Showing papers by "Vahakn B. Shahinian published in 2020"

Adherence and out-of-pocket costs among Medicare beneficiaries who are prescribed oral targeted therapies for advanced prostate cancer.

Abstract: BACKGROUND Abiraterone and enzalutamide are high-cost oral therapies that increasingly are used to treat patients with advanced prostate cancer; these agents carry the potential for significant financial consequences to patients. In the current study, the authors investigated coping and material measures of the financial hardship of these therapies among patients with Medicare Part D coverage. METHODS The authors performed a retrospective cohort study on a 20% sample of Medicare Part D enrollees who underwent treatment with abiraterone or enzalutamide between July 2013 and June 2015. The authors described the variability in adherence rates and out-of-pocket payments among hospital referral regions in the first 6 months of therapy and determined whether adherence and out-of-pocket payments were associated with patient factors and the socioeconomic characteristics of where a patient was treated. RESULTS There were 4153 patients who filled abiraterone or enzalutamide prescriptions through Medicare Part D in 228 hospital referral regions. The mean adherence rate was 75%. The median monthly out-of-pocket payment for abiraterone and enzalutamide was $706 (range, $0-$3505). After multilevel, multivariable adjustment for patient and regional factors, adherence was found to be lower in patients who were older (69% for patients aged ≥85 years vs 76% for patients aged <70 years; P < .01) and in those with low-income subsidies (69% in those with a subsidy vs 76% in those without a subsidy; P < .01). Both Hispanic ethnicity and living in a hospital referral region with a higher percentage of Hispanic beneficiaries were found to be independently associated with higher out-of-pocket payments for abiraterone and enzalutamide. CONCLUSIONS There were substantial variations in the adherence rate and out-of-pocket payments among Medicare Part D beneficiaries who were prescribed abiraterone and enzalutamide. Sociodemographic patient and regional factors were found to be associated with both adherence and out-of-pocket payments.

The temporal and long‐term impact of donor body mass index on recipient outcomes after kidney transplantation – a retrospective study

Abstract: The impact of increasing body mass index (BMI) on development and progression of chronic kidney disease is established. Even implantation kidney biopsies from obese living donors demonstrate subtle histologic changes despite normal function. We hypothesized that kidneys from obese living (LD) and deceased donors (DD) would have inferior long-term allograft outcomes. In a study utilizing US transplant registry, we studied adult kidney transplant recipients from 2000 to 2014. Donors were categorized as BMI 35 kg/m2 (very obese). Our outcome of interest was death censored graft failure (DCGF). Cox proportional hazards model were fitted separately for recipients of DD and LD kidneys, and adjusted for donor, recipient, and transplant characteristics, including donor and recipient size mismatch ratio. Among 118 734 DD and 84 377 LD transplants recipients, we observed a significant and graded increase in DCGF risk among the overweight (LD:HR = 1.06, DD:HR = 1.04), mildly obese (LD:HR = 1.16, DD:HR = 1.10), and very obese (LD:HR = 1.22, DD:HR = 1.22) compared to normal BMI (P < 0.05). The graded effect of donor BMI on outcomes begins early and persists throughout the post-transplant period. Donor obesity status is an independent risk factor for inferior long-term renal allograft outcome despite adjusting for donor and recipient size mismatch and other donor, recipient, and transplant factors.

Survival Among Incident Peritoneal Dialysis Versus Hemodialysis Patients Who Initiate With an Arteriovenous Fistula.

Abstract: Rationale & Objective Comparisons of outcomes between in-center hemodialysis (HD) and peritoneal dialysis (PD) are confounded by selection bias because PD patients are typically younger and healthier and may have received longer predialysis care. We compared first-year survival between what we hypothesized were clinically equivalent groups; namely, patients who initiate maintenance HD using an arteriovenous fistula (AVF) and those selecting PD as their initial modality. Study Design Observational, registry-based, retrospective cohort study. Setting & Participants US Renal Data System data for 5 annual cohorts (2010-2014; n=130,324) of incident HD with an AVF and incident PD patients. Exposures and Predictors Exposure was more than 1day receiving PD or more than 1day receiving HD with an AVF. Time at risk for both cohorts was determined for 12 consecutive 30-day segments, censoring for transplantation, loss to follow-up, or end of time. Predictors included patient-level characteristics obtained from Centers for Medicare & Medicaid Services 2728 Form and other data sources. Outcomes Patient survival. Analytical Approach Unadjusted and multivariable risk–adjusted HRs for death of HD versus PD patients, averaged over 2010 to 2014, were calculated. Results The HD cohort's average unadjusted mortality rate was consistently higher than for the PD cohort. The HR of HD versus PD was 1.25 (95% CI, 1.20-1.30) in the unadjusted model and 0.84 (95% CI, 0.80-0.87) in the adjusted model. However, multivariable risk–adjusted analyses showed the HR of HD versus PD for the first 90 days was 1.06 (95% CI, 0.98-1.14), decreasing to 0.74 (95% CI, 0.68-0.80) in the 270- to 360-day period. Limitations Residual confounding due to selection bias inherent in dialysis modality choice and the observational study design. Form 2728 provides baseline data at dialysis incidence alone, but not over time. Conclusions US patients receiving HD with an AVF appear to have a survival advantage over PD patients after 90 days of dialysis initiation after accounting for patient characteristics. These findings have implications in the choice of initial dialysis modality and vascular access for patients.

Accountable Care Organizations and Spending for Patients Undergoing Long-Term Dialysis.

Abstract: Background and objectives Despite representing 1% of the population, beneficiaries on long-term dialysis account for over 7% of Medicare’s fee-for-service spending. Because of their focus on care coordination, Accountable Care Organizations may be an effective model to reduce spending inefficiencies for this population. We analyzed Medicare data to examine time trends in long-term dialysis beneficiary alignment to Accountable Care Organizations and differences in spending for those who were Accountable Care Organization aligned versus nonaligned. Design, setting, participants, & measurements In this retrospective cohort study, beneficiaries on long-term dialysis between 2009 and 2016 were identified using a 20% random sample of Medicare beneficiaries. Trends in alignment to an Accountable Care Organization were compared with alignment of the general Medicare population from 2012 to 2016. Using an interrupted time series approach, we examined the association between Accountable Care Organization alignment and the primary outcome of total spending for long-term dialysis beneficiaries from prior to Accountable Care Organization implementation (2009–2011) through implementation of the Comprehensive ESRD Care model in October 2015. We fit linear regression models with generalized estimating equations to adjust for patient characteristics. Results During the study period, 135,152 beneficiaries on long-term dialysis were identified. The percentage of long-term dialysis beneficiaries aligned to an Accountable Care Organization increased from 6% to 23% from 2012 to 2016. In the time series analysis, spending on Accountable Care Organization–aligned beneficiaries was $143 (95% confidence interval, $5 to $282) less per beneficiary-quarter than spending for nonaligned beneficiaries. In analyses stratified by whether beneficiaries received care from a primary care physician, savings by Accountable Care Organization–aligned beneficiaries were limited to those with care by a primary care physician ($235; 95% confidence interval, $73 to $397). Conclusions There was a substantial increase in the percentage of long-term dialysis beneficiaries aligned to an Accountable Care Organization from 2012 to 2016. Moreover, in adjusted models, Accountable Care Organization alignment was associated with modest cost savings among long-term dialysis beneficiaries with care by a primary care physician.