Proposal to Substantially Revise the National Kidney Allocation System Sponsored by: The Kidney Transplantation Committee

Proposal to Substantially Revise the National Kidney Allocation

System

Sponsored by: The Kidney Transplantation Committee

High discard rates

Access variability due to geography and biology

Mismatch in graft/patient survival

Current System Limitations

The Growing Waiting List

OPTN data as of September 1, 2012

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)

Unbalanced System Components

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

Proposed Policy Objectives

Provide comprehensive data to guide transplant decision making

Reduce differences in access for ethnic minorities and sensitized candidates

Proposed Policy Objectives

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 LYFT2008 RFI released: main topics KDPI/LYFT2009 Public Forum held in St. Louis; main topics LYFT/KDPI 2009 Donor/recipient age matching reviewed as possibility2011 Concept document released: main topics EPTS/age

matching/ KDPI2011 Age matching no longer under consideration2012 Public comment proposal

The course of policy development

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

Preview of Expected Outcomes

SYSTEM DESIGN

Overview of proposed policy

Current Proposed

All allocation sequences to be based on KDPI

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

KDPI values now displayed with all organ offers in DonorNet®

Sequences based on KDPI

Kidney becomes available

KDPI<=20%

KDPI >20% but <35%

KDPI >=35% but <=85%

KDPI > 85%

Sequence A

Sequence B

Sequence C

Sequence D

Sequences based on KDPI

Sequence AKDPI<=20%

Sequence BKDPI >20% but <35%

Sequence CKDPI>=35% but

<=85%

Sequence DKDPI>85%

Sequence AKDPI<=20%


Sequence CKDPI>=35% but

<=85%

Sequence DKDPI>85%

Sequence AKDPI <=20%


Sequence CKDPI >=35% but

<=85%

Sequence DKDPI>85%

Highly Sensitized0-ABDRmm (top 20% EPTS)Prior living donorLocal pediatricsLocal top 20% EPTS0-ABDRmm (all)Local (all)Regional pediatricsRegional (top 20%)Regional (all)National pediatricsNational (top 20%)National (all)

Highly Sensitized0-ABDRmmPrior living donorLocal pediatricsLocal adultsRegional pediatricsRegional adultsNational pediatricsNational adults

Highly Sensitized0-ABDRmmPrior living donorLocal RegionalNational

Highly Sensitized0-ABDRmmLocal + Regional National *all categories in Sequence D are limited to adult candidates

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

Proposed Classification: Longevity Matching




<=85%

Sequence DKDPI>85%





Propose

d

Longe

vity

matching

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

Proposed Classifications: Very Highly Sensitized

CPRA=100% NationalCPRA=99% RegionalCPRA=98% Local




<=85%

Sequence DKDPI>85%





New

categories

for highly

sensitized

candidates

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

Unmodified Classification: Prior Living Organ Donor




<=85%

Sequence DKDPI>85%





Continued priority for prior living donors

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

Modified Classification: Pediatric




<=85%

Sequence DKDPI>85%



Highly Sensitized0-ABDRmmPrior living organ donorLocal RegionalNational


Continued

priority

pediatric

candidates

(now based

on KDPI)

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

Modified Classification: Local + Regional for High KDPI Kidneys




<=85%

Sequence DKDPI>85%

Highly Sensitized0-ABDRmm (top 20% EPTS)Prior living organ donorLocal pediatricsLocal top 20% EPTS0-ABDRmm (all)Local (all)Regional pediatricsRegional (top 20%)Regional (all)National pediatricsNational (top 20%)National (all)

Highly Sensitized0-ABDRmmPrior living organ donorLocal pediatricsLocal adultsRegional pediatricsRegional adultsNational pediatricsNational adults

Highly Sensitized0-ABDRmmPrior living organ donorLocal RegionalNational


Proposed

Regional

Sharing

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

Modified Classification:B Candidates receiving A2/A2B Kidneys

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.

Removed Classification:Kidney Paybacks

PRIORITY WITHIN CLASSIFICATIONS

Candidates are rank-ordered according to points within each classification.

Proposed Changes to Point System

No proposed point changes for

Proposed point changes for

•HLA-DR•Prior living organ donors•Pediatric candidates

•Sensitized candidates•Waiting time

Proposed Point Changes: Sensitization

Current policy: 4 points for CPRA>=80%. No points for moderately sensitized candidates. Proposed policy: sliding scale starting at CPRA>=20%

0 0 0 0.08 0.21 0.34 0.48 0.81 1.091.58 2.46

4.05

6.71

10.82

12.17

17.30

02468

101214161820

0 10 20 30 40 50 60 70 80 90 100

Poin

ts

CPRA

CPRA Sliding Scale (Allocation Points)(CPRA<98%)

4 points

Proposed

Current

(CPRA=98,99,100 receive 24.4, 50.09, and 202.10 points, respectively.)

Darren E Stewart

This is the graph used for the ATC presentation. Feel free to use it, or not.

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

Proposed Point Changes: Waiting Time

SIMULATED POLICY RESULTS

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

Evaluating Potential Policy Changes

Proposed Change N1 N2 N3 N4Enhanced definition of waiting time to include pre-listing time since initiation of dialysis

X X X

A2/A2B donor to B candidates priority X X XLongevity matching (based on KDPI and EPTS) X XCPRA sliding scale point assignment X XNational Priority for CPRA>=98% XTiered Priority for CPRA>=98% XRegional sharing for kidneys with KDPI scores >85%

X X

Major Proposed Changes by Run

N1 represents simulation of the allocation rules as they existed in 2010

Average for 10 iterations N1 N2 N3 N4 Number of candidates (on waitlist at start or joining during run)

122,669 122,669 122,669 122,669

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(11.75 - 11.85)

11.72(11.68-11.83)

12.63(12.3-12.45)

12.73(12.65-12.79)

Overall KPSAM Results

Average(min-max)

of runs

KPSAM Results by blood type

0

10

20

30

40

50

60

A AB B O

Perc

ent

Waitlist 2010 N1 N4

KPSAM results by candidate age

0

5

10

15

20

25

30

35

40

45

<18 18-34 35-49 50-64 65+

Perc

ent

Waitlist 2010 N1 N4

KPSAM results by ethnicity

05

101520253035404550

Pe

rce

nt

Waitlist 2010 N1 N4

KPSAM results by 0-ABDR mismatch

0

1

2

3

4

5

6

7

8

9

10

0 Total HLA mismatches

Perc

ent

2010 N1 N4

KPSAM results by CPRA

0

10

20

30

40

50

60

Perc

ent

Waitlist 2010 N1 N4

KPSAM results by CPRA (95-100%)

KPSAM results by degree of sharing

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

Summary

Submit comments online:

optn.transplant.hrsa.gov

Access webinar schedules

Download educational materials

Participate in Policy Development

Publiccomment period ends December 14

John J. Friedewald, MDCommittee Chair

Richard N. Formica, Jr, MDCommittee Vice Chair

Ciara J. Samana, MSPHUNOS Committee [email protected]

Committee Leadership and Support

BACKUP SLIDES

Percent of candidates in national top 20%, by Donor Service Area of candidate’s listing center

Percent of kidney donors in national top 20%, by DSA of donor

Documents

Proposal to Substantially Revise the National Kidney Allocation System Sponsored by: The Kidney Transplantation Committee