Disclosures Towards a more equitable organ distribution system I - - PowerPoint PPT Presentation

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Disclosures Towards a more equitable organ distribution system I - - PowerPoint PPT Presentation

May 15, 2023 25 likes •159 views

9/29/2016 Disclosures Towards a more equitable organ distribution system I have no financial disclosure I am a surgeon at UCSF The views portrayed are not necessarily those of UNOS or of the UNOS liver committee. Ryutaro Hirose, MD

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9/29/2016 1

Towards a more equitable

  • rgan distribution system

Ryutaro Hirose, MD Professor in Clinical Surgery Chair, UNOS Liver Committee UCSF Transplant Symposium 2016

Disclosures

I have no financial disclosure I am a surgeon at UCSF The views portrayed are not necessarily those of UNOS or of the UNOS liver committee.

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9/29/2016 2

US Department of HHS Final Rule

  • Allocation of cadaveric organs – the allocation

polices:

Shall seek to achieve the best use of donated organs; Shall be designed to avoid wasting organs, to avoid

futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement;

Shall not be based on the candidate's place of

residence or place of listing

Sickest first

  • Setting priority rankings…that shall be ordered

from most to least medically urgent. There shall be a sufficient number of categories (if categories are used) to avoid grouping together patients with substantially different medical urgency;

Organ allocation – balancing conflicting principles

  • UTILITY

Maximizing usefulness of scarce resource

  • EFFICIENCY

Cost Value

  • JUSTICE

Fairness Equal access

U.S. liver allocation changes since 2000

  • Feb 2002 - MELD score replaces Status 1,

Status 2a, 2b , Status 3 and wait list times at status, more objective criteria

Better transplant outcomes, despite sickest first

triage

Lower waitlist mortality

  • 2005 – Regional Share 15
  • 2010 – Regional Sharing for status 1 patients

across all UNOS regions

Reduction in waitlist mortality for status 1 pts,

especially peds

  • June 2013 – Regional Share 35/National

Share 15

Decreased wait time, increased access and

decreased waitlist mortality for candidates with MELD>=35

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Most recent allocation changes

  • October 2015 - HCC cap and delay

6 month delay before HCC points awarded HCC exception points: capped at 34

  • Jan 11, 2016 – MELD Na

Change in MELD to add Na Hyponatremia added to adjust for waitlist

mortality

Hopefully eliminate subjective exceptions for

refractory ascites

Map of OPO boundaries/DSAs Allocation vs Distribution

  • Allocation

The algorithm that determines the order of patients

  • n the waitlist

MELD score Exceptions

  • Distribution

Defining the areas that determine the geographical

segments of distribution

UNOS regions

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Liver disease – MELD score

  • After patients with acute liver failure (Status 1a)
  • MELD score

Na Bili PT/INR Cr

  • MELD exception score

For conditions/patients whose degree of illness or

need for liver txp is not reflected in MELD score, e.g. metabolic diseases, HCC

REGIONAL REVIEW BOARDS

Allocation sequence

  • Status 1 – REGIONAL
  • MELD >=35 – REGIONAL
  • MELD 15-34 – LOCAL (DSA)
  • MELD 15-34 – REGIONAL
  • Status 1 – NATIONAL
  • MELD >=15 – NATIONAL
  • MELD <15 - Local

Region Era 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 1 26.0 29.0 29.0 27.5 29.0 29.0 29.0 31.0 31.0 31.0 2 23.0 25.0 25.0 26.0 26.0 27.0 28.0 29.0 30.0 30.0 3 22.0 22.0 22.0 22.0 22.0 23.0 24.0 25.0 25.0 25.0 4 22.0 22.0 24.0 25.5 27.0 28.0 28.0 30.0 31.0 29.0 5 27.0 28.0 28.0 30.0 31.0 33.0 33.0 33.0 35.0 35.0 6 22.0 22.0 22.0 22.0 25.0 25.0 27.0 28.0 28.0 28.5 7 24.0 25.0 25.5 26.0 29.0 31.0 30.0 30.0 31.0 30.5 8 22.0 23.0 24.0 25.0 25.0 27.0 27.0 25.0 25.0 25.0 9 23.0 25.0 27.0 28.0 29.0 31.0 29.0 31.0 31.0 33.0 10 22.0 22.0 22.0 22.0 22.0 22.0 22.0 25.0 24.0 23.0 11 22.0 22.0 22.0 22.0 22.0 22.0 23.0 24.0 25.0 25.0 All 23.0 23.0 24.0 25.0 25.0 27.0 27.0 28.0 28.0 28.0

Median MELD/PELD Score at Transplant by Year and Region

Northern CA, MELD 30-34

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Louisiana, MELD 30-34 Inequity and Disparity

  • Inequity – (def.) lack of fairness or justice (syn)

unfairness, injustice

  • Disparity – (def.) lack of similarity or equality; a

great difference; (syn) discrepancy, inconsistency, imbalance

The map of distribution CAUSES much of the disparity

  • Gerrymandering (voting districts)
  • The current map divides up areas of large supply

and large demand

  • The 11 Regions are also not drawn well

Supply/Demand Metrics

  • Measured supply

Actual Liver donor Potential liver donors (eligible deaths, total deaths)

  • Measured demand

Waitlisted patients Waitlisted patients MELD>15

  • Surrogate metrics

MELD/PELD score at transplant In economic supply/demand model, the ‘price’ of on

  • rgan as the organ is assigned to the highest ‘bidder’

(MELD score)

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What determines local supply of livers?

  • OPO performance, e.g. conversion rates?

To a relatively small degree…yes In 58 OPO’s actual donors/eligible ranges from 58.1-

90.9 donors/100 eligible deaths

1.5x fold difference between lowest and highest

  • Death rates? YES

To a much larger degree (e.g. 10-20x fold differences

in stroke rates)

Stroke rates – range from

13.5-300 stroke deaths/yr/100k

Supply – preventable death by state

Deaths due to firearms (correlates with strength of gun laws)

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How does demand vary?

Supply/Demand ratios of areas depends on borders of areas

  • NO MODELLING but ACTUAL DATA (2013)
  • Current distribution borders results in physical

separation of areas with HIGH SUPPLY and areas with HIGH DEMAND

  • Compare supply/demand ratios

ALL DSA’s with liver transplant programs vs 11 UNOS regions 8 districts 4 districts

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9/29/2016 8

Eligible deaths/WL> 15 11 Regions Optimization

Based on 3 things:

1.

Number of donors recovered in each DSA (actual data)

2.

Number and match MELD of candidates in each DSA (actual data)

3.

Constraints determined by the Committee When Committee the chooses another disparity metric to analyze outcomes, the maps do not change.

Constraints

No new modeling performed, same constraints:

Contiguous-DSA districts Between 4 and 8 districts Minimum of 6 transplant centers in

any district

Waitlist deaths cannot increase Maximum average travel time of 5

hours

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9/29/2016 9

Proposed 8 District Map for Liver Allocation

33

8 5 1 6 4 3 2

Example of Proximity Circle:

5

*Meant to represent 150- mile radius circle. Not to scale.

3

7

Eligible deaths/WL >15 8 districts

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9/29/2016 10

Eligible deaths/WL>15 (4 districts) Metrics of disparity

  • Variance in MELD score at transplant

Agreed upon in Liver committee

  • Variance in transplant rates
  • Variance in waitlist mortality

Mathematical Modeling

  • SRTR – LSAM
  • Based on large actual patients who were waitlisted,

and their outcomes –

Transplanted Died Still waiting

Variance of median MELD at transplant

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Variance in transplant rates Variance in waitlist mortality Supporting Evidence

43

Proposed 8 districts projected to cut the current

variance in median MELD or PELD at transplant in half (2.9 vs. 6.2).

Conclusion

  • Redistricting fixes supply/demand ratio disparity
  • Proximity circles do not compromise the gains in

disparity with 8- and 4- district map

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9/29/2016 12

National Liver Review Board

  • Why?
  • Need consistency
  • 11 different RRBs with different practices, different

guidelines

  • Regional differences in exception application,

acceptances, transplant under exception

Transplants 2015 Lab vs Exception patients (% exception)

UNOS Region # txp

Median allocation MELD at transplant 2015

UNOS region

  • Differences in regional approaches to “other”

diagnoses can hopefully be reached by creation of formal “guidance document”, as previously noted.

  • Differences in rates of exceptions by region are

multifactorial (many are within standard policy) but may be reduced by NRB.

  • Differences in Median MELD at transplant:

consider exception points based on MELD in Region/DSA

  • MELD Inflation: as above

Solutions:

48

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9/29/2016 13

Conclusions

  • The UNOS liver intestine committee continues working

towards making the system more fair

  • Political barriers remain
  • There are valid concerns about wider sharing

Costs (proximity circles) Flying livers for small MELD differences (proximity

circles)

Exception policy (NLRB) Payors must change reimbursement practices (cost

savings due to management of pre-transplant patients)

Committee Work Plan

50

June 2017 Board (est) June 2017 Board (est) Dec 2016 Board (est)

Redistricting NLRB HCC

Next steps forward

  • 8- districts with proximity circle (3 points at 150

miles)

  • For subset of patients as first step – 29
  • National Liver Review Board
  • Standardize more exceptions – less work for NLRB
  • Exception points – should they be fixed, instead of

elevator?, how should they be assigned

  • Questions??