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

� 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 Professor in Clinical Surgery Chair, UNOS Liver Committee UCSF Transplant Symposium 2016 � 1

� 9/29/2016 US Department of HHS Final Sickest first Rule Setting priority rankings…that shall be ordered � Allocation of cadaveric organs – the allocation from most to least medically urgent. There shall � polices: be a sufficient number of categories (if categories are used) to avoid grouping together patients with � Shall seek to achieve the best use of donated organs; substantially different medical urgency; � 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 U.S. liver allocation changes Organ allocation – balancing since 2000 conflicting principles Feb 2002 - MELD score replaces Status 1, � UTILITY � Status 2a, 2b , Status 3 and wait list times at � Maximizing usefulness of scarce resource status, more objective criteria EFFICIENCY � � Better transplant outcomes, despite sickest first triage � Cost � Lower waitlist mortality � Value 2005 – Regional Share 15 � JUSTICE � 2010 – Regional Sharing for status 1 patients � � Fairness across all UNOS regions � Equal access � 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 � 2

� 9/29/2016 Map of OPO boundaries/DSAs 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 Allocation vs Distribution UNOS regions Allocation � � The algorithm that determines the order of patients on the waitlist � MELD score � Exceptions Distribution � � Defining the areas that determine the geographical segments of distribution � 3

� 9/29/2016 Liver disease – MELD score Allocation sequence After patients with acute liver failure (Status 1a) Status 1 – REGIONAL � � MELD score MELD >=35 – REGIONAL � � � Na MELD 15-34 – LOCAL (DSA) � � Bili MELD 15-34 – REGIONAL � � PT/INR Status 1 – NATIONAL � � Cr MELD >=15 – NATIONAL � MELD exception score � MELD <15 - Local � � 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 Median MELD/PELD Score at Transplant by Northern CA, MELD 30-34 Year and Region Era Region 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 � 4

� 9/29/2016 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 Supply/Demand Metrics The map of distribution CAUSES much of the Measured supply � � Actual Liver donor disparity � Potential liver donors (eligible deaths, total deaths) Measured demand � � Waitlisted patients � Waitlisted patients MELD>15 Gerrymandering (voting districts) � Surrogate metrics � The current map divides up areas of large supply � � MELD/PELD score at transplant and large demand � In economic supply/demand model, the ‘price’ of on The 11 Regions are also not drawn well � organ as the organ is assigned to the highest ‘bidder’ (MELD score) � 5

� 9/29/2016 What determines local Stroke rates – range from supply of livers? 13.5-300 stroke deaths/yr/100k 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) Deaths due to firearms Supply – preventable death (correlates with strength of gun by state laws) � 6

� 9/29/2016 Supply/Demand ratios of areas How does demand vary? 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 � 7

� 9/29/2016 Eligible deaths/WL> 15 11 Regions Optimization Constraints Based on 3 things: No new modeling performed, same Number of donors recovered in each DSA constraints: 1. (actual data) � Contiguous-DSA districts Number and match MELD of candidates in 2. � Between 4 and 8 districts each DSA (actual data) Constraints determined by the Committee � Minimum of 6 transplant centers in 3. When Committee the chooses another disparity any district metric to analyze outcomes, the maps do not � Waitlist deaths cannot increase change. � Maximum average travel time of 5 hours � 8

� 9/29/2016 Proposed 8 District Map for Liver Allocation Example of Proximity Circle: 5 5 8 3 2 3 7 1 4 6 *Meant to represent 150- mile radius circle. Not to scale. 33 Eligible deaths/WL >15 8 districts � 9

� 9/29/2016 Eligible deaths/WL>15 Metrics of disparity (4 districts) Variance in MELD score at transplant � � Agreed upon in Liver committee Variance in transplant rates � Variance in waitlist mortality � Variance of median MELD at Mathematical Modeling transplant SRTR – LSAM � Based on large actual patients who were waitlisted, � and their outcomes – � Transplanted � Died � Still waiting � 10

� 9/29/2016 Variance in transplant rates Variance in waitlist mortality Supporting Evidence Conclusion � Proposed 8 districts projected to cut the current variance in median MELD or PELD at transplant in half Redistricting fixes supply/demand ratio disparity � (2.9 vs. 6.2). Proximity circles do not compromise the gains in � disparity with 8- and 4- district map 43 � 11

� 9/29/2016 Transplants 2015 National Liver Review Board Lab vs Exception patients (% exception) # txp Why? � Need consistency � 11 different RRBs with different practices, different � guidelines Regional differences in exception application, � acceptances, transplant under exception UNOS Region Solutions: Median allocation MELD at transplant 2015 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 � UNOS region 48 � 12

� 9/29/2016 Committee Work Plan Conclusions The UNOS liver intestine committee continues working � June Redistricting towards making the system more fair 2017 Political barriers remain Board � (est) There are valid concerns about wider sharing � � Costs (proximity circles) � Flying livers for small MELD differences (proximity NLRB June circles) 2017 � Exception policy (NLRB) Board (est) � Payors must change reimbursement practices (cost savings due to management of pre-transplant patients) Dec 2016 HCC Board (est) 50 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?? � � 13