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Future of Medicare immunosuppressive drug coverage for kidney transplant recipients in the United States.

ABSTRACT: Kidney transplantation is the preferred treatment for patients with ESRD. It improves the quality of life in recipients, increases patient survival, and is also substantially less costly than maintenance dialysis. Long-term transplant success requires immunosuppressant drug therapy for the life of the allograft. Under current law, Medicare coverage for most recipients (except for those recipients over 65 years of age or with nonkidney-related disabilities) lasts only 3 years, leaving many recipients unable to afford these medications. Lack of drug therapy often leads to allograft rejection, resulting in premature graft failure, return to dialysis, or death. This article reviews the current policy for Medicare immunosuppressive drug coverage and analyzes the potential impact of pending legislative proposals H.R. 2969 and S. 1454 and the Patient Protection and Affordable Care Act.

SUBMITTER: Tanriover B

PROVIDER: S-EPMC3700693 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Future of Medicare immunosuppressive drug coverage for kidney transplant recipients in the United States.

Tanriover Bekir B Stone Patricia W PW Mohan Sumit S Cohen David J DJ Gaston Robert S RS

Clinical journal of the American Society of Nephrology : CJASN 20130404 7

Kidney transplantation is the preferred treatment for patients with ESRD. It improves the quality of life in recipients, increases patient survival, and is also substantially less costly than maintenance dialysis. Long-term transplant success requires immunosuppressant drug therapy for the life of the allograft. Under current law, Medicare coverage for most recipients (except for those recipients over 65 years of age or with nonkidney-related disabilities) lasts only 3 years, leaving many recipi ...[more]

PMID: 23559679

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Project description:BackgroundKidney transplant recipients must take immunosuppressant drugs to prevent rejection and maintain transplant function. Medicare coverage of immunosuppressant drugs for kidney transplant recipients ceases 36 months after transplantation, potentially increasing the risk of transplant failure. A contemporary economic analysis of extending Medicare coverage for the duration of transplant survival using current costs of immunosuppressant medications in the era of generic equivalents may inform immunosuppressant drug policy.MethodsA Markov model was used to determine the incremental cost and effectiveness of extending Medicare coverage for immunosuppressive drugs over the duration of transplant survival, compared with the current policy of 36-month coverage, from the perspective of the Medicare payer. The expected improvement in transplant survival by extending immunosuppressive drug coverage was estimated from a cohort of privately insured transplant recipients who receive lifelong immunosuppressant drug coverage compared with a cohort of Medicare-insured transplant recipients, using multivariable survival analysis.ResultsExtension of immunosuppression Medicare coverage for kidney transplant recipients led to lower costs of -$3077 and 0.37 additional quality-adjusted life years (QALYs) per patient. When the improvement in transplant survival associated with extending immunosuppressant coverage was reduced to 50% of that observed in privately insured patients, the strategy of extending drug coverage had an incremental cost-utility ratio of $51,694 per QALY gained. In a threshold analysis, the extension of immunosuppression coverage was cost-effective at a willingness-to-pay threshold of $100,000, $50,000, and $0 per QALY if it results in a decrease in risk of transplant failure of 5.5%, 7.8%, and 13.3%, respectively.ConclusionsExtending immunosuppressive drug coverage under Medicare from the current 36 months to the duration of transplant survival will result in better patient outcomes and cost-savings, and remains cost-effective if only a fraction of anticipated benefit is realized.

Project description:Survival of solid organ grafts depends on life-long immunosuppression, which results in increased rates of infection and malignancy. Induction of tolerance to allografts would represent the optimal solution for controlling both chronic rejection (CR) and side effects of immunosuppression. Although spontaneous ‘‘operational tolerance’’ can occur in human kidney transplantation, the lack of noninvasive peripheral blood biological markers of this rare phenomenon precludes the identification of potentially tolerant patients in whom immunosuppression could be tapered as well as the development of new tolerance inducing strategies. Here, the potential of high throughput microarray technology to decipher complex pathologies allowed us to study the peripheral blood specific gene expression profile and corresponding EASE molecular pathways associated to operational tolerance in a cohort of human kidney graft recipients. In comparison with patients with CR, tolerant patients displayed a set of 343 differentially expressed genes, mainly immune and defense genes, in their peripheral blood mononuclear cells (PBMC), of which 223 were also different from healthy volunteers. Using the expression pattern of these 343 genes, we were able to classify correctly >80% of the patients in a cross-validation experiment and classified correctly all of the samples over time. Collectively, this study identifies a unique PBMC gene signature associated with human operational tolerance in kidney transplantation. 250 samples were analyzed, replicates included: some patients from the TOL and CR groups were sampled twice with an interval between the two different time points of at least 16 months (mean 25.8 months, range 16–31 months). All the samples were analyzed in duplicate or quadruplicate. 1. TOL (n = 21). patients with stable graft function (blood creatinemia<150 mmol/L, proteinuria<1 g/24 h) for at least 1 year (mean 6.4 years,range 1.6–17.2 years) after complete interruption of immunosuppressive therapy. 2. STA (n = 190). Patients with stable kidney graft function under immunosuppressive therapy. 3. CR (n = 31). Patients having a progressive degradation of their renal function (blood creatinemia ≥150 mmol/L, proteinuria ≥1 g/24 h). CR was diagnosed on a graft biopsy according to the updated Banff criteria. CR was defined by histological signs of chronic allograft arteriopathy (arterial intimal fibrosis with mononuclear cell infiltration) and/or transplant glomerulopathy with glomerular double contours. 4. HV (n = 8). Subjects having normal blood formulae and no infectious or other concomitant pathology for at least 6 months before the study.

Project description:Background: This study aimed to better characterize morbidly obese kidney transplant recipients, their clinical characteristics, and outcomes by using an unsupervised machine learning approach. Methods: Consensus cluster analysis was applied to OPTN/UNOS data from 2010 to 2019 based on recipient, donor, and transplant characteristics in kidney transplant recipients with a pre-transplant BMI ≥ 40 kg/m2. Key cluster characteristics were identified using the standardized mean difference. Post-transplant outcomes, including death-censored graft failure, patient death, and acute allograft rejection, were compared among the clusters. Results: Consensus clustering analysis identified 3204 kidney transplant recipients with a BMI ≥ 40 kg/m2. In this cohort, five clinically distinct clusters were identified. Cluster 1 recipients were predominantly white and non-sensitized, had a short dialysis time or were preemptive, and were more likely to receive living donor kidney transplants. Cluster 2 recipients were older and diabetic. They were likely to have been on dialysis >3 years and receive a standard KDPI deceased donor kidney. Cluster 3 recipients were young, black, and had kidney disease secondary to hypertension or glomerular disease. Cluster 3 recipients had >3 years of dialysis and received non-ECD, young, deceased donor kidney transplants with a KDPI < 85%. Cluster 4 recipients were diabetic with variable dialysis duration who either received non-ECD standard KDPI kidneys or living donor kidney transplants. Cluster 5 recipients were young retransplants that were sensitized. One-year patient survival in clusters 1, 2, 3, 4, and 5 was 98.0%, 94.4%, 98.5%, 98.7%, and 97%, and one-year death-censored graft survival was 98.1%, 93.0%, 96.1%, 98.8%, and 93.0%, respectively. Cluster 2 had the worst one-year patient survival. Clusters 2 and 5 had the worst one-year death-censored graft survival. Conclusions: With the application of unsupervised machine learning, variable post-transplant outcomes are observed among morbidly obese kidney transplant recipients. Recipients with earlier access to transplant and living donation show superior outcomes. Unexpectedly, reduced graft survival in cluster 3 recipients perhaps underscores socioeconomic access to post-transplant support and minorities being disadvantaged in access to preemptive and living donor transplants. Despite obesity-related concerns, one-year patient and graft survival were favorable in all clusters, and obesity itself should be reconsidered as a hard barrier to kidney transplantation.

Project description:BackgroundAlthough kidney transplant improves reproductive function in women with end-stage kidney disease (ESKD), pregnancy in kidney transplant recipients' remains challenging due to the risk of adverse maternal and fetal outcomes.MethodsWe evaluated a retrospective cohort of 7,966 women who were aged 15-45 years and received a kidney transplant between January 1, 2005 and December 31, 2011 from the United States Renal Data System with Medicare as the primary payer for the entire three years after the date of transplantation. Unadjusted and adjusted rates of pregnancy in the first three post-transplant years were calculated, using Poisson regression for the adjustment. Factors associated with pregnancy, including race, were examined using logistic regression.ResultsOverall, 293 pregnancies were identified in 7966 women. The unadjusted pregnancy rate was 13.8 per thousand person-years (PTPY) (95% confidence interval (CI), 12.3-15.5). Pregnancy rates were roughly constant in the years 2005-2011 except in 2005 and 2010. The rate of pregnancy was highest in Hispanic women (21.4 PTPY; 95% CI, 17.2-26.4) and Hispanic women had a higher likelihood of pregnancy as compared to white women (OR, 1.56; CI, 1.12-2.16). Pregnancy rates were lowest in women aged 30-34 years and 35-45 years at transplant, and women aged 30-34 years and 35-45 years at transplant were less likely to ever become pregnant during the follow-up (odds ratio [OR], 0.69; CI, 0.49-0.98 and OR, 0.14; CI 0.09-0.21 respectively) as compared to women aged 25-29 years at time of transplant. Women had higher rates of pregnancy in the second and third-year post-transplant (16.0 PTPY, CI 13.2-19.2 and 16.9 PTPY, CI 14.0-20.4) than in the first-year post-transplant (9.0 PTPY, CI 7.0-11.4). In transplant recipients, pregnancy was more likely in women with ESKD due to cystic disease (OR, 2.42; CI, 1.02-5.74) or glomerulonephritis (OR, 2.14; CI, 1.07-4.31) as compared to women with ESKD due to diabetes.ConclusionHispanic race, younger age, and ESKD cause due to cystic disease or glomerulonephritis are significant factors associated with a higher likelihood of pregnancy. Pregnancy rates have been fairly constant over the last decade. This study improves our understanding of factors associated with pregnancy in kidney transplant recipients.

Project description:To evaluate the association of community health indicators with outcomes for kidney transplant recipients.Retrospective observational cohort study using multivariable Cox proportional hazards models.Transplant recipients in the United States from the Scientific Registry of Transplant Recipients merged with health indicators compiled from several national databases and the Centers for Disease Control and Prevention, including the National Center for Health Statistics, the Behavioral Risk Factor Surveillance System, and the National Center for Chronic Disease Prevention and Health Promotion.A total of 100 164 living and deceased donor adult (aged 18 years) kidney transplant recipients who underwent a transplant between January 1, 2004, and December 31, 2010.Risk-adjusted time to posttransplant mortality and graft loss.Multiple health indicators from recipients' residence were independently associated with outcomes, including low birth weight, preventable hospitalizations, inactivity rate, and smoking and obesity prevalence. Recipients in the highest-risk counties were more likely to be African American (adjusted odds ratio, 1.59, 95% CI, 1.51-1.68), to be younger (aged 18-39 years; 1.46; 1.32-1.60), to have lower educational attainment (<high school; 1.84; 1.62-2.08), and to have public insurance (1.46; 1.38-1.54). Proportions of recipients from higher-risk counties varied dramatically by center and region. There was an independent graded effect between health indicators and posttransplant mortality, including notable hazard associated with the highest-risk counties (adjusted hazard ratio, 1.26; 95% CI, 1.13-1.40).In a national cohort of patients undergoing complex medical procedures, health indicators from patients' communities are strong independent predictors of all-cause mortality. Findings highlight the importance of community conditions for risk stratification of patients and development of individualized treatment protocols. Findings also demonstrate that standard risk adjustment does not capture important factors that may affect unbiased performance evaluations of transplant centers.

Dataset Information

Future of Medicare immunosuppressive drug coverage for kidney transplant recipients in the United States.

Publications

Future of Medicare immunosuppressive drug coverage for kidney transplant recipients in the United States.

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