Real-World Analysis of Treatment Patterns, Healthcare Utilization, Costs, and Mortality Among People with Biliary Tract Cancers in the USA.

INTRODUCTION: People with advanced biliary tract cancers (BTCs) have a 5-year survival of approximately 2% in the USA. Most cases are inoperable or require systemic treatment following surgery. This study adds to current literature by describing treatment patterns, healthcare resource utilization (HCRU), costs, and mortality among people with BTCs. METHODS: Adults diagnosed with BTCs were identified in the Merative MarketScan administrative claims databases from 1 January 2016 to 30 June 2020. Descriptive analysis was used to measure treatment patterns (i.e., regimen types, therapy duration) during three lines of therapy (LOT). All-cause and disease-related HCRU and costs were measured per-patient-per-month (PPPM) during the entire follow-up and in each LOT. Mortality was reported among the subset linked to the National Death Index (NDI). RESULTS: There were 2648 eligible people with BTCs [mean age 64.0 (standard deviation [SD] 12.4) years, 51.5% female, average follow-up 11.9 (SD 11.1) months]. Treatment was received by 56.3% (n = 1490), and 20.9% (n = 5534) and 7.1% (n = 187) moved on to a second and third LOT, respectively. The average treatment duration decreased across LOTs, from 3.8 (SD 3.1) months in LOT1 to 2.6 (SD 2.4) months in LOT3. Gemcitabine + cisplatin was the most common regimen in LOT1 (44.6%). Total all-cause mean healthcare costs PPPM increased after LOT1 (mean $21,517, $29,721, and $28,557, for LOT1, LOT2, and LOT3, respectively) and the majority (71.2%) were related to BTCs. Of people with BTCs linked to the NDI (n = 2168), 66.1% died and average time to death was 11.3 (SD 11.2) months. CONCLUSIONS: These findings, showing a high rate of mortality, a decrease in treatment duration, and an increase in costs as people progress after LOT1, add recent data to current literature highlighting the unmet need for more effective treatment options for people with BTCs.

Treatment patterns and direct medical costs among patients with advanced hepatocellular carcinoma.

AIMS: This study assessed the real-world United States (US) treatment patterns and the associated economic burden in patients diagnosed with advanced hepatocellular carcinoma (HCC). METHODS: The MarketScan database was used to identify patients newly diagnosed with HCC who received systemic therapy between 2011 and 2018 and continuously enrolled for ≥6 months (baseline period) prior and ≥1 month following HCC diagnosis. Treatment patterns (systemic and locoregional therapy), healthcare resource utilization, and costs were reported during follow-up. RESULTS: The final sample included 1580 patients (median age, 61; 78% male; median follow up, 8.7 months). The most common first line of therapy (LOT) was sorafenib (78%). The median time from HCC diagnosis to start of sorafenib was 43 days, and the median duration of sorafenib therapy was 60 days. Only 17% of patients received second LOT, and non-sorafenib treatment use increased to 66% (mostly chemotherapy combination). Transarterial chemoembolization was the most commonly observed locoregional therapy prior to the first LOT. The multivariable-adjusted average all-cause total cost among sorafenib treated patients was $17,642 (95% CI: $16,711-$18,558) per-patient per-month), of which $11,393 were HCC-specific. CONCLUSIONS: In patients who received first-line therapy for HCC, the duration of therapy was short (potentially due to progression or tolerability). Most patients did not continue to second-line therapy. Despite the short duration of therapy, HCC patients still incur a high economic burden, and there is a need for more effective and tolerable treatments.

The economic burden of metastatic pancreatic cancer.

BACKGROUND: Objectives: Pancreatic cancer (PC) is a costly disease with a limited life-expectancy as it generally presents as an advanced, metastatic disease. Though current literature suggests cost varies by first line treatment, there is limited real-world knowledge about the economic burden of pancreatic cancer. This study describes the economic burden of pancreatic cancer patients overall and by observed first line treatments. METHODS: The IBM MarketScan databases were used to identify adult metastatic PC patients from January 1, 2010 through 3/31/2017. Those without other primary cancers, pregnancy, or prior PC treatment, and with 6 months of continuous enrollment prior to PC were included. Treatment patterns and healthcare utilization and expenditures were measured during the variable-length follow-up period. Continuous measures were presented as per patient per month (PPPM). RESULTS: A total of 6,360 patients met all inclusion criteria. Almost half (46.8%) of patients were untreated. Gemcitabine alone (15.6%) and FOLFIRINOX (11.4%) were the most commonly observed first line regimens. Treated patients incurred $17,513 PPPM (Gemcitabine alone) to $27,889 PPPM (FOLFIRINOX) during follow-up. Untreated patients incurred the highest unadjusted ($30,777 PPPM) and adjusted ($20,392 PPPM) cost. CONCLUSIONS: Metastatic PC patients incur a high economic burden driven by high utilization of healthcare resources, which varies by first line treatment. Also, the high proportion of untreated patients is alarming as these patients may be the most expensive of all patients. There is an unmet need in these patients for effective treatments that also reduce their economic burden.

Cost of cystectomy-related complications in patients with bladder cancer in the United States.

Aims: To describe healthcare utilization and cost associated with the short-term and long-term complications of cystectomy among commercially insured bladder cancer patients in the United States.Materials and methods: This retrospective, observational cohort study evaluated adults with bladder cancer receiving a transurethral resection of bladder tumor followed by a partial or radical cystectomy procedure using U.S. administrative claims from the 2005-2015 IBM MarketScan Commercial and Medicare Supplemental databases. Bladder cancer patients were classified into two cohorts: partial cystectomy or radical cystectomy. Cystectomy complications were identified during the cystectomy admission, short-term period, and long-term period. Complication-related utilization and cost outcomes were reported in aggregate during the cystectomy admission and per patient per month (PPPM) during the short-term and long-term follow-up periods.Results: Of 5136 patients who received a cystectomy, 488 (9.5%) received partial cystectomy and 4648 (90.5%) received radical cystectomy. The mean (SD) costs of complications during the cystectomy admission were $11,728 ($43,380) for radical cystectomy and $4657 ($25,668) for partial cystectomy. In the short-term period, PPPM complication-related healthcare costs were $638 [$3793] for partial cystectomy and $2681 [$14,705] for radical cystectomy. In the long-term period, PPPM complication-related healthcare costs were $544 [$2580] for partial cystectomy and $1619 [$7874] for radical cystectomy.Conclusions: Cystectomy-related complications, especially with radical cystectomy, present a substantial financial burden to patients and payers immediately after surgery as well as in the long term. Targeted interventions which improve clinical outcomes but reduce substantial costs associated with cystectomy for bladder cancer are needed.

Real-World Injection Frequency and Cost of Ranibizumab and Aflibercept for the Treatment of Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

BACKGROUND: Ranibizumab and aflibercept are FDA-approved treatments for patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Although these agents differ in cost and labeled dosing, it is unclear whether these differences are reflected in clinical practice. OBJECTIVE: To compare the real-world frequency and cost of ranibizumab and aflibercept injections among treatment-naive and previously treated patients with nAMD and DME. METHODS: Claims data from MarketScan Research Databases were retrospectively reviewed to identify treatment-naive patients with nAMD who initiated intravitreal ranibizumab or aflibercept between January 1, 2014, and January 1, 2016, and treatment-naive patients with DME who initiated intravitreal ranibizumab or aflibercept between July 29, 2014, and July 1, 2016. Patients who switched to subsequent-line aflibercept or ranibizumab during the study period were eligible to enter previously treated subgroups. Multivariable regression models were derived to compare the per-patient frequency and cost of injections between ranibizumab- and aflibercept-treated patients with nAMD over 12 months (treatment-naive: n = 1,087 and n = 1,578; previously treated: n = 221 and n = 751) and 24 months (treatment-naive: n = 454 and n = 568; previously treated: n = 93 and n = 284) and in patients with DME over 6 months (treatment-naive: n = 507 and n = 681; previously treated: n = 53 and n = 223) and 12 months (treatment-naive: n = 326 and n = 382; previously treated: n = 24 and n = 122). RESULTS: After adjusting for patient demographics and clinical characteristics, per-patient injection frequency and cost were not significantly different between treatment-naive patients with nAMD who received ranibizumab versus aflibercept over 12 months (5.62 vs. 5.54; P = 0.52, and $11,351 vs. $10,702; P = 0.06, respectively) and 24 months (7.86 vs. 8.37; P = 0.16, and $16,286 vs. $16,666; P = 0.69, respectively). In previously treated patients with nAMD, injection frequency was significantly lower among ranibizumab- versus aflibercept-treated patients over 24 months (7.98 vs. 9.63; P = 0.03), whereas treatment costs were comparable over 12 months ($11,512 vs. $12,050; P = 0.44) and 24 months ($16,303 vs. $19,361; P = 0.13). In treatment-naive patients with DME, ranibizumab was associated with significantly fewer injections and lower costs than aflibercept over 6 months (2.60 vs. 2.92 and $3,379 vs. $5,925, respectively; both P < 0.001) and 12 months (3.33 vs. 3.87 and $4,136 vs. $7,656, respectively; both P < 0.001). Similar cost savings were observed among previously treated patients with DME who received ranibizumab over 6 months ($3,834 vs. $6,775 for aflibercept; P = 0.0001) and 12 months ($4,606 vs. $9,190; P = 0.02), despite nonsignificant differences in injection frequency during follow-up. CONCLUSIONS: Although the frequency and cost of ranibizumab and aflibercept injections were generally comparable among patients treated for nAMD, ranibizumab was associated with estimated per-patient-per-year cost savings of $3,500-$4,500 in those treated for DME. Most patients received fewer injections than any FDA-indicated dosing schedule, suggesting potential undertreatment that may result in suboptimal vision outcomes. DISCLOSURES: Study funding was provided by Genentech, a member of the Roche Group. The sponsor participated in the design of the study; collection, analysis, and interpretation of the data; preparation of the manuscript; and the decision to submit the article for publication. Kiss has been a consultant for and received honoraria from Alcon, Alimera, Allergan, BioMarin, Novartis, and Spark; has been on the advisory board for, a consultant for, received honoraria from, and held stock options in Adverum and Regenxbio; has been a consultant for, received honoraria from, and held stock/stock options in Fortress; has been on the advisory board for, a consultant and investigator for, and received grants and honoraria from Genentech and Regeneron; and has been on the advisory board for, a consultant for, and received grants and honoraria from Optos. Malangone-Monaco, Wilson, Varker, Stetsovsky, and Smith are employees of IBM Watson Health, which received funding from Genentech to undertake this study. Garmo is an employee of Genentech. Data reported in this manuscript were presented in part at the Academy of Managed Care Pharmacy (AMCP) Managed Care and Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Comparative analysis of US real-world dosing patterns and direct infusion-related costs for matched cohorts of rheumatoid arthritis patients treated with infliximab or intravenous golimumab.

PURPOSE: The objectives of this study were to evaluate and compare treatment patterns and infusion-related health care resource expenditures for rheumatoid arthritis (RA) patients initiating golimumab for intravenous use (GLM-IV) and infliximab (IFX) therapy and to assess cost implications from the commercial perspective. METHODS: Adult RA patients with a new episode of GLM-IV or IFX treatment between Janu-ary 1, 2014 and March 31, 2016 were identified from MarketScan databases and evaluated for maintenance infusion intervals and related costs of treatment. IFX and GLM-IV patients were matched 1:1 on index medication treatment duration, gender, payer type, prior biologic use, and post-index methotrexate use. Paid amounts for drugs and associated administration costs were applied to treatment group dosing patterns. RESULTS: Final matched treatment groups included 547 GLM-IV and 547 IFX patients (mean age = 55-56 years). Mean (SD) follow-up was 609 (161) days for GLM-IV and 613 (163) days for IFX. Treatment duration was 396 (240) days for GLM-IV and 397 (239) days for IFX. Overall, 80% of GLM-IV and 39% of IFX maintenance infusions were given approximately every 8 weeks; and 6% of GLM-IV and 53% of IFX maintenance infusions occurred more frequently than every 8 weeks (P<0.001). When weighting of the maintenance infusion interval was applied, the mean number of induction plus maintenance infusions during the first year of treatment was estimated at 7.03 for GLM-IV and 9.48 for IFX. From the commercial perspective, drug plus administration costs per infusion were $5,846 for GLM-IV and $5,444 for IFX with total annual cost of therapy for GLM-IV patients costing $10,507 less than that for IFX patients in the first year and $6,774 less than that for IFX patients in subsequent years. CONCLUSION: Annual GLM-IV drug plus administration costs for commercial health plans were significantly less than IFX in RA patients due to differences in real-world dosing and administration.

Association of Bariatric Surgery and National Medication Use.

BACKGROUND: Bariatric surgical procedures are an effective and enduring treatment for severe obesity. In addition to improvements in health status, bariatric operations have been noted to potentially decrease postoperative healthcare costs, particularly medication use. STUDY DESIGN: We performed a longitudinal analysis of 2007-2012 claims data comparing a bariatric surgical cohort with a propensity-matched nonsurgical control group during a 5-year time period. Truven Health Analytics MarketScan Commercial Claims and Encounters Database, with a total enrollment of 56 million covered lives from all insurers and representing all 50 states, was used. An initial sample of 384,343 obese patients was identified, with a total of 5,978 matched 1:1 pairs of obese bariatric surgical patients and nonsurgical control patients designated after matching and propensity score matching procedure. Two thousand seven hundred of those matched pairs had at least 4 years of follow-up after index date. RESULTS: The matched cohorts included 2,700 patients (77.2% female, mean age 47.1 years). During the 4-year follow-up period, bariatric surgical patients had 22.6% lower pharmacy costs compared with nonsurgical control patients (p < 0.001). Mean total pharmacy costs showed a sustained decrease in the surgical group compared with the matched control group ($8,411 vs $9,900; p < 0.001). Medication use in the surgical group declined significantly from 1 year preoperative to 4 years postoperative in contrast to the control group. In the 4-year postoperative period, the numbers of antidiabetic, antihypertensive, and cardiac prescriptions in the surgical patients were reduced by 73.7%, 48.3%, and 48.9%, respectively, compared with the control patients. CONCLUSIONS: Total pharmacy use and costs showed a significant and sustained reduction during a 4-year follow-up period among patients undergoing gastric bypass or band operations in comparison with a propensity-matched control group.

Age-appropriate compliance and completion of up to five doses of pertussis vaccine in US children.

Background: In the United States (US), diphtheria, tetanus, and acellular pertussis (DTaP) vaccination is recommended at 2, 4, and 6 months (doses 1-3), 15-18 months (dose 4), and 4-6 years (dose 5). The objective of this study (GSK study identifier: HO-14-14383) was to examine DTaP completion and compliance rates among commercially insured and Medicaid-enrolled children. Secondarily, the study aimed at identifying predictors of compliance/completion. Methods: Truven Health MarketScan Commercial and Multi-State Medicaid databases (2005-2013) were analyzed separately. Children born during 2005-2011 with ≥ 2 years continuous enrollment from birth provided data for doses 1-4; those with continuous enrollment from birth to their seventh birthday provided dose 5 data. Series compliance (each recommended dose by 3, 5, and 7 months; 19 months; seventh birthday) and completion (3 doses by 8 months; 4 by 24 months; 5 by seventh birthday) were calculated. Predictors of compliance/completion were identified using multivariable logistic regression. Results: A total of 367,493 commercially insured and 766,153 Medicaid-enrolled children were followed for ≥ 2 years; and 23,574 and 41,284, respectively, for ≥ 7 years. Series compliance to doses 1-3, 1-4, and 1-5 were 67.2%, 55.3%, 47.5% (commercial) and 37.4%, 27.3%, 14.4% (Medicaid), respectively. Predictors of better compliance/completion included: later birth year (commercial/Medicaid) and higher household income (commercial); predictors of worse compliance/completion included: Northeast residence (commercial), birth hospitalization ≥ 14 days (commercial/Medicaid), and Black race/ethnicity (Medicaid). Conclusions: DTaP series compliance/completion improved over time, but appear to be suboptimal. As this could increase pertussis risk, greater awareness of the importance of timely vaccination completion is needed. GSK study identifier: HO-14-14383.

Statin Utilization Patterns and Outcomes for Patients with Acute Coronary Syndrome During and Following Inpatient Admissions.

PURPOSE: High-intensity statins (HIS) are recommended by current treatment guidelines for patients with clinical atherosclerotic cardiovascular disease and should be administered soon after an acute coronary syndrome (ACS) event and maintained thereafter. However, adherence to guidelines remains adequate. Statin utilization patterns during index hospitalization and the first year after ACS event, and the association between statin utilization and post-discharge clinical and economic outcomes, are described. METHODS: Retrospective, observational study of US adults from the MarketScan Research Databases (2002-2014) with ≥ 1 inpatient admission for ACS and no evidence of previous ACS event < 12 months prior to index. RESULTS: In total, 7802 patients met inclusion criteria. The most common index hospitalization primary diagnosis was myocardial infarction (94.6%). In the 3-month period before ACS admission, 3.4 and 14.9% of patients received HIS or low-to-moderate intensity statin, versus 13.2 and 30.7% during index hospitalization, and 16.4 and 45.1% in the year of follow-up. Of 1336 patients with a statin prescription filled on/after discharge, 53.2% filled prescriptions within 15 days of discharge and 14.9% delayed for > 91 days. The most common post-index hospital admissions for cardiovascular events were due to recurrent ACS (incidence rate = 115.2), heart failure (110.0), and revascularization (76.4). During follow-up, 2355 patients (30.2%) had all-cause inpatient admissions and 1136 (14.6%) had cardiovascular-specific admissions; mean all-cause medical and healthcare costs were $2456 and $2870, respectively, per patient per month. CONCLUSIONS: Statin dosing and utilization of HIS remains lower than recommended in current treatment guidelines, leaving patients at considerable risk of subsequent cardiovascular events.

LDL cholesterol levels after switch from atorvastatin to rosuvastatin.

OBJECTIVE: Initial statin therapy may not always adequately reduce elevated low-density lipoprotein cholesterol (LDL-C) levels. Although alternative therapies are available, switching to another statin may be beneficial, especially for those at highest risk of cardiovascular disease and events. This study examined changes in LDL-C levels following a switch from 40/80 mg of atorvastatin (ATV) to 20/40 mg of rosuvastatin (RSV). METHODS: This retrospective cohort study used data from the MarketScan administrative claims databases linked to laboratory values. Patients with or at risk for atherosclerotic cardiovascular disease (ASCVD) who switched from ATV 40/80 mg to RSV 20/40 mg and had LDL-C values measured within 90 days before and 30-180 days after the switch were included. The change in LDL-C was quantified for each patient and summarized across all patients and within each switch pattern (e.g. ATV40 to RSV20). RESULTS: There was a significant mean (SD) decrease in LDL-C of 21% (30%) across the whole sample (N = 136) after switching from ATV to RSV. The greatest decrease occurred in patients who switched from ATV40 to RSV40 (N = 20; -29% [19%]; p < .001). Similar changes were observed overall and within each switch pattern when the analysis was limited to patients who were persistent on RSV in the post-switch period (N = 112; -24% [24%]; p < .001). CONCLUSIONS: Switching from ATV to RSV was associated with a significant decrease in LDL-C among high-risk patients. Switching between these two high-intensity statins may offer a viable alternative to other treatment modifications aimed at lowering LDL-C in this population.

Real-world Direct Health Care Costs for Metastatic Colorectal Cancer Patients Treated With Cetuximab or Bevacizumab-containing Regimens in First-line or First-line Through Second-line Therapy.

BACKGROUND: The present study examined real-world direct health care costs for metastatic colorectal cancer (mCRC) patients initiating first-line (1L) bevacizumab (BEV)- or cetuximab (CET)-containing regimen in 1L or 1L-through-second-line (1L-2L) therapy. PATIENTS AND METHODS: Using a large US insurance claims database, patients with mCRC initiating 1L BEV- or 1L CET-containing regimen from January 1, 2008 to September 30, 2014 were identified. The per-patient per-month (PPPM) all-cause health care costs (2014 US dollars) were measured during 1L therapy and, for patients continuing to a 2L biologic-containing regimen, 1L-2L therapy. Multivariable regression analyses were used to compare PPPM total health care costs between patients initiating a 1L BEV- versus 1L CET-containing regimen. RESULTS: A total of 6095 patients initiating a 1L BEV- and 453 initiating a 1L CET-containing regimen were evaluated for 1L costs; 2218 patients initiating a 1L BEV- and 134 initiating a 1L CET-containing regimen were evaluated for 1L-2L costs. In 1L therapy, 1L CET had adjusted PPPM costs that were $3135 (95% confidence interval [CI], $1174-$5040; P < .001) greater on average than 1L BEV. In 1L-2L therapy, 1L BEV-2L CET had adjusted PPPM costs that were $1402 (95% CI, $1365-$1442; P = .010) greater than those for 1L BEV-2L BEV, and 1L CET-2L BEV had adjusted PPPM costs that were $4279 (95% CI, $4167-$4400; P = .001) greater on average than those for 1L BEV-2L BEV. The adjusted PPPM cost differences for 1L BEV-2L other biologic or 1L CET-2L other biologic agent were numerically greater but statistically insignificant. CONCLUSION: PPPM total health care costs for 1L and 2L therapy tended to be greater for patients treated with 1L CET-containing regimens than for 1L BEV-containing regimens. Also, continuing treatment with BEV-containing regimens 1L-2L was less costly than switching between BEV and CET. The cost differences between BEV and CET hold important implications for treatment decisions of mCRC patients in real-world clinical practice.

Costs and Work Loss Burden of Diagnosed Opioid Abuse Among Employees on Workers Compensation or Short-term Disability.

OBJECTIVE: To compare 12-month healthcare costs between employees with versus without diagnosed opioid abuse within 12 months after an injury-related workers' compensation (WC) or short-term disability (STD) claim. METHODS: Retrospective study using 2003 to 2014 US insurance claims linked to administrative data on WC/STD claims. Multivariable models compared healthcare costs between employees with versus without diagnosed opioid abuse. RESULTS: Study included 107,975 opioid-treated employees with an injury-related WC or STD claim. Mean number of opioid prescription fills and adjusted total healthcare costs were substantially greater in employees with diagnosed opioid abuse versus without (WC: 13.4 vs. 4.5, P < 0.001; $18,073 vs. $8470, P < 0.001; STD: 13.7 vs. 4.5, P < 0.001; $25,693 vs. $14,939, P < 0.001). CONCLUSION: Opioids are commonly prescribed to employees with injury-related WC/STD claims. Employers may benefit from proactively addressing the issue of opioid abuse in these populations.

Prescribing Patterns of Oral Antineoplastic Therapies Observed in the Treatment of Patients With Advanced Prostate Cancer Between 2012 and 2014: Results of an Oncology EMR Analysis.

PURPOSE: The purpose of this study was to examine, using a US electronic medical records (EMR) database, the clinical characteristics and real-world treatment sequences in men with advanced prostate cancer who initiated treatment with abiraterone acetate or enzalutamide. METHODS: This retrospective, observational study evaluated adult male patients with a diagnosis of prostate cancer (International Classification of Diseases, Ninth Revision, Clinical Modification code 185) in the EMR database between July 1, 2011, and March 31, 2014, who had initiated first-line treatment with abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014. The first record for a patient initiating abiraterone acetate or enzalutamide was the index date. Patients had 6 months of pre-index medical record history and a variable length follow-up period, extending from the index date to the end of medical record data availability or date of the end of the study (March 31, 2014). The sequence of first- and second-line therapies for advanced prostate cancer therapy was reported. FINDINGS: A total of 809 patients met study inclusion and exclusion criteria. This study found that the majority of patients who initiated treatment with either abiraterone acetate or enzalutamide between September 1, 2012, and March 31, 2014, received a single line of therapy (72%); abiraterone acetate was the most common first-line treatment (74% of first-line patients). A subset of patients treated first-line with either abiraterone acetate or enzalutamide were transitioned to an oral second-line agent (17% of first-line abiraterone acetate-treated patients transitioned to second-line enzalutamide, and 16% of first-line enzalutamide-treated patients transitioned to second-line abiraterone acetate). Chemotherapy with docetaxel was also a commonly observed second-line treatment selection, occurring in 8% of first-line abiraterone acetate-treated patients and in 7% of first-line enzalutamide-treated patients. IMPLICATIONS: This EMR study is among the first to present evidence of US physician practice prescribing patterns regarding initiation of oral antineoplastic agents and use of subsequent therapies in patients with advanced prostate cancer.