Barriers to increasing pancreatic islet cell transplants in the USA

B. Flanagan¹, J. Markmann², H. Rilo³, D. Kaufman⁴, A. Cole⁵, A. Hwa⁶, D. Niedfeldt⁷, P. Stock⁸, R. Kandaswamy⁸, J. Wainright⁹, C. Waller^9
1 University of Minnesota, Minneapolis, USA; ² Massachusetts General Hospital, Boston, USA; ³ University of Arizona, Tucson, USA; ⁴ University of Wisconsin Hospital, Madison, USA; ⁵ LifeNet Health, Virginia Beach, USA; ⁶ Juvenile Diabetes Research Foundation, New York, USA; ⁷ Carolina Donor Services, Durham, USA; ⁸ University of California - San Francisco, San Francisco, USA; ⁹ United Network for Organ Sharing, Richmond, USA

Objective: Pancreatic islet transplantation in the US has experienced a dramatic rise and fall in activity since report of the Edmonton trial in 2000. After peaking in activity in 2002 at 142, transplants declined to 66 in 2008. To understand the current state of islet transplantation and barriers to greater islet transplant activity, we surveyed all programs requesting information regarding the 2-year period 2009-2010.

Methods: A survey was generated by the Islet transplant sub-committee of the UNOS pancreas committee. Each of the 43 US islet centers were asked to complete an on-line survey. 100% of active sites (n=20) and 95.7 % of inactive sites (n=22) responded. Two active centers reported having autoislet programs only and were excluded.

Results: 18 centers were active during the 2-year period, of which 14 had performed ≥1 islet infusion, for a total of 91 patients transplanted (range 1-14 patients). When asked the importance of 20 possible barriers to islet transplantation, five of the top six were financial and included organ procurement costs (OPO charges, transport costs, isolation costs and SAC applied to non-transplantable preparations, and denial of waivers by OPO) and the sixth was logistical issues related to organ receipt. A variety of sources were used by sites to fund islet transplantation including: NIH-non-CIT (68.8%), Institutional funds (62.5%), philanthropy (56.3%), NIH-CIT consortia (43.8%), and JDRF (37.5%), and IIDP (31.3%).

Conclusions: Islet transplant activity in the US contracted dramatically in the last 6 years. Our survey results suggest that the major barriers are primarily financial in nature. Specifically, handling of organ acquisition charges, transportation costs and transportation charges are major obstacles. Modification of current financial charge practices or approval of islets by third party payers as a reimbursable therapy for Type I diabetes is needed for islet transplantation to expand to its full potential.