1. The New Kidney Allocation System Gautham Mogilishetty, MD Associate Professor of Medicine Division of Nephrology and Transplantation University of Cincinnati Medical Center

2. Disclosures I have no disclosures relevant to this presentation

3. Perspective Perspective (as of 8/28/15; Source: UNOS.org) There are currently 133,721 people waiting for lifesaving organ transplants in the U.S. Of these, 108,915 await kidney transplants. In 2014, 17,109 kidney transplants took place in the U.S. Of these, 11,570 came from deceased donors and 5539 came from living donors.

4. Perspective Perspective (as of 8/28/15; Source: UNOS.org) –On average: Nearly 3150 new patients were added to the kidney waiting list each month in 2014. Every 15 minutes someone is added to the kidney transplant list 14 people die each day while waiting for a life- saving kidney transplant –In 2012, 5,209 patients died while waiting for a kidney transplant.

5. The Gap Continues to Widen The Gap Continues to Widen (All organs = 122,352; Kidney = 101,055; Liver = 15,159; Pancreas = 1,050) Kidney Source: http://optn.transplant.hrsa.gov/media/1049/organshortage.png

6. All organs = 122,352; Kidney = 101,055; Liver = 15,159

7. 2012 Annual Report

8. US is divided into 11 geographic regions OPTN/UNOS

9. PREVIOUS NATIONAL DECEASED- DONOR KIDNEY ALLOCATION POLICY Kidney by age- SCD, ECD and DCD Deceased-donor kidneys are allocated by blood group Geographic sequence of kidney allocation- kidneys are allocated locally first, then regionally, and then nationally. Mandatory sharing of zero-antigen-mismatched kidneys Kidney payback

10. Previous Points System Waiting time-begins when an active candidate listed- 1 point for every year. Sensitized candidates-CPRA of 80% or greater assigned 4 points Quality of Antigen Mismatch-DR locus 2 points if there are no DR mismatches 1 point if there is 1 DR mismatch Pediatric Kidney Transplant Candidates-4 Prior Living Organ Donor- 4 Medical Urgency – no points

11. WHY DO WE NEED A NEW SYSTEM? ( Went into effect 12-2014)  Higher than necessary discard rates  Improved graft survival rates with unrealized graft years as well as unnecessarily high re-transplant rates  Variability in access to transplants for candidates with certain blood types, sensitization levels, and geographic locations

12. Kidney Allocation Score (KAS) Three concepts to determine a candidate Kidney Allocation Score (KAS): 1. Dialysis Time (DT): Time spent on dialysis allows candidates to gain priority over the period they receive this treatment, adding the essential element of justice into the allocation system. 2. Life Years from Transplant (LYFT): Determines the estimated survival that a recipient of a specific donor kidney may expect to receive versus remaining on dialysis. LYFT is primarily a measure of utility. 3. Donor Profile Index (DPI): Provides a continuous measure of organ quality based on clinical information, providing a better metric for deciding which organs are appropriate for which candidates. LYFT, DPI, and DT are incorporated so that kidneys are matched to candidates based on the expected survival of both the kidney and the recipient.

13. Preview of Expected Outcome form the new KAS New system forecasted to result in:  Approximately 8,000 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

15. Major Allocation Components Replaces SCD/ECD with KDPI Add longevity matching Increased priority for sensitized candidates/cPRA sliding scale Include pre-registration dialysis time Incorporated A 2 / A 2 B to B Base pediatric priority on KDPI Remove payback system Remove variances

16. SCD and ECD ?

17. Revised Kidney Classifications: Previously, kidneys were classified as coming from either - Standard Criteria Donor (SCD) - Expanded criteria donor (ECD) - Donation after Cardiac Death (DCD) New System now uses: - Standard Criteria Donor (SCD) - Donation after Cardiac Death (DCD) - Public Health Service High Risk (PHS)

18. OVERVIEW OF POLICY CURRENT PREVIOUS Kidney Becomes Available SCD EDC DCD & ECD DCD & SCD Kidney Becomes Available KDPI < 20% KDPI 21- 34% KDPI 35- 85% KDPI > 85%

20. Inclusion of Estimated Post Transplant Survival (EPTS) and Longevity Matching Previous system did not include measure of potential longevity with transplant Considering longevity for some candidates could reduce the need for repeat transplants Four medical factors used to calculate EPTS score –Age –History of diabetes –Length of time on dialysis –History of prior transplant

21. OPTN/SRTR SRTR established the score by analyzing the relationship between characteristics of deceased donor kidney recipients and their survival times after transplant A candidate's EPTS score can range from 0% to 100% The EPTS score is not used in allocation of kidneys from donors with KDPI scores greater than 20% The candidates with EPTS scores of 20% or less will receive offers for kidneys from donors with KDPI scores of 20% or less before other candidates at the local, regional, and national levels of distribution

22. EPTS Calculator

23. How does it impact? Candidates with lower EPTS scores tend to be younger Diabetics tend to have higher EPTS scores Prior solid organ transplant Those having spent many years on dialysis

24. EPTS in tandem with KDPI

25. Early Returns – New KAS Source: UNOS.org Improved longevity matching in the new KAS

26. Longevity Matching Longevity matching will affect different regions and DSAs differently because of the effects of multi-organ transplants DSAs with active multi-organ transplant programs or large pediatric programs will absorb more of the KDPI < 20 donor kidneys Despite this, there appears to be an effect already (may be as much due to dialysis waiting time bolus effect)

27. Regional Sharing for KDPI>85% First level of allocation for KDPI>85% is Local+Region Determine which candidates may benefit from a shipped KDPI>85% organ Update acceptance criteria for imports Get the kidney to a willing recipient with less cold time – increase utilization of marginal kidneys

28. Discard rate Graft Survival & Discard Rates by KDPI – Broader Sharing for High KDPI Kidneys Gradual decline in graft survival, yet steep increases in kidney discard rates. 2-year graft survival Source: Darren Stewart, UNOS Research

29. Waiting Time The new KAS is still a primarily waiting time driven system Aside from “fairness”, a waiting time driven system was thought to increase predictability for candidates and allow transplant centers to better manage waitlist management and patient flow

30. Revised Waiting Time Calculation Previous policy begins waiting time points for adults at or after registration with: o GFR<20ml/min o On Dialysis Current policy awards waiting time points for dialysis time prior to registration: o Applies to both pediatric and adult candidates o Better recognizes time spent with ESRD as the basis for priority Policy for assigning waiting time points based on GFR remains the same: o Waiting time points begin on date at or after registraion with GFR <20ml/min

32. Early Returns – New KAS Source: UNOS.org Early “bolus” effects of the new KAS – Dialysis Waiting Time Effect?

33. Early Returns – New KAS Source: UNOS.org Younger patients more likely to accumulate more dialysis time?

34. Changes to Immune Sensitivity Matching Sensitized candidates wait substantially longer due to biological challenges Some candidates are so sensitized, they require access to a larger pool of kidneys to find a match Current system will give national priority to individuals with cPRA 99-100%

35. Previous

37. Early Returns – New KAS Source: UNOS.org Early “bolus” effect of the new KAS

38. Modifications to Blood Type Subgroup Matching Candidates with blood type B face biological challenges to matching Many blood type B candidates are ethnic minorities Current system will allow access for blood type B candidates to additional kidneys from donor with specific subtypes of blood type A

39. Unmodified Classification: Prior Living Organ Donor Prior living organ donors receive the same level of priority as current policy EVERYLiving organ donors get additional priority and 4 points with EVERY new registration

41. Modified Classification: Pediatric Prior policy prioritizes donors younger than 35 to candidates listed prior to 18 th birthday Current policy will provide comparable level of access while streamlining allocation system Current policy will –Prioritize donors with KDPI scores <35% –Eliminate pediatric categories for non 1-ABDR KDPI >85%

43. New KAS will challenge transplant centers to evolve their waitlist management strategies Predictability for candidates and transplant centers was an important consideration in the new KAS and was considered and balanced with multiple other objectives of the system The changes in candidate age, comorbidities and other medical factors present as much of a challenge to waitlist management, and the cost and burden on transplant centers needs to be considered in global decisions about staffing and reimbursement Summary