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.

Costs of colorectal cancer screening with colonoscopy, including post-endoscopy events, among adults with Medicaid insurance.

OBJECTIVE: To examine the healthcare utilization and costs associated with colorectal cancer (CRC) screening by colonoscopy, including costs associated with post-endoscopy events, among average-risk adults covered by Medicaid insurance. METHODS: This cohort study evaluated a population of adults (ages 50-75 years) with CRC screening between 1/1/2014 and 12/31/2018 (index = earliest test) from the IBM MarketScan Multi-State Medicaid database. Individuals at above-average risk for CRC or with prior CRC screening were excluded. CRC screening was reported by screening type: colonoscopy, fecal immunochemical test [FIT], fecal occult blood test [FOBT], multi-target stool DNA [mt-sDNA]. Frequency and costs of events potentially related to colonoscopy (defined as occurring within 30 days post-endoscopy) were reported overall, by event type, and by individual event. RESULTS: We identified a total of 13,134 average-risk adults covered by Medicaid insurance who received screening by colonoscopy; 63.6% (8350) had Medicare dual-eligibility while 36.4% (4785) did not have Medicare dual-eligibility. The mean (SD) cost of a colonoscopy procedure was $684 ($907) and mean (SD) out-of-pocket costs were $6 ($132). Serious gastrointestinal (GI) events (perforation and bleeding) were observed in 4.6% of individuals with colonoscopy, 4.3% had other GI events, and 3.0% had an incident cardiovascular/cerebrovascular event. Mean (SD) event-related costs were $1233 ($5784) among individuals with a serious GI event, $747 ($1961) among individuals with other GI events, and $4398 ($19,369) among individuals with a cardiovascular/cerebrovascular event. CONCLUSIONS: This large, claims-based cohort study reports average (SD) out-of-pocket costs for Medicaid beneficiaries at $6 ($132), which could be one factor contributing to the accessibility of CRC screening by colonoscopy. The incidence of events potentially associated with colonoscopy (i.e. within 30 days after the screening) was 3-4%, and the event-related costs were considerable.

Treatment patterns and health care costs among patients with psoriatic arthritis treated with biologic or targeted synthetic disease-modifying antirheumatic drugs.

BACKGROUND: Biologic and targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies are used in management of psoriatic arthritis (PsA). Although previous studies have demonstrated that rates of adherence, persistence, discontinuation, and switching, as well as health care costs, are variable among treatments, limited published data exist on more recently approved therapies. OBJECTIVE: To describe adherence, persistence, discontinuation, reinitiation, switching, dosing patterns, and health care costs among PsA patients treated with biologics and tsDMARDs. METHODS: This was a real-world, retrospective administrative claims study. Adult PsA patients with at least 1 claim for an approved PsA biologic (adalimumab, certolizumab, etanercept, golimumab, infliximab, secukinumab, or ustekinumab) or tsDMARD (apremilast or tofacitinib) between January 1, 2015, and June 30, 2019, were selected from the IBM MarketScan administrative claims databases. The first claim for one of the study treatments determined the index date and drug cohort. Patients were required to be continuously enrolled in their health plans for 12 months before and after the index date and to have at least 1 claim with a diagnosis of PsA in the 12 months before or on the index date. Adherence (measured by proportion of days covered [PDC] and medication possession ratio [MPR]), persistence (< 60-day gap in treatment), discontinuation (> 90-day gap), reinitiation of index drug, switching, and dosing patterns for each index drug were assessed during the 12-month follow-up period. Health care costs were reported per patient per month (PPPM) during the 12-month follow-up and assessed after adjusting PsA treatment costs by the Institute for Clinical and Economic Review discount factors to account for discounts and rebates not usually reflected in claims data and by adherence. RESULTS: Overall, 6,674 patients met the selection criteria. The top 3 index drugs were adalimumab (37%), apremilast (26%), and etanercept (18%). Over 12 months of follow-up, 31%-59% of patients remained persistent on the index drug, whereas 35%-56% discontinued, 13%-29% switched to a different biologic or tsDMARD, and 3%-15% reinitiated the index therapy, depending on the index drug. The mean PDC ranged from 0.51 to 0.69 during the 12-month follow-up and 0.80 to 0.93 during the follow-up period before discontinuation. Dose values were largely consistent with prescribing information, with the exception of secukinumab. Index drug costs PPPM ranged from $2,361 (apremilast) to $6,528 for ustekinumab after adjustment for discounts and adherence. CONCLUSIONS: Results from this real-world analysis suggest that there is substantial variability in persistence, discontinuation, adherence, reinitiating, and switching patterns among the different biologic and tsDMARD treatment options for PsA patients. In addition, this study provides real-world cost data for biologics and tsDMARDs among patients with PsA. DISCLOSURES: This study was funded by Eli Lilly Inc., which participated in analysis and interpretation of data, drafting, reviewing, and approving the publication. All authors contributed to the development of the publication and maintained control over the final content. Murage, Malatestinic, Zhu, Atiya, Kern, Stenger, and Sprabery are employees and stockholders of Eli Lilly Inc. Princic and Park are employed by IBM Watson Health, which received funding from Eli Lilly Inc. to conduct this study. Ogdie has received consulting fees from Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Novartis, and Pfizer and has also received grant support from Pfizer, Novartis, and Amgen. Portions of these data have been presented in poster form at the virtual International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2020 and Congress of Clinical Rheumatology (CCR) West 2020 conferences.

Adherence to fecal immunochemical test screening among adults at average risk for colorectal cancer.

PURPOSE: This study examined adherence to screening for fecal immunochemical test (FIT). METHODS: Adults (≥ 50-75) with a FIT between 1/1/2014 and 6/30/2019 in MarketScan administrative claims were selected (index = earliest FIT). Patients were followed for 10 years pre- and 3 years post-index. Patients at increased risk for CRC or with prior screening were excluded. Year over year adherence was measured post-index. RESULTS: Of 10,253 patients, the proportion adherent to repeat testing at year 2 was 23.4% and 10.6% at year 3. Of 76.6% not adherent in year 2, 5.4% were adherent in year 3. CONCLUSION: Results suggest adherence to FIT tests is poor, minimizing potential benefits. Future studies are needed to consider alternative test options and whether more choice will improve long-term adherence.

Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States.

OBJECTIVE: To examine the healthcare costs associated with colorectal cancer (CRC) screening and the frequency and costs of events potentially related to colonoscopy among average-risk adults. METHODS: In this cohort study, adults (ages 50-75 years) with CRC screening between 1/1/2014 and 6/30/2019 (index = earliest test) were selected from the IBM MarketScan Research databases. Individuals at above-average risk for CRC or with prior CRC screening were excluded. Frequency of utilization was reported by screening type: colonoscopy, fecal immunochemical test (FIT), fecal occult blood test (FOBT), multi-target stool DNA (mt-sDNA). For colonoscopy, frequency and costs of potential events were reported overall, by event type, and by an individual event in the 30 days after colonoscopy. RESULTS: Among the 333,306 average-risk adults, colonoscopy was the most common CRC screening modality (70.6%), followed by FIT (17.7%), FOBT (8.1%), and mt-sDNA (3.2%). The mean cost of a colonoscopy procedure was $2,125 and the mean out-of-pocket costs were $79. Serious gastrointestinal (GI) events were observed in 1.3% of individuals with colonoscopy, 1.9% had other GI events, and 1.2% had an incident cardiovascular event. Mean event-related costs were $2,631 among individuals with a serious GI event, $1,774 among individuals with any other GI event, and $4,234 among individuals with a cardiovascular event. CONCLUSIONS: This study provides updated and more detailed information regarding the costs of CRC screening and potential colonoscopy events based on a comprehensive review of a robust claims dataset.

Costs of treatment change following first-line somatostatin analog monotherapy among patients with neuroendocrine tumors.

BACKGROUND: This study describes treatment characteristics and healthcare costs prior to and following treatment change from somatostatin analog (SSA) monotherapy among a privately-insured NET patient population in the US. METHODS: Patients with newly diagnosed NET and treated with SSA monotherapy were retrospectively identified in IBM MarketScan claims between 1/1/2014 and 3/31/2019. NET treatment change was captured ≥30 days after the SSA start date (earliest new treatment = index date). Healthcare costs (reimbursed amount in 2019 dollars) were reported for 1, 3, and 6 months pre- and post-index intervals. RESULTS: A total of 305 patients were identified (mean age: 58 years; female: 52%; metastatic disease: 49%). Most patients started on octreotide (81%) vs. lanreotide (19%). Common treatment changes included alternate SSA (38%), targeted therapy (30%), or chemotherapy (23%). Total costs increased on average by $13,272 between the month preceding and following treatment change (p < .001), with the highest increase among patients changing to targeted therapy ($19,677, p < .001) vs. an alternate SSA ($10,240, p < .001) or chemotherapy ($4,057, p = .155). The trajectory in mean cost difference using a 1, 3, and 6-month time period followed an increasing trend for patients who changed to targeted therapy (Δ$19,677, Δ$34,856, Δ$58,387) but was flat for patients who changed to the alternate SSA (Δ$10,240, Δ$10,026, Δ$11,727). CONCLUSIONS: Higher total healthcare costs were observed following treatment change from first-line SSA. Switching to the alternate SSA was associated with a fixed, one-time cost; whereas, switching to targeted therapy was associated with both an initial switching cost and a persistent monthly increase.

Real-World Treatment Patterns and Healthcare Costs in Patients with Psoriatic Arthritis Treated with Ixekizumab: A Retrospective Study.

OBJECTIVE: To describe adherence, persistence, discontinuation, restarting, switching, dosing, and health care costs among patients with psoriatic arthritis (PsA) treated with ixekizumab (IXE). METHODS: MarketScan administrative claims databases were used to select adults (≥18 years) initiating IXE between January 1, 2016, and June 30, 2019, for this retrospective study (earliest IXE claim = index). Eligible patients had one or more PsA diagnoses during the 12 months preceding the index and had 12 months of follow-up time after the index. Adherence (measured by proportion of days covered [PDC]) persistence (<60-day gap), discontinuation (≥90-day gap), switching, and dosing patterns were reported. Health care costs were reported per patient per month (PPPM) during follow-up and were assessed after adjusting PsA treatment costs for discount rates reported by the Institute for Clinical and Economic Review (ICER). RESULTS: A total of 496 patients met the selection criteria (mean age, 51.1 years; 50.4% female). Over the 12-month follow-up, 52.8% remained persistent, 38.7% discontinued, 13.5% had no other treatment, 4.6% restarted, and 20.6% switched to a new biologic/traditional synthetic disease-modifying antirheumatic drug. 70.6%of patients were identified as highly adherent (i.e. PDC > 0.80)to IXE prior to discontinuation. Dose values were consistent with prescribing information for patients with and without comorbid psoriasis. Although IXE costs ($5233 [SD = $2497]) accounted for 85.6% of PsA-related health care costs, only 3.5% of IXE costs were patient out-of-pocket expenses. Adjusting for the ICER discounts decreased all-cause and PsA-related costs by $2509 PPPM. CONCLUSION: Results from this real-world analysis suggest that treatment patterns and costs among patients with PsA initiating IXE are consistent with prior literature for other biologics.

Utilization of a Colorectal Cancer Screening Test Among Individuals With Average Risk.

Importance: Colorectal cancer (CRC) screening reduces CRC incidence and mortality. It is important to examine screening patterns over time, including after the introduction of new screening modalities. Objective: To compare use of CRC screening tests before and after the availability of the multitarget stool DNA (mt-sDNA) test, given that endorsed options have changed. Design, Setting, and Participants: This longitudinal cohort study used administrative claims data to examine CRC screening use in 2 discrete periods: before (August 1, 2011, to July 31, 2014) and after (August 1, 2016, to July 31, 2019) the mt-sDNA test became available. The MarketScan Commercial and Medicare Supplemental databases were queried for individuals aged 45 to 75 years between August 1, 2011, and July 31, 2019, with average risk of CRC and with continuous enrollment in the databases from August 1, 2001, to July 31, 2019. Main Outcomes and Measures: The proportion of individuals up to date or not due for CRC screening during each measurement year and the type of screening test used among individuals due for screening. Data were reported overall and among individuals aged 45 to 49 or 50 years and older on August 1, 2011. Results: A total of 97 776 individuals with average risk were identified. Individuals had a mean (SD) age of 50.8 (3.5) years, and 54 227 (55.5%) were women. The proportion of individuals with average risk aged 50 to 75 years with commercial or Medicare supplemental insurance who were up to date with CRC screening increased from 50.4% in 2011 (30 605 of 60 770) to 69.7% in 2019 (42 367 of 60 770). Among individuals due for screening and screened, the use of high-sensitivity fecal occult blood test (FOBT) decreased between 2011 (1088 of 6241 eligible individuals [17.7%]) and 2019 (195 of 2943 eligible individuals [6.6%]), and the use of mt-sDNA increased between 2016 (58 of 3014 eligible individuals [1.9%]) and 2019 (418 of 2943 eligible individuals [14.2%]). No consistent trends were observed with fecal immunochemical test (FIT) or screening colonoscopy. Computed tomography colonography, double-contrast barium enema, and flexible sigmoidoscopy were rarely performed. Conclusions and Relevance: In this cohort study, the proportion of individuals with average risk who were up to date with CRC screening increased between 2011 and 2019 but remained suboptimal. There were no substantial changes in the use of the colonoscopy or FIT; however, there was an increase in the adoption of mt-sDNA and a decrease in the use of FOBT during the study period.

Exploration of machine learning techniques to examine the journey to neuroendocrine tumor diagnosis with real-world data.

Aim: Machine learning reveals pathways to neuroendocrine tumor (NET) diagnosis. Patients & methods: Patients with NET and age-/gender-matched non-NET controls were retrospectively selected from MarketScan claims. Predictors (e.g., procedures, symptoms, conditions for which NET is misdiagnosed) were examined during a 5-year pre-period to understand presence of and time to NET diagnosis using conditional inference trees. Results: Among 3460 patients with NET, 70% had a prior misdiagnosis. 10,370 controls were included. Decision trees revealed combinations of factors associated with a high probability of being a patient with NET (e.g., abdominal pain, an endoscopic/biopsy procedure, vomiting) or longer times to diagnosis (e.g., asthma diagnosis with visits to >6 providers). Conclusion: Decision trees provided a unique examination of the journey to NET diagnosis.

Lay abstract We present the novel analytic approach of machine learning using real-world data to describe patient pathways to neuroendocrine tumor (NET) diagnosis. Due to the rarity and presentation of the disease, NET diagnosis is commonly inaccurate and delayed. We aimed to demonstrate the potential of analytics using conditional inference trees. Decision trees revealed specific combinations of characteristics associated with a high probability of being a patient with NET (e.g., abdominal pain, an endoscopic/biopsy procedure, vomiting) or longer times to diagnosis (e.g., asthma diagnosis with visits to >6 providers). Results from this study support prior literature and add advanced analyses that take initial steps toward developing tools aimed to help clinicians with early and accurate NET diagnosis. The methodology can be improved upon and translated to other diseases.

Retrospective database analysis of healthcare resource utilization and costs in patients who develop post-transplant lymphoproliferative disease within the first year following allogeneic hematopoietic stem cell transplants.

AIMS: Healthcare resource utilization (HRU) and costs in post-transplant lymphoproliferative disease (PTLD) patients following allogeneic hematopoietic stem cell transplant (HCT) were evaluated in the USA. METHODS: MarketScan Commercial and Medicare Supplemental database claims from 01 July 2010 to 31 December 2017 were analyzed. Patients eligible for analysis received allogeneic HCT between 01 January 2011 to 31 December 2015, had ≥6 months of continuous enrollment before HCT, and had ≥1 claim for PTLD or ≥1 inpatient or ≥2 outpatient claims for a clinically-relevant lymphoma within 1 year following HCT (PTLD index = first claim of diagnosis). Patients with clinically-relevant lymphomas within 6 months before HCT were excluded. HRU and total paid amounts were assessed from the week before the HCT through 1-day pre-PTLD index (HCT to PTLD) and monthly from PTLD index through 1-year post-PTLD index. HRU is reported as mean (SD). Results were also provided by survival status. RESULTS: Overall, 92 patients were eligible for analysis. From HCT to PTLD, 98.9% of patients were hospitalized, with 1.7 (1.2) hospitalizations/patient. The average length of stay was 25.3 (22.2) days/patient. From HCT to PTLD, 98.9% of patients had outpatient services with 233.7 (261.1) services/patient and 91.3% of patients had a prescription fill with 32.9 (26.0) prescriptions/patient. In the first month post-PTLD index, 51.2% of patients were hospitalized. Mean paid amounts were $399,470/patient (range $7542-$1.7 M) from HCT to PTLD. Cumulative mean paid amounts 1-year post-PTLD were $429,043/patient. Total cost/patient/month was ∼7 times higher in patients who died (n = 49; $232,591) than those who lived (n = 43; $33,677). Costs were mainly driven by hospitalizations. LIMITATIONS: Limitations include those inherent to retrospective analyses (i.e. miscoding, lack of clinical detail). CONCLUSIONS: HRU and costs from HCT to PTLD were high and more than doubled within 1-year post-PTLD. PTLD patients who died had ∼7 times higher costs than those who lived, driven by hospitalizations. Effective treatments are needed to reduce the burden of PTLD.

Evaluation of the accuracy of algorithms to identify soft tissue sarcoma (STS) in administrative claims.

BACKGROUND: Lack of using a validated algorithm to select patients is a source of selection bias in oncology studies using administrative claims. The objective of this study to evaluate published algorithms to identify patients with soft tissue sarcoma (STS) in administrative claims and to evaluate new algorithms to improved performance. METHODS: Two cancer populations including STS cases and non-STS controls were selected from the MarketScan Explorys Linked Claims-Electronic Medical Record (EMR) Database between January 1, 2000 and July 31, 2018. Eligible cases had a diagnosis on a clinical record for STS in the EMR while controls had no evidence of STS on any EMR records. Both cases and controls were enrolled in administrative claims during a period of observation and were aged ≥ 18 years. A split sample was used to test and validate algorithms using data from administrative claims. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated for 14 algorithms. Prior literature validating algorithms in administrative claims across other cancer types report both sensitivity and specificity ranging from as low as 73% to as high as 95%. This was used as a benchmark for defining algorithm success. RESULTS: There were 784 STS cases and 249,062 non-STS cancer controls eligible for analysis. Requiring at least two claims with an ICD-CM diagnosis code for STS achieved a sensitivity of 67% but had a specificity of 72%. Algorithms that required NCCN-recommended systemic treatment for STS improved the specificity to over 90% but dropped the sensitivity to below 20%. Other combinations of diagnostic tests, symptoms, and procedures did not improve performance. CONCLUSIONS: The algorithms tested in this study sample did not achieve sufficient performance and suggest the ability to accurately identify the STS population in administrative data is problematic. Difficulties are likely due to the origin of STS in a variety of locations, the non-specific symptoms of STS, and the common diagnostic tests recommended to diagnose the disease. Future research applying machine learning to examine timing and patterns of variables that comprise the diagnostic process may further investigate the ability to accurately identify STS cases in claims databases.

Healthcare resource utilization and costs in patients with multiple myeloma with and without skeletal-related events.

AIM: To compare healthcare resource use and costs between newly diagnosed multiple myeloma (NDMM) patients with and without skeletal-related events (SREs). METHODS: Adults newly diagnosed with MM (1 January 2006 and 30 June 2017) with at least 12 months continuous health coverage prior to diagnosis were identified using the IBM MarketScan administrative claims. To control for baseline differences, NDMM patients with SREs were propensity score matched to NDMM patients without SREs. Outcomes included annual HRU and costs during follow-up along with number and type of SREs (SRE cohort only). Patients with SREs were stratified by number of SREs, and annual SRE-related costs were reported. Student's t test and Chi-squared test were used to compare outcomes. RESULTS: Before matching, the 6648 patients in the SRE cohort had more comorbidities, were more likely to have MM treatment, and had higher pre-index healthcare costs than the 7458 patients in the non-SRE cohort. After matching, cohorts of 3432 patients were well balanced on baseline characteristics. Patients with SREs (vs. without SREs) had significantly higher inpatient, outpatient, and pharmacy HRU. Patients with SREs had significantly higher mean annual all-cause healthcare costs ($213,361 vs. $94,896, p < 0.001) with hospitalization being the leading driver of increased costs (38.7% of total). Among 6648 patients with SREs, the mean annual SRE-related healthcare costs were $39,603, $45,463, and $50,111 for patients with one, two, and three or more events, respectively. CONCLUSIONS: NDMM patients with SREs have more than twice the all-cause healthcare costs than matched patients without SREs. Costs increase with the number of SRE events.

Economic Impact of Adherence to Pain Treatment Guidelines in Chronic Pain Patients.

OBJECTIVES: This research compared health care resource use (HCRU) and costs for pharmacotherapy prescribing that was adherent vs nonadherent to published pain management guidelines. Conditions included osteoarthritis (OA) and gout (GT) for nociceptive/inflammatory pain, painful diabetic peripheral neuropathy (pDPN) and post-herpetic neuralgia (PHN) for neuropathic pain, and fibromyalgia (FM) for sensory hypersensitivity pain. METHODS: This retrospective cohort study used claims from MarketScan Commercial and Medicare Databases identifying adults newly diagnosed with OA, GT, pDPN, PHN, or FM during July 1, 2006, to June 30, 2013, with 12-month continuous coverage before and after initial (index) diagnosis. Patients were grouped according to their pharmacotherapy pattern as adherent, nonadherent, or "unsure" according to published pain management guidelines using a claims-based algorithm. Adherent and nonadherent populations were compared descriptively and using multivariate statistical analyses for controlling bias. RESULTS: Final cohort sizes were 441,465 OA, 76,361 GT, 10,645 pDPN, 4,010 PHN, and 150,321 FM, with adherence to guidelines found in 51.1% of OA, 25% of GT, 59.5% of pDPN, 54.9% of PHN, and 33.5% of FM. Adherent cohorts had significantly (P < 0.05) fewer emergency department (ED) visits and lower proportions with hospitalizations or ED visits. Mean health care costs increased following diagnosis across all conditions; however, adherent cohorts had significantly lower increases in adjusted costs pre-index to postindex (OA $5,286 vs $9,532; GT $3,631 vs $7,873; pDPN $9,578 vs $16,337; PHN $2,975 vs $5,146; FM $2,911 vs $3,708; all P < 0.001; adherent vs nonadherent, respectively). CONCLUSIONS: Adherence to pain management guidelines was associated with significantly lower HCRU and costs compared with nonadherence to guidelines.

Predictors of systemic therapy sequences following a CDK 4/6 inhibitor-based regimen in post-menopausal women with hormone receptor positive, HEGFR-2 negative metastatic breast cancer.

Objective: To identify systemic treatment in the real-world following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDKi) among post-menopausal women with hormone receptor positive, human epidermal growth factor receptor 2 Negative (HR+/HER2-) metastatic breast cancer (mBC).Methods: Post-menopausal women with HR+/HER2- mBC were identified from MarketScan claims databases between January 1, 2012 and October 31, 2017. Eligible mBC patients who received a CDKi-based line of therapy following metastasis diagnosis were selected. A line of therapy ended at the earlier of systemic therapy discontinuation, switch to new treatment, or censoring.Results: In total, 525 patients that received systemic therapy after a CDKi-based line were included (39.6% transitioned from use of a CDKi-based regimen in first line following metastasis diagnosis to any second line, and 60.4% shifted from a CDKi-based [second, third, or fourth line] to a subsequent line). Of post-CDKi second line regimens (n = 208), 38.0% were endocrine only, 35.6% were chemotherapy-based, 14.4% were everolimus-based, 9.6% were also CDKi-based line, and 2.4% were others. After adjusting for demographic and clinical characteristics, patients transitioning from a CDKi-based line to chemotherapy (vs others) had a trend of being more likely to have recurrent rapidly progressing disease, and were significantly less likely to have the prior CDKi-based line in combination with an AI (both p < .05).Conclusions: This population-based study suggests that rapidly progressing disease, metastatic site location, age, and endocrine therapy partner may be predictive of subsequent systemic therapy regimen selection after progression on a CDKi-based line therapy in patients with HR+/HER2- mBC.

Real-world analysis of cost, health care resource utilization, and supportive care in Hodgkin lymphoma patients with frontline failure.

PURPOSE: The purpose of this study was to evaluate the economic burden of frontline failure (FLF) among classical Hodgkin lymphoma (HL) patients during and after treatment. PATIENTS AND METHODS: The population consisted of adult HL patients identified from January 2010 through September 2015 without any other primary cancer prior to HL diagnosis, who also had a frontline (FL) regimen indicative of curative intent. Patients were characterized as FLF (those who restart, switch to any chemotherapy; had a hematopoietic stem cell transplant; or newly initiated radiation therapy [RT] after discontinuing FL) or non-FLF (those not considered as FLF). Direct health care utilization and expenditures were measured over both fixed and variable length follow-up periods and during FL therapy. RESULTS: There were 77 FLF and 602 non-FLF patients who met the final inclusion criteria. FLF and non-FLF patients were demographically similar with mean age 38.5 years and 47.5% females. Average per patient per month (PPPM) costs were significantly higher for FLF patients during all follow-up (US$20,266 vs US$7,772, P<0.05). Annual total expenditures were significantly higher among FLF patients (US$198,388) vs non-FLF patients (US$37,549). FLF (vs non-FLF) patients had a significantly shorter duration of FL therapy (116 vs 131 days, P=0.024) and higher total PPPM expenditures during FL (US$29,040 vs US$16,369, P<0.05). Annual cost varied by failure type with those who failed due to restart incurring the highest cost (US$269,189) and those who switched incurring the lowest cost (US$46,951). FLF patients had a significantly greater utilization in every health care resource category during follow-up. CONCLUSION: FLF (vs non-FLF) patients utilized substantially more health care resources and incurred a substantially higher economic burden. Over 5 years, FLF patients with at least two lines of treatment were projected to incur US$535,846 of health care costs. Further research is needed to determine optimal treatment that could reduce the risk of progression, need for treatment after FL, and enhance long-term clinical and economic outcomes.

Comparison of treatment patterns and economic outcomes among metastatic pancreatic cancer patients initiated on nab-paclitaxel plus gemcitabine versus FOLFIRINOX.

BACKGROUND: The economic burden of metastatic pancreatic cancer (mPC) is substantial while treatment options are limited. Little is known about the treatment patterns and healthcare costs among mPC patients who initiated first-line gemcitabine plus nanoparticle albumin-bound paclitaxel (nab-P + G) and FOLFIRINOX. METHODS: The MarketScan® claims databases were used to identify adults with ≥2 claims for pancreatic cancer, 1 claim for a secondary malignancy, completed ≥1 cycle of nab-P + G or FOLFIRINOX during 4/1/2013 and 3/31/2015, and had continuous plan enrollment for ≥6 months pre- and 3 months after the first-line treatment. Duration of therapy, per patient per month (PPPM) costs of total healthcare, mPC-related treatment, and supportive care were measured during first-line therapy. RESULTS: 550 mPC patients met selection criteria (nab-P + G, n = 294; FOLFIRINOX, n = 256). There was no difference in duration of therapy (p = 0.60) between nab-P + G and FOLFIRINOX. Compared with FOLFIRINOX, patients with nab-P + G had higher chemotherapy drug costs but lower treatment administration costs and supportive care costs (all p < 0.01). CONCLUSIONS: Patients treated with nab-P + G (vs FOLFIRINOX) had similar treatment duration but lower costs of outpatient prescriptions, treatment administration and supportive care. Lower supportive care costs in the nab-P + G cohort were mainly driven by lower utilization of pegfilgrastim and anti-emetics.

Comparing Healthcare Utilization and Costs Among Medicaid-Insured Patients with Chronic Noncancer Pain with and without Opioid-Induced Constipation: A Retrospective Analysis.

BACKGROUND: Constipation is a common adverse effect of opioid use and has been associated with increased healthcare utilization and costs among patients receiving opioids for pain management. OBJECTIVE: To compare the healthcare utilization and costs of Medicaid patients with chronic noncancer pain with and without constipation who were receiving opioids. METHODS: This retrospective, claims-based study was conducted using data from the Truven Health MarketScan Medicaid Multi-State database. Patients with no evidence of cancer who initiated opioid therapy between January 1, 2009, and June 30, 2013, were eligible for the study. Patients had to have continuous enrollment in the database in the 6 months before and 12 months after opioid initiation, with no evidence of substance abuse or functional or inflammatory bowel disease. Medical and pharmacy claims during the 12 months after opioid initiation were evaluated for a diagnosis of constipation or for prescription or over-the-counter medications indicative of constipation. All-cause healthcare utilization and costs were measured over the same period and were compared between propensity score-matched cohorts of patients with evidence of constipation and patients without constipation. RESULTS: Of the 25,744 patients meeting the study inclusion criteria, 2716 (10.5%) had evidence of constipation. After 1:1 propensity score matching, the 2 cohorts had similar demographic and clinical characteristics (ie, mean age, 47 years; 26%-27% male). During the 12-month follow-up period, healthcare utilization was more frequent among patients with constipation, including inpatient admissions and emergency department visits, than in the matched patients without constipation. The total all-cause mean healthcare costs were substantially higher among the patients with constipation ($28,234; 95% confidence interval [CI], $24,307-$32,160) than in the patients without constipation ($13,709; 95% CI, $12,618-$14,801), with a median cost difference of $4166 per patient (P <.001). CONCLUSION: Among Medicaid enrollees who receive opioids for chronic noncancer pain, constipation is associated with increased all-cause healthcare utilization and costs.

Development of a novel algorithm to determine adherence to chronic pain treatment guidelines using administrative claims.

OBJECTIVE: To develop a claims-based algorithm for identifying patients who are adherent versus nonadherent to published guidelines for chronic pain management. METHODS: Using medical and pharmacy health care claims from the MarketScan® Commercial and Medicare Supplemental Databases, patients were selected during July 1, 2010, to June 30, 2012, with the following chronic pain conditions: osteoarthritis (OA), gout (GT), painful diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM). Patients newly diagnosed with 12 months of continuous medical and pharmacy benefits both before and after initial diagnosis (index date) were categorized as adherent, nonadherent, or unsure according to the guidelines-based algorithm using disease-specific pain medication classes grouped as first-line, later-line, or not recommended. Descriptive and multivariate analyses compared patient outcomes with algorithm-derived categorization endpoints. RESULTS: A total of 441,465 OA patients, 76,361 GT patients, 10,645 pDPN, 4,010 PHN patients, and 150,321 FM patients were included in the development of the algorithm. Patients found adherent to guidelines included 51.1% for OA, 25% for GT, 59.5% for pDPN, 54.9% for PHN, and 33.5% for FM. The majority (~90%) of patients adherent to the guidelines initiated therapy with prescriptions for first-line pain medications written for a minimum of 30 days. Patients found nonadherent to guidelines included 30.7% for OA, 6.8% for GT, 34.9% for pDPN, 23.1% for PHN, and 34.7% for FM. CONCLUSION: This novel algorithm used real-world pharmacotherapy treatment patterns to evaluate adherence to pain management guidelines in five chronic pain conditions. Findings suggest that one-third to one-half of patients are managed according to guidelines. This method may have valuable applications for health care payers and providers analyzing treatment guideline adherence.

Development and Validation of an Algorithm to Identify Patients with Multiple Myeloma Using Administrative Claims Data.

PURPOSE: The objective was to expand on prior work by developing and validating a new algorithm to identify multiple myeloma (MM) patients in administrative claims. METHODS: Two files were constructed to select MM cases from MarketScan Oncology Electronic Medical Records (EMR) and controls from the MarketScan Primary Care EMR during January 1, 2000-March 31, 2014. Patients were linked to MarketScan claims databases, and files were merged. Eligible cases were age ≥18, had a diagnosis and visit for MM in the Oncology EMR, and were continuously enrolled in claims for ≥90 days preceding and ≥30 days after diagnosis. Controls were age ≥18, had ≥12 months of overlap in claims enrollment (observation period) in the Primary Care EMR and ≥1 claim with an ICD-9-CM diagnosis code of MM (203.0×) during that time. Controls were excluded if they had chemotherapy; stem cell transplant; or text documentation of MM in the EMR during the observation period. A split sample was used to develop and validate algorithms. A maximum of 180 days prior to and following each MM diagnosis was used to identify events in the diagnostic process. Of 20 algorithms explored, the baseline algorithm of 2 MM diagnoses and the 3 best performing were validated. Values for sensitivity, specificity, and positive predictive value (PPV) were calculated. CONCLUSION: Three claims-based algorithms were validated with ~10% improvement in PPV (87-94%) over prior work (81%) and the baseline algorithm (76%) and can be considered for future research. Consistent with prior work, it was found that MM diagnoses before and after tests were needed.