1. Kidney Transplantation Committee Spring 2015

2.  Implemented Dec. 4, 2014  6 month data will be shared at Aug-Oct regional meetings  Monitoring community feedback to determine where clarification and tweaks may be needed in policy and UNet ℠ Revised Kidney Allocation System

3. 17+ data analyses, including:  Longevity matching: are fewer age or longevity- mismatched transplants occurring?  Access: are high CPRA and blood type B patients getting more offers and transplants? What is the distribution of transplants by recipient age?  Utilization: have kidney discard rates decreased, in particular for high KDPI kidneys? How will KAS be monitored?

4.  Geography: are more kidneys being allocated outside of the local DSA?  Unintended consequences:  are fewer kidney patients being listed?  has the number of transplants for any demographic or clinically specific groups changed unexpectedly?  how often are shipped kidneys for CPRA 99 & 100 patients discarded or redirected? How will KAS be monitored? Analysis schedule: 6 months, 1 year, annually

5. The problem:  OPTN Final Rule requires allocation policies be:  based on sound medical judgment and standardized criteria  seek to achieve the best use of organs  avoid futile transplants  No standard rules or medical criteria specified in OPTN policy for SLK allocation  Current policy requires kidney to be allocated with liver if donor and candidate are in same DSA but does not specify rules for regional or national allocation  KAS and elimination of kidney payback system erased incentive for OPOs to share kidney with liver regionally Simultaneous Liver Kidney (SLK) Allocation Project

6.  2006-2007—Societies hold consensus conference on the issue  2009— Kidney and Liver Committees sponsor public comment proposal  Majority of regions, individual commenters, and other committees supported proposed changes  Varying concerns expressed from national groups (ASTS, NKF, AUA)  2010—Committees decided not to move forward due to complex IT programming associated with proposal (mostly due to kidney allocation variances) and development of the new KAS  2014—KAS is implemented, removing all variances Important Historical Background

7.  OPO community perspective: No consistent rules beyond local distribution means the OPO is left to make the decision  Liver community perspective: This inconsistency is counter to goal the regional ‘Share 35’ liver policy seeks to achieve  Kidney community perspective: Some medical criteria should be required to ensure that kidney is not allocated to a candidate who may regain kidney function after liver-alone transplant because this diverts access from a kidney alone candidate Different Perspectives on the Problem

8. The Impact of the Problem by #’s 500—the approximate number of SLK transplants per year 50-65—the number of SLK recipients with no pre-tx dialysis and serum creatinine < 2.5 mg/dl. 110-120—the number of recipients with <2 months of dialysis 48%--the percentage of kidneys used in SLK transplants that had KDPI < 35% (usually prioritized for peds)

9. 2015 SLK Working Group Recommendations 2 main policy elements Medical eligibility criteria for SLK allocation “Safety Net” Prioritization on the kidney alone waiting list for liver recipients with post-operative dialysis dependency or significant renal dysfunction

10. Transplant nephrologist must confirm candidate has one of the following: And tx hospital must document one of the following in the medical record: 1. Chronic kidney disease1.Dialysis for ESRD 2.eGFR/CrCl at or below 35 mL/min 2. Sustained acute kidney non-function 1.Dialysis for six consecutive weeks 2.eGFR/CrCl at or below 25 mL/min for at least six consecutive weeks 3.Any combination of #1 and #2 above for six consecutive weeks 3. Metabolic diseaseDiagnosis of: 1.Hyperoxaluria 2.Atypical HUS from mutations in factor H and possibly factor I 3.Familial non-neuropathic systemic amyloid 4.Methylmalonic aciduria Recommended SLK Eligibility Criteria

11.  If candidate meets the eligibility criteria, the OPO must allocate the kidney with the liver if allocation is local or regional before offering the kidney to a kidney-alone candidate Recommended SLK Allocation Policy

12. Data Reviewed for Safety Net Recommendations 19%--Of those liver recipients listed for a kidney, this is the percentage listed within 1 year after LI tx (the median is 6.5 years) 93%--Of those liver recipients receiving a kidney tx, the percentage of KI tx performed more than a year after LI tx (40%-41% are performed 9 years+ after LI tx) 6 months—the amount of time after LI alone tx when the risk of newly developed ESRD is at its highest according to the literature

13.  If, 2-12 months after a liver transplant, a liver recipient is registered for a kidney and:  has begun dialysis for ESRD or  has an eGFR at or below 20 mL/min  The candidate will receive additional priority on the kidney waiting list  Once the candidate meets this criteria, the candidate will continue to be eligible for additional priority. Recommended ‘Safety Net’ Policy

14. Sequence A KDPI <=20% Sequence B KDPI >20% but <35% Sequence C KDPI >=35% but <=85% Sequence D KDPI>85% Highly Sensitized 0-ABDRmm 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 SLK safety net Local adults Regional pediatrics Regional adults National pediatrics National adults Highly Sensitized 0-ABDRmm Prior living donor SLK safety net Local Regional National Highly Sensitized 0-ABDRmm SLK safety net Local + Regional National

15.  Seeking feedback from:  Regions  Professional transplant societies and national groups  Other Committees  Committees will reconvene in Spring to review feedback/finalize a public comment proposal for Fall 2015  Explore and discuss application of these changes to heart/kidney and lung/kidney allocation Next Steps

16.  Richard Formica, MD Committee Chair richard.formica@yale.edu  Regional Rep name (RA will complete) Region X Representative email address  Gena Boyle, MPA Committee Liaison gena.boyle@unos.org Comments/Questions?

17. Extras

18. Survival advantage of receiving a KI Purpose: Provide evidence supporting SLK eligibility criteria

19. Crude survival advantage of receiving a kidney vs. liver alone Recipient survival Cohort: recipients Mar 31, 2002 – Dec 21, 2012 p-value=0.0007 LI AloneSLK White70%62% Diabetes27%41% MELD*3627 KDPI%5040 Age*5556 LI CIT*6.96.4 LI AloneSLK White73%65% Diabetes23%38% MELD*1728 KDPI%5040 Age*5557 LI CIT*6.76.5 * Medians are shown

20. KI graft survival for SLK vs. KI alone … and Heart-Kidney Purpose: Assess degree of decrease in kidney graft survival in multi-organ transplants

21. Kidney graft survival Cohort: recipients Mar 31, 2002 – Dec 21, 2012 Recipient survival SLK (ren. failure)SLK (no ren. failure)KI White62%65%45% Age (median)565754

22. Kidney graft survival Cohort: recipients Mar 31, 2002 – Dec 21, 2012

23. The effect of a previous LI tx on KI waiting list and recipient survival Purpose: provide evidence supporting the use of the safety net

24. Kidney patient survival: with vs. without prior liver tx Waiting list survivalRecipient survival Time period: Mar 31, 2002 – Dec 21, 2012 With LI (<=1) With LI (>1) W/t LI White75%74%45% Age (median)575953 With LI (<=3) With LI (>3) W/t LI White70%78%45% Age (median)576054

25. Summary Eligibility criteria: survival advantage of receiving a KI SLK: lower KI graft survival rates Safety net: KI after LI transplant

26. Predicting ESRD* after LI tx Israni, at al Am J Transplant 2013; 13: 1782–1792 Hazard function for ESRD (post MELD) Incidence of ESRD * Initiation of maintenance dialysis therapy, KI tx or listing for KI tx

27.  Kidney Transplantation Committee  Liver and Intestinal Organ Transplantation Committee  OPO Committee  Ethics Committee  Minority Affairs Committee  Operations and Safety Committee SLK Working Group

28. Achieving a Balance Access Utility