1. 1 Simultaneous Liver-Kidney (SLK) Allocation Kidney Transplantation Committee Spring 2016

2. 2 What problems will the proposal solve? Final Rule alignmentLack of equity across the systemLack of clear rules for liver-kidney allocation outside of DSA

3. Number of SLK transplants by year SLK transplants with other organs were excluded from the tabulation.

4. Establish medical eligibility criteria for SLK Ensure a balance of fairness and utility in allocation of kidneys Kidney community Provide clearer liver- kidney allocation policies Provide information in UNOS computer system to direct OPO in allocation process OPO community Resolve inconsistency between multi-organ and deceased donor liver allocation policy re: liver Share 35 policy Ensure safety net for liver recipients who need a kidney tx soon after liver tx Liver community What are the goals of this proposal? Main goal: Establish SLK allocation policy that addresses different perspectives within the transplant community

5. Requires all adult candidates seeking a liver-kidney transplant to meet medical eligibility criteria Kidney community Establishes rules for OPOs that specify when liver-kidney allocation is required, prohibited, or permissible (at all levels) Computer system will guide OPOs OPO community Resolves inconsistency between deceased donor liver and liver-kidney allocation Establishes “safety net” for liver recipients with continued dialysis dependency/kidney dysfunction in first year after liver transplant Liver community How does the proposal address the problems?

6. Transplant nephrologist must confirm candidate has one of the following: And tx hospital must report to UNOS and document one of the following in the medical record: 1. Chronic kidney disease with measured or calculated GFR less than or equal to 60 mL/min for greater than 90 consecutive days Dialysis for ESRD Most recent eGFR/CrCl is at or below 30 mL/min at or after registration on kidney waiting list 2. Sustained acute kidney injuryOne or a combination of both of the following in the past six weeks: Dialysis for six consecutive weeks eGFR/CrCl at or below 25 mL/min for six consecutive weeks. The program must confirm criteria continues to be met at least once every seven days. 3. Metabolic diseaseDiagnosis of: Hyperoxaluria Atypical HUS from mutations in factor H or factor I Familial non-neuropathic systemic amyloid Methylmalonic aciduria SLK Medical Eligibility Criteria

7. Fall 2015 Public Comment ProposalUpdated Proposal Pediatric and adult SLK candidates required to meet medical eligibility criteria in order to receive SLK allocation eligibility. Pediatric SLK candidates not required to meet any medical criteria in order to receive SLK eligibility. If candidate turns 18 while waiting, will maintain pediatric priority. It was not contemplated how existing SLK candidates would be treated upon implementation. Upon implementation, all adult SLK candidates (new and already registered for SLK) must meet medical eligibility criteria in order to receive SLK. UNOS will give programs time to prepare by allowing data entry for a specific period of time before implementation. Programs required to report diagnosis info in UNet, document specific medical factors around dialysis, GFR/CrCl in medical record. Programs required to report diagnosis info and specific medical factors in UNet, must document data in the medical record. Medical Eligibility Criteria Changes 7

8. Proposed Liver-Kidney Allocation Rules 8 If a liver-kidney candidate…And the donor is…Then the OPO: is highest on the liver match run and was registered on the liver waiting list prior to 18 th birthday (pediatric) in the same DSA, regional, nationalis required to offer the kidney with the liver before the kidney alone waiting list is highest on the liver match run, an adult candidate, and meets the SLK medical eligibility criteria in the same DSAis required to offer the kidney with the liver before the kidney alone waiting list is highest on the liver match run, an adult candidate, meets the medical eligibility criteria, and has a MELD of at least 35 in the candidate’s regionis required to offer the kidney with the liver before the kidney alone waiting list is highest on the liver match run, meets the medical eligibility criteria, and has a MELD lower than 35 in the candidate’s regionmay offer the kidney with the liver before the kidney alone waiting list but is not required to do so is highest on the liver match run, meets the SLK medical eligibility criteria, and has any MELD score nationalmay offer the kidney with the liver before the kidney alone waiting list but is not required to do so is highest on the liver match run, an adult candidate, and does not meet the SLK medical eligibility criteria in the same DSA, regional, nationalmust not offer the kidney with the liver

9. Fall 2015 Public Comment ProposalUpdated Proposal Local candidates must meet medical eligibility criteria and have MELD score ≥ 35 Local candidates must only meet medical eligibility criteria Before allocating to the kidney alone list, OPOs required to offer to regional SLK candidates who meet medical eligibility criteria and have MELD score ≥ 35 Before allocating to the kidney alone list, OPOs required to offer to regional SLK candidates who meet medical eligibility criteria and have MELD score ≥ 35 or status 1A Regional candidates with MELD score below 35 not eligible for SLK allocation Regional candidates with MELD score below 35 are eligible if they meet medical eligibility criteria. OPO is not required to allocate the kidney with the liver to these patients but allocation is permissible National SLK allocation prohibitedNational SLK allocation is permissible and OPO will decide whether to allocate as national SLK or to a kidney alone candidate once offers to local and regional SLK candidates have been completed (consistent with policy for allocating kidney/pancreas) SLK Allocation Changes 9

10. Fall 2015 Public Comment ProposalUpdated Proposal Pediatric candidates receive local/regional priority when meeting the medical eligibility criteria Pediatric candidates will receive local, regional, and national priority regardless of whether they meet the medical eligibility criteria Proposed language silent in directing OPOs for regional SLK allocation Proposed language makes clear that OPO must offer kidney to regional SLK candidates with MELD of at least 35 or status 1A before offering to the kidney alone waiting list SLK Allocation Changes (Continued) 10

11. This type of member…Will be required to… Liver transplant programsEnsure that a tx nephrologist has diagnosed liver- kidney candidates with 1 of 3 diagnoses outlined in the medical eligibility criteria. Document the tx nephrologists diagnosis in the medical record. Enter the diagnosing tx nephrologist name on the liver waiting list. Enter medical eligibility criteria data on the liver waiting list for liver-kidney candidates. If sustained acute kidney injury diagnosis, enter data at least once every seven days. Provide medical record documentation for all data entered. Document and enter required information on existing liver-kidney candidates prior to implementation. How will members implement new liver-kidney allocation rules? 11

12. This type of member…Will be required to… OPOsAssess eligibility status in DonorNet prior to allocating a kidney with a liver to a SLK candidate. Assess whether liver-kidney allocation is required before allocating kidney to kidney alone list. How will members implement new liver-kidney allocation rules? 12

13.  Impact on number of SLK transplants?  Inclusion of SLK outcomes into PSRs?  Implications for other types of multi-organ tx? Most Frequently Asked Q’s—New SLK Allocation Rules 13

14. SLK Recipients, Jan 2005 – Jun 2015 Approximately 19% of previous SLK recipients would not have qualified under proposed eligible criteria. Would SLK recipient have met proposed SLK eligibility criteria? Total N% Chronic kidney disease On Dialysis for ESRD at Time of Transplant 1,87441.6 Not on Dialysis for ESRD, eGFR <21 1,08124.0 Not on Dialysis for ESRD, eGFR 21-25 3287.3 Not on Dialysis for ESRD, eGFR 26-30 2675.9 Sustained acute kidney injuryOn dialysis for 6+ weeks before transplant # 1012.2 Would not have qualified for SLK No Dialysis for ESRD or temporary dialysis for 6+ weeks, eGFR 31-35 2134.7 No Dialysis for ESRD or temporary dialysis for 6+ weeks, eGFR > 35 63614.1 Total 4,543100.0

15.  Candidates who are on the kidney waiting list and have eGFR/CrCl at or below 20 mL/min or are on dialysis in the 60-365 days after liver transplant will be eligible to appear in this new kidney allocation match classification.  To continue to be eligible, the transplant program must report at least once every 30 days that this medical criteria continues to be met. Once this has been confirmed for three consecutive periods, the candidate will be eligible indefinitely* *the three consecutive 30-day period rule will still apply if the candidate’s first report of eligibility is in month 10, 11, or 12 after the liver transplant. Proposed “Safety Net” Eligibility 15

17. This type of member…Will be required to… Kidney transplant programsEnter medical eligibility criteria data on the kidney waiting list for liver recipients in the 60-365 day period after the liver transplant. Confirm eligibility data at least once every 30 days until the confirmation has been entered for three consecutive periods after the first qualifying date. Provide documentation (in the medical record) for all data entered. Document and enter required information on existing liver recipients (registered on the kidney waiting list) prior to implementation. How will members implement new safety net? 17

18.  Safety net impact on kidney alone candidates  Safety net impact on living kidney transplants for liver recipients Most Frequently Asked Q’s-Safety Net 18

19. 2015-2018 OPTN Strategic Plan Goal: Increase equity in access to transplants Objective: Establish clearer rules for allocation of multiple organs to a single candidate, especially liver-kidney candidates How does this proposal support the OPTN Strategic Plan? 19

20. Mark Aeder, MD Committee Chair mark.aeder@uhhospitals.org Gena Boyle SLK Project Liaison gena.boyle@unos.org Questions? 20

21. SLK Data Slides 21

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

23. 23 SLK transplants post KAS by sharing type (12/04/14-09/30/15) 64% of SLK transplants were local N = 509

24. Safety Net related slides 24

25. Liver-alone recipients, Jan 2005 – Jun 2013 Would liver-alone recipient have met proposed SLK eligibility criteria? ESRD Within 1 Year of Liver Transplant?** Total YesNo N%N%N% Chronic kidney disease On Dialysis for ESRD at Time of Transplant N/A ^ 200.0 Not on Dialysis for ESRD, eGFR <21 3069.82,81290.23,1186.4 Not on Dialysis for ESRD, eGFR 21- 25 986.61,39793.41,4953.1 Not on Dialysis for ESRD, eGFR 26- 30 1056.31,56393.71,6683.4 Sustained acute kidney injury On dialysis for 6+ weeks before transplant # 126.617093.41820.4 Would not qualify for SLK No Dialysis for ESRD or temporary dialysis for 6+ weeks, eGFR 31-35 613.61,61696.41,6773.5 No Dialysis for ESRD or temporary dialysis for 6+ weeks, eGFR > 35 6331.639,73098.440,36383.2 Total 1,2152.547,30897.548,523100.0  2.5% of liver-alone recipients developed ESRD within 1 year of the liver transplant.  % developing ESRD decreased as eGFR increased.  The vast majority (87%) of liver-alone recip. would not have qualified for SLK.

26. Kidney patient survival: with vs. without prior liver tx Waiting list survival Recipient survival Time period: Mar 31, 2002 – Dec 31, 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

27. 27 Kidney transplants after liver transplants (2005-6/2013) by kidney donor type Analyses are based on first deceased and living donor kidney alone transplants that occurred during 2005-6/2013 and followed a liver alone transplant that was still functioning at the time of the subsequent kidney transplant.

28. 28 KPDI distribution for deceased donors recovered (12/04/14-05/31/15)