The Costs of Human Uterus Transplantation

A Study Based on the Nine Cases of the Initial Swedish Live Donor Trial

Thomas Davidson; Jana Ekberg; Lars Sandman; Mats Brännström

Disclosures

Hum Reprod. 2021;36(2):358-366. 

In This Article

Abstract and Introduction

Abstract

Study Question: What are the costs of live donor uterus transplantation in a European setting?

Summary Answer: The total costs for preoperative investigations, including IVF, and live donor uterus transplantation including postoperative costs for 2 months, were calculated to be €74 564 (mean), with the costs of recipient being somewhat higher than for donor and the cost components of total costs distributed between sick leave (25.7%), postoperative hospitalization (17.8%), surgery (17.1%), preoperative investigations (15.7%), anaesthesia (9.7%), drugs (7.8%), tests after surgery (4.0%) and for re-hospitalization (2.2%).

What is Known Already: Uterus transplantation has proved to be successful by demonstrations of live births, both after live donor and deceased donor procedures. The transplantation is considered as a complex and expensive infertility treatment. There exist no analyses of costs involved in uterus transplantation.

Study Design, Size, Duration: This prospective cohort study included nine uterus transplantations procedures, performed in Sweden in 2013. Study duration of this health economic study included 6–12 months of pre-transplantation investigations and the time interval from transplantation to 2 months after.

Participants/Materials, Setting, Methods: Nine triads of uterus recipient, partner of recipient and uterus donor participated. All prospective recipients were in stable relationships and performed IVF with their partners before transplantation. The nine donors were relatives or family friends. The recipients and donors underwent pre-transplantation investigations with imaging, laboratory tests and psychological/medical screening prior to transplantation. Transplantation was by laparotomy in both donor and recipient. Standard immunosuppression and postoperative medication were used. After discharge from the hospital, the recipients were followed frequently with laboratory tests and examinations.

Main Results and the Role of Chance: The mean costs for preoperative investigations, including IVF, and live donor uterus transplantation with postoperative costs for 2 months, were calculated to be €74 564 (range €50 960–€99 658), from a societal perspective. The four largest components were cost of sick leave (€19 164), cost of postoperative hospitalization (€13 246), surgery cost (€12 779) and costs for preoperative investigations, including IVF (€11 739). Smaller components were costs for anaesthesia (€7207), costs for drugs (€5821), costs for post-surgical tests (€2985) and costs for re-hospitalization (€1623). The costs of the recipient (€42 984) were somewhat higher than the costs of the donor (€31 580), but in terms of costs, they should be viewed as one entity. By using a health care perspective, excluding cost for productivity loss, the total costs would be reduced by 26%.

Limitations, Reasons for Caution: A limitation is the restricted sample size and that this is in the experimental, clinical stage of development.

Wider Implications of the Findings: The results provide the first information concerning the costs for pre-transplantation investigations and uterus transplantation procedures with postoperative follow-up. We consider the total estimate to be in the higher interval, because of the extensive research protocol. It is likely that the cost of live donor uterus transplantation will vary between countries and that the costs will be lower in a future clinical setting.

Study Funding/Competing Interest(S): Funding was received from the Jane and Dan Olsson Foundation for Science; the Knut and Alice Wallenberg Foundation; an ALF grant from the Swedish state under an agreement between the government and the county councils; and the Swedish Research Council. None of the authors have a conflict of interest with regard to the study.

Trial Registration Number: NCT01844362.

Introduction

Uterus transplantation (UTx) is the first available treatment of absolute uterine factor infertility (AUFI), affecting approximately 10 000 women of fertile age in a total population of 100 million (Sieunarine et al., 2005). This infertility condition is due to either a congenital/surgical absence of a uterus or presence of a non-functional uterus, with no capacity for implantation or to carry a pregnancy. Our group initiated a basic-research project on UTx, involving several animal models, more than two decades ago to develop UTx as a treatment for AUFI (Brannstrom et al., 2012). The proof-of-concept of UTx as an infertility treatment for women with no uterus came with the report of the first live birth after UTx, occurring in September 2014 (Brannstrom et al., 2015). This birth was from one of the transplantations of the present study cohort (Brannstrom et al., 2014). Subsequently, repeated live births have been reported both after live (Brannstrom et al., 2016a; Testa et al., 2018) and deceased (Ejzenberg et al., 2019; Flyckt et al., 2020) donor UTx procedures.

Uterus transplantation is still an experimental clinical procedure with many years until it may enter the stage as a routine clinical procedure. Consequently, the worldwide activity within the UTx field is restricted to a limited number of clinical trials. Results concerning surgery and follow-up of both donors and recipients are only reported in a small number of UTx studies (Testa et al., 2017; Chmel et al., 2019), in addition to the cohort of the present study.

In the research setting, a UTx trial typically involves more than standard preoperative screening and investigations of recipients and in the case of live-donor UTx trials, also of donors. Furthermore, IVF with embryo cryopreservation is performed prior to surgery. Thus, in comparison to the common infertility treatments such as ovulation induction and IVF, UTx is a very complex process involving assisted reproduction and major transplantation surgery.

The UTx procedure can be performed with a uterus from either a live donor or from a deceased donor, the latter also referred to as a multiorgan donor. The deceased donor UTx procedure is faster and less complicated, since it involves straightforward surgery in the female donor, where also several of the abdominal and thoracic organs will be harvested in the same surgical session. Obviously, such a procedure should be markedly less costly than a live donor procedure, that involves more extensive preoperative investigations, longer surgical time as well costs for hospitalization and sick leave of donor.

Uterus transplantation has raised a vivid discussion of ethical concerns, many of which have been settled through ongoing research (Catsanos et al., 2013). However, a major remaining ethical concern is how UTx should be prioritized in relation to other healthcare interventions (Wilkinson and Williams, 2016). In a previous article, one of the authors argued that the cost and cost-effectiveness of UTx will play a major role in making such prioritization (Sandman, 2018), given that assisted reproductive technologies belong to 'borderline' cases of what should be publicly funded in a healthcare system. The ongoing UTx trials in the world are mainly financed by research grants, and in some cases with pre-surgery IVF paid by the couple. There exist no publications regarding the costs of a UTx procedure. Important health economics aspects concern both the direct and indirect costs of the treatment, as well as the cost-effectiveness. The purpose of this study was to estimate the total societal cost of a live donor UTx procedure in a European setting.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....