Kidney Transplant and Living Donation. Martin L. Mai, MD Chair Division of Transplant Medicine Medical Director Kidney/Pancreas Transplant

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3 Kidney Transplant and Living Donation Martin L. Mai, MD Chair Division of Transplant Medicine Medical Director Kidney/Pancreas Transplant

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5 Mortality: General Population vs Dialysis Am J Kidney Dis 2008; 1(Suppl 1):S1.

6 Kidney Transplantation Treatment of choice for chronic kidney disease stage 5, end-stage renal disease Pre-emptive transplantation is preferred (CKD 4 with GFR 20 ml/min or less) Not a cure, medications (and their side-effects) are required long-term Studies demonstrate better quality of life and longevity with transplantation compared to those on dialysis awaiting transplantation

7 Kidney Transplant Facts Waiting list 13,943 70, ,000 DDRT 6,965 10,587 13,400 LDRT 1,783 6,041 5,600 Total 8,748 (63%) 16,628 (24%) 19,000 (16%) Died waiting 4,700 4,600

8 How can I get transplanted quickest?

9 Change the Culture Living Donor Option 2018 Proj 2017 Total 2016 Total 2015 Total 2014 Total 2013 Total Evals LD Tx

10 The Role of the Kidney/Pancreas Transplant Social Workers at Mayo Clinic Jacksonville Presented by: Karrson Smith, LCSW

11 What we do: We have 3 types of patient appointments Initial psychosocial evaluations (90 minute consults) Update assessments (60 minute consults) 4 Month post-transplant visits (30 minute consults)

12 Initial Psychosocial Evaluation Our 90 minute interview which helps us identify the following: Psychosocial issues Coping & support Mental health & substance abuse Insurance coverage Caregiver plan Relocation options & affordability Medication & insurance premium affordability

13 Psychosocial Evaluation What we assess: Transplant candidacy of the patient Competency of the caregiver who must attend the interview (or at least be vetted via phone) Financial ability to maintain health insurance Financial ability to purchase lifelong medications

14 Mental Health Psychiatry Screenings Patient complete the following: PHQ-9 to assess depression GAD-7 to assess anxiety AUDIT to assess alcohol use/abuse Depending on the scores and the verbal responses during the assessment, we inform the nurse coordinator if a psychiatry consult is warranted Following the assessment we complete the Stanford Integrated Psychosocial Assessment for Transplant (SIPAT) form which is reported at the Selection Conference meeting. Psychiatry also completes the SIPAT

15 Caregiver Requirements Patient s must have a primary caregiver to be listed A backup caregiver is STRONGLY recommended If the primary is not present for the psychosocial, they must contact us by phone If a patient has a SHARED caregiver plan where multiple people are involved, we must meet OR speak by phone with ALL members Patients are NOT clear for listing if we have not spoken with all caregivers of the shared caregiver plan We strongly recommend caregivers attend the caregiver class

16 Insurance Information Most of our patients are Medicare (MCR) eligible due to ESRD If a patient only elects MCR A, they will need B prior to their coordination of benefits flip (30 months after obtaining MCR) If a patient has Medicare A/B primary, they also need a drug plan (MCR D) if they do not have a secondary with a drug plan Medicare B only pays 80% of the immunos. The 20% without other coverage costs about $150 per month A Medicare supplement or a secondary would pick up the 20% of immunos MCR only lasts 3 years from the date of transplant if the patient s disability is due to ESRD We discuss long term insurance and financial planning

17 Insurance Information Medicare (MCR) Ideally for patients only with MCR, they should have MCR A, B, D & a supplement if eligible We make sure they can afford the donut hole ($5,000) and their premiums Medicaid (MCD) Full MCD- covers 20% of immunos (usually have LIS) QMB MCD- covers 20% of immunos (usually have LIS) SOC, SLMB, QI1- does not cover the 20%, fundraising often needed (sometimes have LIS) MCR Advantage Plans (MAPs) MCR A/B/D bundled into 1 insurance plan Pros: One low cost premium per month, often has a relocation benefit Cons: Cannot have a supplement, no coverage for the 20% (must fundraise if the 20% is not affordable)

18 American Kidney Fund (AKF) Our patients often have grants through AKF to fund their insurance premiums Once transplanted, AKF can continue to assist patients who are already receiving assistance through the end of the insurance year If a patient cannot afford the premiums post-transplant, they will need to fundraise for that cost

19 Fundraising Patients must open a fundraising account or show proof of progress made within 90 days of listing date Our SWA assists with the 90 day follow up If a patient does not establish an account or begin fundraising, he/she is at risk of being delisted

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21 Psychosocial Update We complete annual updates to review the social work plan & inquire as to any changes within the last year Review the transplant plan Address insurance, financial, & caregiver changes Reassess medication affordability, pharmacy selection, advance directives, & relocation plan If the transplant or financial plan changed & the plan is no longer solid, we let the nurse coordinator know that the patient will need to be status 7, or on hold

22 Kidney/Pancreas Transplant Recovery Inpatient for 3-5 days for kidney Inpatient 7-10 days for k/p or just pancreas If not local, must stay in Jax for 30 days with a 24/7 caregiver Caregiver Role can include: Med management (possibly including injections) Wound care if needed Monitoring daily vital signs (weight, temperature & blood pressure) Providing transportation & accompaniment to all clinic appointments Providing emotional support

23 Post-transplant Visits We see patients at 4 months post-transplant to assess the following: Recovery, ADL s, medication management, changes to family/living situations, pharmacy, mental health/ coping, caregiver status, finances, insurance, employment/ssdi Remind patients of the Medicare regulations & discuss an insurance/financial plan for the future Writing a letter to the donor family Discuss the Ticket to Work program through SSA if appropriate

24 Waitlist Management We attempt to contact the top 10 patients within each blood type on our waiting list every 6 months We review the social work plan If issues arise, the nurse coordinator is notified and patients are placed on status 7

25 Thank you for your attention. Please do not hesitate to contact the kidney/ pancreas transplant social work team at

26 Living Donation Interview with Cameron and Savannah Mullis

27 Kidney Paired Donation 2013 MFMER slide-27

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33 Donor Chains 2013 MFMER slide-33

34 Paired Kidney Donation - Compatible Female to male, male to female Size difference Age difference Infection risk Altruistic donors Use of deceased donor kidneys 2013 MFMER slide-34

35 Transplant centers who had preformed at least 1 KPD transplant in the U.S. + HI Segev, D KPD Consensus Conference April 2012 Dulles 2013 MFMER slide-35

36 Number of KPD Transplants in U.S. by Year Living Donor Transplants By Donor Relation Based on OPTN data as of March 30, MFMER slide-36

37 Coordination KPD Logistics are complicated Share records Confirm consents Preop blood work (infection) Surgery times/surgeon communication Ground/Air transportation 2013 MFMER slide-37

38 Mayo Clinic KPD Program ~ 350 transplants 2013 MFMER slide-38

39 Pre-emptive transplantation egfr 20 or less to be listed Advantage to transplant before dialysis starts Living donor kidney: shorter hospital stay, less complications, kidney lasts longer, patient lives longer We believe costs are less 2013 MFMER slide-39

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41 Effect of pre-transplant dialysis duration on post-kidney transplant graft loss CJASN 2017; 12: MFMER slide-41

42 Effect of pre-transplant dialysis duration on post-kidney transplant patient survival CJASN 2017; 12: MFMER slide-42

43 Survival advantage of pre-emptive kidney transplantation 2013 MFMER slide-43

44 Despite advantages, pre-emptive kidney transplant underutilized 2013 MFMER slide-44

45 2013 MFMER slide-45

46 Modeling the Costs and Benefits of Pre-Emptive Kidney Transplantation Martin Mai MD Chair Division of Transplant Medicine Medical Director Kidney/Pancreas Transplant Mayo Clinic For: James M. Naessens, ScD Professor, Health Services Research

47 Background By the beginning of 2015, End Stage Renal Disease affected approximately 678,000 individuals in the U.S., a rate that is rising by about 21,000 cases per year. Prevalence of all stages of Chronic Kidney Disease (including ESRD) in the U.S. adult general population was estimated to be approximately 14.8% from , with Stage 3 being the most prevalent. Medicare spending on this population in 2014 exceeded $50 billion (20% of all Medicare spending for those 65 and older) Spending for beneficiaries with ESRD was estimated to be $32.8 billion. Significant economic impact USRDS 2016 Report

48 Study Objective We are developing a model to estimate the cost savings generated when comparing pre-emptive kidney transplantation to the traditional dialysis therapy prior to transplant using economic evaluation methods. The study includes two arms for evaluation and comparison of costs: Listed for transplant and on dialysis Listed and receiving a transplant preemptively with no dialysis before transplant

49 Introduction to Economic Evaluations The purpose of an economic evaluation is to compare two or more treatments or processes of care in which we consider both the costs of treatment and the outcomes generated. Outcomes can be positive (extended life span, increased quality of life, etc.) or negative (adverse events, increased pain, etc.) Such analysis offer a way to formally make decisions regarding multiple treatment options.

50 Cost, Cost Effectiveness and Cost Benefit Analysis Cost Analysis is an evaluation that only considers the differences in cost between treatment arms Used when the effectiveness of an alternative treatment (or treatments) is unknown or assumed to be the same or better than the standard of care. Also called cost minimization studies, as the process identifies the least costly treatment option.

51 Cost, Cost Effectiveness and Cost Benefit Analysis Cost Effectiveness looks at differences in cost per differences in effect. CE = (cost t 1 cost t 2 )/ (effect t 1 effect t 2 ) Cost Effectiveness generally compares a gain in outcomes per increase in health care costs from the new treatment. Initial evaluations of renal dialysis estimated that it cost $50,000 to gain 1 Quality-adjusted life-year ($50,000/QALY)

52 Cost, Cost Effectiveness and Cost Benefit Analysis Cost Benefit analysis are similar to cost effectiveness analyses but the gain in outcomes is converted into a monetary value. Cost Benefit is much less commonly used in health care than other fields

53 Steps in Decision Analysis Model Identify Health States and Transitions Develop Decision Trees Populate probabilities, utilities and costs Run Monte Carlo process Sensitivity analysis

54 Identification of Health States State Transition Diagram Listed Improved, removed from list Receiving Dialysis Transplant Death Post- Transplant - DD Post- Transplant - LD Graft- Failure

55 Decision Tree Legend *Same as Pre-Emptive M = Markov Process

56 Transitioning Through the Tree In this illustration, 10 people are in the cohort The probability of staying well is 0.5, sick is 0.3 and dead is 0.2 They are allocated in the second round according to those probabilities Finally, after many cycles everyone ends up in the dead state Nyman, J. State Transition and Microsimulation Models. Cost Effectiveness Analysis in Helath Care. Lecture March 2017.

57 Transition Probability Differences Between Arms Proportion Transplanted from a Living Donor Proportion Transplanted from a Deceased Donor 1-year Probability of Graft Failure* 1-year Probability of Death* *Not currently accounted for in preliminary analyses NonPre-Emptive Group Pre-Emptive Group 27.1% 59.1% 72.9% 40.9% 4.0% 1.0% 4.6% 2.4%

58 Costs Per Person Per Year Spending Health State Medicare Commercial Improvement $0 $0 Baseline PPPY Spending (pre-emptive group) $22,745* $28,967 Dialysis (NonPre-emptive group) $94,961 $149,837 Transplant $38,870 - Living Donor Pre-Emptive $51,269 - Deceased Donor Pre-Emptive $50,475 - Living Donor NonPre-emptive $49,329 - Deceased Donor NonPre-emptive $54,564 Transplant within year $130,545 Post-Transplant $24,282 - Living Donor Pre-Emptive $20,613 - Deceased Donor Pre-Emptive $26,585 - Living Donor NonPre-emptive $25,122 - Deceased Donor NonPre-emptive $37,310 Graft Failure within year $115,426 $115,426** Death $0 $0 *This estimate represents the PPPY Medicare spending for non-esrd individuals with chronic kidney disease **Due to lack of available information for the commercial population, this estimate is based on Medicare data from the USRDS 2016 Report

59 Preliminary Results Total Costs 5 years Population Mean Median Minimum Maximum Commercial NonPre-Emptive $550,548 $630,270 $6243 $799,061 Pre-Emptive $147,643 $144,835 $1207 $201,308 Difference $485,435 Medicare NonPre-Emptive $355,105 $404,712 $3951 $511,424 Pre-Emptive $123,525 $113,725 $ 948 $168,823 Difference $290,987

60 Next Steps/Model Enhancements Perform Sensitivity Analysis to address assumptions Incorporate: Differences in graft and patient survival for those pre-emptively transplanted Delayed Graft Function Living donor transplants may receive transplant faster than those with deceased donor transplants Discounting dollars for inflation Effectiveness/benefits (e.g., added life years, QALYs, etc.)

61 All models are wrong. Some models are useful George Box

62 Deceased Donor Transplant Aggressive in finding kidneys for patients Use usual patient data and biopsies and pumping information 2013 MFMER slide-62

63 Kidney Options KDPI Kidney Donor Profile Index Score of Standard kidneys are 0-85 Patients sign consent for KDPI > 85 Half life years years > years 2013 MFMER slide-63

64 Kidney Options Public Health Service increased risk infection Donors who use IV drugs, buy/sell sex, recent jail time PHS risk HIV Hepatitis No 1:100,000 1:10,000 Yes 1:10,000 1:1, MFMER slide-64

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66 Clean blood Control BP Control RBC production Balance water Affect bone metabolism Maintain acid-base status Alter health of your heart and blood vessels Help eliminate some drugs

67 Know Your egfr

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