1. Proposal to Substantially Revise the National Kidney Allocation System
Sponsored by: The Kidney Transplantation Committee
Good <<morning>>, <<afternoon>>, <<evening>>
I am <<name>>, <<Committee position>> to the Kidney Transplantation Committee. It is my pleasure to present to you today the Committee’s proposal to substantially revise the National Kidney Allocation System. This is a proposal nearly a decade in the making with several components. The purpose of today’s presentation is to describe to you the problems the proposal is intended to address, the approach being proposed by the Committee, and the expected results from that approach.
No organ allocation policy can resolve the existing gap between donated organs and candidates listed for a deceased donor transplant. That gap is greatest in kidney transplantation, as the kidney is by far the most commonly needed organ. A shared personal commitment to save lives through organ donation is the best way to help all candidates have an opportunity for a transplant.
This proposal is intended to maintain access for kidney transplantation for all candidates while making sure more recipients get the greatest possible survival benefit from a transplant. The proposed policy also would offer harder-to-place kidneys over a wider geographic area to increase use these kidneys. Finally, the proposal seeks to give an appropriate level of access for candidates who are hard to match for most kidneys and thus face a wait much longer than average.

2. Current System Limitations
High discard rates
Access variability due to geography and biology
Mismatch in graft/patient survival
At the start of this process, the Committee undertook a 360 degree review of the current kidney allocation system. While there are many limitations, the system has operated for nearly 30 years and has many components that function well without substantial revision. There are three main areas, however, where the system is not designed well and needs revision to achieve better results.
These areas are (1) the high discard rate of kidneys that we know can provide benefit to candidates on the waiting list, (2) differences in access based on geography and biology—and by this we are specifically referring to the substantially longer waiting times that sensitized candidates face, we are also hoping to address the variable use of kidneys from expanded criteria donors in different areas of the country and (3) the mismatch in graft and patient survival. Nearly 20% of those on the waiting list are not waiting for their first kidney transplant which means that when we do not match graft and patient survival, the cost is repeat transplants which deplete the number of available kidneys available for those who require a first transplant.
Wide variability in any region as to how you get a kidney, we’re trying to standardize

3. The Growing Waiting List
This graph illustrates another reason why revisions to the kidney allocation system are necessary at this time. Over the 30 years since we have been allocating kidneys, the demand for kidney transplant has increased dramatically, from around 10,000 candidates to over 90,000 candidates while the number of kidney transplants has not kept pace with the growing demand. This means that candidates must wait, oftentimes for years to receive a kidney transplant.
OPTN data as of September 1, 2012

4. Unbalanced System Components
Over time, waiting time has become the primary driver of kidney allocation
Histocompatibility components have diminished over time
This overreliance led to a system that does not accomplish any goal other than transplanting the candidate waiting the longest
Doesn’t recognize that not all can wait the same length of time
Fails to acknowledge different needs for different candidates (e.g., speed over quality)
Additionally, the allocation system has been incrementally changed over the years. Initially, the primary driver of kidney allocation was based on the degree of biological match between the kidney and the recipient. Points were given for HLA-A, B, and DR matching. Over time, points for HLA-A and HLA-B were removed and a candidate’s waiting time became the primary driver of kidney allocation.
Unfortunately, the overreliance on waiting time has led to a system that does not accomplish any goal other than transplanting the candidate waiting the longest. This system does not recognize that not everyone has the same ability to survive the wait.
These limitations led the Committee to design a system intended to achieve several objectives…

5. Proposed Policy Objectives
Make the most of every donated kidney without diminishing access
Promote graft survival for those at highest risk of retransplant
Minimize loss of potential graft function through better longevity matching
Improve efficiency and utilization by providing better information about kidney offers
<<Review objectives listed>>

6. Proposed Policy Objectives
Provide comprehensive data to guide transplant decision making
Reduce differences in access for ethnic minorities and sensitized candidates
<<Review objectives listed>>

7. The course of policy development
Date
Sentinel Event
2003
Board requests review of kidney allocation system; public hearings held
2004
Board directs investigation of benefit use in a kidney allocation system
2007
Public Forum held in Dallas; main topic LYFT
2008
RFI released: main topics KDPI/LYFT
2009
Public Forum held in St. Louis; main topics LYFT/KDPI
Donor/recipient age matching reviewed as possibility
2011
Concept document released: main topics EPTS/age matching/ KDPI
Age matching no longer under consideration
2012
Public comment proposal
This process officially began in 2003 and the Committee has solicited public feedback throughout the process. After each hearing, public forum, or other public solicitation, the Committee adjusted its approach based on the feedback received. The proposal being presented today is a product of the consensus-driven process that has been ongoing for nearly a decade.

8. Preview of Expected Outcomes
New system forecasted to result in:
8,380 additional life years gained annually
Improved access for moderately and very highly sensitized candidates
Improved access for ethnic minority candidates
Comparable levels of kidney transplants at regional/national levels
Before we begin, it’s important to see where we’re going. The changes that I am about to describe result in a gain in life years for transplant recipients, as well as improved access for candidates who currently face difficulty receiving a transplant while not disrupting the current geographic distribution of kidneys.

9. System Design

10. Overview of proposed policy
Current
Currently, the kidney allocation sequence has four distinct pathways based on the characteristics of the kidney. Kidneys from donors younger than 35 are allocated preferentially to pediatric candidates. Kidneys from expanded criteria donors (ECD) are allocated to candidates who consent to receiving these organs. Kidneys from standard criteria donors (SCD) are allocated to all candidates on the waiting list. Kidneys from donation after cardiac death (DCD) donors are allocated according to a sequence that speeds placement by focusing on local distribution.
Similarly, there are four distinct pathways for kidney allocation within the proposed system. Unlike the current system which uses different criteria for determining the pathways (ECD status, DCD status, donor age), the proposed system uses the kidney donor profile index (KDPI). The diagram below demonstrates the four different pathways based on KDPI. For example, if a kidney becomes available with a KDPI score greater than 20% but less than 35%, then the kidney would follow allocation sequence B. For reference, kidneys with higher estimated quality have lower KDPI scores.
All allocation sequences to be based on KDPI

11. Kidney Donor Profile Index (KDPI)
KDPI Variables
Donor age
Height
Weight
Ethnicity
History of Hypertension
History of Diabetes
Cause of Death
Serum Creatinine
HCV Status
DCD Status
Ten medical factors about the potential donor are used to calculate the Kidney Donor Profile Index (KDPI) score:
Age
History of diabetes
Height
Cause of death
Weight
Serum creatinine (a measure of kidney function)
Ethnicity
Hepatitis C virus status
History of hypertension
Whether the donation occurred after circulatory death
These factors are used in a clinical formula. A percentage score estimates how long a kidney offer is likely to function when compared with all other offers. A low KDPI percentage indicates likely longer function, and a high percentage indicates likely shorter function. A KDPI of 20 percent, for example, suggests the kidney will likely function longer than 80 percent of available kidneys.
Donor age and certain medical facts about the donor are known to affect how long a donated kidney is likely to function. Under current policy definitions, any deceased kidney donor age 60 or older is considered an “extended criteria donor,” as are those between age 50 and 59 who have certain medical history profiles. All other kidney donors are defined as “standard” criteria donors.
Currently, kidneys from extended criteria donors are used in patients who are expected not to do well on dialysis over a long period of time. By undergoing transplantation with a kidney from an extended criteria donor, they can be transplanted more rapidly than if they waited a standard criteria donor kidney.
Research has shown that the current definitions do not always precisely estimate the length of donor kidney function. Kidneys from some donors currently considered “extended criteria” may function longer than kidneys from some “standard criteria” donors. The Kidney Donor Profile Index provides a more detailed and accurate estimate of kidney longevity from each donor than the current criteria. KDPI would replace the current designations of ECD and SCD.
KDPI values now displayed with all organ offers in DonorNet®

12. Sequences based on KDPI
Sequence A
KDPI >20% but <35%
Sequence B
Kidney becomes available
KDPI >=35% but <=85%
Sequence C
<<This slide is a transition to get to the classifications>>
KDPI > 85%
Sequence D

13. Sequences based on KDPI
Sequence A
KDPI<=20%
Sequence B
KDPI >20% but <35%
Sequence C KDPI>=35% but <=85%
<<This slide is a transition to get to the classifications>>
Sequence D
KDPI>85%

14. Sequence C KDPI>=35% but <=85%
Sequence A
KDPI<=20%
Sequence B
KDPI >20% but <35%
Sequence C KDPI>=35% but <=85%
Sequence D
KDPI>85%
<<This slide is a transition to get to the classifications>>

15. Sequence A Sequence B Sequence C Sequence D KDPI <=20%
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
This table provides a summary of the allocation categories for each of the sequences. We will refer to this table throughout the rest of the presentation to show what changes are being proposed.
Within each of the categories, candidates are rank-ordered according to points for circumstances such as waiting time, sensitization, being a prior living organ donor or a pediatric candidate.

16. Proposed Classification: Longevity Matching
Estimated Post-Transplant Survival
Candidate age, time on dialysis, prior organ transplant, diabetes status
Top 20% of candidates by EPTS to receive kidneys matched on longevity
Applies only to kidneys with KDPI scores <=20% not allocated for multi-organ, very highly sensitized, or pediatric candidates
The first proposed change is that of Longevity Matching which uses a formula called Estimated Post-transplant Survival (EPTS). Unlike the liver allocation system or the lung allocation system, the current kidney allocation system does not have a candidate classification based risk of death while on the waiting list or estimated post-transplant survival. Incorporating a metric like estimated post-transplant survival would allow for better matching of candidates and donated grafts so that individuals with very long estimated post transplant survival do not receive kidneys with very short survival (necessitating a second or third transplant from an already limited donor pool) and vice versa.
Four medical factors about the transplant candidate are used to calculate the Estimated Post-Transplant Survival (EPTS) score:
Age
History of diabetes
Length of time on dialysis
History of a prior kidney transplant
These factors are also used in a clinical formula. A percentage score estimates how long a candidate is expected to benefit from a functioning kidney when compared to the experience of other recipients over a recent time. A low EPTS percentage indicates likely longer-term survival, and a high percentage indicates shorter likely benefit. An EPTS of 20 percent, for example, suggests that if the candidate is transplanted, he or she would likely survive longer than 80 percent of other recipients.
The use of EPTS would not change how the majority of kidney candidates get priority for kidneys – only those expected to need and benefit from a transplant the very longest.

17. Proposed Longevity matching
Sequence A
KDPI <=20%
Sequence B
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
Proposed Longevity matching
The new categories for candidates with a top 20% EPTS score are highlighted in the red circles. They only apply for kidneys with a KDPI score less than or equal to 20% that are not otherwise allocated to candidates with CPRA scores of greater than or equal to 98% or for multi-organ transplants. It is important to note that local candidates with scores greater than 20% will still receive local offers before regional and national candidates.

18. Proposed Classifications: Very Highly Sensitized
Candidates with CPRA >=98% face immense biological barriers
Current policy only prioritizes sensitized candidates at the local level.
Proposed policy would give following priority
To participate in Regional/National sharing, review & approval of unacceptable antigens will be required
CPRA=100%
National
CPRA=99%
Regional
CPRA=98%
Local
Sensitized candidates are known to wait substantially longer than unsensitized candidates, suggesting that more needs to be done to equalize waiting times between these two groups. Additionally, candidates with CPRA greater than 98% see a marked decline in the number of compatible offers received (Figure 9). Due to their level of sensitization, these candidates require access to a larger donor pool in addition to priority within their donation service area.
The proposed policy would give national priority to those candidates with CPRA scores of 100%, regional priority to those candidates with CPRA scores of 99% and local priority to candidates with CPRA scores of 98%.

19. New categories for highly sensitized candidates
Sequence A
KDPI <=20%
Sequence B
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
New categories for highly sensitized candidates
These highly sensitized candidates would appear in the top category for each sequence, stratified by CPRA score and level of distribution.

20. Unmodified Classification: Prior Living Organ Donor
Prior living organ donors receive the same level of priority as current policy
Requirements remain the same for registering a prior living organ donor
Policy proposal to allow priority with subsequent registrations to be considered by Board in November 2012
Proposed policy will base qualification on date of procurement not date of transplant
Would provide priority for prior donors whose organs were removed but not transplanted
This proposal updates the prior living organ donor policy to specify that the date of procurement, not the date of transplant, is necessary to certify a candidate as a prior living organ donor. The current policy is vague on situations where an organ is procured from a living donor but not transplanted into a recipient. These occurrences are infrequent but may be due to a change in the recipient’s health status, the discovery of disease or trauma in the donated organ, or other factors outside of the donor’s control. The proposed policy language clarifies that a candidate will be considered a prior living organ donor if they donated an organ, even if that organ did not ultimately result in a transplant.

21. Continued priority for prior living donors
Sequence A
KDPI <=20%
Sequence B
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
Continued priority for prior living donors
The placement of the prior living organ donors’ category does not change with the proposed policy.

22. Modified Classification: Pediatric
Current policy prioritizes donors younger than 35 to candidates listed prior to 18th birthday
Proposed policy would
Prioritize donors with KDPI scores <35%
Eliminate pediatric categories for non 0-ABDR KPDI >85%
Provides comparable level of access while streamlining allocation system
Candidates who were younger than 18 at the time of registration receive priority ahead of all other local candidates for kidneys from donors younger than 35. This system was designed to expedite transplant for pediatric candidates by providing increased access to organs with longer estimated post-transplant function. The system has been working well and achieving its stated objectives.
As the Kidney Transplantation Committee began working to design a kidney allocation system based on KDPI, it asked the Pediatric Transplantation Committee to consider whether the donor age threshold could be converted to KDPI, a more refined measure of donor quality compared to age alone. The purpose of this change would be to maximize system flexibility. After modeling various thresholds, the Pediatric Transplantation Committee recommended that the KDPI threshold be set at With this threshold, SRTR simulation modeling has forecasted that pediatric candidates would maintain the same level of access that is experienced under the current system.
Additionally, in the proposed system, pediatric candidates would no longer receive offers for kidneys from donors with KDPI scores greater than 85%. An analysis of OPTN data determined there have been zero transplants of solitary ECD kidneys into pediatric candidates since Removing pediatric candidates from this allocation sequence would streamline system efficiency without harming access for this patient population.

23. Continued priority pediatric candidates
Sequence A
KDPI <=20%
Sequence B
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Prior living organ donor
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
Continued priority pediatric candidates
(now based on KDPI)
Pediatric candidates are categorized in the same manner as in the current system.

24. Modified Classification: Local + Regional for High KDPI Kidneys
KDPI >85% kidneys would be allocated to a combined local and regional list
Would promote broader sharing of kidneys at higher risk of discard
DSAs with longer waiting times are more likely to utilize these kidneys than DSAs with shorter waiting times
Currently, kidneys from expanded criteria donors are offered first locally and candidates who elect to receive ECD kidneys are rank ordered only according to waiting time. The goal is to expedite placement of these kidneys. Unfortunately, discard rates for ECD kidneys are high and also vary widely across OPOs. Generally, OPOs with longer waiting times tend to procure and transplant more ECD kidneys than OPOs with shorter waiting times. This suggests that demand drives decision making on whether to utilize these kidneys more so than clinical utility.
The Committee investigated ways to improve procurement and transplantation rates for kidneys at a high risk of discard. Among the options considered was expanding the distribution area for these kidneys so that these kidneys are offered first to a combined regional and local unit. This proposed approach would make available with less cold ischemic time those kidneys that would be discarded in one OPO due to shorter candidate waiting times but utilized in a neighboring OPO with longer waiting times.

25. Proposed Regional Sharing
Sequence A
KDPI <=20%
Sequence B
KDPI >20% but <35%
Sequence C
KDPI >=35% but <=85%
Sequence D
KDPI>85%
Highly Sensitized
0-ABDRmm (top 20% EPTS)
Prior living organ donor
Local pediatrics
Local top 20% EPTS
0-ABDRmm (all)
Local (all)
Regional pediatrics
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
0-ABDRmm
Local adults
Regional adults
National adults
Local
Regional
National
Local + Regional
*all categories in
Sequence D are limited to adult candidates
Proposed Regional Sharing
Whereas the current system places ECD kidneys locally and then regionally, the proposed system would combine these two distribution units to expedite placement.

26. Modified Classification: B Candidates receiving A2/A2B Kidneys
Candidates with blood type B who meet defined clinical criteria will be eligible to accept kidneys from donors with blood type A2 or A2B
Reported anti-A titer values required on regular schedule
No titer values of greater than or equal to 1:8 allowed for candidate participation
Blood type B is more common among minority populations, but only about 12 percent of deceased donors have this blood type. As a result, many type B candidates face a longer wait for a transplant than those with more common blood types. The proposed matching of donors with compatible subgroups of blood type A is expected to reduce waiting time for type B candidates, many of whom are minorities. The additional priority for candidates with high immune system sensitivity should also provide additional transplant access for minority candidates who are highly sensitized.

27. Removed Classification: Kidney Paybacks
Current payback policy was evaluated and found to be
Administratively challenging
Unfair in that it affected all candidates in an OPO even if only one center was responsible for accruing debt
Ineffective in improving outcomes of recipients
Kidney paybacks would no longer be permitted.
All payback credits and debts would be eliminated upon the implementation of the revised kidney allocation system.
Currently, the kidney allocation system requires an OPO that receives a kidney from another OPO for zero-antigen mismatch or for a combined organ transplant to payback a kidney to the originating OPO from the same blood type. Policy sets requirements for which types of kidneys must be offered as paybacks.
From an administrative perspective, the kidney payback system has been fraught with challenges since its implementation. Penalties for exceeding debt thresholds are levied against all transplant programs served by an OPO, even if only one program is responsible for accruing the debt. Several OPOs have reported difficulty in paying down debt because credited OPOs do not accept payback offers. The Kidney Transplantation Committee has spent considerable time hearing complaints about the payback system and has, over the years, adjusted the system to no apparent benefit. Furthermore, the benefit of shipping kidneys purely for administrative purposes is not clear. Payback kidneys tend to have more cold ischemic time than kidneys transplanted locally. For these reasons, the Committee proposes eliminating the kidney payback system entirely. Kidneys that are shared for zero antigen mismatches, for extremely highly sensitized candidates, and for combined organ transplant would no longer incur a payback debt.
All payback credits and debts would be eliminated upon the implementation of the revised kidney allocation system.

28. Priority within Classifications

29. Proposed Changes to Point System
Candidates are rank-ordered according to points within each classification.
No proposed point changes for
Proposed point changes for
HLA-DR
Prior living organ donors
Pediatric candidates
Sensitized candidates
Waiting time
The current system awards points for zero HLA-DR and one HLA-DR mismatches, for prior living organ donors and for pediatric candidates. These points are not slated to be changed. The Committee is recommending revisions to the points awarded to sensitized candidates, and the points awarded for waiting time.

30. Proposed Point Changes: Sensitization
4 points
Proposed
Current
(CPRA=98,99,100 receive 24.4, 50.09, and points, respectively.)
Based on a time-to-offer analysis, the Committee found that that candidates began to experience barriers to transplant starting at a CPRA score of 20% which gradually increased with increasing sensitization until an inflection point at about 95%. Above 95%, waiting time increases more substantially due to the decreasing offer and transplant rate for these candidates. In response to these observations, the following point system, a “sliding scale” based on candidate CPRA was derived via a mathematical transformation of the offer rate patterns shown above.
This sliding scale would replace the current 4 points offered only to candidates with CPRA scores greater than or equal to 80%.
Current policy: 4 points for CPRA>=80%. No points for moderately sensitized candidates. Proposed policy: sliding scale starting at CPRA>=20%

31. Proposed Point Changes: Waiting Time
Current policy begins waiting time points for adults at registration with:
GFR<=20 ml/min
Dialysis time
Proposed policy would also award waiting time points for dialysis time prior to registration
Applies to both pediatric and adult candidates
Better recognizes time spent with ESRD as the basis for priority
Pre-emptive listing would still be advantageous for 0-ABDR mismatch offers
Studies have shown that some minority candidates are less likely than Caucasians to be listed for a kidney transplant either at or before the time they start dialysis. Thus by the time they are listed and start getting waiting time priority for a transplant, their kidney disease is more advanced and they are more likely to experience additional health complications. In some cases, this time gap between dialysis and transplant listing may happen because the potential candidate hasn’t received reliable information about the option of getting a transplant. Under the proposed policy, waiting time priority for all candidates would begin from the time they begin dialysis or meet a medical definition of end-stage kidney failure. This should make transplant waiting times more equivalent in terms of medical need and benefit among all candidates.

32. Simulated Policy Results

33. Evaluating Potential Policy Changes
Scientific Registry of Transplant Recipients (SRTR) simulates proposed policy changes
Kidney-Pancreas Simulated Allocation Model (KPSAM)
50+ KPSAM runs conducted throughout policy development
4 KPSAM runs presented here for comparison
<<Review bullet points>>
While simulation modeling is immensely useful for evaluating the potential effects of policy changes, it has its limitations. The results presented here can only show what may happen with the current supply of donated kidneys and the candidates currently on the waiting list. The modeling does not take into account any changes in behavior that will likely follow a policy change.
Additionally it is more important to look at trends and directions of the results rather than determining whether small percentage changes are remarkably different from one another. For example, a four percent increase in the number of transplants for minority candidates under one simulation run may not be statistically different from a five percent increase—what is important is the increase itself.

34. Major Proposed Changes by Run
Enhanced definition of waiting time to include pre-listing time since initiation of dialysis X
A2/A2B donor to B candidates priority
Longevity matching (based on KDPI and EPTS)
CPRA sliding scale point assignment
National Priority for CPRA>=98%
Tiered Priority for CPRA>=98%
Regional sharing for kidneys with KDPI scores >85%
To better determine the individual effects of the proposed policy changes, four separate simulation runs were conducted. These are referred to as N1, N2, N3, and N4 for reference purposes. Simulation run N1 represents the current kidney allocation system with results that closely mimic those actually observed in Simulation run N2 included the following proposed changes to the current allocation system: the revised definition of waiting time, allocation of A2 and A2B kidneys to B candidates, etc. Simulation run N3 includes those enhancements from N2 and also longevity matching, national priority for candidates with CPRA greater than or equal to 98%, regional sharing for kidneys with KDPI scores greater than 85%. Simulation run N4 is identical to simulation run N3 but alters the priority for candidates with CPRA greater than or equal to 98% to provide national priority for candidates with CPRA scores of 100%, regional priority for candidates with CPRA scores of 99%, and local priority for candidates with CPRA scores of 98%.
N1 represents simulation of the allocation rules as they existed in 2010

35. Overall KPSAM Results Average for 10 iterations N1 N2 N3 N4
Number of candidates (on waitlist at start or joining during run)
122,669
Average number of primary KI+KP transplant recipients (min, max of runs)
11,531 (11,463-11,586)
11,595
(11,526-11,655)
11,386
(11,359-11,429)
11,365 (11,324-11,409)
Average median lifespan post-transplant (min, max of runs)
11.82
( )
11.72
( )
12.63
( )
12.73
( )
Overall, the system results in a projected total of 144,676 “life years” from the approximately 11,000 annual deceased donor kidney transplants. By comparison, the current system (N1) results in a simulated 136,296 life years, reflecting an estimated increase of 8,380 life years achieved annually for the proposed system (N4) compared to the current system. This increased is based on a projected 7.7% increase in the median life years per transplant, from to The new system is also expected to increase the median life years of benefit (relative to staying on the waitlist) per transplant from 5.01 to 5.27, a 5.2% increase (Table 6). In addition, the proposed system results in an increase in the number of sensitized candidates receiving transplants, especially those with very high levels of sensitization. This system also results in an increased transplant rate for African American and Hispanic candidates. These results are obtainable with a minimal increase in the rate of shipping kidneys.
Average
(min-max)
of runs

36. Overall KPSAM Results Average for 10 iterations N1 N2 N3 N4
Average median graft years of life
8.82
( )
8.8
( )
8.99
( )
9.1
( )
Average median extra life-years for tx recipient versus waitlist candidate
5.01
( )
4.95
( )
5.24
( )
5.27
( )
Average median LYFT per transplant
5.7
( )
5.65
( )
5.93
( )
5.97
( )
Average
(min-max)
of runs

37. KPSAM Results by blood type
The simulation results show an increase in the number of transplants for candidates with Blood type B, many of whom are minorities.

38. KPSAM results by candidate age
The proposed policy continues to allow broad access for candidates who are age 50 and older. Candidates who are 50 or older make up more than 60 percent of the kidney transplant waiting list and currently receive more than 60 percent of deceased donor kidney transplants.

39. KPSAM results by ethnicity
The proposed policy appears to better align transplants with the distribution of candidates on the waiting list based on candidate ethnicity.

40. KPSAM results by 0-ABDR mismatch
The proposed policy does result in somewhat fewer zero ABDR mismatched transplants

41. KPSAM results by CPRA
The simulation modeling shows a decrease in transplants for candidates with CPRA scores of 0%. Currently, there is no point incentive for listing unacceptable antigens unless the candidate can achieve a CPRA score of at least 80%. As the proposed point system would start at 20%, the Committee expects that many of these candidates with CPRA scores of 0% actually have some degree of sensitization. The sliding scale point system shows an increase for moderately sensitized candidates with 20-79% CPRA scores, and a small decline for those with CPRA scores over 80%. Based on the time to offer analysis, the current policy of awarding 4 points to candidates with CPRA scores over 80% may have lead to on over-advantage for candidates with CPRA scores between 80% and 90%. The sliding scale corrects this.

42. KPSAM results by CPRA (95-100%)
The Committee initially examined giving national priority to all candidates with CPRA scores of 98% and higher, as shown in Run N3 (the purple bars) above. It was found that national priority resulted in a disproportionate number of transplants for candidates with CPRA scores of 98% and 99%, indicating that the donor pool was too broad. The Committee then revised its approach in Run N4 (the light blue bars above) to give national priority to candidates with 100% CPRA, regional priority to candidates with 99% and local priority to candidates with 98% CPRA. This approach resulted in a distribution of transplants that more closely reflected the waitlist distribution for each CPRA category.

43. KPSAM results by degree of sharing
The percent of kidney sharing, or kidneys being transplanted in a DSA other than the DSA of procurement, is expected to increase under the proposed policy. This was anticipated, as the policy specifically adds new rules for sharing for candidates with CPRA scores of 99% or 100% and also combines local and regional allocation for kidneys with KDPI scores greater than 85%. However, the level of sharing for the proposed policy was found to be less than the level of sharing under simulation run N3.

44. Summary New system forecasted to result in:
8,380 additional life years gained annually
Improved access for moderately and very highly sensitized candidates
Improved access for ethnic minority candidates
Comparable levels of kidney transplants at regional/national levels
To summarize…
<<Read the bullet points>>

45. Participate in Policy Development
Submit comments online:
optn.transplant.hrsa.gov
Access webinar schedules
Download educational materials
Public
comment period ends December 14
This and other current public comment proposals are available online on the OPTN website: Before commenting, please read the proposal. It explains in detail the intended goals, alternative approaches that have been considered, and statistical modeling of possible effects of the policy. You may then submit a comment online through the website. Comments will be accepted through Friday, December 14, 2012.

46. Committee Leadership and Support
John J. Friedewald, MD Committee Chair
Richard N. Formica, Jr, MD Committee Vice Chair
Ciara J. Samana, MSPH UNOS Committee Liaison

47. Backup Slides

48. Percent of candidates in national top 20%, by Donor Service Area of candidate’s listing center
From Feb 6 SRTR Presentation

49. Percent of kidney donors in national top 20%, by DSA of donor
From Feb 6 SRTR Presentation