Total Per-patient Per-month Costs Research Articles

Real-World Study of Patients with Triple-Class Exposed Relapsed/Refractory Multiple Myeloma: Analysis across a Spectrum of Advanced Disease Stage Medicare Patients in the United States

Background Treatment of relapsed/refractory (RR) multiple myeloma (MM) has been transformed by novel therapies including anti-CD38 monoclonal antibodies (mAb), 2 nd and 3 rd generation immunomodulatory drugs (IMiD), and proteasome inhibitors (PI). This has resulted in increasing numbers (no.) of triple-class exposed (TCE) patients (pts), defined as pts who have received an IMiD, ≥1 PI, and ≥1 anti-CD38 mAb. Many TCE pts are exposed to ≥5 drugs in these classes (i.e. penta-exposed [PE]: ≥2 IMID, ≥2 PI, and an anti-CD38 mAb). Some are refractory to ≥1 drug in each class (triple-class refractory [TCR]) and some are both PE and TCR (PE-TCR). Data on real-world outcomes for the spectrum of heavily pre-treated, advanced RRMM pts are limited. This study examined treatment patterns and healthcare resource utilization (HRU) and costs in Medicare-insured pts with TCE RRMM. Methods Adult pts with an incident diagnosis (Dx) of MM (≥2 outpatient claims 30-365 days apart OR ≥1 inpatient AND 6 months [mos.] of continuous eligibility prior to first Dx) during the study period (Nov 14, 2006-Dec 31, 2020) who were TCE were selected from the Center for Medicare and Medicaid Services Chronic Conditions Data Warehouse. TCE was defined as having ≥1 claim each for an IMiD, a PI, and an anti-CD38 mAb; PE was defined as having ≥2 claims each for an IMiD and a PI and ≥1 claim for an anti-CD38 mAb (TCE pts were assumed to have RRMM based on exposure). Pts were deemed TCR if refractory to ≥1 regimen each which included a PI, an IMiD, and an anti-CD38 mAb. Pts were considered refractory to a regimen if the period between the last claim or days supplied for any drug in the regimen and the start of the subsequent regimen was <60 days AND none of the drugs in the regimen were present in the next regimen. For each pt, the 1 st line of therapy (LOT) after becoming TCE was considered the index LOT and the date that this LOT initiated was defined as the index date. Pts were followed from the index date until the earliest of end of continuous enrollment or the end of study period. LOTs and treatment regimens were defined using an adaptation of published algorithm developed based on clinical expert opinion (Madduri et al. Future Oncol. 2021). Outcomes included anti-MM treatments received for index LOT, time to discontinuation (TTD), time to next treatment (TTNT), overall survival (OS), and post-index HRU and healthcare costs (adjusted to 2021 USD). Median TTD and OS were obtained by Kaplan-Meier (KM) methods. TTNT was analyzed by cumulative incidence methods with death as a competing risk. HRU and costs (in 2021 USD) were reported on a per patient per month (PPPM) basis. Results 137,707 pts with an MM Dx during the study period were identified. A total of 2,830 TCE, 1,371 TCR, 1,121 PE, and 774 PE-TCR pts met all other inclusion criteria. Mean age was 76 years in all 4 cohorts, 50-51% were female, 21% (TCR) to 29% (PE) had prior autologous stem cell transplant. The mean no. of prior LOTs ranged from 3.3 (TCE) to 4.5 (PE-TCR). The no. of new TCE pts increased almost 8-fold from 114 in 2016 to 890 in 2020; similar increases were observed for TCR, PE, and PE-TCR pts. Mean (SD) follow-up time (mos.) was 12.4 (10.6) for TCE, 11.9 (10.0) for TCR, 10.9 (10.3) for PE, and 10.1 (9.3) for PE-TCR. There was no apparent standard of care (SOC) treatment across the 4 cohorts; the most frequently used index LOT regimens were pomalidomide + daratumumab for TCE (17%) and PE (7%), pomalidomide + carfilzomib for TCR (10.3%), and pomalidomide + elotuzumab for PE-TCR (7.4%). In all 4 cohorts, pomalidomide was the most frequently received medication during the index LOT (32.6% [PE-TCR] to 43.3% [TCR]). Median TTD (mos.) ranged from 4.2 (PE-TCR) to 6.9 (TCE). Median TTNT (mos.) ranged from 8.1 (TCR) to 14.6 (TCE). Median OS (mos.) ranged from 13.0 (TCR) to 15.9 (PE). TCE pts had a mean PPPM 0.20 ED visits, 7.02 outpatient visits, 3.73 outpatient pharmacy claims, 0.14 hospitalizations, and 1.18 inpatient days. For TCE pts, mean PPPM total costs were $23,091, the largest share of which was for MM medications ($16,812), followed by other MM-related services ($4,824). Monthly HRU and costs for TCR, PE, and PE-TCR pts were similar to those for TCE. Conclusions Despite increasing no. of Medicare-insured TCE, TCR, PE, and PE-TCR MM pts, there is no apparent SOC treatment regimen. With current treatments, TTD, TTNT, and OS are short and HRU and costs are high. These data underscore the high unmet need for new therapies in this growing population.

Better together? costs of first-line chemoimmunotherapy for advanced non-small cell lung cancer.

Recent advances have created options for first-line (1L) treatment of advanced/metastatic non-small cell lung cancer (aNSCLC). The study objectives were to describe the utilization of 3 classes of 1L treatment-chemotherapy (CT), immunotherapy (IO), and chemoimmunotherapy (IO+CT)-and the total, third-party payer, direct health care costs. Retrospective, administrative claims database analysis of patients with aNSCLC who initiated 1L treatment between January 1, 2017, and May 31, 2019, with IO, CT, or IO+CT. Microcosting enumerated health care resource utilization, including antineoplastic drug costs, using standardized costs. Generalized linear models estimated per-patient per-month (PPPM) costs during 1L treatment, and adjusted cost differences in 1L among treatment cohorts were calculated using recycled predictions. A total of 1317 IO-, 5315 CT-, and 1522 IO+CT-treated patients were identified. Utilization of CT declined from 72.3% to 47.6% between 2017 and 2019, replaced by use of IO+CT, which increased from 1.8% to 29.8%. Total PPPM costs in 1L were highest with IO+CT at $32,436, compared with $19,000 and $17,763 in the CT and IO cohorts, respectively. Adjusted analyses showed that PPPM costs were $13,933 (95% CI, $11,760-$16,105) higher in the IO+CT vs IO cohort (P < .001) and IO costs were $1024 (95% CI, $67-$1980) lower than CT (P = .04). IO+CT accounts for almost one-third of 1L aNSCLC treatment modalities, coinciding with a reduction in treatment with CT. Costs for patients treated with IO were lower than those for patients treated with both IO+CT and CT alone, driven primarily by antineoplastic drug and associated medical costs.

Real-world treatment patterns and healthcare costs in patients with psoriasis taking systemic oral or biologic therapies

BackgroundPsoriasis is a chronic, immune-mediated, systemic inflammatory disorder associated with high costs. This study evaluated real-world treatment patterns and associated costs in patients in the United States with psoriasis initiating systemic oral or biologic treatments.MethodsThis retrospective cohort study used IBM® (now Merative™) MarketScan® Commercial and Medicare claims (1 January 2006–31 December 2019) to evaluate patterns of switching, discontinuation, and nonswitching in two cohorts of patients initiating oral or biologic systemic therapy. Total pre-switch and post-switch costs were reported per-patient per-month (PPPM).ResultsEach cohort was analyzed (oral, n = 11,993; biologic; n = 9753). Among the oral and biologic cohorts, 32% and 15% discontinued index and any systemic treatment within 1 year of initiation; 40% and 62% remained on index therapy; and 28% and 23% switched treatment, respectively. In the oral and biologic cohorts, total PPPM costs within 1 year of initiation for nonswitchers, patients who discontinued, and patients who switched were $2594, $1402, and $3956, respectively, and $5035, $3112, and $5833, respectively.ConclusionThis study identified lower persistence in the oral treatment cohort, higher costs associated with switching, and a need for safe and effective oral treatment options for patients with psoriasis to delay the switch to biologic therapy.

Burden of insomnia among cancer patients undergoing treatment: A retrospective claims database analysis.

e18816 Background: Almost half of all cancer patients have trouble sleeping, usually insomnia or other sleep-wake disorders. Cancer treatment can exacerbate sleep problems. This study evaluated all-cause healthcare resource utilization (HCRU) and costs in cancer patients undergoing treatment who also have insomnia relative to a matched cohort of cancer patients undergoing treatment who do not have insomnia. Methods: This retrospective study used the IBM MarketScan Commercial and Medicare Supplemental Databases (Jan 2014-Dec 2019) to identify patients: (1) age ≥18 years; (2) with ≥1 ICD-9/ICD-10 codes for insomnia OR with ≥2 prescriptions for zolpidem immediate release (IR) OR trazodone ≤150mg OR benzodiazepine; (3) with ≥12 months of continuous enrollment pre-/post-index date (earliest diagnosis or medication fill date); (4) with ≥2 ICD-9/ICD-10 codes for any cancer; and (5) ≥1 claim for oncology treatment. Patients with sleep disorders other than insomnia were excluded. The resulting patients (“insomnia cohort”) were 1:1 matched on age, sex and Elixhauser Comorbidity Index (ECI) score to patients with cancer undergoing treatment without insomnia or other sleep disorders (“control cohort”). HCRU and costs were reported per patient per month (PPPM). Generalized linear models were used to compare adjusted outcomes between cohorts. Results: For each cohort, 7,132 patients (mean age 60.8 years, 69.5% female, 13.6 ECI score) were identified. In adjusted analyses, significantly more patients in the insomnia cohort had at least one inpatient visit per month, inpatient stays were significantly longer, and mean outpatient visits were significantly higher (all p &lt; 0.001) relative to the control cohort. The insomnia cohort had higher mean number of emergency department (ED) visits (p &lt; 0.05); however, mean number of inpatient visits was not significantly different between cohorts. Adjusted analyses also showed significantly higher mean total PPPM costs for the insomnia cohort than the control cohort ($4,864 and $3,302, respectively; mean ratio = 1.47; p &lt; 0.0001). Mean PPPM costs for inpatient visits, ED visits, and outpatient costs were also higher for the insomnia cohort (p &lt; 0.001). Conclusions: Cancer patients undergoing treatment who have insomnia had more intensive HCRU and higher costs relative to those without insomnia. These results suggest that better managing insomnia in this population may have a beneficial impact on both patients and payers.

Treatment patterns and economic burden among cervical and endometrial cancer patients newly initiating systemic therapy.

Aim: To evaluate treatment patterns, healthcare resource use (HCRU)and all-cause healthcare costs among patients with cervical or endometrial cancer newly initiating systemic therapy. Methods: We identified patients with cervical orendometrial cancer newly initiating systemic therapy -a claims-based proxy for advanced disease -between 2014 and2019, described them by line of therapy (LOT), and summarized the per patient per month (PPPM) HCRU and healthcare costs per LOT. Results: Among 1229 patients with cervical cancer and 2659 patients with endometrial cancer, LOT1 therapies included systemic only (cervical, 50.1%; endometrial, 83.2%) and systemic with radiation therapy (cervical, 49.9%; endometrial, 16.8%). Mean PPPM total costs were: LOT1 (cervical, US$15,892; endometrial, US$11,363), LOT2 (US$20,193; US$14,019)and LOT3+ (US$16,576; US$14,645). Conclusions: Overall, patients received guideline-concordant care and experienced significant economic burden, which increased with LOT.

Health Care Utilization and Costs Associated With Systemic First-Line Metastatic Melanoma Therapies in the United States.

US Food and Drug Administration approvals of immune checkpoint inhibitors and targeted therapies revolutionized the treatment of metastatic melanoma. Our aim was to assess health care resource utilization and costs for patients with metastatic melanoma treated with systemic therapies in first line between January 2012 and December 2017. We conducted a retrospective cohort study of patients with metastatic melanoma using MarketScan data. We included patients diagnosed with melanoma and secondary malignant neoplasm who used pembrolizumab, nivolumab, ipilimumab, ipilimumab plus nivolumab, BRAF-inhibitor (BRAF-i) plus MEK inhibitor (MEK-i), BRAF-i or MEK-i monotherapy, or chemotherapy in first line. We compared health care utilization and costs per patient per month (PPPM) using two-part and generalized linear models. We identified 1,870 patients, including 185 pembrolizumab, 103 nivolumab, 689 ipilimumab, 185 nivolumab plus ipilimumab, 214 BRAF-i plus MEK-i, 240 BRAF-i or MEK-i monotherapy, and 254 chemotherapy users. Highest PPPM rates of hospitalizations, emergency room visits, and outpatient visits were observed in patients with ipilimumab plus nivolumab therapy (adjusted difference v pembrolizumab [aDiff], 0.18, 0.12, and 0.88, respectively; all P < .001). Ipilimumab monotherapy users (aDiff, 0.07 and 0.93; all P < .001) and chemotherapy users (aDiff, 0.10 and 2.63; all P < .001) showed higher PPPM rates of hospitalizations and outpatient visits compared with pembrolizumab users, respectively. Utilization rates in nivolumab, BRAF-i plus MEK-i, and BRAF-i or MEK-i groups were similar to the pembrolizumab group. Highest PPPM total costs and drug-related costs were observed in the ipilimumab group ($80,139 US dollars [USD] and $70,051 USD; all P < .001), followed by the ipilimumab plus nivolumab ($71,689 USD and $56,217 USD; all P < .001) and the BRAF-i plus MEK-i group ($31,184 USD and $19,648 USD; all P < .001). PPPM costs in the nivolumab group were similar to the pembrolizumab group. Significant differences in health care resource utilization and costs were found across first-line metastatic melanoma regimens. Utilization rates were highest in patients using ipilimumab-containing therapies. High drug costs constituted a major fraction of total PPPM health care costs.

Lenalidomide Maintenance for Patients with Newly Diagnosed Multiple Myeloma Post Autologous Stem Cell Transplant: A Comparison of Real-World Treatment Outcomes and Costs

BACKGROUNDIn 2017, lenalidomide maintenance therapy (R-MT) was approved for patients (pts) who received an up-front autologous hematopoietic stem cell transplantation (ASCT) in the United States (US) and Europe. The total cost of care for pts on R-MT in the US has not been previously studied using a large administrative claims database. This study aimed to compare real-world outcomes and costs among pts with newly diagnosed multiple myeloma (MM) receiving R-MT vs no maintenance (No-MT) post ASCT.METHODSFrom the Truven Marketscan data set, we identified adult pts with ≥ 2 claims for MM (International Classification of Diseases, 9th/10th Revision, Clinical Modification code: 203.0x, C90.0x) 30 days apart and ≥ 1 MM treatment during the identification period (1/1/2011 to 9/30/2016). Pts were required to have continuous enrollment for 6 months pre and ≥ 6 months post initial ASCT date plus 90 days (index date), in addition to ≥ 1 full cycle of therapy with a valid first-line regimen, and evidence of ASCT during follow-up period. Patients were excluded if they had evidence of prior MM diagnosis or treatment. R-MT was defined as lenalidomide monotherapy of < 20 mg per day for ≥ 21 of 28 days. Treatment outcomes and healthcare costs during follow-up were compared among those initiating R-MT vs No-MT. Time to treatment discontinuation (TTTD) was defined as the duration from initiation of R-MT to discontinuation of R-MT. Time to next treatment (TTNT) was defined as the duration from the index date until the initiation of another second-line therapy. Kaplan-Meier (KM) and Cox proportional hazard models were performed to evaluate TTTD and TTNT. Per patient per month (PPPM) total healthcare costs were calculated at 12, 24, and 36 months among pts initiating R-MT or No-MT. Pharmacy costs included oral MM treatments and other oral medications. Outpatient costs were composed of IV medications and physician and ER visits, while hospitalizations were part of inpatient costs. Generalized linear regression models with negative binomial distribution and log link function were used to assess differences in PPPM while adjusting for differences in baseline characteristics.RESULTSA total of 250 and 233 pts initiated R-MT and No-MT, respectively. Mean age (58.5 vs 58.0 y, P= .5236) and Charlson Comorbidity Index score (5.2 vs 5.3, P= .5234) were similar, but there were more males in the No-MT group (52.0% vs 61.4%, P= .0378). Time from start of first-line regimen to ASCT (5.48 vs 5.47 months, P= .9589) and the mean follow-up time post index date (22.1 vs 21 months, P= .1414) were similar in both groups. R-MT pts had a median duration of maintenance of 10 months. The median TTTD using the KM method was 21.02 months (95% CI: 16.78, 25.76). During the study period, a total of 60 (24%) and 99 (42.5%) R-MT and No-MT pts received a second-line treatment. At 12, 24, and 36 months, the proportion of pts who had a second-line treatment was as follows: R-MT-12.4%, 21.2%, 22.8%; No-MT-35.2%, 40.3%, 42.1%. Median TTNT was significantly longer among those treated with R-MT vs No-MT (Figure 1). Adjusted total PPPM costs during the first 12 months of follow-up was higher among pts treated with R-MT vs No-MT ($13,095 vs $8,910, adjusted difference $4,514, P < .0001). Mean pharmacy PPPM costs were higher in R-MT pts ($8,603 vs $2,269, P < .0001) while outpatient costs were higher in the No-MT group ($3,761 vs $5,360, P < .0001), and inpatient costs were similar ($731 vs $1,281, P < .5076). The adjusted difference in total PPPM costs during 12-24 months of follow-up was $6,579, P < .0001. A similar cost trend was observed in months 24-36 of follow-up; however, even fewer patients had sufficient follow-up: Adjusted difference: $6,110, P= .0024.CONCLUSIONPts remain on R-MT for several months to well over a year. R-MT pts incurred higher costs within the study period; however, their TTNT was significantly longer, and they were over half as likely to progress to a second-line treatment compared with No-MT pts. Pharmacy costs in R-MT pts were higher in the initial year of follow-up while No-MT pts had higher outpatient costs, presumably driven by the need for second-line therapy in a higher proportion of patients. Additional follow-up is required to assess total healthcare costs in subsequent years. [Display omitted] DisclosuresHari:Celgene: Consultancy, Honoraria, Research Funding. Ung:Celgene Corporation: Other: Fellowship is funded by Celgene. Abouzaid:Celgene Corporation: Employment, Equity Ownership, Research Funding. Ni:Celgene: Employment. Parikh:Celgene Corporation: Employment. Agarwal:Celgene Corporation: Employment.

Economic Burden of Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) in the US

Introduction: A majority of AML patients ultimately relapse after achieving remission or exhibit refractory disease. Some patients, e.g., those carrying FLT3 -ITD mutation or other risk factors, may relapse early, i.e., within 6 months of initial diagnosis. Limited data exist regarding the economic impact of R/R AML. The present study was conducted to assess the economic burden associated with R/R AML, including early relapse, among commercially insured US patients.Methods: Adults (≥18 years) with ≥2 independent claims of new AML diagnosis code not in remission or relapse (ICD-9-CM: 205.00) were identified from 2006-2016 in the QuintilesIMS Real-World Data Adjudicated Claims - US representing a large commercially insured US population. Included patients had continuous enrollment in a health plan for ≥6 months prior to and at ≥3 months after a new AML diagnosis and were longitudinally followed up until end of continuous enrollment or end of follow-up. Patients were categorized as R/R or non-R/R AML during the follow-up period, based on a validated algorithm (Earle et al, Med Care . 2002;40(8), IV-75), augmented by including ICD-9/-10 AML relapse diagnosis codes. R/R patients were further stratified as rapid progressors (RP) if the R/R event occurred within 6 months of first AML diagnosis. Healthcare resource utilization (HCRU) and costs were compared between: (1) R/R and non-R/R cohorts, and (2) RP and non-RP groups within the R/R cohort. HCRU was compared using adjusted incidence rate ratios (IRR) derived from multivariate generalized linear models (GLM) controlling for baseline demographic characteristics (age, sex, region, payer type) and Charlson comorbidity index (CCI), and was reported as the likelihood of using a defined healthcare resource over a patient month. The burden of total cost and its components was compared using mean total per patient per month (PPPM) healthcare costs to account for variable follow-up. The adjusted cost differences were derived from separate GLMs.Results: 5,274 newly diagnosed AML patients were included. Median age was 58 years, 52% were male, 12% had CCI ≥3, and median follow-up time was 16 months. Forty percent (2,088 out of 5,274) had R/R AML. Among R/R patients, the median (95% CI) time from AML diagnosis to R/R was 7.5 (7.4-7.8) months. Compared to non-R/R patients, R/R patients had 71% more transfusions (IRR: 1.71 [95% CI: 1.53-1.91]), 45% more hospitalizations (IRR: 1.45 [95% CI: 1.29-1.62]), 14% longer median days in hospital (IRR: 1.14 [95% CI: 1.05-1.24], 87% more outpatient visits (IRR: 1.87 [95% CI: 1.73-2.03]), and almost 3 times more hospice admissions (IRR: 2.70 [95% CI: 1.40-5.19]); all P <0.001. ER admissions were not significantly different (IRR: 1.19 [95% CI: 0.87-1.61]), P= 0.278. Unadjusted PPPM total costs were significantly higher for R/R vs non-R/R patients ($28,148 vs $25,077; adjusted difference of $3,368; P <0.001), with the main driver being hospitalizations ($16,867 vs $14,551; adjusted difference of $2,036; P <0.001). In the R/R cohort, RP patients had 44% more transfusions (IRR: 1.44 [95% CI: 1.23-1.68]), 62% more hospitalizations (IRR: 1.62 [95% CI: 1.37-1.92]), 92% longer median days in hospital (IRR: 1.92 [95% CI: 1.73-2.14]), 32% more outpatient visits (IRR: 1.32 [95% CI: 1.18-1.48]), 86% more ER admissions (IRR: 1.86 [95% CI: 1.16-2.99]), and over 3 times more hospice admissions (IRR: 3.11 [95% CI: 1.35-7.17]); all P <0.001, than non-RP patients. Unadjusted PPPM total costs were significantly higher in the RP versus non-RP patients ($38,755 vs $22,153; adjusted difference of $17,588; P <0.001), with the main driver being hospitalizations ($24,196 vs $12,725; adjusted difference of $11,427; P <0.001). See Table for cost components comparison.Conclusions: Compared to the non-R/R AML patients, the R/R patients experienced significantly higher monthly healthcare resources and costs. This economic burden was particularly high among those progressing early. Hospitalization was the key driver of this increased burden. Delaying relapse in rapidly progressing patients may reduce the burden to the health care system. [Display omitted] DisclosuresAly:Pharmerit International: Employment; Daiichi Sankyo, Inc.: Other: Grant; BMS: Other: Grant; Celgene: Other: Grant; Amgen: Other: Grant; AstraZeneca: Other: Grant; Pharmacyclics: Other: Grant; Celldex Therapeutics: Other: Grant. Bapat:Daiichi Sankyo, Inc.: Other: Grant; Pharmerit International: Employment. Ray:Daiichi Sankyo, Inc.: Employment, Equity Ownership. Chen:Pharmerit International: Employment; Daiichi Sankyo, Inc.: Other: Grant. Botteman:Daiichi Sankyo, Inc.: Other: Grant; Pharmerit International: Employment.

Direct Medical Costs Associated With Treatment Nonpersistence in Patients With Higher-Risk Myelodysplastic Syndromes Receiving Hypomethylating Agents: A Large Retrospective Cohort Analysis

BackgroundSuboptimal use of hypomethylating agents (HMAs) among higher-risk myelodysplastic syndrome (HR-MDS) patients can translate into worse health outcomes and economic burden. We estimated the direct medical costs associated with HMA treatment nonpersistence among HR-MDS patients. Patients and MethodsUsing the Surveillance, Epidemiology, and End Results–Medicare linked database, a retrospective cohort of patients diagnosed with refractory anemia with excess blasts (RAEB), a diagnosis that substantially overlaps with HR-MDS, between January 2011 and December 2015 was analyzed. Patients who had ≥ 1 year of continuous Medicare enrollment before diagnosis and who did not receive stem cell transplant or lenalidomide in the follow-up period were included. Patients receiving HMAs were stratified into HMA persistent (≥4 HMA cycles) and HMA nonpersistent (<4 cycles or a gap of ≥ 90 days between cycles) groups. Healthcare resource use and costs during the follow-up period were reported descriptively as total and per patient per month (PPPM). Weighted generalized linear models (GLM) were used to compare estimated healthcare resource use and costs between HMA groups. ResultsAmong the 664 patients with RAEB, 295 (44.4%) were HMA nonpersistent and 369 (55.6%) HMA persistent. On the basis of weighted GLM analysis, the HMA nonpersistent group incurred significantly (P < .05) higher total PPPM costs compared to the HMA persistent group ($18,039 vs. $13,893), particularly for hospitalization ($3,375 vs. $2,131), and emergency room ($5,517 vs. $2,867) costs. ConclusionThere is a substantial economic burden associated with early discontinuation of guideline-recommended HMA therapy in RAEB patients. The study findings necessitate closer care management in this population in order to improve outcomes and reduce healthcare spending.

Real-world economic burden of rapid disease progression (RDP) in patients (pts) with advanced/metastatic non-small cell lung cancer (aNSCLC).

e20716 Background: RDP on initial therapy imposes significant clinical burden among pts with aNSCLC. This retrospective claims study provides estimates of the economic burden associated with RDP during subsequent therapy following RDP v non-RDP on platinum-based (Pt) therapy. Methods: Adult Medicare Advantage or commercially insured aNSCLC pts receiving a subsequent line of therapy (LOT) from 03/2015 to 08/2017 after initial Pt therapy were identified in the Optum Research Database and assigned to unmatched RDP &amp; non-RDP cohorts based on Pt treatment duration (≤ 12 and &gt; 12 weeks, respectively) as a surrogate. All-cause healthcare costs were inflation adjusted to 2017 US$ and computed as per patient per month (PPPM) during the subsequent LOT. Total costs were the sum of medical (inpatient, ambulatory, ER, and other costs) and outpatient pharmacy costs. Results: Patient characteristics were similar between RDP (n = 751) and non-RDP (n = 1,304) cohorts, with mean age of 68 years for the total study sample (n = 2,055). Overall, nivolumab was the most common subsequent regimen post Pt; 40% of the total study sample. While duration of subsequent LOTs was shorter for RDP pts (Kaplan-Meier median, 167 v 192 days and log rank test P = 0.03), mean systemic therapy drug costs were similar ($10,516 v $9,642, P = 0.14) during the LOT and PPPM total costs for RDP pts were $4,103 higher than those for non-RDP pts, driven by higher PPPM costs for inpatient stays and ambulatory visits (Table). Conclusions: This study sheds light on the significant economic burden of aNSCLC that rapidly progresses, and may inform management strategies to improve outcomes and lower downstream costs for RDP pts. Future research should continue to explore unmet needs for RDP pts, including underlying cost drivers, to provide context for the rapidly changing aNSCLC treatment landscape.[Table: see text]

Cost of peripheral neuropathy in patients receiving treatment for multiple myeloma: a US administrative claims analysis.

Background:Peripheral neuropathy (PN) is a common consequence of multiple myeloma (MM) among those commonly treated with older-generation proteasome inhibitors (PIs). In this study, we evaluated the economic burden attributable to PN among MM patients in real-world practice settings in the US.Methods:Adults diagnosed with MM and first treated (index event) between 1 July 2006 and 28 February 2017 were identified from MarketScan® Commercial and Medicare claim databases. Continuous enrollment for at least 12 months without treatment and PN diagnoses were required pre-index. Patients were followed for at least 3 months until inpatient death or end of data. The International Classification of Diseases, ninth revision, Clinical Modification (ICD-9-CM) and ICD-10-CM diagnosis codes were used to identify PN. Propensity-score matching was applied to match every patient with PN to two MM patients without a PN diagnosis (controls). Healthcare utilization and expenditures per patient per month (PPPM) in the postindex period were estimated.Results:Of 11,851 patients meeting the study criteria, 15.5% had PN. After matching 1387 patients with PN and 2594 controls were identified. Baseline characteristics were well balanced between cohorts; mean follow up was 23–26 months. PPPM total costs were significantly higher by $1509 for patients with PN than controls, driven by higher hospitalization (PN 77.4%, controls 67.2%; p < 0.001) and emergency department rates (PN 67.8%, controls 58.4%; p < 0.001) and more outpatient hospital-based visits PPPM (PN 13.5 ± 14.7, controls 11.5 ± 18.0; p < 0.001).Conclusions:PN is a prevalent MM treatment complication associated with a significant economic burden adding to the complexity and cost of MM treatment. Highly effective novel treatments such as carfilzomib may reduce the overall disease burden.

Medical Costs by Disease Stage in Medicare Patients with Metastatic Melanoma

Background: Melanoma is a rare but serious skin cancer that is responsible for >90% of skin cancer-related deaths. This retrospective data analysis quantifies the direct cost of medical care by disease stage at diagnosis for patients with metastatic melanoma. Methods: The Surveillance, Epidemiology, and End Results (SEER)-Medicare database was queried for patients diagnosed between 2004-2009 with stage IIIB/C and stage IV (M1a, M1b, M1c) melanoma. The primary outcome was overall medical utilization and associated costs from diagnosis to death, the end of Medicare enrolment, or 12/31/2010. Results are stratified by disease stage at diagnosis and presented as per-patient per-month (PPPM) costs. Results: Of the 1263 patients meeting the study criteria (mean age: 75 years; 64% male, 92% white, mean duration of follow up: 37.5 months), 66.6% were diagnosed at stage IIIB/C and 33.4% at stage IV. Cost of care increased with disease stage. Total PPPM costs ranged from $1966 for patients diagnosed with stage IIIB to $4585 among patients diagnosed with stage M1c. Outpatient costs accounted 48.9% of total medical costs among stage IIIB patients, and 38.7% of total medical costs for stage M1c patients. Inpatient costs accounted for 37.1% (stage M1b) - 40.9% (stage M1c) of total medical costs. Conclusions: Healthcare costs for treating patients with metastatic melanoma increase by disease stage. The cost of care was more than double among patients with late stage compared to those with early stage. Treatments demonstrating ability to prevent disease progression from early stage to late stage may confer an economic benefit among other clinical advantages.

Abstract 301: Healthcare Costs Following Stroke and Major Bleeding Events in Nonvalvular Atrial Fibrillation Patients

Objectives: We sought to determine the impact of stroke and major bleeding excluding intracranial hemorrhage (MB) events on healthcare costs in a real-world nonvalvular atrial fibrillation (NVAF) population. Methods: Healthcare claims data from U.S. commercial and Medicare health plans were used to identify beneficiaries with NVAF during 2008-2012. Patients were classified into cohorts according to event type (No event, Stroke only, MB only, or Stroke plus MB). All-cause total healthcare costs and inpatient costs related to stroke and MB were calculated during 1-year period following the index date (date of initial event or first qualifying AF claim for No event group). Inpatient hospitalizations related to events were identified using ICD-9-CM diagnosis codes. Costs were standardized to 2012 US dollars. Results: Of the 40,654 patients included in the study, 28% had events (8.9% Stroke only, 14.5% MB only, and 4.7% Stroke plus MB). Relative to the No event cohort, all-cause unadjusted per-patient per-month (PPPM) total costs were $4,669 higher for Stroke only and $4,160 for MB only. For Stroke plus MB patients, unadjusted all-cause PPPM total costs were $6,322 higher compared to the No event cohort. Among Stroke only and MB only patients, the economic burden of hospitalizations related to MB (57% of total costs) was similar to Stroke only (63% of total costs). Hospitalizations related to stroke or MB accounted for 65% of total costs for Stroke plus MB. Conclusions: NVAF patients who have a stroke or MB event incur higher healthcare costs relative to patients without events. Interventions preventing stroke or MB events have the potential to reduce the healthcare burden associated NVAF.

Differences In Treatment Patterns and Costs Among Diffuse Large B-Cell Lymphoma Patients Treated In The Clinic Vs. The Hospital Outpatient Setting

BackgroundDiffuse large B-cell lymphoma (DLBCL) is the most common subtype of Non-Hodgkin's Lymphoma (NHL) accounting for approximately 30% of newly diagnosed casesi. DLBCL is an aggressive form of NHL and without treatment, median survival estimates are <1 year.ii Rituximab in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) is recommended first-line therapy for DLBCL patients and has been shown to improve overall survival compared with CHOP alone (previous standard therapy).iii In addition, published evidence suggests that receipt of granulocyte-colony stimulating factor (G-CSF) may improve outcomes among patients who initiate CHOP-based therapy.ivIt is unclear whether differences in treatment and outcomes exist among cancer patients by site where care is delivered. This study examines differences in treatment patterns, health care resource use and costs among DLBCL patients receiving rituximab (R) or R+ chemotherapy in the office/clinic (OC) setting vs. the hospital outpatient (HOSP) setting. MethodsThis retrospective study used medical and pharmacy claims (1/2007 - 7/2012) from a national US commercial health plan to identify patients at least18 years old with ≥2claims for R. Patients were required to have evidence of DLBCL (≥1 claim with ICD-9-CM 200.78 or ≥2 claims with unique diagnosis codes from ICD-9-CM 200.70 to 200.77) and be enrolled in the health plan for ≥6 months before and after the index date (date of the first R claim). The follow-up period, that is, the episode of care (EOC), was the date of the first R infusion through 30 days after the last infusion prior to a gap in R administration of at least 7 months; those with less than 6 months of follow-up due to death were included. Patients with multiple cancers or receipt of R at both the OC and HOSP setting during the EOC were excluded. Differences in number of infusions, receipt G-CSF, healthcare utilization and per-patient per-month (PPPM) health care costs by cohort were examined. ResultsA total of 491 patients were identified, 65% OC (n=320) and 35% HOSP (n=171): by insurance type, 140 Medicare Advantage patients, 39% HOSP and 351 commercially insured patients, 33% HOSP. From 2007 to 2011/2012, the percentage of patients in HOSP increased from 32% to 43%.Descriptive results are shown in the Table. The cohorts had similar mean age, baseline Charlson comorbidity index scores and similar EOC lengths. However, compared to the OC cohort, the HOSP cohort had fewer infusions during the EOC and fewer infusions per month. In addition, fewer HOSP patients had evidence of combination therapy and receipt of any G-CSF during the EOC. HOSP patients also had significantly higher rates of emergency room visits, but not hospitalizations compared to OC patients. Total PPPM costs during the EOC as well as average costs of anti-cancer systemic therapy drugs plus administration costs incurred on days of rituximab infusions were significantly higher among the HOSP cohort compared to the OC cohort. ConclusionsIncreasing proportions of DLBCL patients receive infusions in the HOSP setting. HOSP patients had fewer infusions per month and incurred greater costs on the day of infusion compared to the OC cohort. There were fewer patients in HOSP with evidence of G-CSF during the EOC compared to OC patients. Overall, total PPPM costs were higher among the HOSP cohort compared to the OC cohort. Future research is warranted to assess the impact of these differences on clinical outcomes by site of care.[i] Armitage et al. JCO 1998;16(8):2780-95[ii] Mey et al. Swiss Med Wkly 2012;140:w13511[iii] NCCN Guidelines Version 1.2013 Diffuse Large B-cell Lymphoma[iv] Donnelly, et al, Leuk Lymphoma. 2000;39(1-2):67-75 Disclosures:Reyes:Genentech, inc: Employment, Equity Ownership. Dacosta Byfield:Genentech, Inc: Genentech contracted with OptumInsight to conducting the work described in the abstract. Stacey is employed at Optum but did not receive funds directly from Genentech and employment is not contingent on work with Genentech., Genentech contracted with OptumInsight to conducting the work described in the abstract. Stacey is employed at Optum but did not receive funds directly from Genentech and employment is not contingent on work with Genentech. Other; OptumInsight: Employment. Becker:Genentech, Inc: Genentech contracted with OptumInsight to conducting the work described in the abstract. Laura is employed at Optum but did not receive funds directly from Genentech and employment is not contingent on work with Genentech., Genentech contracted with OptumInsight to conducting the work described in the abstract. Laura is employed at Optum but did not receive funds directly from Genentech and employment is not contingent on work with Genentech. Other; OptumInsight: Employment. Small:Genentech, Inc: Employment, Equity Ownership.

The Cost of Antiretroviral Drug Resistance in HIV-Positive Patients

Antiretroviral (ARV) drug resistance limits treatment choices, often necessitating the selection of drugs with less desirable pill burdens, toxicity profiles, drug interactions and dosing schedules, and may increase cost. We examine the impact of resistance on the cost of HIV care. All adult HIV-positive individuals newly referred for HIV care from 1 January 2007 to 1 January 2011 and followed until 31 December 2011 at the Southern Alberta Clinic, Calgary, AB, Canada, were included. We determined the cost of all ARV drugs, and HIV-related outpatient and inpatient care, reported as mean per patient per month (PPPM) costs in 2011 Canadian dollars (CDN). Overall, 78% of patients received genotypic antiretroviral resistance testing (GART); 57% among ARV-naive patients, 21% after suspected viral failure, and 20% during a treatment interruption. Resistance was detected in 6%, 49% and 21% of all tests respectively. The total mean PPPM cost for patients with GART was CDN 1,179. Patients with primary resistance had mean total PPPM costs of CDN 956. Patients with no resistance had mean PPPM costs of CDN 1,058, by contrast with the CDN 1,291 costs of patients with secondary/acquired resistance. Mean costs for one, two or three ARV class resistance was CDN 1,278, 1,337 and 1,801, respectively. Mean PPPM costs increased by 31% from CDN 1,068 to 1,396, respectively, before and after a positive resistance test. Transmission of resistant virus as well as emergence of resistance during ARV therapy leads to increased costs. Mean costs increased by number of resistant classes. Routine GART and optimizing ARV regimens to avoid resistance might minimize the long-term costs of HIV care.

Are There Differences in Patient Characteristics, Treatment Patterns and Costs by Treatment Setting?

AbstractAbstract 4259 Background:Few studies have examined whether differences in treatment and outcomes exist among cancer patients by the setting where care is delivered. This study investigates differences in treatment patterns, health care resource use and costs among non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) patients receiving rituximab (R) or R+ chemotherapy based on site of care: office/clinic (OC) vs. hospital outpatient (HOSP). Methods:Patients ≥18 years with evidence of NHL or CLL diagnoses codes at least 30 days apart and received ≥2 R claims from Jan 2007 to Mar 2011 were identified from a large US commercial insurance claims database. Patients were required to be enrolled in the health plan for at least 6 months before and after the index date (date of first R claim). The follow-up period was the date of the first infusion to 30 days after the last infusion prior to a gap of ≥7 months. Patients with evidence of multiple cancers or receipt of R at both sites of care were excluded. Cohorts were created based on site of care where R was administered and type of insurance, commercial (COM) vs. Medicare Advantage (MA). Descriptive analyses were conducted to examine differences in treatment patterns and per-patient per-month (PPPM) health care costs. Multivariate analyses adjusting for age, gender, baseline Charlson index score and receipt of monotherapy was also conducted to examine differences in PPPM health care costs. Results:A total of 2,594 OC and 286 HOSP patients were identified. A higher percentage of Medicare Advantage patients (27% of 878 patients, n=236) received Rituxan therapy in the HOSP setting compared to commercially insured patients (2% of 2002 patients, n=50).Among the Medicare Advantage patients, age, gender, and baseline Charlson comorbidity index were not significantly different by cohort. The mean length of the episode of care was not significantly different by site of service but the number of Rituxan infusions (5.4 vs. 6.8, p<0.01) and infusions/mth (0.99 vs. 1.27, p<0.01) were significantly less in the HOSP compared to the OC. Incidence rates of ER visits (0.11 vs. 0.08, p=0.02), but not hospitalizations were higher among the HOSP cohort. Unadjusted infusion day costs were higher among the HOSP compared to the OC ($6,479 vs. $4,998, p<0.01) but total PPPM costs were not significantly different by cohort ($9,323 vs. $10,051, p>0.05). In multivariate analyses, total PPPM costs were slightly less among the HOSP cohort (cost ratio=0.92, p<0.01).Among the commercially insured population, gender and baseline Charlson comorbidity index were not significantly different by cohort though patients in the HOSP were slightly younger than those in the OC (55 years vs. 59 years). The mean length of the episode of care was not significantly different by site of service but compared to the OC the number of Rituxan infusions (5.52 vs. 7.56, p<0.01) and infusions per month (1.05 vs. 1.17, p>0.05) were less in the HOSP though the difference in infusions/month was not significant. Incidence rates of ER visits and hospitalizations were also not significantly different. Unadjusted infusion day costs were higher among the HOSP cohort compared to the OC cohort ($10,939 vs. $5,464, p<0.01) as well as total PPPM costs ($17,230 vs. $11,549, p=0.01). In multivariate analyses, total PPPM costs remained significantly higher among the HOSP cohort (cost ratio=1.40, p<0.01). Conclusions:A lower percentage of COM patients receive Rituxan infusions in the HOSP setting compared to MA patients. However, regardless of insurance type, patients in the HOSP cohort incurred greater costs on the day of Rituxan infusion compared to the OC cohort. Among MA patients, although costs incurred on the day of infusions were significantly higher in the HOSP cohort, patients treated in the HOSP setting had slightly lower total PPPM costs likely due to fewer administrations per month of Rituxan during an episode of care. Among COM patients, higher infusion day costs contributed to higher total overall costs among the HOSP cohort. These results warrant further investigation to assess the impact of these differences on clinical outcomes by site of care. Disclosures:Dacosta Byfield:OptumInsight: Employment, OptumInsight received payment from Genentech to conduct the study described in the abstract Other. Reyes:Genentech, Inc.: Employment, Roche Stock Other. Becker:OptumInsight: Employment, OptumInsight received payment from Genentech to conduct the study described in the abstract Other. Small:Genentech, Inc: Employment, Roche stock Other.

Cost and patterns of care among patients with advanced non-melanoma skin cancer.

e16517 Background: Few studies examine health care utilization (HCU) and cost among basal cell carcinoma (BCC) patients. Although BCC has no specific ICD-9 code, it is known to constitute ~80% of all non-melanoma skin cancers (NMSC). More than 1 million new cases of NMSC were reported in the US in 2010, and there were ~1000 deaths due to NMSC. Methods: A claims-based analysis was conducted using data from January 2002 to March 2010 from a national commercial health insurer. Patients with ≥ 2 claims with a NMSC diagnosis (ICD-9-CM 173.xx) at least 60 days apart, or at least 1 claim for a skin cancer-specific excision with diagnosis code 173.xx were identified. Those with additional primary cancers were excluded. Patients were grouped into 1 of 3 cohorts: metastatic, locally advanced (LA), or “all other.” Metastatic patients had ≥ 2 claims with a metastasis code (ICD-9-CM 196.xx-198.xx) at least 30 days apart. LA patients had ≥ 2 visits with a medical oncologist, ≥ 1 diagnostic imaging service, ≥2 services for radiation therapy or ≥1 visit to 2 or more physician specialties. The remaining patients were “all other.” The time of first NMSC or metastatic disease diagnosis was considered the index date. Total HCU and average per-patient per-month (PPPM) costs during follow-up were estimated. Results: Among 188,795 patients, 155 (0.1%), 2,412 (1.3%) and 186,228 (98.6%) patients, were identified as metastatic, LA or “all other,” respectively with an overall mean follow-up of 917 days. Compared to “all others,” metastatic and LA patients were significantly older and had a higher baseline Charlson comorbidity index (0.64 vs. 2.08 and 1.46 respectively, p-value <0.01). Compared to “all others” and LA patients, more metastatic patients had inpatient stays (19% and 30% vs. 48% respectively, p-value <0.01) and emergency room visits (37% and 43% vs. 55% respectively, p-value <0.01). In addition, total PPPM costs for LA and metastatic patients were ~2x or ~3x higher, respectively, than costs for “all others (p-value <0.01). Conclusions: HCU and cost for NMSC (which includes ~80% BCC) increases significantly as disease advances. Effective treatment could reduce this burden.

Assessing the economic burden of breast cancer in a US managed care population

Breast cancer is the most commonly diagnosed non-skin cancer and second leading cause of cancer deaths among women in the US. This study compared healthcare resource utilization and costs in women with breast cancer to a control group in a managed care population. Women >or= 18 years with breast cancer were identified using ICD-9 codes from claims databases of five US health plans during 2004. A randomly matched control group of women without cancer served as a comparator group. Healthcare costs included all medical and pharmacy costs during the year. Comparisons were made using per patient per month (PPPM) costs (total costs per patient within 2004 calendar year/months of eligibility). 10,697 women (mean age 55 years) with breast cancer were identified (prevalence of 250 per 100,000) in 2004, with prevalence increasing with age. Mean attributable PPPM costs associated with breast cancer were $2,896 (median = $1,940) with hospitalization contributing most of the costs ($1,340), followed by pharmacotherapy ($537), and surgical intervention ($470). Mean unadjusted all-cause PPPM total costs were $4,421 (median = $2,964) compared to $3,352 (median = $665) p < 0.0001) for cases and controls respectively. Multivariate analyses controlling for differences in comorbidities showed mean adjusted PPPM costs to be 2.28 times (p < 0.0001) higher than non-breast cancer controls. This study demonstrated that breast cancer treatment was associated with substantial healthcare costs, driven mainly by hospitalizations. Projected annual costs for a breast cancer patient would be at least $12,828 higher than that for women without breast cancer based upon unadjusted cost differences.