Current and future regulatory and financial challenges in vascularized composite allotransplantation

To discuss current and future regulatory and financial issues affecting the field of vascularized composite allotransplantation (VCA).

Vascularized composite allografts are regulated by the US Department of Health and Human Services Organ Procurement and Transplantation Network Final Rule (42 CFR part 121) in the United States and Directive 2010/53/EU of the European Parliament and the Council of 7 July 2010 in the European Union (EU). However, in the United States and most of the EU, VCA is not yet paid for by insurance or third-party payers and many centers depend upon grant funding, philanthropic gifts, and/or supplemental hospital/institutional funding strategies to pay for the transplants and postoperative care.

In the absence of randomized clinical trial data, which is infeasible for studying VCA outcomes, consensus data sets are needed to document these procedures' value proposition and have them accepted as part of the standard of care. Procedure and immunosuppression protocol variability applied to a small patient cohort necessitates collaborative efforts by field experts to devise creative approaches, such as determining return-on-investment for anatomical subunits, to better understand these transplants' value and impact on patient quality-of-life.