OOP Costs Research Articles

173-OR: High Out-of-Pocket Health Care Burden for Medicare Beneficiaries with Diabetes, 1999-2015

People with diabetes face higher out-of-pocket (OOP) health care costs than those without diabetes. This burden can lead to low adherence to treatments and adverse health outcomes, particularly among older adults. The OOP burden in older adults with diabetes has not been studied in the U.S. We estimated the OOP burden from 1999-2015 in Medicare beneficiaries with diabetes aged ≥65 using the Medicare Current Beneficiary Survey. OOP costs included premiums, deductibles, copays, coinsurance, and payments not covered by insurance. High OOP burden was defined as a person’s OOP costs ≥ 10% of their income. We estimated the prevalence of high OOP burden in all beneficiaries, by income quartile, and by race/ethnicity. Average OOP costs ranged from $2,864 to $4,212 (2015 $) and the percentage of those with high OOP burden varied from 38% to 46%, with slight increases over time. By income quartile, the average OOP costs were $2,292, $3,661, $4,032, and $4,430 for <25%, 25-50%, 50-75% and >75% groups, with decreases only in <25% group over time. There were large income-related disparities in prevalence of high OOP burden, with the highest in 25-50% group. Non-Hispanic whites had the highest prevalence of high OOP burden. In elderly Medicare beneficiaries with diabetes, OOP burden was high and increased over time, with large income-related disparities. Efforts to reduce both OOP burden and disparities in this population may be needed. Disclosure J. Park: None. Y. Wang: None. K.A. Look: None. E. Luman: None. P. Zhang: None.

OOP costs high in older Australians with hypertension

OOP costs high in older Australians with hypertension

Patient-reported out-of-pocket costs and financial toxicity during early-phase oncology clinical trials.

7082 Background: Clinical trials are an important therapeutic option for cancer patients (pts). Although financial burden in cancer treatment is well-documented, the financial burden associated with clinical trials is not well understood, especially for pts with lower income. Methods: We conducted a survey regarding economic burden and financial toxicity in cancer pts who had been on Phase I clinical trials for ≥1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicate worse toxicity). Pts also reported monthly out-of-pocket (OOP) medical and non-medical expenses. We applied multivariable logistic regression to analyze risk of financial toxicity, and unanticipated expenses. Results: Early-phase clinical trial pts (N = 213, median age = 59y; 59% female; 74% White, 45% w/ annual income ≤$60K; 50% lived > 300 miles from the clinic; 40% required air travel; 37% had Medicare, 54% had employer sponsored insurance) had a median FTS of 20, with interquartile range of 12. Median monthly OOP costs for non-medical expenses was $1075, and for medical expenses was $475. Median total monthly OOP costs was $1750. 55% and 64% of pts reported that actual medical and non-medical expenses were higher than expected, respectively. Worse financial toxicity (≤ median FTS) in pts was associated with yearly household income < $60K (OR: 2.7, P = 0.008), having medical costs higher than expected (OR: 3.2, P = 0.024), participation on ≥1 Phase I clinical trial prior to their current trial (OR: 2.2, P = 0.028), and living > 100 miles away from the clinical trials hospital (OR: 2.3, P = 0.043). However, 34% of pts who lived > 100 miles away received partial/full reimbursement of clinical trial-related travel costs from study sponsor/other/insurance. Racial/ethnic minority (OR: 2.6, P = 0.008) and pts who were unemployed or not working outside the home (OR: 2.4, P = 0.023) were more likely to report that actual medical costs were much higher than expected. 53% of pts used savings and 18% retirement accounts to pay for treatment. Conclusions: Among cancer pts participating on clinical trials, economic burden is high, and most of pts’ OOP costs were on non-medical expenses. Financial toxicity is disproportionally higher in pts with lower income. OOP costs can be substantial and are often unexpected for pts. Furthermore, prior participation in ≥1 Phase I clinical trial and living far away from the clinical trials hospital seem to increase risk of financial toxicity.

The evolution of financial toxicity in patients with lung cancer.

e19406 Background: Financial toxicity (FT), or the cost-related side effect of cancer therapy, has been linked to poor clinical outcomes, greater symptom burden, and worse quality of life. While the repercussions of FT have been thoroughly explored, the longitudinal patient relationship with FT in the initial course of therapy is unknown. Methods: Patients with stage II – IV lung cancer were recruited in a prospective longitudinal non-interventional study between July 2018 and January 2020. FT was measured via the COST score, a validated questionnaire for benchmarking FT, at a) the time of cancer diagnosis and then later at b) 6-month follow up (6MFU). In this model, a lower COST score indicates increased financial hardship. Completed 6MFU data was compared to corresponding baseline data for each patient. Linear regression analysis was used to compare patient characteristics with baseline COST (COSTbase) and 6-month COST (COST6M) scores. Results: At the time of analysis, 209 patients were screened and 194 (95.1%) patients agreed to participate and complete the baseline survey. Subsequently, 93 patients completed the 6MFU survey, 32 patients had died, and 7 patients were lost to follow up. The remaining 62 patients have not met the study end point to date. Of the 93 patients that completed the 6MFU and baseline survey, the median age was 65 (range 35-89), 50.5% were male, and 76.3% were Caucasian. Over the first six months of therapy 36.5% overestimated OOP expenses by > $1000 and 22.5% reported a decrease in total monetary savings, but only 4.3% of patients made decisions about health care based on cost of care. FT was present at both time points but was worse at diagnosis than at 6MFU (median COSTbase 25 [range 1-44] vs. median COST6M 27 [range 0-44]; p = 0.04). Linear regression correlated risk factors with FT at baseline ( < 1 month monetary savings, employed but on sick leave, and inability to afford basic necessities; all p < 0.001) that were different from risk factors at 6MFU (paying much more than expected OOP and sacrificing spending to meet medical costs; p < 0.001). There was no significant difference between estimated OOP costs at baseline (median $2550 [range $0 - $500,000]) and actual OOP costs (median $2496 [range $0 – 25,900]; p = 0.25). Conclusions: FT toxicity is pervasive at both diagnosis and at 6-month follow up, however, the magnitude of toxicity changes with time. Few patients are willing to sacrifice medical care regardless of the cost. Risk factors for FT evolve, suggesting that different groups may benefit from financial intervention at diagnosis versus 6MFU.

Immune-checkpoint inhibitors among privately insured cancer patients: Utilization pattern and out-of-pocket cost.

e19252 Background: Immune-checkpoint inhibitors (ICI) is a form of immunotherapy that “releases the brakes” on the immune cells to restore antitumor immunity and promote tumor cell death to treat cancer. In March 2011, the United States Food and Drug Administration (FDA) approved ipilimumab, the 1st ICI, to treat advanced-stage melanoma. Since December 2014, FDA successively approved another six ICIs: nivolumab, pembrolizumab, avelumab, durvalumab, cemiplimab, and atezolizumab. Beside melanoma, the treatment indications for these agents have been expanded to renal cell carcinoma, microsatellite instability (MSI)-high malignancies, small-cell lung cancer, non-small-cell lung cancer, and cutaneous squamous cell carcinoma. No study had examined the patterns and out-of-pocket (OOP) costs of ICI among cancer patients (pts) with private insurance. Methods: We used the IBM MarketScan Commercial Claims and Encounters database to document the uptake of ICI from 2011 to 2017. Using the Healthcare Common Procedure Coding System (HCPCS) codes, and national Drug code, we identified ICI claims among pts 18 to 64 years old. OOP cost for ICI was computed as sum of coinsurance, copayment, and deductible. To determine whether financial burden was higher for pts with high-deductible (HD) plans, we dichotomized pts’ insurance plan as HD vs. non-HD. Summary statistics was used to describe the patterns of ICI use. We used Wilcoxon Rank Sum test to compare the OOP by HD status. Results: The study cohort included 7,855 pts with 62,636 ICI claims of ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, and atezolizumab between 2011 and 2017. The median age was 57 years and about 56.9% pts were male. Approximately 90% of pts used ICI as monotherapy, and the median number of claims per patient was 4. The most commonly used ICI was nivolumab (55.4%), accounting for about 90% of claims after 2014, followed by lpilimumab (24.6%), pembrolizumab (18.5%). Among the ICI pts, 17.2% enrolled in HD plans and 82.8% had non-HD plans. The median OOP for both HD and non-HD groups was $0, whereas the 3rd quartile of OOP was significantly higher for pts in HD plans ($556 vs. $26, P < 0.01). In addition, approximately 18.7% of pts (17.3% of pts in non-HD and 25.6% in HD plans) paid over $500 OOP per patient for ICI. Conclusions: The use of ICI was dramatically increased as more ICI agents were approved since 2015. Although more than 50% of pts had $0 OOP, possibly due to the out-of-pocket max provision in private insurance, pts with HD plans are especially susceptible to high financial burden of ICIs.

Abstract 285: Association Of Patient Out-of-pocket Costs And Financial Assistance With Prescription Abandonment: The Case Of PCSK9 Inhibitors

Background: Specialty drugs are typically subject to high out-of-pocket (OOP) costs, especially for Medicare Part D patients and commercially insured patients facing high deductibles and/or coinsurance. Financial assistance offered by charities or manufacturers often helps reduce OOP burden. Studies in several disease areas have shown that high OOP costs are associated with prescription abandonment, defined as failure to purchase an insurer-approved prescription at the pharmacy. We examined how OOP costs and financial assistance were associated with abandonment of PCSK9i prescriptions. Methods: This retrospective study utilized 2015-2017 claims data from Decision Resources Group for Medicare and commercially insured patients. We defined PCSK9i abandonment rate as the percentage of patients with no evidence of a dispensed PCSK9i in the 90 days after their first PCSK9i prescription was approved by the insurer. Logistic regressions controlling for demographic, clinical, and treatment characteristics were used to estimate risk-adjusted rates of abandonment across different OOP cost levels. We conducted simulations to predict abandonment rates if a patient’s OOP cost level changed and/or they did not receive financial assistance, while holding all other covariates constant. Analyses were conducted separately in the Medicare and commercially insured patients. Result: Our final sample included 8,024 Medicare beneficiaries and 3,865 commercially-insured patients. We found that higher OOP cost was associated with higher risk-adjusted PCSK9i abandonment rates in both groups. For instance, Medicare beneficiaries with $0 OOP cost had a 7.4% risk-adjusted abandonment rate, compared to 9.8% for the $1-$9 group (odds ratio [OR]:1.37; 95% CI:1.04-1.81), 19.6% for the $10-$99 group (OR: 3.12; 95% CI: 2.62-3.72), 42.6% for the $100-$199 group (OR: 9.99; 95% CI: 7.60-13.14), 51.9% for the $200-$299 group (OR: 14.48; 95% CI: 11.14-19.76), 58.5% for $300-$399 group (OR: 19.7; 95% CI: 15.01-25.86), and 59% for the ≥$400 group (OR: 20.13; 95% CI: 14.96-27.09). All comparisons were significant at P<0.05. About 4% of Medicare beneficiaries (n=288) and 32% of commercially insured patients (n=1,243) received financial assistance. Without it, their mean OOP costs would have increased from $31 to $386 for Medicare and $7 to $534 for commercial insurance and abandonment rates would have increased from 9.7% to 46.4% (change: 36.7% [95% CI: 31.4% -41.9%]) for Medicare and 4.4% to 27.4% (change: 23% [95% CI: 19.1% -26.9%] for commercial insurance. Conclusions: Higher OOP costs were associated with higher rates of PCSK9i abandonment. Lack of financial assistance was associated with increased abandonment. Our findings help inform current policy efforts to protect patients from high cost sharing, such as current bills in Congress aiming to reduce patient OOP burden under Medicare Part D.

Vicious cycle of chronic disease and poverty: a qualitative study in present day Nepal.

BackgroundIn countries with out-of-pocket (OOP) payment systems for healthcare, the combination of chronic disease and poverty can have damaging socio-economic and health impacts for affected households. Using a life course perspective, this article aims to explore how Nepalese people struggle with, experience and adapt to chronic disease, poverty and their consequences, and how chronic diseases and poverty reinforce each other.MethodsIn-depth semi-structured interviews were conducted with 21 chronically ill Nepalese people with one or more chronic diseases and/or their caretakers. Data were transcribed and analysed thematically.ResultsThe adaptation strategies for the consequences of the huge OOP costs make patients and their households financially disadvantaged. The impoverishment has major social impacts and often persists across generations. The situation forces people to choose between avoiding medical treatment or further impoverishing their families.ConclusionsThis study explored how chronically ill Nepalese people struggle with socio-economic and health consequences of OOP payments for their disease. The article sheds light on circumstances and adaptation strategies that obstruct every attempt to escape from the vicious cycle of the poverty trap. Hence poverty and health adversities accumulate across generations and contribute to greater health expenditures, worse health outcomes and severely compromised social life.

Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals.

Purpose: Although pharmacologic hormone therapy represents one of the mainstays of gender-affirming therapy for transgender individuals, there are many access barriers for these therapies, including insurance coverage of these drugs. The purpose of this study was to examine Medicare coverage of hormone therapies used by transgender individuals. Methods: Using Centers for Medicare and Medicaid Services prescription drug plan formulary files, we determined plan coverage, coverage restrictions, and out-of-pocket (OOP) costs for all 10 drugs recommended in the 2009 and 2017 Endocrine Society treatment guidelines for transgender patients. Results: For masculinizing therapies, the proportion of plans providing unrestricted coverage ranged from 22% to 79% in 2010 and from 5% to 75% in 2018. For feminizing therapies, the proportion providing unrestricted coverage ranged from 24% to 100% in 2010 and from 13% to 100% in 2018. Median annual OOP costs for masculinizing therapies ranged from $232 to $1112 in 2010 and from $180 to $2176 in 2018. For feminizing therapies, OOP costs ranged from $84 to $2716 in 2010 and from $72 to $3792 in 2018. Conclusion: Our findings highlight the variability in access to guideline-recommended hormone therapies for individuals insured through Medicare.

Preferences for Hearing Aid Attributes Among People with Moderate or Greater Hearing Loss in Rural China: A Discrete Choice Experiment.

PurposeHearing loss has not received sufficient attention, especially in low- and middle-income countries where more than 80% of the people with hearing loss reside. Little is known about the preference for hearing aids among people with hearing loss in developing countries. The aim of this study is to elicit the preferences for hearing aid attributes among rural Chinese adults with moderate or greater hearing loss and examine how preferences vary across different individual socioeconomic characteristics.Patients and MethodsWe interviewed 125 adults in two rural counties in Shandong province in China. A discrete choice experiment (DCE) with eight attributes, comprising out-of-pocket (OOP) costs, hearing aid style, effective in quiet settings and noisy settings, feedback (whistling), connectivity, water/sweat resistance and battery life, were employed to examine participants’ preference for hearing aids. Mixed logit models were used for the statistical analyses.ResultsWhile OOP costs, effectiveness in quiet settings, water/sweat resistance and battery life were significantly associated with choosing a hearing aid, rural Chinese adults with moderate or greater hearing loss valued effectiveness in noisy settings above other attributes of hearing aids, followed closely by lack of feedback. The preference of the attributes of OOP costs, in the canal hearing aids, effectiveness in noisy settings, connectivity and battery life varied across individual socioeconomic characteristics including sex, marriage, employment, income and education level.ConclusionOur study supported the view that the development of noise suppression and feedback cancellation systems remained the main challenge for the hearing aid industry. Since OOP costs were also associated with choosing a hearing aid, the policy advice is to improve reimbursements from insurance schemes and/or reduce the costs of hearing aids.

Higher OOP costs reduce adherence to neurological therapies

Higher OOP costs reduce adherence to neurological therapies

Out-of-Pocket Spending for Thumb Carpometacarpal Arthritis: Capitation Matters.

Background: Patients are increasingly responsible for direct medical expenditures with a growth in out-of-pocket (OOP) expenses, which can impede access to care and affect treatment. This study aims to investigate the impact of capitation on OOP expenses for surgical and presurgical treatment for thumb carpometacarpal (CMC) joint arthritis. Methods: Patients with a diagnosis of thumb CMC arthritis who underwent surgery (2009-2016) comprised our study cohort. Sociodemographic data, total cost, and OOP expenses were collected at the time of surgery and 2 years prior. Patients were stratified by insurance type: fee-for-service (FFS), managed care (MC), Medicare-MC, and Medicare-FFS. Capitated plans were included in the MC and Medicare-MC groups. A generalized linear regression was performed to investigate the association between OOP expenses and insurance type. Results: Our cohort consisted of 7780 patients with FFS insurance, 953 with MC insurance, 2136 with Medicare-FFS, and 265 with Medicare-MC. There was no difference in total costs for FFS and MC (FFS $7281 vs. MC $7306, P = .73; Medicare-FFS $6663 vs. Medicare-MC $6183, P = .19). However, patients with FFS incurred significantly greater OOP costs (FFS $952 vs. MC $434, P < .01; Medicare-FFS $343 vs. Medicare-MC $232, P < .01). In the adjusted regression, MC, Medicare-FFS, and Medicare-MC had approximately 21% to 46% of the predicted OOP expenses of patients with FFS plans (P < .01). Conclusion: Despite similar total costs, OOP expenses were significantly greater for patients with FFS or Medicare-FFS insurance. With healthcare costs transitioning to patients, providers should consider cost sharing when conferring care to help alleviate the financial burden placed on patients.

General Health Care Utilization Among Nonelderly Cancer Survivors Before and After Affordable Care Act Implementation: Early Results.

The number of nonelderly cancer survivors is expected to grow and so are their health care costs. Many cancer survivors worry about medical bills. This study examined the impact of the Affordable Care Act (ACA) on the rate of insurance, average annual health care expenditure, and patient care experience among cancer survivors and investigated the patient characteristics that were associated with highly rated care experiences before and after ACA implementation. The study is a cross-sectional analysis of adult, nonelderly cancer survivors in the 2011 and 2016 Medical Expenditure Panel Survey who completed health care experience questionnaires. Percent covered by insurance both before and after the ACA was calculated, including total out-of-pocket (OOP) expenses as a percentage of overall health care expenditure per patient. Regression was performed to determine characteristics associated with patient experience ratings. Health insurance coverage for cancer survivors was higher in 2016 than in 2011 (98.4% v 94.4%; P = .006). OOP spending as a percentage of health care expenditure among those with expenses decreased and was most striking in those with no insurance. Privately insured individuals were 3 times as likely to rate their care experience high compared with those with no insurance (odds ratio, 3.31; P < .0001). Those with above-average ratings of self-health and with few comorbidities rated their care experiences highly. After the ACA, OOP costs have decreased for all types of insurance coverage. The association between patient experience and health status warrants additional study to better manage and coordinate the care of such patients.

Out-of-pocket payments and economic consequences from tuberculosis care in eastern China: income inequality

BackgroundDespite the availability of free tuberculosis (TB) diagnosis and treatment, TB care still generates substantial costs that push people into poverty. We investigated out-of-pocket (OOP) payments for TB care and assessed the resulting economic burden and economic consequences for those with varying levels of household income in eastern China.MethodsA cross-sectional study was conducted among TB patients in the national TB programme networks in eastern China. TB-related direct OOP costs, time loss, and coping strategies were investigated across households in different economic strata. Analysis of Variance was used to examine the differences in various costs, and Kruskal-Wallis tests were used to compare the difference in total costs as a percentage of annual household income.ResultsAmong 435 patients, the mean OOP total costs of TB care were USD 2389.5. In the lower-income quartile, OOP payments were lower, but costs as a percentage of reported annual household income were higher. Medical costs and costs prior to treatment accounted for 66.4 and 48.9% of the total costs, respectively. The lower the household income was, the higher the proportion of medical costs to total costs before TB treatment, but the lower the proportion of medical costs patients spent in the intensive phase. TB care caused 25.8% of TB-affected households to fall below the poverty line and caused the poverty gap (PG) to increase by United States Dollar (USD) 145.6. Patients in the poorest households had the highest poverty headcount ratio (70.2%) and PG (USD 236.1), but those in moderately poor households had the largest increase in the poverty headcount ratio (36.2%) and PG (USD 177.8) due to TB care. Patients from poor households were more likely to borrow money to cope with the costs of TB care; however, there were fewer social consequences, except for food insecurity, in poor households.ConclusionsMedical and pretreatment costs lead to high costs of TB care, especially among patients from the poorest households. It is necessary to train health system staff in general hospitals to promptly identify and refer TB patients. Pro-poor programmes are also needed to protect TB patients from the medical poverty trap.

Higher insulin prices increase OOP costs despite reduced coverage gap

Higher insulin prices increase OOP costs despite reduced coverage gap

Early Adoption and Outcomes of Ibrutinib As Treatment for Older Patients with Chronic Lymphocytic Leukemia (CLL): A Population-Based Study

Background: The availability of ibrutinib, an oral Bruton's tyrosine kinase inhibitor, has transformed the management of CLL. For older patients, first-line ibrutinib (± obinutuzumab) has shown advantage over chlorambucil (± obinutuzumab; Burger, NEJM 2015; Moreno, Lancet Oncol 2018) or bendamustine/rituximab (Woyach, NEJM 2019). However, its high cost raises concerns about potential disparities in access. Other concerns in older patients include the risk of atrial fibrillation (AFib), ventricular arrhythmias (VArr), or central nervous system hemorrhage (CNSh) associated with ibrutinib. We examined treatment patterns and outcomes among Medicare beneficiaries with CLL after the approval of ibrutinib in 2014. Methods: Using the linked SEER-Medicare registry, which covers ~34% of the US population, we identified Medicare beneficiaries with CLL diagnosed in 2007-2015, who had complete claims (including outpatient prescriptions), and who received systemic treatment in 2007-2016. We identified ibrutinib use as first or subsequent lines of therapy. We classified common first-line regimens as: 1) rituximab alone, 2) bendamustine ± CD20 antibody, 3) obinutuzumab ± chlorambucil, 4) other cytotoxic agents, and 5) ibrutinib (± CD20 antibody). We calculated total spending (observed in SEER-Medicare data) on CLL drugs per year, described duration of ibrutinib therapy, survival after starting ibrutinib, and the cumulative incidence function (CIF) for AFib, VArr, and CNSh during ibrutinib therapy. Using time-split survival analysis, we calculated the incidence rate ratio (IRR) for these events among patients starting ibrutinib compared with those managed without ibrutinib. All estimates report 95% confidence intervals (CI). Results: Ibrutinib was administered to 594 (18.2%) of 3,271 beneficiaries with CLL (at median age of 77 years [y]), including 196 in first line. The proportion of patients receiving ibrutinib as first-line therapy increased from 7% in 2014 to 36% in 2016 (Fig. A). As a result, Medicare spending on ibrutinib skyrocketed, surpassing all other CLL chemotherapeutics in 2016 (total $29.2M for ibrutinib, $18.5M for other drugs combined; Fig. B). Median gross cost of the first ibrutinib prescription was $9,301 (interquartile range [IQR], $8,635-10,233). Median patient's out-of-pocket (OOP) responsibility was $2,296 (IQR, $30-2,739), markedly lower for beneficiaries with the low-income subsidy ($4) than those without it ($2,538). Despite this variation, first-line ibrutinib use was not associated with any socio-demographic factor, including the low-income subsidy (P=.67 in χ2 test), age (P=.95), sex (P=.52), race/ethnicity (P=.31), or prevalent poverty (P=.35). Median duration of ibrutinib therapy was 13.6 months [mo.] (95%CI, 11.7-16.1), similar in first and subsequent line (P=.93, Fig. C). Median overall survival after starting ibrutinib was 30.3 mo. (95%CI, 22.3-not reached) in first line, and 24.6 mo. (95%CI, 21.6-28.7) in subsequent lines (Fig. D; P=.08). Median survival after stopping ibrutinib was 12.4 mo. (95%CI, 7.5-20.6) in first line, and 7.5 mo. (95%CI, 4.6-11.1) in subsequent lines (P=.06). The CIF of AFib on ibrutinib was 15.7% at 1 y (95%CI, 12.3-19.4), and 23.7% at 2 y (95%CI, 18.9-28.8; Fig. E). The incidence of AFib was significantly higher among patients receiving ibrutinib compared with other treatments (IRR, 1.65; 95%CI, 1.37-2.00). The CIF of VArr at 1 y was 4.4% (95%CI, 2.8-6.5%), also significantly increased (IRR, 1.62; 95%CI, 1.10-2.39). The CIF of CNSh at 1 y was 1.7% (95%CI, 0.8-3.0) (Fig. F), and significantly increased on ibrutinib (IRR, 4.48; 95%CI, 2.31-8.68). Among patients starting ibrutinib, 11.4% were on anticoagulants, 19.2% had prior atrial fibrillation, and 10.8% were on CYP3A4 inhibitors interacting with ibrutinib. Conclusions: Ibrutinib has been rapidly adopted for treatment of Medicare beneficiaries with CLL, resulting in major shifts in spending on CLL drugs. Despite high OOP costs, the use of first-line ibrutinib is not associated with sociodemographic characteristics, suggesting that therapeutic decisions are determined by clinical factors. The real-world survival of older patients on ibrutinib is poorer than seen in clinical trials, and rates of AFib, VArr and CNSh are higher. The use of ibrutinib in patients with pre-existing Afib or at risk for bleeding because of anticoagulation warrants particular attention. Disclosures Olszewski: Spectrum Pharmaceuticals: Research Funding; Adaptive Biotechnologies: Research Funding; TG Therapeutics: Research Funding; Genentech: Research Funding. Davids:Acerta Pharma, Ascentage Pharma, Genentech, MEI pharma, Pharmacyclics, Surface Oncology, TG Therapeutics, Verastem: Research Funding; AbbVie, Astra-Zeneca, Genentech, Janssen, MEI, Pharmacyclics, Syros Pharmaceuticals, Verastem: Consultancy; Research to Practice: Honoraria; AbbVie, Acerta Pharma, Adaptive, Biotechnologies, Astra-Zeneca, Genentech, Gilead Sciences, Janssen, Pharmacyclics, TG therapeutics: Membership on an entity's Board of Directors or advisory committees.

Mergers in Medicare Part D: Assessing market power, cost efficiencies, and bargaining power

We empirically examine horizontal mergers amongst Part D insurers with the aim of assessing how market power, cost efficiencies, and bargaining power affect premiums and coverage characteristics, including drug access and out-of-pocket (OOP) cost. Our results reveal that market power raises premiums, but this is only a local effect that occurs in markets where the merging firms overlap. Mergers alter the bargaining process with upstream suppliers at both local and national levels, affecting drug access and OOP cost. We find evidence of cost efficiencies when firms restructure by consolidating their plan offerings.

Rural-urban disparities in colonoscopies after the elimination of patient cost-sharing by the Affordable Care Act

IntroductionImproving the prevention and early detection of colorectal cancer is a priority for reducing rural-urban disparities in colorectal cancer mortality. By eliminating out-of-pocket (OOP) costs for preventive colonoscopies, the Affordable Care Act (ACA) could have reduced rural-urban disparities in screening. MethodsWe used the Maine Health Data Organization All-Payer Claims Database including all commercially-insured and Medicare beneficiaries aged 50–75 between 2009 and 2012. Rural-urban commuting areas were used to classify rural/urban residence. ICD-9 and CPT codes identified colonoscopies. We summed all OOP payments per patient-day. An interrupted time series model estimated the impact of the ACA on trends in rural-urban disparities in colonoscopy rates and OOP costs. ResultsBefore the ACA, colonoscopy rates were 16% lower in rural than urban areas (5.1% vs. 6.1% of enrollees annually) and median OOP costs were nearly double ($195 vs. $98). The ACA reduced median OOP payments by $94 (p = .001) initially and $4 monthly (p = .038) in rural areas, and $63 (p < .001) in urban areas. The rural-urban gap in OOP payments dropped by $4 monthly (p = .007). The ACA also reduced rural-urban disparities in colonoscopy rates (disparity decrease of 0.005 (6%) monthly, p < .001). The rural-urban gap in colonoscopy rates declined 40% relative to the pre-ACA period by December 2012. ConclusionsThe ACA was associated with significant reductions in rural-urban disparities in colonoscopies in Maine, suggesting that OOP costs are an important barrier for rural residents. Further research is needed to determine whether increased uptake, particularly in rural areas, translated into better patient outcomes for colorectal cancer.

2656. Eliciting Preferences for Zoster Vaccination in US Adults Aged 50 Years and Older

BackgroundIn October 2017, the Centers for Disease Control and Prevention (CDC) recommended the adjuvanted Recombinant Zoster Vaccine (RZV) for all adults aged ≥ 50 years, regardless of previous vaccination. Understanding patient preferences for herpes zoster (HZ) vaccination can inform providers, payers, and policymakers about barriers, hesitancies, and utilization of available vaccines.MethodsA discrete choice experiment survey was completed by 1,454 US adults aged ≥50 years in January 2019, with targeted sampling quotas of African Americans (25%), recent influenza vaccine recipients (50%), and individuals with autoimmune disease or chronic comorbidities (37%), to enable subgroup analyses. HZ vaccine profiles were characterized using seven attributes: vaccine efficacy (VE), duration of protection, location of service, number of doses, injection-site reaction severity, systemic reactions duration, and out-of-pocket (OOP) costs. In a series of choice questions, respondents chose between a pair of hypothetical HZ vaccine profiles, determined by an efficient experimental design, and a no vaccination option. In a second series, respondents stated intentions to complete a 2-dose vaccination series, conditioned on varying levels of side effects experienced with a first dose and expected OOP costs. Differences across subgroups were explored.ResultsRespondents placed the greatest weight on OOP costs and VE when choosing among HZ vaccination options (Figure 1). African American respondents were more sensitive to increases in OOP costs than non-African American respondents (Figure 2). ~75% of respondents indicated they would complete the series of a two-dose HZ vaccine if the cost of completing the series was $8-$13. Second-dose compliance drops about 25% when OOP costs increase to $140–150.ConclusionOOP cost had the greatest influence on respondents’ intention to select and complete HZ vaccination. Efforts to remove financial barriers to improve implementation of the CDC recommendations for HZ vaccination should be considered. GlaxoSmithKline Biologicals SA, GSK study identifiers: 208677/HO-17-18066. Disclosures All authors: No reported disclosures.

Impact of in-house specialty pharmacy on access to novel androgen axis inhibitors in men with advanced prostate cancer.

132 Background: Novel androgen axis inhibitors are standard of care treatments in advanced prostate cancer. The billed amounts for these medications are often very high, which may create significant financial toxicity for patients and lead to delays in treatment. Our institution implemented an in-house specialty pharmacy in 2014, that provides these medications and evaluates copay assistance options for all patients. We evaluated the program’s impact on out of pocket cost (OOP) and turnaround time (TAT). Methods: We reviewed available internal specialty pharmacy records to identify prescriptions for abiraterone or enzalutamide filled between 1/1/17 and 12/31/18. Payments were stratified by primary payment (amount reimbursed by the patient’s prescription plan based on the benefit’s design) and copayment assistance. Turnaround times (TAT) in business days were stratified by prescriptions requiring intervention (prior authorization, copayment assistance, or insufficient inventory) and clean prescriptions (those requiring no intervention). Results: One thousand for hundred seventeen prescriptions for 175 unique patients requiring abiraterone (n = 869, 61.3%) or enzalutamide (n = 548, 38.7%) were filled through the institution’s specialty pharmacy. The average amount paid by primary payer was $9,492.96 for a 30 day supply (range: $3,382.48-$12,939.84). Average quoted copay was $577.53 (range $3.08-$10,560.39). 64% of patients received copayment assistance. Average OOP cost per prescription after co-pay assistance was $100.83 (range $0-$8556.64). Three patients declined treatment due to cost (1.7% of overall). Average TAT was 2.98 days for clean prescriptions and 3.36 days for prescriptions needing intervention (p = 0.055). Conclusions: OOP cost varied significantly based on plan design and copayment assistance eligibility. The majority of patients received copayment assistance, which markedly reduced OOP cost. Cost rarely precluded access to treatment. TAT was not significantly prolonged for prescriptions requiring intervention. Further studies to determine impact of pharmacy type on access to specialty medications are indicated.

The Clinical and Financial Consequences of the Centers for Medicare and Medicaid Services’ Two-Midnight Rule in Total Joint Arthroplasty

BackgroundTo lessen the financial burden of total joint arthroplasty (TJA) and encourage shorter hospital stays, the Centers for Medicare and Medicaid Services (CMS) recently removed TKA from the inpatient-only list. This policy change now requires providers and institutions to apply the two-midnight rule (TMR) to short-stay (1-midnight) inpatient hospitalizations (SSIH). MethodsThe National Inpatient Sample from 2012 through 2016 was used to analyze trends in length of stay following elective TJA. Using publically-available policy documentation, published median Medicare payments, and National Inpatient Sample hospital costs, we analyzed the application of the TMR to SSIHs and compared the results to the previous policy environment. Specifically, we modeled 3 scenarios for all 2016 Medicare SSIHs: (1) all patients kept an extra midnight to satisfy the TMR, (2) all patients discharged as an outpatient, and (3) all patients discharged as an inpatient. ResultsThe overall percentage of Medicare SSIHs increased significantly from 2.7% in 2012 to 17.8% in 2016 (P < .0001). Scenario 1 resulted in no change in out-of-pocket (OOP) costs to patients, no change in CMS payments, and hospital losses of $117.0 million. Scenario 2 resulted in no change in patient OOP costs, reduction in payments from CMS of $181.8 million, and hospital losses of $357.3 million. Scenario 3 resulted in no change in patient OOP costs, no change in CMS payments, and an estimated $1.71 billion of SSIH charges at risk to hospitals for audit. ConclusionThe results of this analysis reveal the conflict between length of stay trends following TJA and the imposition of the TMR.