Improved health care utilization and costs in transplanted versus non-transplanted adults with sickle cell disease.

Patients with sickle cell disease (SCD) have access to fewer health care resources and therapies compared to other diseases, which contributes to increased morbidity and health care utilization. We compared health care utilization (inpatient hospital days, emergency care visits) and health care-related costs between SCD adults that underwent hematopoietic stem cell transplantation (HSCT) using a nonmyeloblative conditioning regimen versus those referred for HSCT but did not proceed due to lack of an HLA-matched sibling donor, denial by insurance, red blood cell antibodies to the potential donor, or declining further evaluation. Between 8/2011 and 4/2016, 83 SCD patients were referred for allogeneic HSCT and 16 underwent the procedure. The HSCT and non-HSCT groups were similar by age, sex, prior SCD-related therapy and complications. Compared to pre HSCT, significantly fewer inpatient hospital days (median of 1 versus 22 days, P = 0.003) and emergency care visits (median of 1 versus 4 visits, P = 0.04) were observed by the 2nd year post-HSCT. Similar results were observed in comparison to the standard-of-care group (median of 1 versus 12 hospital days, P = 0.002; median of 1 versus 3 emergency visits, P = 0.03). Lower health care costs were observed by the 2nd year post-HSCT (median of $16,281 versus $64,634 pre-HSCT (P = 0.01) and versus $54,082 in the standard-of-care group (P = 0.05). A median reduction of -$20,833/patient/year (IQR, -$67,078-+$4,442/patient/year) in health care costs compared to pre-HSCT was observed in the 2nd year post-HSCT. In conclusion, allogeneic HSCT leads to improvements in health care utilization and costs compared to standard-of-care therapy in high-risk SCD adults.

Large-Scale Variability of Inpatient Tacrolimus Therapeutic Drug Monitoring at an Academic Transplant Center: A Retrospective Study.

BACKGROUND: Inpatient tacrolimus therapeutic drug monitoring (TDM) lacks standardized guidelines. In this study, the authors analyzed variability in the preanalytical phase of the inpatient tacrolimus TDM process at their institution. METHODS: Patients receiving tacrolimus (twice-daily formulation) and tacrolimus laboratory analysis were included in the study. Times of tacrolimus administration and laboratory study collection were extracted, and time distribution plots for each step in the inpatient TDM process were generated. RESULTS: Trough levels were drawn appropriately in 25.9% of the cases. Timing between doses was consistent, with 91.9% of the following dose administrations occurring 12 ± 2 hours after the previous dose. Only 38.1% of the drug administrations occurred within 1 hour of laboratory study collection. Tacrolimus-related patient safety events were reported at a rate of 1.9 events per month while incorrect timing of TDM sample collection occurred approximately 200 times per month. Root cause analysis identified a TDM process marked by a lack of communication and coordination of drug administration and TDM sample collection. Extrapolating findings nationwide, we estimate $22 million in laboratory costs wasted annually. CONCLUSIONS: Based on this large single-center study, the authors concluded that the inpatient TDM process is prone to timing errors, thus is financially wasteful, and at its worst harmful to patients due to clinical decisions being made on the basis of unreliable data. Further work is needed on systems solutions to better align the laboratory study collection and drug administration processes.

The Pancreas Can Take the Cold: Lower Waitlist Times Through Importation.

BACKGROUND: Our center has used a strategy of pancreas importation owing to long regional waitlist times. Here we assess the clinical outcomes and financial considerations of this strategy. METHODS: This was a retrospective observational cohort study of patients who received a pancreas transplant at Montefiore Medical Center (MMC) from 2014 to 2017 (n = 28). Clinical parameters, including hemoglobin A1c and complications, were analyzed. The cohort was compared with United Network for Organ Sharing (UNOS) Region 9 with the use of the UNOS/Organ Procurement and Transplantation Network database. Cost analysis of length of stay (LOS), standard acquisition (SAC) fees, and transportation was performed with the use of internal financial data. RESULTS: Pancreas importation resulted in significantly shorter simultaneous pancreas kidney transplant waitlist times compared with Region 9: 518 days vs 1001 days (P = .038). In addition, postoperative complications and 1-year HbA1c did not differ between groups: local 6.30% vs import 6.17% (P = .87). Patients receiving local pancreata stayed an average of 9.2 days compared with 11 days for the import group (P = .36). As such, pancreas importation was associated with higher mean charges ($445,968) compared with local pancreas recipients ($325,470). CONCLUSIONS: Long waitlist times in Region 9 have encouraged our center's adoption of pancreas importation to address the needs of our patient population. This practice has resulted in a reduction of waitlist times by an average of 483 days. Understandably, centers have long been wary of importation owing to perceived risk in clinical outcomes. In our single-center experience, we have demonstrated equivalent postoperative glucose control and graft survival. Importantly, there does appear to be increased costs associated with importation, which are mainly driven by LOS. Curiously, importation from regions with lower SAC fees has the potential to offset costs related to transportation expenses. Notwithstanding these findings, pancreas importation does have the potential to lessen the financial societal burden through reduction in waitlist times.

Business oriented EU human cell and tissue product legislation will adversely impact Member States' health care systems.

The transplantation of conventional human cell and tissue grafts, such as heart valve replacements and skin for severely burnt patients, has saved many lives over the last decades. The late eighties saw the emergence of tissue engineering with the focus on the development of biological substitutes that restore or improve tissue function. In the nineties, at the height of the tissue engineering hype, industry incited policymakers to create a European regulatory environment, which would facilitate the emergence of a strong single market for tissue engineered products and their starting materials (human cells and tissues). In this paper we analyze the elaboration process of this new European Union (EU) human cell and tissue product regulatory regime-i.e. the EU Cell and Tissue Directives (EUCTDs) and the Advanced Therapy Medicinal Product (ATMP) Regulation and evaluate its impact on Member States' health care systems. We demonstrate that the successful lobbying on key areas of regulatory and policy processes by industry, in congruence with Europe's risk aversion and urge to promote growth and jobs, led to excessively business oriented legislation. Expensive industry oriented requirements were introduced and contentious social and ethical issues were excluded. We found indications that this new EU safety and health legislation will adversely impact Member States' health care systems; since 30 December 2012 (the end of the ATMP transitional period) there is a clear threat to the sustainability of some lifesaving and established ATMPs that were provided by public health institutions and small and medium-sized enterprises under the frame of the EUCTDs. In the light of the current economic crisis it is not clear how social security systems will cope with the inflation of costs associated with this new regulatory regime and how priorities will be set with regard to reimbursement decisions. We argue that the ATMP Regulation should urgently be revised to focus on delivering affordable therapies to all who are in need of them and this without necessarily going to the market. The most rapid and elegant way to achieve this would be for the European Commission to publish an interpretative document on "placing on the market of ATMPs," which keeps tailor-made and niche ATMPs outside of the scope of the medicinal product regulation.

Organ economy: organ trafficking in Moldova and Israel.

Organ trafficking is an illegal means of meeting the shortage of transplants. The activity flourishes for several interacting reasons, such as medical needs, poverty and criminality. Other factors are fundamental conceptual structures such as the dream of the regenerative body as well as the view of the body as an object of utility and an object of value. The article aims to go behind the normative discussions that usually surround organ trafficking. Why this is happening, and what the societal consequences are, is examined through ethnographic fieldwork. The focus is on the shadow economies that govern existence and in which people, goods, weapons, money, bodies, etc. constitute components of the global market.

Regulating the sale of human organs: a discussion in context with the global market.

PURPOSE OF REVIEW: Insufficient availability of human organs for transplantation has given rise to a flourishing global market. This review addresses current thinking and practical considerations regarding legalization of organ sales. RECENT FINDINGS: Increasing competition for human organs has led to egregious human rights violations. Governmental proscription of organ sales has failed to slow this process. Organ sales in China and the regulated market in Iran have received much attention. Some believe that a regulated market is an ethical vehicle for shortening waiting lists and decreasing illegal organ sales. Others consider it a blow to human dignity and to altruistic donation. There is alternative support toward reimbursing living donors for their financial losses. The World Health Organization advocates increased reliance on cadaver donor transplantation. Some countries have enacted presumed consent laws that have increased cadaver organ donation. In the USA an Organ Breakthrough Collaborative has generated comparable success. SUMMARY: Serious discussion continues with regard to regulated sale of human organs. There is increased interest in reimbursement for living organ donation. Research is needed to elucidate workings of the global organ market, and to assess attitudes about stakeholders with regard to proposed changes in transplantation policy.

Concentration of transfusion resources on a few pathologies and a few patients: analysis of the comprehensive in-hospital patient database.

BACKGROUND: Blood is a sparse commodity. Transfusion needs increase while the number of donors decreases. These constraints incite Belgian authorities to pay more attention to transfusion financing. This implies pathologic knowledge of the epidemiology of in-hospital transfusion and the consumption of blood products. STUDY DESIGN AND METHODS: This study is a retrospective analysis of in-hospital stays from the year 2000 and includes data from all 124 Belgian hospitals. The database contains information on diagnoses, procedures, and all-patients refined diagnosis-related groups (APRDRGs) but also on expenses linked to blood products transfused and to transfusion-related pharmaceutical products. RESULTS: Three percent of surgical patients used 55.7 percent of transfusion resources and 75.4 percent of transfusion costs were associated with 24 APRDRGs. In the medical group, 3 percent of the patients accounted for 80.2 percent of transfusion costs and 20 APRDRGs consumed 71.9 percent of transfusion resources. The variables with the highest impact on the proportion of patients transfused were severity, pathology, and age. The effect of hospitals remained significant but had less impact. No substitution of blood products by transfusion-related pharmaceutical products was observed in our analysis. CONCLUSION: Our study confirms that transfusion now centers on a limited number of pathologic entities and, within those, in small subsets of patients. This implies that the costs linked to setting up and running the transfusion system can no longer be shared by a large number of patients who receive transfusions but rely increasingly on patients at higher risks of more unpredictable needs. The system must nevertheless be able to cope with them at any time.

Strategies for establishing organ transplant programs in developing countries: the Latin America and Caribbean experience.

The Latin America and Caribbean region is composed of 39 countries. It is remarkable the progress of transplantation in the region in despite of the low economic resources when compared to other regions. The criteria for brain death are well established and culturally accepted. The consent for retrieval is based on required family consent in most countries. The regulations for living donors are also well established, with restrictions to unrelated donors and prohibition of any kind of commerce. The access to transplant is limited by the model of public financing by each country, and those with public universal coverage have no financial restrictions to cover the costs for any citizen; in countries with restricted coverage, the access is restricted to the employment status. There is a progressive increment in the annual number of solid organ transplants in Latin America, reaching near 10,000 in 2004, accomplished by adequate legislation that is also concerned with the prohibition of organ commerce.