Simultaneous Liver Kidney (SLK) Allocation Policy

Kidney Transplantation CommitteeFall 2015

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What problems will the proposal solve?

Number of SLK transplants by year

Analyses are based on deceased donor SLK transplants performed during 2005-2013. SLK transplants with other organs were excluded from the tabulation.

What are the goals of this proposal?

Main goal: Establish SLK allocation policy that addresses different perspectives within the transplant community

Did the Committee review prior work and history?

How does the proposal address the problem statement?

SLK Medical Eligibility Criteria

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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 disease with measured or calculated GFR less than or equal to 60 mL/min for greater than 90 days

• Dialysis for ESRD• Most recent eGFR/CrCl is at or below 35 mL/min at the

time of registration on kidney waiting list

2. Sustained acute kidney injury • Dialysis for six consecutive weeks• eGFR/CrCl at or below 25 mL/min for at least six

consecutive weeks• Any combination of #1 and #2 above for six consecutive

weeks

3. Metabolic disease Diagnosis of:•Hyperoxaluria•Atypical HUS from mutations in factor H and possibly factor I•Familial non-neuropathic systemic amyloid•Methylmalonic aciduria

Updated Recommendations

KDOQI criteria

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 disease with a measured or calculated GFR less than or equal to 60 mL/min for greater than 90 days

• Dialysis for ESRD• Most recent eGFR/CrCl is at or below 35 mL/min

at the time of registration on kidney waiting list

2. Sustained acute kidney injury • Dialysis for six consecutive weeks• eGFR/CrCl at or below 25 mL/min for at least six

consecutive weeks (reported every 7 days)• Any combination of #1 and #2 above for six

consecutive weeks

3. Metabolic disease Diagnosis of:•Hyperoxaluria•Atypical HUS from mutations in factor H and possibly factor I•Familial non-neuropathic systemic amyloid•Methylmalonic aciduria

How will this be operationalized?

Programmed into UNet℠

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 disease with a measured or calculated GFR less than or equal to 60 mL/min for greater than 90 days

• Dialysis for ESRD• Most recent eGFR/CrCl is at or below 35 mL/min

at the time of registration on kidney waiting list

2. Sustained acute kidney injury • Dialysis for six consecutive weeks• eGFR/CrCl at or below 25 mL/min for at least six

consecutive weeks (reported every 7 days)• Any combination of #1 and #2 above for six

consecutive weeks

3. Metabolic disease Diagnosis of:•Hyperoxaluria•Atypical HUS from mutations in factor H and possibly factor I•Familial non-neuropathic systemic amyloid•Methylmalonic aciduria

How will this be monitored?UNOS staff will request documentation in medical record

Proposal does NOT create SLK listing criteria

Liver candidates can still be registered on kidney waiting list whether they meet proposed medical criteria

Current OPTN policy does NOT require any kidney candidate (kidney alone or kidney + other organs) to meet medical requirements in order to be registered on the kidney waiting list

Transplant programs have complete discretion as to which patients to register on the kidney waiting list

Once registered, kidney candidates are prioritized through match classification or points priority based on medical criteria

SLK medical eligibility criteria will add to the different types of priority applied for different types of kidney candidates

Important Distinction: Eligibility v. Listing Criteria

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Proposed SLK Allocation

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Anticipated Post-Public Comment Changes—SLK Allocation

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lCohort: recipients Mar 31, 2002 – Dec 21, 2012

p-value=0.0007

LI Alone SLK

White 70% 62%

Diabetes 27% 41%

MELD* 36 27

KDPI% 50 40

Age* 55 56

LI CIT* 6.9 6.4

LI Alone SLK

White 73% 65%

Diabetes 23% 38%

MELD* 17 28

KDPI% 50 40

Age* 55 57

LI CIT* 6.7 6.5

* Medians are shown

Crude survival advantage of receiving a kidney vs. liver alone

If OPO recovers a kidney with liver, heart, lung, or pancreas, must allocate kidney locally as part of local multi-organ combination

OPO has discretion to choose between following combinations: Local heart/kidney candidate Local liver/kidney candidate Local lung/kidney candidate Pancreas/kidney candidates (local through regional/national zero mismatch offers)

How Multi-Organ Involving KI works

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If OPO recovers a kidney with liver, heart, lung, or pancreas, must allocate kidney locally as part of local multi-organ combination

OPO has discretion to choose between following combinations: Local heart/kidney candidate Local liver/kidney candidate (eligible local/regional offers) Local lung/kidney candidate Pancreas/kidney candidates (local through regional/national zero mismatch offers)

How Multi-Organ Involving KI Will Work if Approved

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SLK ‘Safety Net’ Policy

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Kidney patient survival: with vs. without prior liver txWaiting list survival Recipient survival

Time period: Mar 31, 2002 – Dec 31, 2012

With LI (<=1)

With LI (>1)

W/t LI

White 75% 74% 45%

Age (median) 57 59 53

With LI (<=3)

With LI (>3)

W/t LI

White 70% 78% 45%

Age (median) 57 60 54

Recommended ‘Safety Net’ Policy

Other Important ‘Safety Net’ Details

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How will this be operationalized/monitored?

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How does this proposal support the OPTN Strategic Plan?

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Mark Aeder, MDCommittee Chair mark.aeder@uhhospitals.org

Regional representative name (RA will complete) Region X Representative email address

Gena BoyleProject Liaison gena.boyle@unos.org

Questions?

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Extra SLK slides

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Who did the Committee collaborate with?

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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 disease 1. Dialysis for ESRD2. eGFR at or below 35 mL/min

2. Sustained acute kidney failure 1. Dialysis for six consecutive weeks2. eGFR/CrCl at or below 25 mL/min for at least six consecutive

weeks (documented every 7 days)3. Any combination of #1 and #2 above for six consecutive

weeks

3. Metabolic disease Diagnosis of:1.Hyperoxaluria2.Atypical HUS from mutations in factor H and possibly factor I3.Familial non-neuropathic systemic amyloid4.Methylmalonic aciduria

Medical Eligibility Criteria (as presented for community feedback)

Kidney graft survival

Cohort: recipients Mar 31, 2002 – Dec 31, 2012

Recipient survival

SLK (ren. failure)SLK (no ren.

failure)KI

White 62% 65% 45%

Age (median) 56 57 54

Regional Feedback (SLK medical eligibility criteria)

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Constituency Group Feedback (SLK medical eligibility criteria)

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Regional Feedback (Safety Net)

Constituency Group Feedback (Safety Net)

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The Impact of the Problem by #s

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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.

Multi-Organ Project Timeline

Classification Candidates that are within the:

And are:

1 OPO’s DSAZero antigen mismatch, CPRA greater than or equal to 80%, and either pancreas or kidney-pancreas candidates

2 OPO’s DSACPRA greater than or equal to 80% and either pancreas or kidney-pancreas candidates

3 OPO’s regionZero antigen mismatch, CPRA greater than or equal to 80%, and are either pancreas or kidney-pancreas candidates

4 NationZero antigen mismatch, CPRA greater than or equal to 80%, and either pancreas or kidney-pancreas candidates

5 OPO’s DSA Pancreas or kidney-pancreas candidates

Kidney-Pancreas Allocation