Development of the New Lung Allocation System in the United States*

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This article reviews the development of the new U.S. lung allocation system that took effect in spring 2005. In 1998, the Health Resources and Services Administration of the U.S. Department of Health and Human Services published the Organ Procurement and Transplantation Network (OPTN) Final Rule. Under the rule, which became effective in 2000, the OPTN had to demonstrate that existing allocation policies met certain conditions or change the policies to meet a range of criteria, including broader geographic sharing of organs, reducing the use of waiting time as an allocation criterion and creating equitable organ allocation systems using objective medical criteria and medical urgency to allocate donor organs for transplant. This mandate resulted in reviews of all organ allocation policies, and led to the creation of the Lung Allocation Subcommittee of the OPTN Thoracic Organ Transplantation Committee. This paper reviews the deliberations of the Subcommittee in identifying priorities for a new lung allocation system, the analyses undertaken by the OPTN and the Scientific Registry for Transplant Recipients and the evolution of a new lung allocation system that ranks candidates for lungs based on a Lung Allocation Score, incorporating waiting list and posttransplant survival probabilities.

Key words:

Lung transplantation
organ allocation
modeling
OPTN
SRTR
transplant benefit
waiting list

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*

Note on sources: The articles in this report are based on the reference tables in the 2005 OPTN/SRTR Annual Report, which are not included in this publication. Many relevant data appear in the tables figures included here; other tables from the Annual Report that serve as the basis for this article include the following: Tables 12.2, 12.3 and 13.4. All of these tables may be found online at http://www.ustransplant.org.

1

The Organ Procurement and Transplantation Network is the network that links the organizations of the solid organ donation and transplantation system in the United States, including transplant centers, organ procurement organizations and histocompatibility laboratories. The United Network for Organ Sharing (UNOS) is a private nonprofit membership organization that has operated the OPTN under contract with the Health Resources and Services Administration (HRSA), part of the U.S. Department of Health and Human Services, since 1986. The SRTR, administered under contract to HRSA by the University Renal Research and Education Association with the University of Michigan, supports the ongoing evaluation of the scientific and clinical status of solid organ transplantation in the United States.

2

Report of the OPTN Thoracic Organ Transplantation Committee to the Board of Directors, June 1998.

3

Report of the OPTN Thoracic Organ Transplantation Committee to the Board of Directors, November 1998.

4

Report of the OPTN Thoracic Organ Transplantation Committee to the Board of Directors, November 1999.

5

Report of the OPTN Thoracic Organ Transplantation Committee to the Board of Directors, June 2000.

6

Report of the OPTN Thoracic Organ Transplantation Committee to the Board of Directors, June 2004, Exhibit A.

7

When each diagnostic group was modeled separately using Cox proportional hazards models, the data specific to each group were used to estimate hazards and survival curves. There was no assumption of proportional hazards linking these different survival models to one another. The respective proportional hazards assumptions applied to the risk factors in each of these models separately. Upon combining all diagnosis groups together, diagnosis group indicators become risk factors as well, and the assumption of proportional hazards of these group indicators in relation to one another was assessed as described.

8

Report to the UNOS Board of Directors, June 23, 2005.

Copyright © 2006 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved. Published by Elsevier B.V. All rights reserved.