Redesigning Liver Distribution Liver and Intestinal Organ Transplantation

Redesigning Liver Distribution Liver and Intestinal Organ Transplantation Committee 1

What problem will the proposal address? § Significant variation in a candidate’s chances of receiving a lifesaving organ offer depending on where the candidate is registered § Final Rule: “allocation policies must be based on sound medical judgment, seek to achieve the best use of donated organs, and shall not be based on the candidate’s place of residence or place of listing” except to the extent needed to satisfy other regulatory requirements § OPTN/UNOS recognizes that there are not enough organs and is invested in increasing the number of transplants each year by: § § § increasing donation reducing organ discards improving OPO performance 2

What problem will the proposal address? Current regional boundaries often separate candidates from eligible donors. Ratio of eligible deaths to waitlisted candidates with an allocation MELD or PELD greater than 15, by OPTN/UNOS region, in 2013 3

What problem will the proposal address? § 12 point MELD difference among regions (35 vs. 23) § 60% difference in risk of death in the next three months without transplant § Even if everyone who could donate a liver did so, it wouldn’t address the problem of geographic imbalances § § Organ availability determined mostly by death rates and cause of death, not by organ procurement organization (OPO) performance Rates of candidates added to the waitlist differ widely 4

What is the proposed solution? § Modify boundaries used for liver distribution to better match organ supply with demand § Use mathematical optimization to select the best solution with regard to a set of criteria or “constraints” § Minimize the sum of disparities over all the districts § “Disparity”: difference between the # of donors a region should have if organs went to the highest MELD candidate anywhere in the US and the # of donors in a proposed district, subject to the following constraints: § § § Districts must respect DSA boundaries and be contiguous Minimum of 6 programs in any district 4 - 8 districts No significant increase in waitlist deaths or waitlist death rate Median volume-weighted travel time is less than 3 hours 5

Proposed 8 District Map for Liver Allocation Example of Proximity Circle: 5 5 8 3 7 4 6 3 2 1 *Meant to represent 150 -mile radius circle. Not to scale. 6

Proposed allocation of livers from deceased donors at least 18 years old* Classification 1 2 Candidates that are within the: OPO’s district 3 4 5 6 7 8 OPO’s DSA OPO’s district Nation And are: Proximity points for any candidates in this classification? Adult or pediatric status 1 A No Pediatric status 1 B No MELD or PELD of at least 29 Yes, if the candidate is within both the district and a 150 -mile radius of the donor hospital MELD or PELD of at least 15 No Adult or pediatric status 1 A No Pediatric status 1 B No MELD or PELD of at least 15 Yes, if the candidate is within a 150 mile radius of the donor hospital *Candidates with a MELD or PELD of at least 15 7

Supporting Evidence § Used LSAM to evaluate options § Based on actual data for candidates waiting as of 12/31/06 and those added and organs donated 1/1/07 -12/31/11 § Cannot predict exact numbers or changes in behavior § Best at projecting large-scale changes, effects on large patient populations, and direct impacts of distribution changes § Results are for proposed 8 district model without sharing threshold of MELD or PELD 29 for adult deceased donors 8

Supporting Evidence Proposed 8 districts projected to cut the current variance in median MELD or PELD at transplant in half (2. 9 vs. 6. 2). 9

Additional Predicted Outcomes § Pre-transplant deaths not predicted to increase § Median transport distance increases ≈80 miles (to 200 miles) § Median transport time remains about the same § Estimates that 14% more organs fly (overall 68%) § ≈95% of transplants projected to occur within the district, 50% within the 150 -mile proximity circle § Predicts <2% decrease in the number of transplants § Interpret with caution since model cannot account for changes in acceptance behavior 10

How will members implement this proposal? § Any broader sharing policy, and especially one this significant, poses logistical and financial challenges § OPOs and transplant hospitals may need to devote significant effort to develop new working relationships § OPOs and transplant centers will need to prepare for the additional cost and coordination of transportation: § § Important for OPOs to verify whether a center requires a back-up Centers may consider using local procurement teams in some instances 11

How is redistricting related to the rest of the Committee work plan? 12

Committee Work Plan Redistricting NLRB June 2017 Board (est) HCC Dec 2016 Board (est) 13

How will the OPTN implement this proposal? § OPTN will coordinate implementation so that changes to exception system (NLRB, HCC) are in place by the time redistricting is implemented § Significant programming effort § Offer learning opportunities to promote awareness and compliance with all policies in the work plan 14

Questions? Ryutaro Hirose, MD Committee Chair ryutaro. hirose@ucsf. edu Christine Flavin, MPH Committee Liaison christine. flavin@unos. org 15

Proposed allocation of livers from deceased donors 11 -17 years old Classification 1 2 3 4 5 6 7 8 Candidates that are within the: OPO’s district OPO’s district And are: Pediatric status 1 A Adult status 1 A Pediatric status 1 B Any PELD MELD of at least 15, 12 -17 years old MELD of at least 15, at least 18 years old MELD less than 15, 12 -17 years old MELD less than 15, at least 18 years old* Proximity points for any candidates in this classification? No No No Yes, if the candidate is within both the district and a 150 -mile radius of the donor hospital *Followed by national sharing 16

Proposed allocation of livers from deceased donors less than 11 years old Classification 1 2 3 4 5 6 7 8 9 Candidates that are within the: OPO’s district Nation OPO’s district OPO’s district And are: Pediatric status 1 A, 0 -11 years old Adult status 1 A Pediatric status 1 B Any PELD MELD of at least 15, 12 -17 years old MELD of at least 15, at least 18 years old MELD less than 15, 12 -17 years old MELD less than 15, at least 18 years old Proximity points for any candidates in this classification? No No Yes, if the candidate is within both the district and a 150 -mile radius of the donor hospital *Followed by national sharing 17