Docstoc

Proposal to Substantially Revise the National

Document Sample
Proposal to Substantially Revise the National Powered By Docstoc
					Proposal to Substantially Revise 
 the National Kidney Allocation 
            System
     Sponsored by: The Kidney Transplantation Committee
Current System Limitations
§   High discard rates
§   Access variability due to geography and biology
§   Mismatch in graft/patient survival
The Growing Waiting List 




       OPTN data as of September 1, 2012
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)
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
Proposed Policy Objectives
§   Provide comprehensive data to guide transplant
    decision making
§   Reduce differences in access for ethnic minorities and
    sensitized candidates
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
2009   Donor/recipient age matching reviewed as possibility
2011   Concept document released: main topics EPTS/age
       matching/ KDPI
2011   Age matching no longer under consideration
2012   Public comment proposal
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
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

                   KDPI<=20%       Sequence A


                  KDPI >20% but
                                   Sequence B
                      <35%
 Kidney becomes
    available
                  KDPI >=35% but
                                   Sequence C
                      <=85%


                    KDPI > 85%     Sequence D
Sequences based on KDPI

                            Sequence A
                            KDPI<=20%


                            Sequence B
                          KDPI >20% but <35%


                            Sequence C
                            KDPI>=35% but 
                               <=85%


                            Sequence D
                              KDPI>85%
Sequence A     Sequence B         Sequence C       Sequence D
                                  KDPI>=35% but 
KDPI<=20%    KDPI >20% but <35%
                                     <=85%
                                                    KDPI>85%
  Sequence A            Sequence B            Sequence C           Sequence D
    KDPI <=20%        KDPI >20% but <35%       KDPI >=35% but         KDPI>85%
                                                     <=85%
Highly Sensitized     Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20%     0-ABDRmm              0-ABDRmm             0-ABDRmm
EPTS)                 Prior living donor    Prior living donor   Local + Regional
Prior living donor    Local pediatrics      Local                National
Local pediatrics      Local adults          Regional             *all categories in
Local top 20% EPTS    Regional pediatrics   National             Sequence D
0-ABDRmm (all)        Regional adults                            are limited to adult
Local (all)           National pediatrics                        candidates
Regional pediatrics   National adults
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
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
  Sequence A            Sequence B            Sequence C           Sequence D
    KDPI <=20%        KDPI >20% but <35%       KDPI >=35% but         KDPI>85%
                                                     <=85%
Highly Sensitized     Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20%     0-ABDRmm              0-ABDRmm             0-ABDRmm
EPTS)                 Prior living donor    Prior living donor   Local + Regional
Prior living donor    Local pediatrics      Local                National
Local pediatrics      Local adults          Regional             *all categories in
Local top 20% EPTS    Regional pediatrics   National             Sequence D
0-ABDRmm (all)        Regional adults                            are limited to adult
Local (all)           National pediatrics                        candidates
Regional pediatrics   National adults
Regional (top 20%)
Regional (all)
National pediatrics

                                     m nge sed
                                        ch ity
National (top 20%)                     Lo opo
                                      at v
                                             g
National (all)

                                          in
                                         Pr
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


               CPRA=100%                   National
               CPRA=99%                    Regional
               CPRA=98%                     Local
§   To participate in Regional/National sharing, review & approval of
    unacceptable antigens will be required
  Sequence A            Sequence B            Sequence C           Sequence D
    KDPI <=20%        KDPI >20% but <35%       KDPI >=35% but         KDPI>85%
                                                     <=85%
Highly Sensitized     Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20%     0-ABDRmm              0-ABDRmm             0-ABDRmm
EPTS)                 Prior living donor    Prior living donor   Local + Regional
Prior living donor    Local pediatrics      Local                National
Local pediatrics      Local adults          Regional             *all categories in
Local top 20% EPTS    Regional pediatrics   National             Sequence D
0-ABDRmm (all)        Regional adults                            are limited to adult
Local (all)           National pediatrics                        candidates
Regional pediatrics   National adults
                                                               w
Regional (top 20%)                                          Ne ries
Regional (all)                                                ego hly
National pediatrics                                        cat hig d
National (top 20%)                                           for sitize s
National (all)                                                sen didate
                                                               can
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
  Sequence A              Sequence B            Sequence C           Sequence D
    KDPI <=20%         KDPI >20% but <35%        KDPI >=35% but         KDPI>85%
                                                       <=85%
Highly Sensitized       Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20% 0-ABDRmm                    0-ABDRmm             0-ABDRmm
EPTS)                   Prior living donor    Prior living donor   Local + Regional
Prior living donor      Local pediatrics      Local                National
Local pediatrics        Local adults          Regional             *all categories in
Local top 20% EPTS Regional pediatrics        National             Sequence D
0-ABDRmm (all)          Regional adults                            are limited to adult
Local (all)             National pediatrics                        candidates
Regional pediatrics     National adults
Regional (top 20%)
              Co
Regional (all) ntinu
             prior      ed
National pediatricsity fo
            pr 20%)
National (topio
                r livi r
National (all)
           dono       ng
                r  s
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
  Sequence A            Sequence B            Sequence C           Sequence D
    KDPI <=20%        KDPI >20% but <35%       KDPI >=35% but         KDPI>85%
                                                     <=85%
Highly Sensitized     Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20%     0-ABDRmm              0-ABDRmm             0-ABDRmm
EPTS)                 Prior living donor    Prior living organ   Local + Regional
Prior living donor    Local pediatrics      donor                National
Local pediatrics      Local adults          Local                *all categories in
Local top 20% EPTS    Regional pediatrics   Regional             Sequence D
0-ABDRmm (all)        Regional adults       National             are limited to adult
Local (all)           National pediatrics                        candidates
Regional pediatrics   National adults
Regional (top 20%)
Regional (all)
National pediatrics                           d
                                           ue
National (top 20%)
                                      n tin ity
National (all)                      Co rior ric
                                       p iat s
                                          ed idate d
                                         p d
                                          ca n base )
                                              ow KDPI
                                            (n n
                                               o
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
  Sequence A            Sequence B            Sequence C           Sequence D
    KDPI <=20%        KDPI >20% but <35%       KDPI >=35% but         KDPI>85%
                                                     <=85%
Highly Sensitized     Highly Sensitized     Highly Sensitized    Highly Sensitized
0-ABDRmm (top 20%     0-ABDRmm              0-ABDRmm             0-ABDRmm
EPTS)                 Prior living organ    Prior living organ   Local + Regional
Prior living organ    donor                 donor                National
donor                 Local pediatrics      Local                *all categories in
Local pediatrics      Local adults          Regional             Sequence D




                                            Pr gio ng
                                              op na
Local top 20% EPTS    Regional pediatrics   National             are limited to adult




                                               Re ari

                                                os l
0-ABDRmm (all)        Regional adults                            candidates




                                                 Sh


                                                  ed
Local (all)           National pediatrics
Regional pediatrics   National adults
Regional (top 20%)
Regional (all)
National pediatrics
National (top 20%)
National (all)
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
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.
PRIORITY WITHIN CLASSIFICATIONS
Proposed Changes to Point System
§   Candidates are rank-ordered according to points within
    each classification.

        No proposed point       Proposed point changes 
            changes  for                   for 
    •HLA-DR                    •Sensitized candidates
    •Prior living organ donors •Waiting time
    •Pediatric candidates
Proposed Point Changes: Sensitization


                                                  Proposed




                                        Current

                                                                    4 points




                                         (CPRA=98,99,100 receive 24.4, 50.09,
                                           and 202.10 points, respectively.)
      §   Current policy: 4 points for CPRA>=80%. No points 
          for moderately sensitized candidates.  Proposed 
          policy: sliding scale starting at CPRA>=20%
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
SIMULATED POLICY RESULTS
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
Major Proposed Changes by Run
               Proposed Change                N1      N2    N3    N4
Enhanced definition of waiting time to                X     X     X
include pre-listing time since initiation of
dialysis
A2/A2B donor to B candidates priority                  X     X    X
Longevity matching (based on KDPI and EPTS)                  X    X
CPRA sliding scale point assignment                          X    X
National Priority for CPRA>=98%                              X
Tiered Priority for CPRA>=98%                                     X
Regional sharing for kidneys with KDPI scores                X    X
>85%

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

 Average for 10 iterations         N1               N2               N3                N4 
Number of candidates
(on waitlist at start or       122,669           122,669          122,669           122,669
joining during run)
Average number of primary
KI+KP transplant recipients     11,531            11,595          11,386            11,365
                              (11,463-11,586) (11,526-11,655)   (11,359-11,429)   (11,324-11,409)
(min, max of runs)
Average median lifespan
post-transplant (min, max        11.82             11.72           12.63             12.73
                              (11.75 - 11.85)   (11.68-11.83)    (12.3-12.45)      (12.65-12.79)
of runs)

                                          Average
                                         (min-max)
                                           of runs
Overall KPSAM Results

 Average for 10 iterations         N1          N2          N3           N4 
Average median graft years        8.82         8.8        8.99          9.1
of life                       (8.80-8.84) (8.77-8.82) (8.97-9.02)   (9.08-9.12)
Average median extra life-
                                  5.01        4.95        5.24          5.27
years for tx recipient versus
                              (4.99-5.03) (4.93-4.99) (5.20-5.27)   (5.24-5.29)
waitlist candidate
Average median LYFT per            5.7        5.65        5.93         5.97
transplant                    (5.68-5.72) (5.63-5.69) (5.89-5.96)   (5.95-6.0)


                                    Average
                                   (min-max)
                                     of runs
KPSAM Results by blood type
KPSAM results by candidate age
KPSAM results by ethnicity
KPSAM results by 0-ABDR mismatch
KPSAM results by CPRA
KPSAM results by CPRA (95-100%)
KPSAM results by degree of sharing
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
Participate in Policy Development


§   Submit comments
    online:
    optn.transplant.hrsa.gov              Publ
                                       com ic
§   Access webinar schedules         perio ment 
                                          d en
                                     Dece      ds 
                                          mbe
§   Download educational materials      14     r 
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
    ciara.samana@unos.org
    804-782-4073
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

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:0
posted:9/9/2013
language:
pages:49