The New Kidney Allocation System: What You Need to Know. Quality Insights Renal Network 3 Annual Meeting October 2, 2014

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The New Kidney Allocation System: What You Need to Know Quality Insights Renal Network 3 Annual Meeting October 2, 2014

Pre Dialysis Era

Dialysis Status in USA 500,000 patients on dialysis in 2013 100,000 patients start dialysis each year 10/8/2014

Why Transplant? Quality of Life Diet Travel Pregnancy Job Lifestyle Athletics Cost Society 5 Year cost Dialysis: 345,000 Transplant: 155,000 Patient Long Term Issues Medical Psychosocial Dietary Financial Life Expectancy Life Expectancy

Treatment Modalities for ESRD Patients N = 331,320 US Renal Data System. USRDS 2000 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, Md: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2000.

10-Year Survival Rates by Modality 3% 28% 69% Transplantation Hemodialysis Peritoneal dialysis US Renal Data System. USRDS 2000 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, Md: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2000.

July 9, 2014

NUMBER OF LIVING AND DECEASED KIDNEY DONOR TRANSPLANTS, UNITED STATES, 1988 2013 11,162 DD 7,061 9,359 6,647 5,732 LD 1,817 1988 2004 2013 Deceased Living www.optn.transplant.hrsa.gov 8

Increasing Waiting List High Success Rates Elderly Diabetics Retransplants Multiorgans 10/8/2014

NJ Transplant Centers: Total Deceased Donor Volume 180 160 140 120 100 80 60 40 20 0 163 158 143 149 59 57 45 50 37 29 30 24 11 17 15 3 7 2010 2011 2012 2013 BH RWJ HUMC OLL 10/8/2014

NJ Procurement : Kidney 350 300 281 273 261 260 250 200 223 207 181 186 150 100 50 0 2010 2011 2012 2013 Kidneys recovered Transplanted locally ** Does not include imports

Active Listing as of 2013

KI 1.10 Median years to kidney transplant for wait-listed adult patients

Discard Rate 18%

Category HLA Antigen matching UNOS Point System Algorithm for organ allocation Points 0 mm Mandatory share 0BDR MM 7 1BDRMM 5 2BDRMM 2 PRA >80% 4 <80% 0 Waiting time on position on the waiting list 1/year, 1 to longest waiting, others fraction based Pediatric <11 : 3 additional, >11 : 2 Additional Previous living donor additional points 10/8/2014

41 year old black male developed ESRD. secondary to hypertension at age 28. Hemodialysis via AVF started at age 29. Patient had 6 AV access surgeries. Referred to Transplant Center at age 40. Blood Group O 10/8/2014

10/8/2014 Blood group B wait times

We labeled kidneys as SCD ( Young) ECD (Old or Marginal) DCD ( Slow functioning) High Risk ( Hep C +) 10/8/2014

We Labeled Patient as Young children < 18 Difficult to transplant based on PRA Unfortunate (Previous living donor) Great match Better match Waiting on the list longest ( In the Queue first as opposed to Not on dialysis) By BG: No advantage given to Blood Group B 10/8/2014

Case number 1 76 year old man ESRD due to hypertension. Creatinine 6.0 mg/dl Listed for transplantation 4 years ago when creatinine was 3.0 mg/dl In excellent health and all recent age appropriate testing is normal Great support system Admitted for a deceased donor transplant 10/8/2014

Case number 1 Continued Donor is a 16 year old girl Brought to ICU intubated following drowning in the backyard pool Declared brain dead after 3 days of treatment 1 kidney Matched the 76 year old recipient and the other matched a 67 year old female 76 year old died 1 year later of an infection and the 67 year old lost the kidney due to BKV nephropathy after 2 years. 10/8/2014

Both started dialysis

3 years old: My mom is the best! 7 years old: Mom I love you! 10 years old: Mom what ever! 17 years old: OMG my mom is so annoying! 25 years old: I wanna go back home! 35 years old: Mom you were right 50 years old: I dont wanna lose my mom! 70 years old: I would give everything to have my mom with me!

Objectives Explain the new kidney allocation policy and its goals Summarize basic changes in allocation components for deceased donor kidneys Describe patient indicators appropriate for transplant evaluation referral List resources for additional information including education of patients

Why change kidney allocation? High kidney discard rates Variability in access to transplant Unrealized graft years Unnecessarily high re-transplant rates 10/8/2014

Predicted outcomes of the change Approximately 8,000 additional life years gained annually Improved access for highly sensitized candidates Improved access for ethnic minority candidates Comparable levels of kidney transplants at regional/national levels 10/8/2014

Current System Points Priority Pediatrics Hi PRA Living Donor O Mismatch Points regardless of adult Age, Dialysis time, or life year benefit or regardless of kidney characteristic Wait- List Time

Sharing and Payback System 18 Year Old donor NJ O MM 78 Year old diabetic Recipient listed 6 mo Florida 44 year old Listed 5 yr NJ O MM 68 year Old Donor with CVA Florida

Sharing and Payback System 16 Year Old donor Ca O MM 72 Year old diabetic Recipient listed 2 mo NJ 68 year old Listed 1 yr Ca O MM 12 year Old Donor Drowning NJ

Factors used to determine groups KDPI Donor age Race/ethnicity Hypertension Diabetes Serum creatinine COD CVA Height Weight DCD HCV Candidate Estimated Post- Transplant Survival (EPTS) Candidate Age Candidate Diabetes Prior transplant ESRD time

KDPI values now displayed with all organ offers in DonorNet 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

Addressing System Limitations Stated Limitation of the Current System Mismatch between potential survival of the kidney and the recipient Variability in access to transplantation by blood group and geographic location High discard rates of kidneys that could benefit candidates on the waiting list Reduce differences in transplant access for populations described in NOTA (e.g., candidates from racial/ethnic minority groups, pediatric candidates, and sensitized candidates). Applicable Concepts Survival matching A2/A2B, broader sharing KDPI, expedited placement, ESRD time, broader sharing, CPRA sliding scale, maintain peds priority 10/8/2014

Major Allocation Components Replace SCD/ECD with Kidney Donor Profile Index (KDPI) Add longevity matching using Estimated Post-Transplant Survival (EPTS) score for candidates and KDPI for donors Increase access for sensitized candidates w/ CPRA sliding scale and additional sharing priority Include pre-registration dialysis time in waiting time calculation Increase access for Blood Type B candidates Base pediatric priority on KDPI Remove payback system 10/8/2014

New System Points Priority Pediatrics Hi PRA Living Donor Points for Kidney with longevity Patient w life yr benefit Dialysis Time credit Advantage Blood Group B Wait- List Time

Kidney Longest survival Kidney Limited survival KDPI 20 KDPI 80 EPTS Hi EPTS low 10 year old 65 year old Patient Longest survival Patient Limited survival 10/8/2014

Case number 2: CPRA 36 year old white female ESRD due to FSGS Started hemo at age 18 ( Had 2 pregnancies) After 2 years received a LDK from a cousin 3 more pregnancies, 1 child Lost kidney due to recurrence at age 26 Received 5 units of pack cells PRA 98 10/8/2014

Sensitized Candidates Current CPRA 80% receive 4 additional points and zero points for moderately sensitized candidates New Points assigned based on a sliding scale starting at CPRA>=20%

Points Point changes: Sensitization 20 18 16 14 12 10 8 6 4 2 0 CPRA Sliding Scale (Allocation Points) (CPRA<98%) 0 0 0 0.08 0.21 0.34 0.48 0.81 1.09 1.58 2.46 6.71 4.05 17.30 12.17 10.82 0 10 20 30 40 50 60 70 80 90 100 CPRA Current New

Revised waiting time calculation Current New Reminder Waiting time begins at/after registration with GFR <=20 ml/min OR On Dialysis Waiting time points awarded for dialysis prior to registration (pediatric and adults) Recognizes time spent with ESRD as basis for priority Waiting time points based on GFR remains the same

Sequence A Sequence B Sequence C Sequence D 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 0-ABDR Mismatch Priority

Implementation Phase I Data updates required New reports released Calculators made available Phase II New allocation rules applied Variances turned off Payback system turned off Anticipated mid 2014 Anticipated end 2014

Early referral There is no established system to ensure that medically appropriate candidates are referred for transplantation

Importance of early referral Sensitized candidates receive additional priority Identify issues that may complicate /prevent transplant Receive 0-ABDR mismatch offers Waiting time accumulates while issues are addressed Accrue Waiting Time with GFR <=20ml/min Pre-emptive listing Slowly progressive renal diseases could receive preemptive transplant

Guidance on early referral Patients with chronic kidney disease (Stage 3 or higher) or ESRD should be referred for transplant evaluation

Guidance on early referral Pre-emptive transplant and timely, early referral is the goal o GFR range = 25-30 Education about transplant must begin before ESRD to be most effective o Stage 3-4 CKD Begin discussing the importance of living donors Initiate weight loss and smoking cessation counseling as necessary

Check for Prior Living Organ Donors Prior living organ donors get additional priority and 4 points

Kidney Allocation System Communication, Education, and Resources

Resources for professionals Kidney Allocation Toolkit FAQs Sample messaging for discussing changes with patients Patient brochure Guidance for early referral considerations Subscribe to RSS feeds and a monthly newsletter http://transplantpro.org/kidney-allocation-system/

More information OPTN web site - http://optn.transplant.hrsa.gov UNOS web site* - http://www.unos.org Transplant Living* - http://www.transplantliving.org Transplant Pro* - http://transplantpro.org *These are a service of United Network for Organ Sharing and are not produced under the OPTN contract.

Thank You