Kidney Transplantation Committee Spring 2014

1.Waiting time calculation - pre-registration dialysis time added 2.Candidate classification - Estimated Post Transplant Survival (EPTS) score 3.Kidney donor classification - replace SCD/ECD with Kidney Donor Profile Index (KDPI) 4.Priority for sensitized candidates - calculated panel reactive antibody (CPRA) sliding scale Allocation component changes

5.Blood type eligibility - A 2 and A 2 B to B compatible 6.Pediatric kidney allocation – KDPI priority 7.Kidney payback policy – eliminated 8.Kidney variances – eliminated Allocation component changes

Communicate with referring physicians: o Pre-emptive listing is still advantageous o Candidates can accrue time with GFR<=20ml/ml o Priority for 0-ABDR mismatch offers Importance of early referral

CurrentNew AdultAccrue time when listed once on dialysis or when GFR or CRCL is =/< 20 ml/min Accrue time when listed once on dialysis and credit for time spent on dialysis prior to listing or when GFR is =/< 20 ml/min Change #1 – Waiting time

CurrentNew PediatricAccrue time immediately when listed and Credit for time spent on dialysis prior to listing Change #1 – Waiting time

Change #2: Candidate classification CurrentNew No priority based on estimated post- transplant survival The 20% of adult candidates who have the longest EPTS receive priority for kidneys from donors with KDPI scores in the top 20%.

 EPTS data variables o Age o Prior transplant o Diabetes status o Time on dialysis  EPTS score range is % Estimated Post Transplant Survival

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) Highly Sensitized 0-ABDRmm Prior living donor Local pediatrics Local adults Regional pediatrics Regional adults National pediatrics National adults Highly Sensitized 0-ABDRmm Prior living donor Local Regional National Highly Sensitized 0-ABDRmm Local + Regional National Longevity matching

Review dialysis start dates Confirm or update dialysis start dates Retain documentation of dialysis start dates Mid–2014 System will cross-reference CMS Crown database (including Form 2728) Flag data inconsistencies System tools Action: Review waiting time

Confirm age and dialysis start dates Collect data and documentation - prior organ transplants diabetes type Begin now Get familiar with the EPTS calculator Spring 2014 Enter data in fields used to calculate EPTS Mid–2014 Editable data in the system Cross-references to OPTN and CMS dialysis dates Flags for data inconsistency System tools Action: Input and confirm data

 Prior living donors get 4 points Action: Assess for living donors Check candidates for prior organ donation Retain documentation of prior donation Begin now

CurrentNew Classified as SCD or ECD based on: o donor age o history of hypertension o creatinine o cerebrovascular accident as cause of death Classified by KDPI based on: o donor age o height o weight o ethnicity o history of hypertension o history of diabetes o cause of death o serum creatinine o hepatitis C virus status o donation after circulatory death Change #3 - Kidney classification

KDPI

 Be mindful that other independent acceptance criteria may conflict with KDPI  Examples: o candidate opts out of DCD but selects KDPI max of 60% = will not see any DCD offers, even from KDPI 50% or less donors o candidate selects max donor age of 55 and KDPI of 60% = will not see offers from 56 y/o donor with KDPI 36% Acceptance criteria

Review listed candidates for criteria entered Discuss acceptance criteria for local versus import Determine candidates that may benefit from a shipped KDPI>85% organ Begin now Enter KDPI acceptance criteria Assess for KDPI and “other” criteria conflicts Mid-2014 Action: Update acceptance criteria

Develop a protocol for acceptance of kidneys based on KDPI Update consent forms - KDPI > 85% instead of ECD Begin now New candidates listed must be consented if willing to accept KDPI>85% Currently listed candidates - Willing to accept ECD? default to 0-100% KDPI Not willing to accept ECD? default to 0-85% KDPI Implementation Sample language for discussing KDPI with patients Patient brochure Tools available Spring 2014 Action: Update consents

Current PriorityNew Priority CPRA score at or above 80% receives 4 points Moderately sensitized (CPRA 0-79%) receive zero points CPRA scores of 20% or above receive points based on a sliding scale Change #4 - Sensitized candidates

Point changes: Sensitization CPRA Points CPRA Sliding Scale (Allocation Points) (CPRA<98%) Current New CPRA

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) Highly Sensitized 0-ABDRmm Prior living donor Local pediatrics Local adults Regional pediatrics Regional adults National pediatrics National adults Highly Sensitized 0-ABDRmm Prior living donor Local Regional National Highly Sensitized 0-ABDRmm Local + Regional National Highly sensitized before 0-ABDR

Review unacceptable antigens reported Begin now Enter any unacceptable antigens that have not previously been entered Prior to implementation Action: Update unacceptable antigens

Review waiting list for candidates with CPRA % Begin now Lab director and transplant physician/surgeon review and sign-off on unacceptable antigens Mid–2014 Message and printable form will display when CPRA % is reached Report listing candidates who require approvals System tools Action: Review and Approve UAs

CurrentNew Kidneys allocated to candidates who are blood type identical to the donor when the donor has blood type O or B. Blood type B candidates are ineligible for A 2 /A 2 B offers. Blood type B candidates that meet defined clinical criteria are eligible for kidneys from donors with blood type A 2 or A 2 B. Change #5 - Blood type eligibility

Create a protocol - maximum titer levels acceptable for blood type B candidates to blood type A2 or A2B donors Begin now Enter whether candidate meets criteria - yes or no Retain documentation of titer levels Mid–2014 Update eligibility every 90 days After implementation Action: Develop clinical criteria

Implementation Phase IPhase II Data updates begin New reports released Calculators made available New allocation rules applied Variances turned off Payback system turned off Summer 2014December 2014

Summary: Member responsibilities Communicate importance of early referral Establish protocols for A 2 and A 2 B donors to B candidates Report/update data to calculate EPTS and waiting time Review candidates to identify prior living organ donors Establish KDPI acceptance criteria and update consents for KDPI>85% Review waiting list for unacceptable antigens Review “other” donor screening criteria Educate candidates and potential candidates on changes

April 24, 2 p.m. (ET) The New Kidney Allocation System: Resources for Protocols and Processes webinar Save the date

OPTN web site - UNOS web site* - Transplant Living* - Transplant Pro* - *These are a service of United Network for Organ Sharing and are not produced under the OPTN contract. Subscribe to RSS feeds and a monthly newsletter at More information

 Richard Formica, MD  Leave a space for regional representative name and contact info – RAs will update  Gena Boyle Questions?