under this system was mentioned. • Group consensus was that they recommend the PAC support this proposal. The principles outlined in this proposal are specific and intended to alter the way transplantation throughout the United States is conducted. The current system, though effective, needs improvement. In order to effectively make the necessary improvements that would ensure a more equitable distribution of these limited resources, structural changes must be made. The existing framework does not demonstrate the flexibility to take advantage of new technological advancements in medicine, thereby enabling greater access to patients who are precluded due to geography and other criteria. This proposal offers a much more flexible framework that changes with future medical advancements and offers a more level “playing field” when it comes to receiving an organ donation. It will facilitate elimination of artificial geographical and other barriers inherent in the classification system and identification of the most important elements of an efficient and effective system. • The PAC voted on this proposal and the results are as follows: Strongly support (57%), Support (43%), Neutral/Abstain (0%), Oppose (0%), Strongly Oppose (0%).

OPTN Region 7 | 09/03/2019

Region 7 comments are as follows: Comments: Members expressed during the breakout session the concept was understandable to transplant professionals and laypersons. They acknowledged the need for compliance with the OPTN Final Rule, balancing efficiency and broad distribution. Also mentioned was the need for integrity in such a new system and mechanism to reduce the potential for “gaming”. Much of the discussion centered on the attributes that may be included in the composite allocation score: • Candidate and donor factors such as size, age, ischemic time, waiting time, candidate medical urgency, and placement efficiency/length of time needed to allocate grafts of varying sizes. • How the following might be addressed in a continuous distribution framework: o disadvantaged populations, o population density, o increasing use of ex vivo lung perfusion (EVLP), o combined heart-lung transplants, and other multi-organ transplants involving deceased donor hearts, o tie-breaker for candidates with the same composite score • Candidate sensitization and the role of prospective cross matching in these candidates, and the logistical challenges that can present regarding shipping donor blood specimens for prospective cross matches. • The need for consensus on levels of sensitization, perhaps based on mean fluorescent intensity (MFI); the mean intensity and level of antibody expression. • How will a candidate’s disease severity be measured against the probability death on the waiting list. • Appropriate weight assigned to the attributes and avoid subjective or arbitrary assignments. One attendee shared the idea of gradually adding attributes to the composite score. Attendees also mentioned the desire to see what SRTR modeling showed for continuous lung distribution. This will be helpful to hopefully avoid unintended consequences, e.g.: negative impact on transplant outcomes, transplant rate, waitlist and post-transplant mortality, transplant counts, etc… Attendees expressed interest in learning more about the depth of OPTN data available on possible attributes. The Region 7 representative stated the Committee will be utilizing Multi-criteria Decision Making to aid in development of a future proposal. This analytical approach is a participatory, multi-criteria, option appraisal process that combines a novel approach to the use of quantitative decision analysis techniques with some significant innovations in the field of participatory deliberation (e.g.: OPTN public comment). Region 7 voted as follows: 8 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly support

OPTN Pediatric Transplantation Committee | 09/06/2019

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on this concept paper. The Pediatric Committee supports the Thoracic Committee in their effort to move towards continuous distribution for lungs and noted that the Thoracic Committee should use previous OPTN publications outlining the ethical principles of pediatric allocation when developing the continuous distribution framework. The Pediatric Committee was encouraged to hear that the Thoracic Committee is willing to consider additional priority for pediatric candidates and looks forward to future collaboration on this project.

OPTN Region 3 | 09/07/2019

Comments and discussion with members included: • Waitlist mortality and ischemic time shouldn’t play a role in this new system for lungs • Sensitized candidates should be highly considered • System efficiency not is well defined • How do you take into account OPOs with centralized procurement centers from a cost and geography standpoint? • Age and underlying diagnosis should be attributes in the calculation • Outside experts should be consulted to ensure this is the best option • Alternative options, including state based distribution, should be objectively assessed. • We should not be moving organs further to do the same number of transplants. • All principles of the final rule need to be considered equally Strongly support (2), Support (9), Neutral/Abstain (12), Oppose (8), Strongly Oppose (2)

Neeraj Sinha | 09/08/2019

I appreciate the composite score concept. The following concerns may need further attention: 1) The new allocation system may be incentivizing the candidates who opt to come very late in their lung disease for transplant evaluation, or the referring pulmonologists who refer very late. These candidates are more likely to be frail, have secondary pulmonary hypertension, have non-compliance issues, and have less time to gain insight about post-transplant needs due to short time of evaluation. 2) The new lung allocation system would be disincentivizing the candidates who opt to come in the appropriate window for lung transplant evaluation, or the referring pulmonologists who refer in the appropriate window based on the available guidelines and evidence. The candidates who have significant symptoms but have a relatively lower waitlist mortality (emphysema and cystic fibrosis are the prominent diagnoses with these attributes, thus having low lung allocation scores) may wait on the waitlist for long periods of time. Being on waitlist brings a certain level of anxiety and stress that has not been appreciated well. The candidate is "on-call" 24-7-365 for an offer, and is constantly prepared to come to the center for a transplant at a short notice. The "waitlist anxiety" is likely to increase with the new geographical rule. 3) The lung allocation scoring system does not take into account the "window of transplant" concept. The "window of transplant" concept is a derivation from "cumulative survival' concept: the time from diagnosis of disease to death with or without transplant. The older system of DSAs acted as an unwitting but somewhat effective speed-breaker to the programs from transplanting a large number of patients beyond the window of transplants.There is a concern that cumulative survival and the cumulative number of quality-adjusted life years for various advanced lung disease cohorts will be negatively affected with the new geographical rule. Please consider the above concerns, and incorporate appropriate metrics into the composite score.

OPTN Region 5 | 09/11/2019

Strongly support (10), Support (16), Neutral/Abstain (3), Oppose (4), Strongly Oppose (1) • One member stated that the community might support the concept, but that “the devil is in the details.” These details are critically important to the success of a future policy proposal. • The slope relative to patient’s medical urgency is important to get right; we do not want to make it so steep that a local patient gets more priority than someone more urgent who is located farther away. During the breakout session, members discussed which attributes should receive points. It was suggested that ischemic time be assigned fewer points, and that blood type needs to be considered, particularly blood type O candidates. We don’t want to make it more difficult for this blood type to receive a transplant. A member suggested that point assignments might be different by blood type and maybe also based on where candidates are listed. There is some variation by area. It was acknowledged that making decisions about attributes and assigning points will be a value judgement to some degree. Another suggestion is to consider population density. There is concern that continuous distribution might disadvantage transplant hospitals that are geographically isolated. Some transplant hospitals are not located near large population areas. Concern was also shared that continuous distribution will change the way transplant hospitals practice and that gaming could be an issue and this needs to be considered.

Voytek Slowik | 09/11/2019

I support further development of this as a possible model. Whenever potential changes are being considered, I believe there should be involvement of pediatric advocates such as the OPTN Pediatric Transplantation Committee to ensure that our most vulnerable patients have a voice in future changes and I hope that this continues.

Anonymous | 09/12/2019

As a double lung recipient, I strongly support these changes, giving those with the greatest need a chance at life, despite nautical miles. While I was very lucky to receive my gift of life, many others in our Seattle transplant region ran out of time waiting. Our region includes a lot of water. Not staying with these hard boundaries, taking into consideration a higher LAS score, could potentially be able to save more lives in time

Anonymous | 09/12/2019

I strongly support the proposal of not using hard demographic areas as the only way of determining where/who should receive a determined organ. If several people would qualify for the same organ, regional lines should not be the only factor in the person with highest score not getting the needed organ first. Some regions I feel benefit more due to population and geographics.

Bob Wheatley | 09/12/2019

As a pre lung transplant patient on the waiting list, this proposal sounds like it would be more equatable for all.

Anonymous | 09/13/2019

As a recipient of a double lung transplant, I fully agree with this proposal. I live in the New York area where people die waiting for a transplant because the net for organ allocation is so small. I do think that removing the hard geographic boundaries would be beneficial and would allow transplant centers here to perform more transplants and therefore, gain more experience and help more patients.

Anonymous | 09/18/2019

As a 73 year old double lung transplant survivor (2 years post) I am very interested in the concept paper. Despite being over 70 years old at the time of my transplant, I am doing great. For me, age was a big issue with getting listed for transplant and I hope in the future, more people like me will be given a fair shot at transplant. Eventhough I've already received my transplant, it seems that modifying the current process to include more data points and criteria would help both facilities and transplant waiting list patients. I realize that determining the specific criteria and ranking or weighting them will be a process requiring much thought and diligence. But, in the end, the need is clearly evident for a more fair allocation process and one that will allow West Coast transplant facilities the ability to more fairly procure organs. Please continue to work for ways to make the process fair and equitable for all.

OPTN Region 2 | 09/20/2019

Region 2 voted as follows and had the following comments: Strongly support (8), Support (15), Neutral/Abstain (3), Oppose (0), Strongly Oppose (0) Members of the region supported the direction the concept paper is taking towards moving to Continuous Distribution. There was some concern about selecting objective criteria for the placement efficiency score and patient access score. A member suggested that mortality rates be considered in future work towards Continuous Distribution. From a lung standpoint, members expressed concern about the current LAS system and there would need to be tweaks made before moving to Continuous Distribution.

Donald Kurz | 09/23/2019

I support a change to a more balanced definable allocation model with the caveat of VA lung center organ support/supply be included in the allocation formula for the regions affected.

Inova Fairfax Lung Transplant Program | 09/24/2019

As a program, we are in support of the continuous distribution concept. In terms of individual attributes to consider: 1) For efficiency, we favor using miles (continuously) instead of ground vs. air transportation to reduce the subjectivity or bias/possible manipulation of the attribute score 2) For outcomes, we favor considering outcomes beyond 1 year post transplant survival to capture best use of organs (total life-years gained) 3) For access, it will be important to be very concrete in the factors considered

OPTN Region 1 | 09/24/2019

Region 1 voted and had the following comments: Strongly support (4), Support (10), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Region 1 overall supports continuous distribution of lungs. Members suggested that the committee should consider attributes that are already prioritized in other allocation organ systems such as sensitization, prior living donors and pediatric candidates. There was some concern about efficiency and the impact of broader sharing on the duration of the case. Late turndowns have increased and the committee could utilize data from OPOs to find out why there is an increase. There needs to be a balance to help decrease discards and OR time.

Lung Bioengineering United Therapeutics Corporation | 09/26/2019

October 2, 2019 Maryl Johnson, MD Board of Directors Organ Procurement and Transplantation Network (OPTN) United Network for Organ Sharing 700 North 4th Street Richmond, VA 23219 Submitted electronically via e-mail: (publiccomment@unos.org) Dear Dr. Johnson and OPTN Board Members, United Therapeutics, a biotechnology company and our wholly owned subsidiary, Lung Bioengineering, Inc. (LBE), appreciates the opportunity to provide comments to the OPTN’s Continuous Distribution of Lungs Concept Paper, sponsored by the Thoracic Organ Transplantation Committee. LBE is passionate about addressing the acute national shortage of transplantable lungs through our research and development of a variety of technologies that either delay the need for organs or expand the supply to patients desperately waiting for life-saving treatment. We support the OPTN Board of Directors’ efforts to develop a framework for a more equitable national transplantation process for patients, provide more transparency to the allocation system, and demonstrate more efficiency in developing and implementing organ allocation policies. We understand that the proposed continuous distribution system would first be used for lung allocation, and then the framework would expand to apply to all organs and transplant candidates at some time currently undetermined. The Concept Paper describes that “continuous distribution incorporates how close a candidate is to a donor using an algorithm that accounts for medical priority, rather than their location inside or outside a boundary.” While the general structure is expected to be the same for all organs, the draft model indicates that the specific scores would be based on the clinical characteristics and ischemic consideration of each organ. Further, the proposed model is described as a move away from a classification-based framework to a points-based framework, with more points for more efficient travel, for example. We believe that it would be beneficial for the OPTN to develop allocation policies now, so that ex vivo lung perfusion (EVLP) is available to more lung transplant candidates as the technology matures. While we can appreciate that converting from the existing allocation model to the proposed model will be a significant effort, we respectfully disagree with waiting until some unforeseen time in the future to incorporate new attributes that could significantly impact the weights of the new point-based system (as noted on page 9 of the Concept Paper). Waiting to consider this type of technology and the perfusion providers that offer it could result in making the proposed continuous distribution model problematic before it is implemented, tentatively scheduled for 2020 (as noted on page 11 in the Concept Paper). Further, we urge the OPTN to include changes now in transportation practices, including organ perfusion, because ex vivo technology is being used for lungs now both commercially and in clinical trials (see information provided on page 2) and it should be anticipated that the technology will be available more broadly within a few years. As you are aware, more than 75% of the potential 10,000 deceased donor lungs are considered unsuitable for transplant each year because they are initially evaluated as medically unsuitable or encounter organ allocation system logistical challenges. In the last 10 years, the use of EVLP on thoracic organs has also gained attention.1 At our dedicated lung perfusion facilities in Silver Spring, Maryland and (in association with the Mayo Clinic) in Jacksonville, Florida, we receive many lungs that are generally regarded as marginal or even unacceptable for transplant during the initial inspection at time of donor surgery.2 We perform EVLP on those lungs in a tightly controlled perfusion environment, which provides transplant clinicians with an extended opportunity to evaluate information about the lung suitability for transplant. As a result, marginal or high-risk donor lungs that would otherwise have been discarded may be available for transplantation. Additionally, the extended time for the assessment could potentially allow and organ procurement organizations additional hours of organ allocation, and transplant centers more time for planning and logistics, allowing for patients in more remote areas to travel further to the transplant center, and for surgeons to have flexibility to schedule enough time to address complex case needs.3 Because most of the work involved in EVLP is documented using computer technology, critical information about the lung is available to transplant physicians electronically from our state-of- the-art facility, reducing the need for surgeons to travel to view the organ in situ and determine viability. The gift of extra time between organ procurement from the donor and transplant allows more time for the transplant physician to evaluate and decide whether to transplant the lungs. Further, the ability for the transplant team to evaluate the lung online, instead of needing to travel, could change current transportation practices as we know it—and result in possibly more time for more patients to receive life-saving transplants. Additionally, it is anticipated that the travel mode aspect of the proposed continuous distribution model would not accommodate centralized EVLP because the extended time will impact the total ischemic time. Therefore, we urge OPTN to work together with perfusion providers, such as ours, while finalizing the methodology for the travel mode aspect of the model. In our clinical trials to date, EVLP technology has enabled 75 lung transplants to take place using lungs that otherwise may have been discarded, along with an additional 17 transplants under the FDA’s emergency use program or exported to Canada when a US-based center was unable to use the lung(s). In the future, EVLP may be used to aid in the transplant clinician’s decision-making process of whether or not organs other than lungs, such as hearts and livers, are suitable for transplantation. It is our hope that the OPTN develops a model that can, at the very least, quickly accommodate emerging technologies as they come to market, so that more patients with end-stage organ disease will be able to benefit from transplant. Thank you again for the opportunity to provide comments. We look forward to working with OPTN to help make organ allocation more equitable for patients and more transparent. Sincerely, Richard E. Pietroski, President, Lung Bioengineering United Therapeutics Corporation 1 Van Raemdonck D, et al. Machine perfusion of thoracic organs. J Thorac Disease. 2018 Apr;10(Suppl 8):S910-S923. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5934115/. Accessed September 4, 2019. 2 In some instances, we may also receive lungs that have not yet been allocated to a transplant recipient, and where the time that the lung can remain viable is running out. LBE is working to extend the window of post-explant viability from approximately 6 hours (for a standard-of-care lung sent direct to transplant) to approximately 22 hours following EVLP, which can enable the rescue of lungs that would otherwise be discarded, including in cases where a recipient has not been identified in time. 3 Kettlewell C. Will organ perfusion transform transplantation? UNOS. April 30, 2019. https://unos.org/news/insights/will-organ-perfusion-transform-transplantation/. Accessed September 4, 2019.

OPTN Transplant Administrators Committee | 09/26/2019

The OPTN Transplant Administrators Committee thanks the OPTN Thoracic Transplantation Committee for its work to develop this concept paper to present a framework for future allocation. The Committee is supportive of continued work on these concepts and looks forward to a future proposal that improves the allocation process for all stakeholders in the transplant community.

OPTN Region 11 | 09/26/2019

Strongly support (3), Support (13), Neutral/Abstain (6), Oppose (1), Strongly Oppose (1) Region 11 generally supports continuous distribution of lungs. During the discussion members encouraged the committee to consider how they value the attributes and make sure that there is consensus around what are values should take priority: efficiency versus outcomes and medical urgency. There was also support for ensuring that rural communities and the centers that serve them are protected. If a change in the policy results in a rural center doing fewer transplants, it may lead to poorer outcomes. There was a request for modeling that would show how a proposal would impact different parts of the country and/or certain centers. Some commented that when considering attributes the committee needs to consider that multi-organ candidates and CF candidates both of which are disadvantaged in the current system. Pediatric candidates also tend to be a disadvantaged group and the committee should weigh the criteria to give pediatric patients an advantage in allocation. If the committee puts a greater emphasis on medical urgency, they should consider that the LAS does not account for risk of death which it probably should. There was also a recommendation that the LAS should be assessed periodically to ensure that it coincides with the changes in policy. Some commented that the committee needs to consider how any change will impact procurement cost. There was some concern with using the term “placement efficiency” and a recommendation that the committee use a different name. Placement efficiency may boil down to costs and the committee should not focus too much on costs for this attribute.

James Sharrock | 09/26/2019

While relying on geographic boundaries imposed by DSAs and Regions is not an appropriate way to control allocations, the implementation of concentric circles is only marginally better. A continuous distribution policy that identifies and prioritizes all relevant factors to provide a basis for allocation is far superior. There is no doubt the devil is in the details and there will be a broad range of opinions of how any such system should be ultimately implemented. However, the sooner the better. Transplant professionals need to understand that patients and the public may not understand a system that recognizes all significant variables, but if they can be shown that their particular issues are addressed in the system, they will accept it. One benefit of developing such a system will be to illuminate how immediate medical necessity is weighed against long term outcomes and expected life years resulting from each potential transplant. If organs are a national resource, they should be utilized to provide the maximum benefit.

Region 8 | 09/27/2019

Members voiced general support for the framework but noted that determining the right elements and how they will be weighted will be a challenge. Comments included: • It is important to identify appropriate metrics to measure success. • There should be transparency of decision making through the stages of this project. There should be a workgroup to review methodologies and variables. • Program variations should be considered as a potential variable • Artificial intelligence or program specific data could help identify critical elements • Technological advances need to be accounted for in the framework. • Placement efficiency is an important consideration. • One member asked if the use of a points-based system would mean that every potential transplant recipient would appear on each match run and shared concern that this would result in national sharing for all offers, which would have multiple logistical challenges. • Another member acknowledged that one of the goals of continuous distribution is to remove or reduce a candidate’s place of listing from causing inequitable access to transplant. However, the member asked how the OPTN would be able to measure this metric and suggested incorporating population density as part of the composite allocation score. The member also suggested that the Thoracic Committee consider consulting with operations researchers and examine multi-criteria decision making. • Another member asked if the composite allocation score would only be calculated based on recipient characteristics. The member suggested included donor characteristics in the composite allocation score. Vote: Strongly support (5), Support (12), Neutral/abstain (2), Oppose (1), Strongly oppose (0)

Anonymous | 09/27/2019

The concept paper is a bit challenging to a reader that is not familiar with vernacular of the transplant community. However, the case for transitioning from the current classification-based system to a points-based system was clearly presented. It appears that there are significant advantages of the points-based system over the current system and some of these were clearly illustrated by the examples provided in the concept paper. Clearly, there are complex factors involved in converting attributes from the current system to a points-based system. However, careful - and possibly extra attention- should be given to two attributes among the group of attributes already identified. These attributes are (a) Sensitization and (b) Vulnerable Populations which are closely related to Equity (or patient access). The development of a scoring mechanism and placement methodology that fairly prioritizes ranking of these attributes may go a long way in addressing public perception that the transplant system is unfair to certain ethnic and socioeconomic groups. The attribute list should be expanded if it proves to be too difficult to address these perceptions within the context of the above referenced attributes. However, here is an opportunity to deal with these prevailing perceptions since it impacts the public’s willingness to participate in the organ transplant system as clients, and as donors as well.

OPTN VCA Transplantation Committee | 09/30/2019

OPTN Vascularized Composite Allograft Committee (VCA) convened on September 11, 2019 and received a presentation on the public comment proposal: Continuous Distribution of Lungs. GoToTraining was utilized to gather the committee’s sentiment vote. The Committee supports the proposal. Results are as follows: Strongly Support = 5 Support= 6 Neutral= 0 Oppose = 0 Strongly Oppose= 1

American Society of Transplantation | 09/30/2019

The American Society of Transplantation acknowledges that this is a concept paper, not a policy proposal. This concept paper appropriately outlines the challenges evident with the current process of recipient matching to donor lungs via geographical mileage circles, ABO compatibility, age and categories of illness, among others. This concept paper outlines the changes necessary to move from a classification-based system to a points-based system of lung allocation. This would entail determining points and weighting for pertinent variables such as medical priority, blood type compatibility, ischemic time, efficiency factor, waiting time, sensitization and others deemed relevant. Recipients would ultimately be given a “score” on a donor run match list. This approach has been approved by the UNOS Board and is the direction that all allocation policies are (or will be) working towards. The relevant constituencies of AST are in agreement that a continuous distribution system has advantages including; ability to be modified when new variables are deemed important, variables evolve to have new points or weighting and ease of programming. Addition factors offered for consideration include; population density, OPO efficiency, cost estimates, quality of life, single vs double lung, age, short stature and blood group O as a disadvantaged group. To assure consistency and fairness to all potential recipients at all centers, all variables on which the composite score is based should be rigorously defined in the development process with clearly detailed procedures for measurement and determination. This would include components of the current Lung Allocation Score (LAS) as well as HLA sensitization. Part of designing a process should also be a consideration for evaluation — how will we decide that the process that we’ve designed is working to serve the communities that it needs to serve? The current document has relatively little to say about how we will evaluate our success, both during this process and after it is complete. We specifically would like to bring attention to a few key considerations for the UNOS Thoracic Organ Transplantation Committee to consider in this process going forward: • Single vs double lung allocation. Current allocation does not consider whether one or both lungs are being allocated to a recipient. In a new system, this should be incorporated into the assessment of urgency, outcomes, and efficiency. The urgency and benefit of a second lung (i.e. double lung transplant vs. single) may be significantly different depending on the patient’s diagnosis and physiology. This issue is of relevance to determination of “best use of donated organs”, “allocation efficiency” and “patient access to transplantation.” • Placement efficiency and ischemic time appear to be overlapping variables largely derived from distance and travel time. Center-specific factors could also affect placement efficiency and could lead to bias favoring better-resourced centers. There is also inherent conflict with the final rule requirement that allocation policies “not be based on the candidate’s place of residence or place of listing.” • Ex vivo perfusion devices; How would this play into the scoring? Their evolution allows the potential for previously unusable organs to now be used but their cost is significant for programs and the outcomes still somewhat unpredictable. Usage of these devices are often in the higher ischemic time and longer distances matches and could be used against the transplant program if only those variables were included without the device support taken into account. • Pediatric candidates. We appreciate the acknowledgment of there being different allocation systems that apply to pediatric candidates. Again, there is relative obscurity about how age will factor into a composite score. The pediatric community is fully committed to the prioritization of pediatric organs for pediatric candidates, and we would urge the parties responsible for this process to maintain our collective commitment to protecting the needs of children. • Preservation mode. We recommend consideration of preservation mode in the composite score. Advances in transportation practices are quickly evolving. Technologies such as perfusion may challenge the current assumptions related to WIT and CIT, among others, and the formulas developed would ideally be flexible enough to incorporate such changes as clinical data comes in. • Outcomes score. This is likely to be based largely on survival. The survival time point post-transplant used in the allocation score is critical. While the use of short-term outcomes (as in the present LAS) may not identify differences, long-term outcomes diverge significantly for different patient populations. In lung transplantation, examples include older patients and re-transplants. This score could also incorporate donor and recipient risk factors for PGD to avoid unfavorable donor/recipient combinations.

NATCO | 10/01/2019

NATCO supports the development of a continuous distribution system which prioritizes waiting list candidates based on a combination of points awarded, as outlined in the Concept Paper: Continuous Distribution of Lungs. We understand the advantages of using a point-based system versus the current classification system and offer the following comments regarding additional factors that we would like to see addressed as the system is developed. With regard to the factors that are included in the calculation, we would like to ensure that medical priority is given to pediatric candidates and other vulnerable populations; we favor an outcomes variable that factors in waitlist mortality and post-transplant survival. When developing a proximity variable, we encourage the consideration of population densities as the basis for variable geographic zones. And, we think it is important to take into account measures of variable OPO costs, transportation costs, and ex vivo perfusion costs as part of the efficient management of organ placement. As this concept is applied to convert other organ systems to a points-based system we would expect that there could be enough flexibility built into the system to allow for variances in the actual variables that become part of the calculation for each specific organ. And, as new technology or medical advances are developed that might impact one variable over another, we hope that it will be possible to isolate specific modifications that might need to be addressed so that future tweaks could be made to the mathematical algorithm without the need to overhaul an entire system. We look forward to seeing the outcome of the continued work of the OPTN Thoracic Committee on this important model of distribution.

Kim Rallis | 10/01/2019

I would like to thank and recognize the Thoracic Committee for their work on this concept paper. Although the paper specifically addresses lung allocation, as discussed at the recent regional meetings, there are great concerns addressed with the newly implemented heart allocation changes. Submitted for your consideration below are observations and thoughts specific to heart allocation as a points-based system develops within the purview of this concept expanding beyond lungs. 1. Recent changes are working in that higher medical acuity patients are being transplant. 2. Extensions for temporary support are being granted regardless of multiple publications indicating that post-transplant 1 year outcomes will be compromised. Should the focus be on life years from heart transplant? Would recommend that extensions not be granted and that if centers continue past the decided number of days that those patients markedly loose points and are ultimately removed from the waitlist. 3. 10% of Status 1 and 2 patients have died or been removed from the waitlist due to being too sick. 4. Status 4 patients represent 45% of the waitlist, with average time to heart transplant? Data not yet available to analyze the full impact of Status 4 patients. A recent publication discussing the outcomes of the 2016 pediatric changes specifically note a negative allocation impact in Restrictive and Hypertrophic Cardiomyopathy patients. It goes on to state “physicians have been more likely to seek special exceptions for certain cardiomyopathy patients, bumping them up to top-priority status and partly undoing the intent of the policy. Survival rates did not improve among any categories of children waiting for heart transplants, and the rates even got a bit worse for patients with certain kinds of cardiomyopathy who were not assigned top-priority status.” Status 4 includes these patients in the current adult guidelines, which are seeing increased waitlist times. 5. Should the goal be to optimize patients for heart transplant and ensure the best outcomes for all organs utilized? 6. Like the idea of a points system. a. Medical priority. This makes sense short term but not long term. A paper out of Cedars Sinai is telling. An exit strategy from short term devices needs to be developed with extensions not approved. The current practice of extending temporary devices and not moving to durable devices early where clinically indicated can negatively impact outcomes. b. Ischemic Time. There is great potential for higher volume centers to benefit most from longer distance travel since they likely have financial income from transplant to absorb the added costs for devices that extend/optimize organ preservation. Medium and small volume centers may not be able to absorb these costs leading to less donor organ availability. c. Age Group. This is always a tricky one as you can have a young 60 and an old 60. Weighting should reflect heart failure frailty score. d. Waiting time. Consideration given after a certain number of days on the waitlist that the medical urgency for the Status 4 is elevated. Metric or points would accumulate the longer they remain on the wait list.

OPTN Pancreas Committee | 10/01/2019

The Pancreas Committee thanks the Thoracic Committee in its work developing this concept paper. One member asked whether patients with O-blood type would have longer waiting times should the system encourage incompatible blood types. The presenter explained that the Thoracic Committee has considered multiple different approaches to points awarded by ABO. They have considered awarding points based on compatibility as well as difficult-to-match blood types. The Chair commented in support overall for the proposal and expressed a desire to see what the actual weight and values that would be placed on criteria. The Chair recognizes that all organ systems will be moving toward this type of system. The presenter affirmed that the committee is taking a very deliberate approach to this concept as they recognize that this may set precedent regarding a continuous distribution framework for other organ systems. The presenter explained that during the course of the Thoracic Committee’s analysis they found the decision regarding priority points for different criteria was not a clinical or statistical question but rather one regarding values in an allocation system. Another committee member commented that many of the criteria appeared to be non-linear, such as cPRA due to the fact that the difficulty of matching lower level cPRA is not consistent with the difference with high cPRA. The committee member looks forward to seeing how these criteria are ultimately weighted. The presenter agreed that some criteria are non-linear and some are categorical which will impact the manner in which they are weighed. One committee member asked if this framework and criteria would be applied inside or outside of a circle based system. A UNOS staff member explained that the continuous distribution framework actually would replace a circle based system entirely. The Committee overall supported the proposal. A sentiment vote showed the following results: 36% strongly support, 36% support, 18% neutral/abstain and 9% oppose.

Region 10 | 10/01/2019

Strongly support (5), Support (15), Neutral/Abstain (3), Oppose (0), Strongly Oppose (1) Members of the region are supportive of the direction that the committee is taking in their approach to Continuous Distribution. Overall, the concept is easy to understand, but it will a large undertaking for each organ to move towards Continuous Distribution. It was noted that as the Thoracic Committee continues with Continuous Distribution for lung allocation the committee should focus on updating the Lung Allocation Score (LAS). LAS will be a key component to any continuous distribution along with other factors such as medical urgency, age, and blood type compatibility.

The Society of Thoracic Surgeons | 10/01/2019

On behalf of The Society of Thoracic Surgeons (STS), I write to provide comments on the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) Thoracic Organ Transplantation Committee’s “Continuous Distribution of Lungs Concept Paper.” We appreciate the opportunity to comment on this critical proposal. Founded in 1964, The Society of Thoracic Surgeons is a not-for-profit organization representing more than 7,200 surgeons, researchers, and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lungs, and esophagus, as well as other surgical procedures within the chest. The current allocation model for cadaveric lungs utilizes a Lung Allocation Score to prioritize candidates and geographic zones based upon concentric circles around the donor center. This model creates access barriers for some transplant candidates and is inequitable for recipients that live in regions with limited donor availability. The policy contradicts the principles of organ donation as established in the OPTN Final Rule that state that OPTN shall be responsible for the equitable allocation of cadaveric organs. Revision of the allocation model may better align OPTN practice with the Final Rule. The concept paper discusses the creation of a "continuous distribution score," where transplant recipient candidates are assigned weighted points that consider factors associated with medical priority, efficiency of organ placement, expected post-transplant outcome, and equity of access. The creation of such a point- based system would be developed by a "continuous distribution workgroup" consisting of members of the OPTN Thoracic Organ Committee as well as other lung transplant experts. Some of the decisions would be based upon data generated by the Scientific Registry of Transplant Recipients (SRTR). When this model is produced, the goal would be to reproduce similar models for other organs to streamline administrative processes within OPTN. STS is concerned that the available data for the multitude of variables required for such a system will not be sufficiently robust to inform conclusions regarding appropriately weighing and scoring. We do not fully understand the current impact of the lung allocation score on waitlist mortality and post-transplant survival. We believe the addition of new elements to the allocation scoring scheme, including geography, efficient placement, and other available evidence, will cause a greater misunderstanding of the lung allocation system. Additionally, we question the feasibility of harmonizing this allocation model across different organs. We caution against broader implementation until this methodology has been proven to be effective. In addition, patient characteristics and factors impacting survivability are extremely dissimilar among the candidates awaiting different solid organ transplants, including the patient’s tolerance to donor cold ischemia times. We believe it is unlikely that a single model could account for all the relevant factors for these heterogeneous populations. Allocation models should be developed by those who have organ- specific expertise and investment in the process. Lastly, there was a recent change in the adult heart allocation model in October 2018. Until the transplant community has a better understanding of the impact of this new model on waitlist mortality and post- transplant survival, we do not believe it is appropriate to change any allocation models to reflect the OPTN/UNOS preferred continuous distribution model at this time. The allocation models for different organ transplants should only be changed after the model changes, such as those adopted under the heart and lung transplant programs in 2018, have been piloted and they have produced information on patient outcomes. We appreciate the chance to comment on these proposals and would welcome the opportunity to serve as a resource to OPTN/UNOS as it continues its work on this important issue. Sincerely, Robert S.D. Higgins, MD President

Society for Transplant Social Workers | 10/01/2019

Kudos to the OPTN Thoracic Organ Transplantation Committee! This concept paper outlines a thoughtful, reasonable process for embarking on a difficult change for the transplant community. So much progress has been made on so many fronts since the early days of transplant, when local allocation made sense. The composite allocation score proposed by this committee could replace the current arbitrary and outdated geographical criteria for lung distribution with objective, evidence-based criteria instead. It is refreshing to see this committee’s good faith effort at compliance with final rule requirements and OPTN Board of Director mandates. Change is hard. The work outlined in this paper will be complex, but equity for patients demands it. Decreased waitlist deaths will surely follow. And in the end it’s not about transplant centers, DSAs, or regions; it’s about patients.

Region 6 | 10/02/2019

Strongly support (9), Support (26), Neutral/Abstain (15), Oppose (0), Strongly Oppose (5) The region generally supports this concept paper. One member stated that transparency throughout the process is key for the community and that consistency is good. All organs will be similar with point systems for continuous distribution and it is important to make it as equitable and consistent as possible across the country. There is concern regarding questions that might arise years from now with the weight assigned to each variable. One member stated that attorneys might view the point assignments as arbitrary and capricious and that we will be in the same situation we are in now. It needs to be less arbitrary and capricious, particularly where we might not have much data to support the point assignment. One member stated there are many variables and they are not linear, for example, distance has a finite cutoff (all or none). There are many variables similar to this that will make for very strange point scales. We need to figure out the dividing points of non-linear factors. Ex. LAS • Where are the dividing points and where do we need to have a nonlinear line. There was also a question about CIT and efficiency, stating these factors are distance based (both are a surrogate for geography) and inquired as to why we need both? It was explained that CIT addresses post-transplant outcomes for lung. • Efficiency is not point-to-point geography; it needs to account for the actual method you use to get there (fly vs drive, looking at roads, etc.). We need to figure out where factors interact with each other and prioritizing weights will be challenging.

OPTN Transplant Coordinators Committee | 10/02/2019

The OPTN Transplant Coordinators Committee heard a presentation on the Thoracic Committee’s proposal during a meeting on September 9, 2019. Members shared the field experience following the most recent lung allocation policy changes was that both organ offers and subsequent declines of these offers have increased. The Committee expressed wider distribution may not correlate with increase in offer acceptances; this may mean that lungs are coming from donors at other locations as compared to today. There was agreement that elements of a composite allocation score cannot be equally weighted and members supported evidence-based approach to deriving these weights. The was broad interested in future monitoring metrics that would show program acceptance rates, cold ischemia times, transplant outcomes, and distances between donor hospitals and accepting transplant programs. They asserted that post-implementation monitoring include attention to transplant equity to ensure this is not decreased as a result of policy changes. At the conclusion of the discussion, the Committee members were in agreement that the concepts profiled represented a good solution as compared to the current OPTN policy. The Committee appreciated the opportunity to provide feedback on this concept document that will have broad impact on the organ donation and transplantation community.

OPTN Organ Procurement Organization | 10/02/2019

The OPTN Organ Procurement Organization Committee did not provide comments on this concept paper. Vote: 0 strongly support, 4 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

OPTN Minority Affairs Committee | 10/02/2019

The OPTN Minority Affairs Committee thanks the OPTN Thoracic Organ Transplantation Committee for their work on this concept paper. Members commented that determining a weighted system for each organ will be difficult, but that severity of a patient’s disease should be considered important. Members asked how candidate age group would play out in the continuous distribution of lungs. Committee members questioned what weight should be given to Cold Ischemic Time when compared to medical priority.

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) opposes the suggested proposals from the concept paper as written. We recommend the OPTN take an iterative approach to all new organ allocation policies by taking small steps with regular reassessments (e.g. defined trial time before broad adoption, regional vs national wide scale change etc.) to identify successes and unintended consequences, particularly concerning logistical issues and outcomes. The American Society of Transplant Surgeons (ASTS) thanks the OPTN Thoracic Committee for its work on the “Continuous Distribution of Lungs Concept Paper.” At this time, we oppose the proposal as written due to ongoing issues that impact a successful implementation of the continuous distribution of lungs. While changing the model does re-distribute the current volume of lungs to what would appear to be the ideal candidate, this model does not account for variations in practice, recipient-donor matching based on actual clinical management perspectives, and the potential for a marked increase in travel time and distance with implications on acceptance/recovery practices. The latter may have been alluded to with “efficient management of organ placement” though distance of travel and associated logistics are not outlined or well understood. Furthermore, it is not clear what is meant with “low,” “medium,” and “high efficiency.” Changing the model of allocation does not address variabilities involving centers’ acceptance or utilization and recovery of lungs and donor management. This may undermine the efforts of many progressive centers that work closely with their OPO to develop protocols that increase lung donation through effective donor management and optimal organ recovery practices. A continuous allocation system may seemingly even out access to organs. An unintended consequence is when patients can afford to dual list, getting better access to transplant, resulting in a socioeconomic inequity to those unable to dual list. Incorporating the “time on wait list” may change the dynamic of listing patients who may be a bit early, changing allocation priorities and adding burden/cost to listing practices. With the proposed model, highly sensitized patients may indeed get better access to transplants; however, the contribution of various components of the composite score and designated weights allow for great and unpredictable variability. This fact, compounded by wider distribution, is cause for concern on patient impact if there are different regions and program positioning across states and regions. We encourage UNOS to include, in any future policy, metrics for successful procurement and transplantation of lungs and considerations to optimize and standardize management of such donors. In our view, centers that are aggressive by going on more recoveries, using EVLP and employing ECMO strategically, will continue to do so. Changing the model will incur additional travel costs and impose more air travel for transplant surgeons and recovery teams often during unconventional hours. We urge UNOS to take these issues into consideration when policies result in a significant increase in personnel travel without the ability for organ recovery by local teams.

OPTN Region 9 | 10/02/2019

Strongly support (6), Support (9), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0) Region 9 is supportive of the Thoracic Committee’s concept paper that addresses the continuous distribution of lungs. During the discussion members noted the complexity of the model and asked about the ability of UNOS IT to continually update it. In fact, once the programming is complete, adjustments to continuous distribution will be relatively easy to update. There were some comments regarding data and modeling – does UNOS have all the data needed and how would the modeling be validated. One member asked whether the timeline is realistic. Participants agreed that the weighting of the components is critical to the framework and that it will be difficult to determine the weights. They also agreed more detail is needed on what makes up placement efficiency (ex. How will the match run account for flying versus driving?). Questions arose about how lungs from DCD donors and lungs that are perfused will be accounted for in this framework. There was conversation around how this framework will handle rural versus urban candidates and the impact of the framework on small centers with large centers nearby. It was noted that this concept aligns well with NOTA and the Final Rule and is a step in the right direction. Transparency will also be key to ensuring community involvement and input and the framework is operating as intended.

OneLegacy | 10/02/2019

OneLegacy supports the work done by the Ad hoc Geography committee to get our community to this point where we can discuss a concept paper on Continuous Distribution. We feel the medical demographics, wait time considerations and blood type compatibility, that are currently used to create the LAS score and current allocation rankings can be slightly modified to break out into one of the new scoring systems proposed. We would advocate for a sliding scale based on population and transplant center density for the Ischemia Score. The West Coast OPOs are for the most part separated by vast distances from each other. A drive from San Diego to San Francisco will take you through San Diego, Los Angeles and San Francisco ~500 miles. Driving 50 more miles on the East Coast will take you through Richmond, Washington DC, Baltimore, Philadelphia, New York, and Boston. The disparity in population density across the nation necessitates strong consideration for a sliding scale for ischemia point allotment. PTR’s living DSAs separated by vast distances from other DSAs should be given higher scaled points to get more priority to access potential organs. The framework discussed in the Neighborhoods Model could be considered in the ischemia points assignment.

OPTN Histocompatibility Committee | 10/02/2019

The OPTN Histocompatibility Committee received a presentation on the Kidney Committee’s proposal during their monthly teleconference on September 10, 2019. The Committee members agreed that this was an excellent and well thought out solution compared to current OPTN policy. The committee asked several questions and shared their concerns regarding this paper: • Highly Sensitized Candidates: o The committee asked how highly sensitized candidates would be factored into the new allocation score. o Members of the committee are willing to aid the Thoracic committee in determining how to include sensitization into the allocation score to ensure equal access for those candidates. • Future Concerns: o Members asked when the effectiveness of this policy once implemented, would be evaluated, due to the importance of that effectiveness data to future iterations of continuous distribution (CD) for other organs. o When will the modeling of CD be available to help illustrate the impact? • Score Calculation: o Members suggested that in the future, during the calculation of the new score, consider using interactions instead of additives between parameters. The Committee appreciated the opportunity to provide feedback on this concept paper.

Johns Hopkins University | 10/02/2019

Overall, we feel that UNOS’ proposal to transition donor allocation from a classification-based system to a point-based system using a continuous distribution framework has the potential to improve organ allocation within the principles of the OPTN Final Rule. However, the success of this change in achieving its desired objectives will be dependent on using best evidenced-based criteria, when available, to determine the appropriate components and weighting within each domain. The ideal framework would reduce wait list mortality, while improving short AND longer term post-transplant outcomes to avoid transplants that do not provide meaningful recovery for a given individual. Per request of the thoracic board, we offer input re: attributes to consider in development of this model. Medical Urgency: We support use of medical urgency as the most important factor in donor allocation1. We would support adjustment of the urgency component of the lung allocation score or equivalent new model, to more accurately reflect variables that impact wait list mortality for disease specific categories. This need has been demonstrated in a recent analysis of the SRTR that critical variables for individuals with CF and COPD, alongside previously known challenges for pulmonary vascular disease are not accounted for in the LAS2. Further adjustments to accurately input the use of newer technology such as high flow oxygen and Extra Corporeal Membranous Oxygenation are needed. Placement Efficiency Score We believe it is reasonable to include a placement efficiency score as a smaller but still valuable component of the overall model. While cost should not be the highest prioritized driver for match decisions, donor recovery comes with substantial staff and transportation costs. Recent changes in donor allocation may actually suggest an increase in donor discard rates and costs, which could be considered an undesirable consequence of reducing the impact of geography in donor allocation. Consideration of placement efficiency may be warranted to prevent inadvertent limitations in transplant access to candidates by third party payers who could potentially reduce reimbursements of other transplant benefits (i.e medication, hospital copays and/or coverage of specialty procedures) in order to absorb increased costs of donor recovery. Revised Benefit Component Despite advances in donor pool expansion using methods such as ex vivo lung perfusion, or increased use of donors with blood borne pathogens, donor organs remain a limited resource. We would support increased weighting of transplant benefit in the overall model for donor allocation, and would further suggest that metrics beyond one-year survival rate should be considered as better determinants of transplant benefit. Benefits such as survival to hospital discharge, quality of life and long-term survival / freedom from chronic rejection should be better reflected in any measure of benefit used in a revised allocation system. Within this framework, there may be opportunities to capture evidenced- based metrics such as frailty, Class II HLA mismatches into the UNOS database to guide further risk assessment3-7. Further, prioritizing donor allocation of candidates before they reach critical illness severity, may improve long term outcomes and/or reduce wait list mortality in subsets of recipients who are removed from the waitlist upon critical deterioration out of concern for poor transplant outcome8. In this regard, while overall 1-year outcomes have improved for recipients at the highest LAS quartile in contemporary eras, they still lag behind that of other LAS quartiles9. Patient Access Measures that reflect patient access to transplant should be considered as a domain. In particular, measures to help transplant candidates who may face increased challenges to matching in the current system, such as those who are highly sensitized to HLA alleles, individuals with short stature, and candidates in need of dual organ transplant, should be devised and assessed10-12. Further the system should allow flexibility and have an equitable process to adjust allocation for individual factors which may not be adequately captured in the models for a given candidate. Conclusion We believe the continuous distribution framework has high potential address the need to appropriately weigh meaningful factors in organ allocation, and we are pleased to see UNOS moving forward with this model. We look forward to model development and its potential benefit for individuals in need of lung transplant. Sincerely, Pali Shah, Medical Director Lung Transplantation, Johns Hopkins University School of Medicine Errol Bush, Surgical Director, Lung Transplantation, Johns Hopkins University School of Medicine References 1. Vock DM, Durheim MT, Tsuang WM, et al. Survival Benefit of Lung Transplantation in the Modern Era of Lung Allocation. Annals of the American Thoracic Society 2017;14:172-81. 2. Lehr CJ, Skeans M, Dasenbrook EC, et al. Effect of Including Important Clinical Variables on Accuracy of the Lung Allocation Score for Cystic Fibrosis and Chronic Obstructive Pulmonary Disease. American journal of respiratory and critical care medicine 2019. 3. Tikkanen JM, Singer LG, Kim SJ, et al. De Novo DQ Donor-Specific Antibodies Are Associated with Chronic Lung Allograft Dysfunction after Lung Transplantation. American journal of respiratory and critical care medicine 2016;194:596-606. 4. Tinckam KJ, Keshavjee S, Chaparro C, et al. Survival in sensitized lung transplant recipients with perioperative desensitization. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2015;15:417-26. 5. Courtwright AM, Zaleski D, Tevald M, et al. Discharge frailty following lung transplantation. Clinical transplantation 2019:e13694. 6. Singer JP, Diamond JM, Anderson MR, et al. Frailty phenotypes and mortality after lung transplantation: A prospective cohort study. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 2018;18:1995-2004. 7. Singer JP, Diamond JM, Gries CJ, et al. Frailty Phenotypes, Disability, and Outcomes in Adult Candidates for Lung Transplantation. American journal of respiratory and critical care medicine 2015;192:1325-34. 8. Weill D, Benden C, Corris PA, et al. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 2015;34:1-15. 9. Crawford TC, Grimm JC, Magruder JT, et al. Lung Transplant Mortality Is Improving in Recipients With a Lung Allocation Score in the Upper Quartile. The Annals of thoracic surgery 2017;103:1607-13. 10. Tague LK, Witt CA, Byers DE, et al. Association between Allosensitization and Waiting List Outcomes among Adult Lung Transplant Candidates in the United States. Annals of the American Thoracic Society 2019;16:846-52. 11. Bosanquet JP, Witt CA, Bemiss BC, et al. The impact of pre-transplant allosensitization on outcomes after lung transplantation. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation 2015;34:1415-22. 12. Keeshan BC, Rossano JW, Beck N, et al. Lung transplant waitlist mortality: height as a predictor of poor outcomes. Pediatric transplantation 2015;19:294-300.

OPTN Living Donor Committee | 10/02/2019

The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this public comment item. The Living Donor Committee is in support of this concept.

Cystic Fibrosis Foundation | 10/02/2019

On behalf of the Cystic Fibrosis Foundation (CFF) and the below signed individuals of the CF Lung Transplant Consortium, we write in response to the OPTN/UNOS Public Comment Proposal, Continuous Distribution of Lungs Concept Paper. Cystic fibrosis (CF) is a rare genetic disease that affects over 30,000 people in the United States. Over 250 people with CF received transplants in 2017, the majority of which were lung transplants. However, some people with CF also may require liver or kidney transplants due to the disease. As we have previously stated, we ask that UNOS and all transplant providers remain focused on what matters most: the people on the waitlist. They deserve an allocation scheme that aspires to reduce waitlist mortality to zero, transplants the most medically urgent, minimizes the risk of post-transplant complications, and does so in a resource efficient manner. Determining the appropriate measures and weights for a continuous distribution framework is critical to ensuring an equitable allocation policy. We offer a number of thoughts below for UNOS to consider as it continues to assess the continuous distribution framework approach and works towards creating a model appropriate for all organ types. Overall, we believe if these concerns are addressed thoughtfully, UNOS’ proposed move from a classification-based system with hard boundaries and inflexible rules to a point-based system using a continuous distribution framework has the potential to improve organ allocation while honoring the intent of the OPTN Final Rule. Benefits of Selecting the Continuous Distribution Framework: We were pleased to see that UNOS chose to move forward with the continuous distribution model for all organ types. A continuous distribution scheme has the best potential to balance the use of proximity with medical urgency along with additional factors in order to minimize the role of geography in determining transplant recipients. The strength of this model lies in its flexibility, and it should be capable of accommodating special considerations for different organ types. The challenge with this model will be successfully identifying appropriate factors and their weights for inclusion in the final allocation system. UNOS will need to be flexible as the organization advances continuous distribution in lung allocation. As new information on the application and impacts of different metrics become available, UNOS will need to revise the scheme to improve the system to best serve patients in need of a transplant. Additionally, UNOS should be mindful that modifications to the framework will also likely be needed in the future as technology (for example ex vivo lung perfusion) or patient populations change over time. We would like to see UNOS be far more receptive and adaptable in responding to data and making necessary changes than the organization has historically been. Flaws in the Lung Allocation Score (LAS) Must Be Addressed: It is critical that all inputs used in the allocation algorithm are reflective of the outcomes we aim to achieve. Medical priority is a key variable in the allocation process – how urgent a patient’s condition is and how likely they are to benefit from a transplant should be the primary considerations for any organ allocation scheme. As transplant allocation shifts towards an individualized approach where pertinent details about a patients’ circumstances are accounted for, medical urgency scores – including the Lung Allocation Score (LAS) – should shift with it. Medical priority scores that are more attuned to a patient’s specific circumstances will give more accurate predictions of urgency and waitlist mortality. Therefore, we strongly believe that revisions to the LAS should be made in conjunction with the development of the new model. With reasonable updates, the LAS would be better situated to predict the risk of mortality on the waitlist, which would in turn would make the model a more useful tool and accomplish the goals set out in the Final Rule. We understand that the Committee’s priority at this time is devising an allocation scheme that removes the use of arbitrary measures like geographic boundaries. However, the LAS is so critical to the organ allocation process that the Committee would be remiss in not making some necessary updates to it if it is to be used as a core measure in this new model. UNOS in the past has promised to be flexible with the LAS and adapt to new information. However, LAS reforms remain minimal despite evidence that further adjustments are needed to decrease waitlist mortality and reduce arbitrary biases in the existing scoring system. Recently, a paper published using merged data from the Scientific Registry of Transplant Recipients and the CF Foundation’s patient registry demonstrated that the LAS fails to account for critical variables reflecting waitlist mortality for individuals with CF and COPD. This data demonstrates that the LAS, as it stands, does not identify those most likely to benefit from transplant. If UNOS fails to address flaws in the existing LAS, it will do a great disservice to those patients who are dying unnecessarily while awaiting transplant. Decreasing waitlist mortality should not be sacrificed in the name of expedited geographic distribution reform; UNOS should take the time to devise a new allocation system that addresses the needs of all patients on the waitlist. Further Factors to Consider: As the Thoracic Committee proceeds with evaluation of the continuous distribution model, there are several considerations we would like to share on potential factors being considered for a revised allocation system. Placement Efficiency Score: We believe it is reasonable to include a placement efficiency score as a component of the model. Our opinion is that ischemic time is not a valuable measure for efficiency of organ placement. Instead, the committee will need to carefully consider what measures best serve as proxies for placement efficiency. Both the time and method of transportation are important factors for efficiency of placement. While cost should never be the foremost driver for match decisions, we cannot ignore the reality that transportation methods come with different costs. Resource use is inherently tied to the sustainability of the organ transplant system as a whole. UNOS must carefully weigh all options for efficiency measures and be exceptionally thoughtful in considering the value of efficiency scores in the overall model. Revised Benefit Component: One-year survival rate alone does not accurately reflect the benefit of transplantation for any given patient. It is unlikely that people undergo lung transplantation with the aim of only surviving for one year. Instead, important benefits such as disease burden, quality of life and long-term survival should be better reflected in any measure of benefit used in a revised allocation system. We suggest UNOS consider additional measures, including three- or five-year outcomes, as endpoints that are more reflective of success and patient wishes. Additionally, UNOS should consider how the revised system can serve to collect additional relevant data on patient benefit, such as Patient Reported Outcome (PRO) scores or number of hospitalizations, to help develop a more robust understanding of meaningful measures of patient benefit. Including Factors that Impact Access: Measures that reflect patient access to transplant should be considered. In particular, special measures to help transplant candidates who may face more barriers to matching in the current system, such as those who are highly sensitized or individuals with short stature, should be devised and assessed. More information is needed to better characterize the highly sensitized lung transplant recipient. The committee should consider methods to collect more granular data on these patients. We could similarly benefit from more robust data collection on the impact of short stature on access to transplant. While there is evidence to support that short stature reduces an individual’s chance to match, more information is needed to assess what measures could be included to counteract the disadvantages experienced by these individuals during the match process. The committee should also begin to think about how continuous distribution for all organ systems will impact a person’s ability to receive a multi-organ transplant. The present allocation system has failed to adequately address the needs of this vulnerable patient population. UNOS should take this opportunity to fully address this issue. Conclusion: We believe the continuous distribution framework has the potential to best address the need to appropriately weigh meaningful factors in organ allocation as proposed, and we are pleased to see UNOS moving forward with this model. However, we are concerned that maintaining a singular focus on this model without simultaneously addressing arbitrary measures and biases in the LAS will be a major disservice to patients on the waitlist. We are happy to serve as a resource and look forward to working alongside OPTN/UNOS in the future on this issue. Sincerely, Albert Faro, MD Senior Director, Clinical Affairs Cystic Fibrosis Foundation CF Lung Transplant Consortium Members: Jason Christie, MD, MS Penn Medicine Elliott Dasenbrook, MD, MHS Cleveland Clinic Joshua Diamond, MD, MSCE Hospital of the University of Pennsylvania Ramsey Hachem, MD Washington University School of Medicine Marshall Hertz, MD University of Minnesota Erin Lowery, MD, MS Loyola University Medical Center Joseph Pilewski, MD University of Pittsburgh Medical Center Kathleen Ramos, MD, MSc University of Washington, Seattle Pali Shah, MD Johns Hopkins Laurie Snyder, MD, MHS Duke University School of Medicine Stuart Sweet, MD, PhD Washington University School of Medicine in St. Louis