Future of Medicare immunosuppressive drug coverage for kidney transplant recipients in the United States.
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ABSTRACT:
SUBMITTER: Tanriover B
PROVIDER: S-EPMC3700693 | biostudies-literature | 2013 Jul
REPOSITORIES: biostudies-literature
Publications
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]
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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.
| S-EPMC6934999 | biostudies-literature
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.
2017-02-09 | GSE47755 | GEO
Project description:Renal cell carcinoma (RCC) is a common malignancy following kidney transplantation. We describe RCC risk and examine RCC risk factors among US kidney recipients (1987-2010). The Transplant Cancer Match Study links the US transplant registry with 15 cancer registries. Standardized incidence ratios (SIRs) were used to compare RCC risk (overall and for clear cell [ccRCC] and papillary subtypes) to the general population. Associations with risk factors were assessed using Cox models. We identified 683 RCCs among 116 208 kidney recipients. RCC risk was substantially elevated compared with the general population (SIR 5.68, 95% confidence interval 5.27-6.13), especially for papillary RCC (SIR 13.3 versus 3.98 for ccRCC). Among kidney recipients, RCC risk was significantly elevated for blacks compared to whites (hazard ratio [HR] 1.50) and lower in females than males (HR 0.56). RCC risk increased with prolonged dialysis preceding transplantation (p-trend < 0.0001). Risk was variably associated for RCC subtypes with some medical conditions that were indications for transplantation: ccRCC risk was reduced with polycystic kidney disease (HR 0.54), and papillary RCC was increased with hypertensive nephrosclerosis (HR 2.02) and vascular diseases (HR 1.86). In conclusion, kidney recipients experience substantially elevated risk of RCC, especially for papillary RCC, and multiple factors contribute to these cancers.
| S-EPMC5104677 | biostudies-literature
Project description:BACKGROUND:Few quantitative assessments have assessed disaster preparation in kidney transplant patients. This is a survey-based assessment of disaster preparedness of 200 patients at the University of California San Francisco, USA. MATERIALS AND METHODS:Patients answered questionnaires assessing their level of preparedness as well as barriers to preparation. Preparedness was scored based on response to 7 questions. Univariate analyses compared participant characteristics extracted from the medical chart against three tertiles of preparedness: low (scores 0 - 2), medium (scores 3 - 4), and high (scores 5 - 7). California counties were coded and mapped by average preparedness scores. RESULTS:Only 30% of patients were highly prepared for disasters. Participants were prepared with available medication for 2 weeks (78.5%) and least prepared in having a medical ID bracelet (13%). Significant minorities of patients (40% of patients or more) were unprepared with lists of medications, important phone numbers and disaster kits. Preparedness was not associated with demographic and clinical characteristics. Monterey County was the most prepared of the 31 California counties sampled (score of 4.25 out of 7). CONCLUSION:All patients should be educated regarding disaster preparation. County and medical services should collaborate to address specialized populations in general preparedness planning.?.
| S-EPMC6102562 | biostudies-literature
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.
| S-EPMC6688836 | biostudies-literature
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.
| S-EPMC3880685 | biostudies-literature
Project description:BACKGROUND:Death with graft function remains an important cause of graft loss among kidney transplant recipients (KTRs). Little is known about the trend of specific causes of death in KTRs in recent years. METHODS:We analyzed United States Renal Data System data (1996-2014) to determine 1- and 10-year all-cause and cause-specific mortality in adult KTRs who died with a functioning allograft. We also studied 1- and 10-year trends in the various causes of mortality. RESULTS:Of 210,327 KTRs who received their first kidney transplant from 1996 to 2014, 3.2% died within 1 year after transplant. Cardiovascular deaths constituted the majority (24.7%), followed by infectious (15.2%) and malignant (2.9%) causes; 40.1% of deaths had no reported cause. Using 1996 as the referent year, all-cause as well as cardiovascular mortality declined, whereas mortality due to malignancy did not. For analyses of 10-year mortality, we studied 94,384 patients who received a first kidney transplant from 1996 to 2005. Of those, 22.1% died over 10 years and the causative patterns of their causes of death were similar to those associated with 1-year mortality. CONCLUSIONS:Despite the downtrend in mortality over the last 2 decades, a significant percentage of KTRs die in 10-years with a functioning graft, and cardiovascular mortality remains the leading cause of death. These data also highlight the need for diligent collection of mortality data in KTRs.
| S-EPMC6347016 | biostudies-literature
Project description:Background. Although delayed graft function (DGF) is associated with an increased risk of acute rejection and decreased graft survival, there are no estimates of the long-term or lifetime health burden of DGF. Objectives. To estimate the long-term and lifetime health burden of DGF, defined as the need for at least one dialysis session within the first week after transplantation, for a cohort representative of patients who had their first kidney transplant in 2014. Methods. Data from the United States Renal Data System (USRDS; 2001-2014) were used to estimate a semi-Markov parametric multi-state model with three disease states. Maximum length of follow-up was 13.7 years, and a microsimulation model was used to extrapolate results over a lifetime. The impact of DGF was assessed by simulating the model for each patient in the cohort with and without DGF. Results. At the end of 13.7 years of follow-up, DGF reduces the probability of having a functioning graft from 52% to 32%, increases the probability of being on dialysis from 10% to 19%, and increases the probability of death from 38% to 50% relative to transplant recipients who do not experience DGF. A typical transplant recipient with DGF (median age = 53) is observed to lose 0.87 quality-adjusted life-years (QALYs). Extrapolated over a lifetime, the same 53-year-old DGF patient is projected to lose 3.01 (95% confidence interval: 2.33, 3.70) QALYs relative to a transplant recipient with the same characteristics who does not experience DGF. Conclusions. The lifetime health burden of DGF is substantial. Understanding these consequences will help health care providers weigh kidney transplant decisions and inform policies for patients in the context of varying risks of DGF.
| S-EPMC6124921 | biostudies-literature
Project description:Background: Tacrolimus (TAC) and mycophenolic acid (MPA) are the main immunosuppressive drugs used in pediatric kidney transplantation. Single nucleotide polymorphisms (SNPs) in metabolizing enzymes and transporters might influence plasma levels of these drugs. Herein, we sought to determine the influence of SNPs on CYP3A5, MRP2 and UGT1A9 genes in Chilean pediatric kidney recipients using TAC and MPA. Patients and Methods: A prospective study was performed on 104 pediatric kidney recipients that used TAC and MPA for immunosuppression. The median age at the time of transplantation was 8.1 years [Q1-Q3 4.5-11.6 years] and the main clinical diagnosis was a structural anomaly. In a subgroup of patients, a complete steroid withdrawal was made at day 7. The CYP3A5 polymorphism (ancestral allele *1; variant allele *3) was determined in the entire cohort, while MRP2 -24G > A, UGT1A9 -275T > A, and UGT1A9 -2152C > T polymorphisms were determined in 53 patients. Genotypes were associated with trough drug concentrations (C0), dose requirements normalized by weight (TAC-D mg/kg) or body surface (MPA-D mg/m2), trough levels normalized by dose requirements (C0/D), and area under the curve in 12 h normalized by dose requirements (AUC0-12h/D). Results: The frequencies of the variant alleles CYP3A5*3, MRP2-24A, UGT1A9-275A, and UGT1A9-2152T were 76.9, 22.1, 6.6, and 2.9%, respectively. AUC0-12h/TAC-D were 1.6-fold higher in CYP3A5*3/*3 patients than in CYP3A5*1 carriers (CYP3A5*1/*3 and CYP3A5*1/*1). When analyzing patients with steroid withdrawal, CYP3A5*3/*3 patients had 1.7-fold higher AUC0-12h/TAC-D than the other genotypes. Patients carrying the CYP3A5*3/*3 genotype had higher TAC-C0, lower TAC-D and higher TAC-C0/D, consistently in a 6-months follow-up. Creatinine clearance was stable during the follow-up, regardless of the genotype. No significant differences between MRP2 and UGT1A9 genotypes were observed in MPA-C0, MPA-D or MPA-C0/D. However, patients carrying the UGT1A9-275A allele had lower AUC0-12h/MPA-D than those carrying the UGT1A9-275T ancestral allele. Conclusions: These results support that CYP3A5 and UGT1A9 genotyping in pediatric recipients might be useful and advisable to guide TAC and MPA dosing and monitoring in children that undergo kidney transplantation.
| S-EPMC8100460 | biostudies-literature
Project description:Kidney transplant recipients aged <65 years qualify for Medicare coverage, but coverage ends 3 years posttransplant. We determined the association between timing of Medicare loss and immunosuppressive medication fills and kidney allograft loss. Using data from the Scientific Registry of Transplant Recipients (SRTR), US Renal Data System, and Symphony pharmacy fill database, we analyzed 78 861 Medicare-covered, kidney-alone recipients aged <65 years, and assessed the timing of Medicare loss posttransplant: early (<3 years), on-time (at 3 years), or late (>3 years). Immunosuppressant use was measured as medication possession ratio (MPR). Allograft loss was assessed using SRTR data. MPR was lower for recipients with early or late Medicare loss compared with no coverage loss for all immunosuppressive medication types. For calcineurin inhibitors, early Medicare loss was associated with a 53% to 86% lower MPR. On-time Medicare loss was not associated with a lower MPR. When recipients were matched by age, posttransplant timing of Medicare loss, and donor risk, the hazard of allograft loss was 990% to 1630% higher after early Medicare loss, and 140% to 740% higher after late Medicare loss, with no difference in the hazard for on-time Medicare loss. Ensuring ongoing Medicare access before and after 3 years posttransplant could affect graft survival.
| S-EPMC6785998 | biostudies-literature