1. Thoracic Organ Transplantation Committee Spring 2014
Proposal to Continue the Adolescent Classification Exception for Pediatric Lung Candidates
Thoracic Organ Transplantation Committee
Spring 2014

2. The Problem
Some young pediatric lung candidates are large enough to accept lungs from donors 12 and older, but do not have priority
Adolescent classification exception gives pediatric lung candidates access to larger sized donors
Adolescent classification exception policy expires July 1, 2014
First, let me clarify up front that for the purposes of this proposal, when I refer to “pediatric” or “young pediatric” candidates I’m referring to lung candidates that are less than 12 years old. Lung allocation policy currently has three separate age ranges: young pediatric (0-11 year olds), adolescent (12-17 year olds) and adults (18 and up). In June 2013, the OPTN/UNOS Executive Committee adopted an emergency policy modification, which allows young pediatric lung candidates less than 12 years old to apply to the Lung Review Board (LRB) for an exception to be listed as an adolescent candidate for allocation of adult and adolescent lungs. Some pediatric candidates less than 12 are large enough to receive lungs from donors aged 12 and up, but the current allocation system prioritizes the pediatric candidates behind adolescent candidates for offers from adolescent donors in the same geographic zone, and behind adult and adolescent candidates for offers from adult donors in the same geographic zone.
The adolescent classification exception allows the candidate to be listed according to their Lung Allocation Score (LAS), which is calculated for candidates of all ages, but is only verified and used to allocate lungs for candidates aged 12 and up. Because candidates with the adolescent classification exception are prioritized with adolescents for offers from adult and adolescent donors, they have a better opportunity to receive offers from donors that may be more suitable based on size.
The adolescent classification exception has an expiration date of July 1, If the policy is not extended, pediatric candidates will no longer be able to apply for this exception and will lose their prioritized access to larger donors.

3. Goal of the Proposal
Reduce waiting list mortality rates for pediatric lung candidates
Gain a better understanding of the relationship between the LAS and pediatric candidates
The goal of the proposal is to reduce the rate of waiting list mortality among pediatric lung candidates by granting them increased priority for a pool of donors that may be more suitable for the candidate based on size. The Thoracic Committee hopes this goal is achieved without negatively affecting the waiting list mortality rates for adolescent or adult candidates, and will closely monitor the data to determine whether the adolescent classification exception results in unintended consequences.
A secondary goal of the proposal is to begin to collect more robust data on pediatric lung candidates so that the Thoracic Committee can analyze the relationship between the LAS and the medical condition of pediatric candidates. The LAS has not been verified for candidates less than 12 due to a lack of data on this cohort of candidates, and this policy may permit the Thoracic Committee to collect enough data to determine whether the LAS can be applicable to pediatric candidates.

4. How the Proposal will Achieve its Goal
Centers can continue to apply for adolescent classification exceptions for young pediatric lung candidates
Must report all LAS data for candidates less than 12 with approved adolescent classification exceptions
If passed, the proposal will remove the July 1, 2014 expiration from the adolescent classification policy. Transplant programs will therefore continue to be allowed to apply to the LRB to request an adolescent classification exception. If approved, the candidate will appear on the match run as an adolescent candidate for adult and adolescent donors, while still retaining their priority as a pediatric candidate for pediatric donors.
Candidates with adolescent classification exceptions will be treated like candidates aged 12 and older for the purposes of lung allocation policy, which means that transplant programs will have to report all LAS data for those candidates even though they are less than 12. In doing so, the OPTN will collect more data on pediatric lung candidates that will eventually help the Thoracic Committee analyze the applicability of the LAS to pediatric candidates. The same default values used in policy for missing or expired variables will be used for candidates with adolescent classification exceptions. If a transplant program is unable to obtain certain LAS variables required by policy, the program can apply to the LRB for approval of estimated values, or for an estimated LAS.

5. Supporting Evidence
10 candidates with approved adolescent classification exception since June 2013
5 transplanted, 4 still waiting, 1 died
Age at time of exception request
7 were years old, 3 were 6-9 years old
Blood type
6 O, 2 A, 2 B
Diagnoses
6 CF, 2 primary arterial hypertension, 1 ARDS/pneumonia, 1 pulmonary veno-occlusive disease
LAS score exception request
4 requests for LAS score exception
In developing this policy, we examined data regarding candidates with an adolescent classification exception since June As of January 13, 2014, five candidates with approved adolescent classification exceptions were transplanted, four were still waiting for transplant, and one died. Of the 10 candidates with approved adolescent exceptions, seven were 10 or 11 years old at the time of the exception request, and three were between 6 and 9 years old. Six of the candidates were blood type O, two were blood type A and two were blood type B. Six of the 10 candidates were diagnosed with cystic fibrosis, two candidates had primary arterial hypertension, one candidate had ARDS/pneumonia, and one candidate had pulmonary veno-occlusive disease.
After receiving LRB approval for the adolescent classification exception, four candidates also requested an LAS score exception.

6. What Members Will Need to Do
Centers can apply for adolescent classification exceptions for young pediatric candidates
Must maintain pediatric and adolescent records for candidates with approved adolescent classification exceptions*
Must report all LAS variables for candidates with an adolescent classification exception
If the removal of the July 1, 2014 expiration date is approved, the policy will continue to operate as it currently does. Transplant programs can apply to the LRB for adolescent classification exceptions following the process detailed in the memo distributed on September 13, 2013, and posted on Transplant Pro, titled Recommendation for Submitting Information and Evidence in Support of Lung  Review Board (LRB) Exception Requests.
If the LRB approves the exception, then the transplant program will be required to maintain two separate records for the candidate – the pediatric record and the adolescent record. All LAS variables that are required by policy for candidates aged 12 and older must be reported, and the same data update requirements also apply.
The transplant program will not be charged a second registration fee for the adolescent record.
*No additional registration fee

7. Questions?
Steven Webber, M.D., MBChB, MRCP Committee Chair
Name Region # Representative
Liz Robbins Callahan Committee Liaison