1. Pancreas Transplantation Committee
Broadened Allocation of Pancreas Transplants Across Compatible ABO Blood Types
Hello Everyone, my name is ____________ from [name of organization]. Today, I’ll be presenting the “Broadened Allocation of Pancreas Transplants Across Compatible ABO Blood Types” proposal put forward by the Pancreas Transplantation Committee.
Pancreas Transplantation Committee

2. What problem will the proposal solve?
Pancreas transplants have declined significantly since early 2000s
Current blood type restrictions prevent compatible transplants from occurring
These restrictions could lead to pancreata being discarded and fewer transplants
The number of pancreas transplants has declined significantly over the past decade, even while outcomes have improved. Current blood type restrictions prevent clinically compatible SPK transplants from occurring and represent an unnecessary barrier to pancreas transplantation. Fewer pancreas transplants means a high discard rate of usable pancreata and fewer candidates receiving a life changing transplant.

3. What are the proposed solutions?
Prioritize high-cPRA ABO-identical candidates, then high-cPRA compatible candidates, then all identical, then all compatible
Allow A, non-A1 and AB, non-A1B compatible pancreas or kidney- pancreas to B candidates
Allow B pancreas or kidney-pancreas to B or AB candidates
Remove restrictions on blood type O compatibility:
A, B or AB candidates need zero antigen mismatch (0-ABDR) + cPRA ≥80 to receive O pancreas or kidney-pancreas in current policy
The Committee seeks to increase pancreas transplantation and reduce discarded pancreata by modifying the allocation system to allow clinically compatible transplants. The Committee chose a solution that prioritizes ABO-identical candidates over ABO-compatible candidates, segmented by whether a candidate has a high cPRA.
The changes to allow A, non-A1 and AB, non-A1B kidney-pancreas or pancreas to B candidates brings pancreas allocation in line with kidney blood type allocation. Same thing for B kidney-pancreas or pancreas to B or AB candidates, a compatibility currently allowed in kidney policy.
The proposed solution allows blood type O compatibility without the current restrictions in pancreas or kidney policy (candidates having 0-ABDR mismatch with the deceased donor and a cPRA ≥ 80).

4. Current KP Policy/Programming
This slide shows the current policy for Allocation of KP by blood type, which the proposal would change to allow clinical compatibility that is currently restricted.

5. Current KP Programming
This slide shows the current programming for Allocation of Pancreas and KP by blood type. The circles indicate the areas of clinical compatibility that are not currently being utilized that would be utilized under the new policy:
Restrictions on blood type O compatibility are lifted
A2/A2B (A, nonA1 and AB, nonA1B) to B compatibility is allowed, with the same requirements as kidney allocation has (see slide 10 for member requirements)
blood type B to AB candidates

6. Current vs. Proposed Allocation System
Currently, organs are allocated to local highly sensitized candidates first through then national level, then to all local candidates on the KP waiting list. On the left you see the current KP/PA allocation rules for donors ≤ 50 and BMI ≤ 30 . On the right, you see how it would change if the proposed changes are implemented.
Under the new allocation proposal, offers would go to ABO-identical highly sensitized candidates through the national level, then ABO-compatible candidates through the national level. Then, KPs would be offered to ABO-identical candidates on the local KP waiting list and subsequently local ABO-compatible candidates on the KP waiting list. After that, we project that OPOs would switch to the kidney-alone list.

7. Supporting Evidence
The Committee asked the SRTR to run simulations to see how to most effectively broaden allocation by compatible ABO blood types. SRTR ran five KPSAM simulations, plus a baseline (R1) (see slide 18 for a list). The Committee chose Run 4, which is the proposed allocation system I described in the last slide. This slide shows that Run 4 showed the highest projected median years of benefit from transplant and projected quality-adjusted median years of benefit from transplant (LYFT) for the reduced cohort.
Median years of benefit from transplant versus waiting list is the extra years of life that a candidate could expect to achieve with a transplant versus never undergoing transplant. Quality Adjusted means that all time spent on dialysis or the waiting list was "discounted" to be 80% the value of time with a functioning graft. The increase is due to a shift to more kidney-pancreas transplants, which on average have a higher LYFT and QA-LYFT than kidney-alone transplants. The full cohorts predicted more total transplants than the reduced cohorts, which is why the total LYFT in the full runs is higher.
Having a much higher projected transplant benefit was an important factor in the Committee deciding to pursue an allocation change based on the Run 4 simulation.
NOTE: The SRTR used both a full and reduced cohort, the latter being a more accurate reflection of current (2015) numbers. Since pancreas transplantation has been on the decline, the full cohort reflects 2010 numbers while the reduced cohort is randomly selected from the 2010 cohort to reflect the decline in pancreas transplantation. I will focus on the reduced cohort results because it more accurately reflects modern pancreas transplantation numbers.

8. Supporting Evidence
Another important factor for the Committee in choosing the Run 4 simulation was the projected net gain in transplants projected. As you can see, in the reduced cohort, Run 4 projects a net increase of 39 transplants, much higher than the other simulations. This slide highlights that the reduction in kidney alone transplants was smaller for Run 4 than any other simulation save Run 6. Run 6, however, shows a reduction in KPs, and also had significantly less impact on both median years of benefit and LYFT.
The Committee feels the reduction of kidney alone transplants is offset by the beneficial net increase in KP transplants and reduced discard rate for pancreata. The projected reduction of kidney-alone is extremely small compared to the number of deceased donor kidney alone transplants (there were in 2016, or a projected decrease of .7%). By contrast, there were only 798 KP transplants in 2016, so an increase of 143 would be an increase of 17.9%.
To see an impact on blood type, see slide 15.

9. Supporting Evidence
The SRTR-modeled option chosen by the Committee shows:
Projected increase of 143 kidney-pancreas transplants
More kidney-pancreas transplants can reduce pancreas discards
The greatest difference in kidney-pancreas versus kidney-alone transplants:
KP = KIA = Difference = +38
Projected net increase in transplants (+38)
Transplant Benefit
Greatest increase in Median Years of Benefit: 249
Greatest increase in Life Years Following Transplant (LYFT): 240
As the previous slides indicate, the modeling chosen by the Committee to modify allocation is projected to increase kidney-pancreas transplants by 143. It has the second smallest projected reduction in kidney-alone transplants (-105), and is projected to result in a net increase of transplants of 38. It is important that an increase in KPs means two organs getting utilized, especially since pancreata have higher rates of being discarded. Run 4 also showed the greatest increase in median years of benefit and LYFT: For the reduced cohort, the difference in LYFT from Run 4 to the other simulations was 90 years.
In sum, modifying current blood type restrictions could lead to an increase in the utilization of pancreata, an overall increase in SPK transplants, and could promote a more efficient allocation system.

10. How will members implement this proposal?
Only one element of proposed changes require member implementation:
For A, non-A1 and AB, non-A1B to B KP or PTA compatibility transplant programs must do the same as they do kidneys
Obtain written, informed consent from B candidate
Establish a written protocol for A, non-A1 and AB, non-A1B to B titer thresholds
Confirm A, non-A1 and AB, non-A1B compatibility for B candidates every 90 days (+/- 20 days)
NOTE: Marking candidates eligible for A, non-A1 and AB, non-A1B kidneys makes them eligible for A, non-A1 and AB, non-A1B kidney- pancreas and pancreas
Transplant programs must fulfill the same written consent and titer threshold requirements as the current requirements in kidney policy for A, non-A1 and AB, non-A1B to B compatibility. They must also confirm A, non-A1 and AB, non-A1B eligibility every 90 days, as is currently the case with kidney policy.
It is important to note that the programming change will meant that if programs mark candidates eligible for A, non-A1 and AB, non-A1B to B compatibility for kidneys, it will automatically make the candidate eligible for the same A, non-A1 and AB, non-A1B for pancreas alone and kidney pancreas.

11. Specific Feedback
Titer thresholds for A, non-A1 and AB, non-A1B kidney-pancreas and pancreas-alone to B candidates:
Same as kidney, or different?
There is no available data on transplanting a blood type A, non-A1 and AB, non-A1B kidney-pancreas or pancreas alone into a blood type B recipient, because these transplants have not been previously permitted by OPTN/UNOS policy. In seeking to encourage these transplants, the Committee seeks feedback on whether transplant programs anticipate using different titer thresholds for an A, non-A1 and AB, non-A1B kidney-pancreas or pancreas alone compared to the titer thresholds used for an A, non-A1 and AB, non-A1B kidney alone. The programming for this policy would allow transplant programs to indicate a candidate’s eligibility to receive blood type A, non-A1 and AB, non-A1B organs for kidney, kidney-pancreas, and pancreas. If the kidney-pancreas or pancreas titer thresholds differ, then the eligibility for receiving these organs should be submitted separately.

12. How will the OPTN implement this proposal?
Anticipated Board Review date: December 3-5, 2017
Programming in UNetSM
Changes to the match system
Evaluation for compliance:
Site surveys: review documentation for written, informed consent
Site surveys: verify that the program has a written protocol regarding titer thresholds
Post-Implementation Evaluation:
# of SPK transplants by blood type
Post-transplant survival and waitlist outcomes of SPK and kidney alone candidates and recipients pre/post implementation
Median time to transplant for SPK and KI by blood type
After public comment, the Committee will incorporate any changes from feedback during public comment and vote to send the proposal to the Board in December. Because it is an allocation change, the proposed changes will require changes in UNet. Site surveyors will review medical records for documentation that blood type B candidates gave written, informed consent for A, non-A1 and AB, non-A1B organs. Site surveyors will also verify that the program has a written titer thresholds protocol for A, non-A1 and AB, non-A1B to blood type B candidates.
UNOS staff will determine if the proposal increased the total number of SPK transplants by blood type and present the results to the Committee. The Committee will also evaluate the effect of this policy on post-transplant survival and waitlist outcomes of SPK and KI candidates and recipients pre and post implementation. Median time to transplant will be an outcome of interest for both SPK and KI candidates by blood type for the Committee to review as well.

13. Questions? Jon Odorico, MD Pancreas Transplantation Committee Chair
Abigail Fox, MPA
Pancreas Transplantation Committee Liaison

14. Extra Slides

15. Impact on Blood Type O
This slide shows the impact on kidney alone transplants by blood type. Blood type O saw a projected reduction of 25 transplants for KPs (13%), and 266 (2%) for kidney alone transplants, while the other blood types increased. While the projected decrease in blood type O transplants is concerning, the simulated reduction is small (2% for kidney alone), and the Committee feels the reduction in blood type O projected to occur is offset by the projected increase in KP transplants, which means fewer discarded pancreata, and the overall increase in transplants projected.

16. Minority Outcomes Change in Number of Transplants: Run 4 cut
Kidney-Pancreas
Kidney Alone
Difference
African American
+28
-22.1
+6.1
Caucasian
+100.7
-74
+26.7
Hispanic
+10.2
-16.5
-6.3
Other
+5.8
-1.5
+4.3 KP
Overall, there was minimal changes in transplants by race projected. All KP transplants increased by race, and all kidney-alone decreased. However, Run 4 reduced cohort showed an overall increase for African American, Other and Caucasian transplants, and a slight projected decrease of 6 fewer Hispanic transplants.

17. Proposed KP Policy
This slide shows you what the new allocation would look like.

18. KPSAM Simulations All compatible blood types allowed (R2)
All compatible blood types allowed and ABO identical candidates are prioritized. (R3)
High-cPRA ABO identical candidates prioritized, followed by ABO compatible candidates with high CPRA, identical candidates with low cPRA, compatible candidates with low cPRA (R4)
ABO-identical candidates prioritized above ABO-compatible candidates according to geographical stratification (local, regional and national classifications) (R5)
ABO-identical candidates receive offers through the national level, then ABO- compatible candidates offers through the national level (R6)

19. Waitlist Mortality by ABO
Waitlist mortality rates were nearly constant across runs.