Administrative Healthcare Claims Database Research Articles

Indirect impact of the COVID-19 pandemic on the care and outcomes of people with MS: A combined survey and insurance claims study

BackgroundIn the context of the COVID-19 pandemic, people with multiple sclerosis (pwMS) have been particularly vulnerable to adverse outcomes due to increased risk of severe infection and/or widespread disruptions in care. The CopeMS study led by The University of Texas at Austin and the MS Association of America investigates the long-term impact of the COVID-19 pandemic on healthcare access, disease modifying therapy (DMT) utilization and outcomes of pwMS. MethodsThis retrospective cohort analysis used Optum's de-identified Clinformatics® Data Mart Database (CDM), a large de-identified administrative healthcare claims database to identify pwMS who were continuously enrolled from 01/01/2019 to 12/31/2020 and assessed changes in the utilization of DMTs and healthcare services during the COVID-19 pandemic compared to the year prior. Additionally, a national survey of pwMS and healthcare providers (HCPs) was conducted to further understand the indirect impact of the pandemic on healthcare resource utilization (HCRU), outcomes and prescription patterns. ResultsOut of 529 pwMS in our national survey, over 47 % reported that their overall health and neurologic symptoms had deteriorated during the COVID-19 pandemic, with increased anxiety, and inability to maintain exercise habits as leading perceived causes for worsening. Survey respondents reported widespread disruption of MS-related services during the pandemic. In the Optum database, we identified 39,209 pwMS validating inclusion criteria. We observed a decrease in the utilization of MS-related services in 2020 compared to 2019. Significantly fewer pwMS had visits with their neurologist, primary care provider, physical or occupational therapist despite an increased utilization of telemedicine services. Fewer pwMS had magnetic resonance imaging (MRI) studies of the brain or spinal cord during the pandemic. Only 22.2 % of HCPs surveyed agreed that the perceived risk of more severe COVID-19 infection on a specific DMT influenced their therapeutic decisions. In the Optum database, individuals with an established diagnosis of MS prior to 2019 saw decreases in utilization of platform and moderate efficacy DMTs. In this group, those over the age of 55 saw a decrease in utilization of B-cell therapies (rate ratio 0.79, CI 0.75–0.83), whereas individuals under the age of 55 saw an increase in utilization of B-cell therapies (rate ratio 1.10, CI 1.03–1.17). We did not see any difference in rates of starting DMTs in persons diagnosed in 2019 prior to the pandemic and those diagnosed in 2020. Compared to 2019, B-cell therapies were prescribed more frequently in pwMS diagnosed in 2020 who were younger than 55 or commercially insured (rate ratio 1.35, CI 1.11–1.63). ConclusionThe COVID-19 pandemic was associated with perceived worsening of neurological symptoms in pwMS. Despite the expansion of telemedicine, we observed decreased access to healthcare services important to the comprehensive care of pwMS. Additionally, we observed changes in DMT utilization in pwMS during the pandemic, particularly in older adults with an established diagnosis of MS.

Comorbidities, Healthcare Utilization, and Costs Associated With Alopecia Totalis and Alopecia Universalis in the United States

Background: Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss. Extensive forms of AA include alopecia totalis (AT; complete scalp hair loss) or alopecia universalis (AU; complete scalp, face, and body hair loss). Limited information exists about the cost and healthcare burden of AT and AU. Methods: Using a large US administrative healthcare claims database, two mutually exclusive patient cohorts were identified: AA cohort: ≥1 diagnosis of AA; AT/AU cohort: ≥1 diagnosis of AT/AU between January 1 and December 31, 2017. Baseline characteristics measured at first AA diagnosis (index date) and all-cause healthcare utilization and costs identified in the 1-year post-index period were compared between AT/AU and non-AT/AU AA cohorts. Results: 14,340 patients with AA were identified, including 1,224 patients with AT or AU. Compared with patients with non-AT/AU AA (n=13,116), patients with AT/AU were older (mean age 43.1 vs 40.6 years, P<0.0001) and more were female (68.1% vs 62.9%, P<0.0001). More patients with AT/AU had baseline comorbidities (atopic disease [28.3% vs 24.1%], anemia [10.4% vs 7.4%], autoimmune disorders [9.6% vs 5.5%]; P≤0.001 for all). Post-index patients with AT/AU had higher per person per policy year healthcare resource utilization and costs (P≤0.001) and total adjusted annual mean costs (P<0.05). Over 50% more patients with AT/AU received immunosuppressive agents than patients with non-AT/AU AA. Conclusion: Patients with AT/AU had higher rates of comorbidities and greater healthcare resource utilization medical costs than patients with non-AT/AU AA, suggesting that improved insight into the patterns of specific comorbid conditions is needed.

Real-World Demographic and Clinical Characteristics of Patients Initiating Avatrombopag in the US: The Real-AVA Study

Introduction: Avatrombopag (AVA) is the most recent thrombopoietin-receptor agonist (TPO-RA) for treatment of adults with chronic immune thrombocytopenia (ITP; 2019) or adults with thrombocytopenia and chronic liver disease (CLD; 2018) who are scheduled to undergo a procedure. Other approved TPO-RA medications for ITP (2008) include eltrombopag (ELT), an oral medication with food restrictions, a boxed warning for hepatotoxicity, and potential need for adjustment of statin dosing; and romiplostim (ROMI), an injectable typically administered at a healthcare facility. Lusutrombopag (LUSU), an oral TPO-RA medication, was approved in 2018 for the treatment of thrombocytopenia in adults with CLD who are scheduled to undergo a procedure. AVA is an oral treatment whose bioavailability is not affected by administration with polyvalent cations (e.g., calcium, magnesium, iron) and may be administered with any food. Unlike ELT, AVA does not carry a boxed warning for hepatoxicity, nor does it require a potential dose adjustment for concomitant statins. Given its more recent approval, there is limited information in the literature on the use of AVA in real-world clinical settings. This is the first study to characterize patients initiating AVA in the US using administrative healthcare claims data and lab data. Methods: This retrospective analysis was conducted using data from the Komodo Healthcare Map dataset. Included patients had ≥1 paid prescription for AVA between May 21, 2018 and February 28, 2022 (first such prescription was defined as the index date) and ≥6 months of closed medical and pharmacy eligibility prior to the index date (baseline period). Patients were stratified into mutually exclusive subgroups by prior evidence of approved indications (i.e., ITP, CLD, both, neither). Patient characteristics (including age, sex, and insurance type as of index date) as well as Charlson Comorbidity Index (CCI), comorbidities, and prior use of TPO-RA treatments (i.e., ELT, ROMI, and LUSU) during the baseline period were described. For patients with ≥5 years of both medical and pharmacy coverage prior to index, previous use of other TPO-RA treatments during that period was also described. Results: A total of 610 patients initiating AVA met the above criteria. These patients included 140 (23%) with a diagnosis of ITP only, 370 (61%) with a diagnosis of CLD only, 69 (11%) with a diagnosis of both ITP and CLD, and 31 (5%) with neither a diagnosis for ITP nor CLD in the six-month baseline period (Table 1). On average, patients with a diagnosis of ITP only were 51 years of age at index date, 59% were female, and a plurality had commercial (45%) insurance coverage only. ITP patients had an average CCI of 1.3 during baseline, and the most common comorbidities were chronic pulmonary disease (16%) and rheumatologic disease (16%). 49.3% of patients with only an ITP diagnosis had been exposed to another TPO-RA within 6 months before initiating AVA treatment. Patients with CLD were, on average, 56 years of age at index date, 43% were female, and 51% had Medicaid insurance coverage only. CLD patients had an average CCI of 4.9, and common comorbidities included diabetes without chronic complications (24%) and chronic pulmonary disease (24%). Among the subgroup of ITP patients with ≥5 years of both medical and pharmacy coverage prior to index (n=50), 34.0% and 36.0% of patients previously initiated ELT and ROMI, respectively, while 46.0% were TPO-RA naïve. Among the subgroup of CLD patients with ≥5 years of both medical and pharmacy coverage prior to index (n=106), 95% had no previous use of other TPO-RA treatments; 5% previously initiated ELT, while no patients had previous exposure to LUSU or ROMI. Conclusions: This is the first real-world characterization of patients initiating avatrombopag using data from an administrative healthcare claims database. Patients were diverse in terms of age, insurance type, and comorbidity burden. The majority of the patients administered AVA had a diagnosis for CLD; a quarter of the patients were diagnosed with ITP only. The vast majority of CLD patients were TRO-RA naïve, whereas half of the patients diagnosed with ITP had used a different TPO-RA treatment within six months before initiating AVA, indicating a recent within-TPO-RA class switch. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Effectiveness of Treatment With Dual Bronchodilation (LABA/LAMA) Compared With Combination Therapy (LABA/ICS) for Patients With COPD: A Population-Based Study

BackgroundInitiation of treatment of COPD with a combination of a long-acting beta-agonist (LABA) and an inhaled corticosteroid (ICS) is frequent irrespective of the risk of exacerbations. MethodWe performed a retrospective, population-based, observational study aimed at comparing the effectiveness of a LABA/long-acting antimuscarinic agent (LAMA) and LABA/ICS in patients with COPD over a one-year follow-up. Data were obtained from an administrative healthcare claims database. The primary outcome was the risk of first exacerbation. A sensitivity analysis was conducted in a propensity-score matched population. ResultsThe population consisted of 14,046 COPD patients; 11,329 (80.6%) initiated LABA/ICS and 2717 (19.4%) LABA/LAMA. The matched population included 1650 patients in each arm. During follow-up, 69.6% patients in the LABA/ICS group and 64.4% in the LABA/LAMA group presented an exacerbation. The mean time to the first exacerbation was 6.03 months (95% confidence interval (CI): 5.94–6.12) for LABA/ICS and 6.4 months (95%CI: 6.21–6.59) for LABA/LAMA; p<0.001. The time to scalation to triple therapy was also significantly prolonged in LABA/LAMA. Similar results were obtained in the matched population. LABA/LAMA was associated with a significantly lower risk of exacerbations and escalation to triple therapy compared to LABA/ICS, except in patients with frequent exacerbations and high blood eosinophils in which no differences were observed in the time to first exacerbation. ConclusionInitiation of treatment with LABA/LAMA was associated with a lower risk of exacerbation and escalation to triple therapy compared to LABA/ICS in the majority of patients with COPD in primary care.

Costs and management of patients with hemophilia A in France: the Hemraude study

The Hemraude study was conducted to describe the profile of patients with HA, disease management, and economic burden in a collective perspective. This retrospective study was conducted using the French administrative healthcare claims database SNIIRAM/SNDS. Male patients treated for hemophilia A with a long-term illness (ALD) status or invalidity were included in the study between January 1, 2016 and December 31, 2017. Patients were classified in six treatment groups: no treatment, on-demand FVIII, prophylactic FVIII, FVIII in immune tolerance induction (ITI) protocol, on-demand bypassing agents, and prophylactic bypassing agents. Patients treated with FVIII in ITI protocol and those treated with bypassing agents are deemed to have developed inhibitors. HA patients were compared to a control population without coagulation disorder and matched (ratio 1:3) on age and sex. A total of 4172 patients were included in the analysis, aged on average 35.2years, 5.3% had HIV infection, and 8.8% had hepatitis B or C. In 2017, half of the patients received no treatment for HA, 46.7% were treated with FVIII (25% on demand, 20.6% with prophylaxis, and 1.1% ITI), 1.5% with bypassing agents. Patients treated with prophylactic treatments, either inhibitor or non-inhibitor, were less likely to be hospitalized for severe bleeding compared to patients receiving on-demand treatments. The average annual costs for HA management per patient were 72,209.60 €. The highest costs were observed in patients treated with FVIII in ITI protocol and those receiving prophylactic bypassing agents. Direct costs of HA treatments for HA may be very high especially in the small percentage of patients developing inhibitors or treated with ITI protocol.

Real-world propensity score comparison of treatment effectiveness of peginterferon beta-1a vs. subcutaneous interferon beta-1a, glatiramer acetate, and teriflunomide in patients with relapsing-remitting multiple sclerosis

BackgroundMultiple disease-modifying therapies (DMTs) have been approved by the U.S. Food & Drug Administration for the treatment of relapsing-remitting multiple sclerosis (RRMS). In separately conducted clinical trials, peginterferon beta-1a, subcutaneous interferon beta-1a (SC IFN beta-1a), glatiramer acetate (GA), and teriflunomide have demonstrated efficacy for reducing relapses. No head-to-head phase III clinical trials have directly compared the treatment efficacy of peginterferon beta-1a with these other DMTs. ObjectivesA propensity score-based comparison was conducted of the treatment effectiveness of peginterferon beta-1a vs. SC IFN beta-1a, GA, and teriflunomide among patients with RRMS identified from a large U.S. administrative healthcare claims database. MethodsAdult patients (18-65 years of age) who had ≥1 claim for an MS diagnosis between November 2013 and June 2017 and ≥1 claim for peginterferon beta-1a, SC IFN beta-1a, GA, or teriflunomide between November 1, 2014, and March 31, 2017 were identified from the IBM® MarketScan® Commercial database. The index date was the first claim of a patient's DMT initiated. Only patients who had ≥12 months of insurance enrollment pre-index (baseline period) and ≥90 days post-index (variable length follow-up period) were included. Patients were grouped into cohorts according to the index DMT. Patient demographics and clinical characteristics were evaluated. Propensity score matching (PSM) was separately conducted for pairwise comparisons of treatment effectiveness between peginterferon beta-1a and the other DMT cohorts. During the post-index follow-up period, annualized relapse rate (ARR; relapse defined as hospitalization or outpatient visit with subsequent treatment), annualized number and length of inpatient stays, and the number of claims for durable medical equipment were evaluated. ResultsWith PSM, there were 325 patients (mean age: 46.0 years) in the peginterferon beta-1a cohort compared to 967 (mean age: 46.9 years) in the SC IFN beta-1a cohort; likewise there were 564 patients (mean age: 47.4 years) in the peginterferon beta-1a and 1688 (mean age: 47.6 years) in the GA cohort; and finally there were 584 patients (mean age: 49.1 years) in the peginterferon beta-1a cohort and 1742 (mean age: 49.0 years) in the teriflunomide cohort. During the post-index follow-up period, the ARR did not significantly differ between the peginterferon beta-1a and SC IFN beta-1a cohorts; the ARR was lower among patients treated with peginterferon beta-1a than among those treated with GA (Least squares mean [LSM] estimate: 0.25 vs. 0.31; LSM ratio: 0.809; P=0.027) or teriflunomide (LSM estimate: 0.26 vs. 0.37; LSM ratio: 0.704; P<0.001). The annualized mean number and length of inpatient stays and the mean number of claims for durable medical equipment during the post-index follow-up did not differ between the matched peginterferon beta-1a and GA cohorts nor the peginterferon beta-1a and teriflunomide cohorts. ConclusionIn this real-world comparative analysis of patients with similar patient characteristics, treatment with peginterferon beta-1a was associated with lower ARRs than treatment with either GA or teriflunomide; ARRs did not differ among patients treated with SC IFN beta-1a. Also, all other measured secondary outcomes did not differ between study cohorts. These real-world data may help support decision-making in the treatment of patients with RRMS.

Body Mass Index Variable Interpolation to Expand the Utility of Real-world Administrative Healthcare Claims Database Analyses.

IntroductionAdministrative claims data provide an important source for real-world evidence (RWE) generation, but incomplete reporting, such as for body mass index (BMI), limits the sample sizes that can be analyzed to address certain research questions. The objective of this study was to construct models by implementing machine-learning (ML) algorithms to predict BMI classifications (≥ 30, ≥ 35, and ≥ 40 kg/m2) in administrative healthcare claims databases, and then internally and externally validate them.MethodsFive advanced ML algorithms were implemented for each BMI classification on a random sampling of BMI readings from the Optum PanTher Electronic Health Record database (2%) and the Optum Clinformatics Date of Death (20%) database, while incorporating baseline demographic and clinical characteristics. Sensitivity analyses with oversampling ratios were conducted. Model performance was validated internally and externally.ResultsModels trained on the Super Learner ML algorithm (SLA) yielded the best BMI classification predictive performance. SLA model 1 utilized sociodemographic and clinical characteristics, including baseline BMI values; the area under the receiver operating characteristic curve (ROC AUC) was approximately 88% for the prediction of BMI classifications of ≥ 30, ≥ 35, and ≥ 40 kg/m2 (internal validation), while accuracy ranged from 87.9% to 92.8% and specificity ranged from 91.8% to 94.7%. SLA model 2 utilized sociodemographic information and clinical characteristics, excluding baseline BMI values; ROC AUC was approximately 73% for the prediction of BMI classifications of ≥ 30, ≥ 35, and ≥ 40 kg/m2 (internal validation), while accuracy ranged from 73.6% to 80.0% and specificity ranged from 71.6% to 85.9%. The external validation on the MarketScan Commercial Claims and Encounters database yielded relatively consistent results with slightly diminished performance.ConclusionThis study demonstrated the feasibility and validity of using ML algorithms to predict BMI classifications in administrative healthcare claims data to expand the utility for RWE generation.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-020-01605-6.

P035 Clostridium difficile infection in ulcerative colitis: Data from the tofacitinib clinical program and an insurance claims database

BACKGROUND: Patients with inflammatory bowel disease (IBD), particularly ulcerative colitis (UC), have a higher risk of Clostridium difficile infection (CDI) than the general population (1). The incidence of CDI is increasing among patients with IBD, and certain UC treatments may be associated with greater risk (1). We report CDI events in the tofacitinib UC clinical program, and the incidence of CDI among patients receiving other treatments for UC. METHODS: For the tofacitinib UC program, rates of CDI (patients with an adverse event [AE] of CDI, Clostridium difficile colitis, or Clostridium test-positive, plus concomitant oral metronidazole or vancomycin, counted once per cohort) are reported for Induction Cohort (patients from an 8-week Phase [P]2 and two 8-week P3 induction studies; placebo or tofacitinib 10 mg twice daily [BID; NCT00787202; NCT01465763; NCT01458951]); Maintenance Cohort (patients from a 52-week maintenance study; placebo or tofacitinib 5 or 10 mg BID [NCT01458574]); and Overall Cohort (all tofacitinib-treated patients in P2/3 induction and maintenance studies and an ongoing, open-label, long-term extension study [as of December 2016; NCT01470612]). Positive Clostridium difficile test at screening was an exclusion criterion for program entry. Overall Cohort incidence rate (IR) was calculated as number of unique patients with events per 100 patient-years (PY). For contextualization, CDI rates among patients receiving other UC medications were obtained from a retrospective cohort study utilizing data from the Truven MarketScan® Database, an administrative healthcare claims database in the US. Patients with moderately to severely active UC, with either an inpatient or outpatient diagnosis code of CDI, plus a prescription for oral therapy (including metronidazole, vancomycin, and fidaxomicin) within 14 days of CDI diagnosis (observation period: October 1, 2010–September 30, 2015), were included. Truven cohort IRs were calculated as number of patients with events per 100 PY. RESULTS: In the tofacitinib Induction Cohort, CDI occurred in 3 patients (placebo, 1/282 [0.4%]; tofacitinib 10 mg BID, 2/938 [0.2%]). In the Maintenance Cohort, CDI occurred in 3 patients (placebo, 3/198 [1.5%]; tofacitinib 5 or 10 mg BID, 0/394 [0.0%]). In the Overall Cohort of all tofacitinib-treated patients (1,664 PY of follow-up), CDI occurred in 8/1,157 patients (0.7%), with an IR (95% confidence interval [CI]) of 0.48 (0.21, 0.95). Two cases were reported as serious AEs. All were mild (n = 4) or moderate (n = 4) in severity; 6 continued with study treatment, one temporarily discontinued, one permanently discontinued. All CDI cases resolved with treatment. In the Truven Cohort, 160 CDI events occurred during 4,918 PY of follow-up, with an overall CDI IR (95% CI) of 3.25 (2.77, 3.80); of which 116 were CDI-associated hospitalizations (4,936 PY of follow-up). Among patients receiving azathioprine, 6-mercaptopurine, or tumor necrosis factor inhibitors, CDI IRs were 3.23 (2.18, 4.62), 2.31 (1.26, 3.87), and 3.58 (2.95, 4.29), respectively. CONCLUSION(S): In the tofacitinib UC program, CDI rates among patients receiving tofacitinib were similar to or lower than those observed with placebo. The IR among patients receiving tofacitinib was numerically lower than those observed for immunomodulators and tumor necrosis factor inhibitors in the Truven Cohort.

Medication-related quality of care in residential aged care: an Australian experience.

To describe medication-related quality of care (MRQOC) for Australian aged care residents. Retrospective cohort using an administrative healthcare claims database. Australian residential aged care. A total of 17 672 aged care residents who were alive at 1 January 2013 and had been a permanent resident for at least 3 months. Overall, 23 evidence-based MRQOC indicators which assessed the use of appropriate medications in chronic disease, exposure to high-risk medications and access to collaborative health services. Key findings included underuse of recommended cardiovascular medications, such as the use of statins in cardiovascular disease (56.1%). Overuse of high-risk medications was detected for medications associated with falls (73.5%), medications with moderate to strong anticholinergic properties (46.1%), benzodiazepines (41.4%) and antipsychotics (33.2%). Collaborative health services such as medication reviews were underutilised (42.6%). MRQOC activities in this population should be targeted at monitoring and reducing exposure to antipsychotics and benzodiazepines, improving the use of preventative medications for cardiovascular disease and improving access to collaborative health services. Similarity of suboptimal MRQOC between Australia and other countries (UK, USA, Canada and Belgium) presents an opportunity for an internationally collaborative approach to improving care for aged care residents.

Characteristics and Management of Patients Following Pulmonary Embolism: A Focus on Screening for Chronic Thromboembolic Pulmonary Hypertension

Purpose Chronic thromboembolic pulmonary hypertension (CTEPH) can develop in 1 out of 25 (4%) patients following an acute pulmonary embolism (PE). It is recommended that high risk patients on anticoagulants, who have persistent shortness of breath post-PE, should be screened for CTEPH. Ventilation-perfusion scan is considered a gold standard tool for screening for CTEPH. This retrospective study sought to describe the use of CTEPH-related diagnostic and medical procedures post-PE in the United States. Methods Adult patients newly diagnosed with acute PE (index date) without prior pulmonary hypertension (PH) were identified from a large US administrative healthcare claims database (01/2007-03/2018; > 150 million patients). Patients were required to be continuously enrolled in their healthcare plan for ≥12 months pre-index (i.e., baseline period) and post-index (i.e., observation period). CTEPH-related diagnoses, procedures, and surgeries were evaluated during the observation period. Results A total of 93,947 patients with acute PE were identified. Mean age was 65.4 years and 54.4% were females. Over an average follow-up of 3.3 years post-index, 75.3% of patients were seen for ‘shortness of breath’, of whom 93.6% had an electrocardiogram, 75.2% an echocardiography, and 57.4% a computed tomographic angiography. Specific to CTEPH screening, 18.0% had a ventilation-perfusion scan, 7.6% a pulmonary angiogram, 4.7% a right heart catheterization. Among the 93,947 patients, 14,510 (15.4%) had a diagnosis of PH documented after acute PE, and 284 (0.3%) had a CTEPH-related procedure (i.e., pulmonary endarterectomy [0.2%; n=193] or balloon pulmonary angioplasty [0.1%; n=97]). Conclusion Real-world evidence shows that patients are not systematically monitored for CTEPH using diagnostic procedures recommended by current guidelines which state. “it is recommended that high risk patients on anticoagulants, who have persistent shortness of breath post-PE, should be screened for CTEPH”. There is an ongoing need to better define the use of CTEPH diagnostic procedures in patients who have experienced acute PE as well as risk prediction tools to identify patients at high risk of developing CTEPH after PE.

Adverse Events in Giant Cell Arteritis and Rheumatoid Arthritis Patient Populations: Analyses of Tocilizumab Clinical Trials and Claims Data.

IntroductionThe safety profile of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) is well established. TCZ was approved to treat giant cell arteritis (GCA) in 2017 in the USA and Europe, and its safety profile in patients with GCA continues to be defined. The objective of this analysis was to examine incidence rates (IRs) of adverse events of special interest (AESI) occurring during the TCZ clinical development program and in healthcare claims data in patients with GCA or RA.MethodsTCZ-naïve patients with GCA or RA were identified in the MarketScan administrative healthcare claims database. TCZ-treated patients with GCA from the GiACTA trial and TCZ-treated patients with RA from pooled clinical trial data were analyzed. The IRs of AESI (AESI IRs) were calculated for all cohorts. In the claims cohorts, risks of AESI were estimated using Poisson regression.ResultsTCZ-naïve claims cohorts comprised 4804 patients with GCA [mean (standard deviation) age 73.4 (9.8) years; follow-up 3.9 (3.1) years] and 15,164 patients with RA [age 60.3 (8.2) years; follow-up, 4.5 (2.8) years]. TCZ-treated clinical trial cohorts comprised 149 patients with GCA [age 69.5 (8.4) years; exposure approx. 138 patient-years (PY)] and 7647 with RA [age 52 (12.6) years; exposure approx. 22,394 PY]. The IRs of infections, stroke, malignancies, myocardial infarction, and gastrointestinal perforations in the GCA claims cohort exceeded those in the RA claims cohort; the risk of AESI (adjusted for age and glucocorticoid use) was higher in patients with GCA than in those with RA. Similar patterns to the claims cohorts in terms of the AESI IRs were observed in clinical trial cohorts, although the number of events was limited in the GCA trial cohort.ConclusionHigher IRs of AESI were observed in patients with GCA versus those with RA in both TCZ-naïve and -treated cohorts. Differences in underlying disease, age, and glucocorticoid use may influence AESI incidence, irrespective of intervention.FundingThis study was funded by F. Hoffmann-La Roche Ltd and Genentech, Inc. Article processing charges were funded by F. Hoffmann-La Roche Ltd.Plain Language SummaryPlain language summary is available for this article.

Medication-related quality of care in residential aged care: an Australian experience.

Objective To describe medication-related quality of care (MRQOC) for Australian aged care residents. Design Retrospective cohort using an administrative healthcare claims database. Setting Australian residential aged care. Participants A total of 17 672 aged care residents who were alive at 1 January 2013 and had been a permanent resident for at least 3 months. Main outcome measures Overall, 23 evidence-based MRQOC indicators which assessed the use of appropriate medications in chronic disease, exposure to high-risk medications and access to collaborative health services. Results Key findings included underuse of recommended cardiovascular medications, such as the use of statins in cardiovascular disease (56.1%). Overuse of high-risk medications was detected for medications associated with falls (73.5%), medications with moderate to strong anticholinergic properties (46.1%), benzodiazepines (41.4%) and antipsychotics (33.2%). Collaborative health services such as medication reviews were underutilised (42.6%). Conclusion MRQOC activities in this population should be targeted at monitoring and reducing exposure to antipsychotics and benzodiazepines, improving the use of preventative medications for cardiovascular disease and improving access to collaborative health services. Similarity of suboptimal MRQOC between Australia and other countries (UK, USA, Canada and Belgium) presents an opportunity for an internationally collaborative approach to improving care for aged care residents.

Testosterone Therapy and Risk of Acute Myocardial Infarction in Hypogonadal Men: An Administrative Health Care Claims Study

BackgroundThere are some ongoing debates on the potential link between testosterone therapy (TT) and risk of acute myocardial infarction (MI). AimTo investigate the association between acute MI and TT use compared with non-use in men having documented hypogonadism (diagnostic International Classification of Diseases, Ninth Revision codes 257.2, 257.8, 257.9, 758.7) in patient claims records. MethodsThis retrospective cohort study used a real-world US-based administrative health care claims database (MarketScan 2004–2013; Truven Health Analytics, Ann Arbor, MI, USA) to compare MI rates between TT-treated men and a cohort of untreated hypogonadal men matched by a calendar time-specific propensity score. Subgroup analyses were performed by route of administration, age, and prior cardiovascular disease (CVD). OutcomesIncidence rates of MI (per 1,000 person-years) and hazard ratio. ResultsAfter 1:1 calendar time-specific propensity score matching, 207,176 TT-treated men and 207,176 untreated hypogonadal men were included in the analysis (mean age = 51.8 years). Incidence rates of MI were 4.20 (95% CI = 3.87–4.52) in the TT-treated cohort and 4.67 (95% CI = 4.43–4.90) in the untreated hypogonadal cohort. Cox regression model showed no significant association between TT use and MI when comparing TT-treated with untreated hypogonadal men overall (hazard ratio = 0.99, 95% CI = 0.89–1.09), by age, or by prior CVD. A significant association was observed when comparing a subgroup of injectable (short- and long-acting combined) TT users with untreated hypogonadal men (hazard ratio = 1.55, 95% CI = 1.24–1.93). Clinical ImplicationIn this study, there was no association between TT (overall) and risk of acute MI. Strengths and LimitationsStrengths included the use of a comprehensive real-world database, sophisticated matching based on calendar blocks of 6 months to decrease potential bias in this observational study, carefully chosen index dates for the untreated cohort to avoid immortal time bias, and implemented sensitivity analysis to further investigate the findings (stratification by administration route, age, and prior CVD). Key limitations included no information about adherence, hypogonadism condition based solely on diagnosis (no information on clinical symptoms or testosterone levels), lack of information on disease severity, inability to capture diagnoses, medical procedures, and medicine dispensing if corresponding billing codes were not generated and findings could contain biases or fail to generalize well to other populations. ConclusionThis large, retrospective, real-world observational study showed no significant association between TT use and acute MI when comparing TT-treated with untreated hypogonadal men overall, by age, or by prior CVD; the suggested association between injectable TT and acute MI deserves further investigation.Li H, Mitchell L, Zhang X, et al. Testosterone Therapy and Risk of Acute Myocardial Infarction in Hypogonadal Men: An Administrative Health Care Claims Study. J Sex Med 2017;14:1307–1317.

Cubital Tunnel Syndrome: Incidence and Demographics in a National Administrative Database.

Compressive neuropathy of the ulnar nerve at the elbow, or cubital tunnel syndrome (CuTS), is the second most common entrapment neuropathy of the upper extremity after carpal tunnel syndrome. While several studies have reported risk factors and outcomes for select populations (mostly surgical), it is difficult to interpret these data without an accurate measure of CuTS disease burden in the general population. To estimate the incidence of CuTS among US health plan enrollees, using a large administrative health care claims database comprised of individuals from all 50 states. An administrative database of commercial insurance beneficiaries was queried for diagnosis and treatment of CuTS over a 6-yr period. We examined subsequent claims to determine frequency of subsequent surgical treatment. Descriptive statistics were used to determine the association of incident cases and surgical treatment with age and gender. The estimated adjusted incidence rate of CuTS is 30.0 per 100 000 person-years. Of the 53 401 identified new cases within this cohort from 2006 to 2012, 41.3% were treated surgically. Incident cases were identified more frequently in men than in women (31.2 vs 28.8 cases per 100 000 person-years), though we observed more cases in women than in men below 50 yr of age (20.9 vs 19.5 cases per 100 000 person-years). Overall, incident cases increase with age in both men and women. In addition to incident cases being more common with increasing age, the percentage of cases treated surgically also increases with age (surgery in 34.4% of cases in the 18-30 yr group vs 48.8% of cases in the 60-65 yr group). The purpose of this study was to estimate the incidence of CuTS among US health plan enrollees. This is the largest published study on the incidence of CuTS, and the first to look at a US population. The overall adjusted incidence of CuTS was 30.0 per 100 000 person-years. Of patients who developed CuTS, 41.3% were treated surgically during the study period. Our results corroborate previously reported literature suggesting incidence increases significantly with age, with a slightly higher incidence in males. A high percentage of people who were diagnosed with CuTS and ended up receiving surgical intervention (41.3%) were older males. These results may aid practitioners in providing some basic prognostic information to patients who develop CuTS.

Immune Checkpoint Inhibition and the Prevalence of Autoimmune Disorders Among Patients With Lung and Renal Cancer.

PURPOSEImmune checkpoint inhibition reactivates the immune response against cancer cells in multiple tissue types and has been shown to induce durable responses. However, for patients with autoimmune disorders, their conditions can worsen with this reactivation. We sought to identify, among patients with lung and renal cancer, how many harbor a comorbid autoimmune condition and may be at risk of worsening their condition while on immune checkpoint inhibitors such as nivolumab and pembrolizumab.METHODSAn administrative health care claims database, Truven MarketScan, was used to identify patients diagnosed with lung and renal cancer from 2010 to 2013. We assessed patients for diagnosis of autoimmune diseases 1 year prior to or after diagnosis of cancer using International Classification of Diseases, Ninth Revision codes for 41 autoimmune diseases. Baseline characteristics and other comorbid conditions were recorded.RESULTSMore than 25% of patients with both lung and renal cancer had a comorbid autoimmune condition between 2010 and 2013 and were more likely to be women, older, and have more baseline comorbidities.CONCLUSIONSThis population presents a dilemma to physicians when deciding to treat with immune checkpoint inhibitors and risk immune-related adverse events. Future evaluation of real-world use of immune checkpoint inhibitors in patients with cancer with autoimmune diseases will be needed.

Cost per Treatment Success of Thrombopoietin Receptor Agonists Vs "Watch and Rescue" Strategy for Treating Adult Non-Splenectomized Patients with Chronic Immune Thrombocytopenia: A US Payer Perspective

Background:Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet count level and increased risk of bleeding. Non-splenectomized patients account for the vast majority of adult patients with ITP in US clinical practice (Cetin et al, Blood, 2014).Two thrombopoietin receptor agonists (TPO-RAs, romiplostim [once-weekly subcutaneous injection] and eltrombopag [once-daily oral agent]) are indicated for the treatment of non-splenectomized adults with chronic ITP who have had an insufficient response to corticosteroids or immunoglobulins. Both TPO-RAs have been shown to increase and maintain platelet counts and reduce the incidence of bleeding-related episode (BRE, defined as a bleeding event and/or use of rescue therapy).Using a US payer perspective and recent price and cost data, this analysis estimates the cost relative to treatment success (measured as overall platelet response) of the two TPO-RAs and a "watch and rescue" strategy (monitoring patients until rescue therapies [eg, intravenous immunoglobulin] are required) in non-splenectomized adults with chronic ITP.Methods:The analysis was conducted based on time horizon (24 weeks) and data for non-splenectomized patients of phase 3 registrational trials of romiplostim (Kuter et al, Lancet, 2008) and eltrombopag (Cheng et al, Lancet, 2011) in adult patients with chronic ITP.Rates of overall platelet response (see definitions based on number of weeks with platelet count ≥ 50 x 109/L in Cooper et al, Int J Technol Assess Health Care, 2014) were estimated using trial data (Kuter et al, Lancet, 2008; NICE Appraisal of Eltrombopag, 2012): 87.8% for romiplostim, 71.8% for eltrombopag, and 14.5% for "watch and rescue" (from pooled data for placebo arms).Drug acquisition cost was calculated using wholesale acquisition cost values as of July 16, 2015 ($5.8256 per mcg for romiplostim, $4.0824 per mg for eltrombopag 25 mg tablet, $3.9875 per mg for eltrombopag 50 or 75 mg tablet) and average dose in the trials (317 mcg/week for romiplostim [assuming 100% wastage of unused dose in an opened vial], 55 mg/day for eltrombopag).Costs for drug administration (for romiplostim only, once per week), physician visit and platelet count monitoring (for all three strategies, once per week in weeks 1-4 and once every 4 weeks in weeks 5-24), and liver function monitoring (for eltrombopag only, once every 2 weeks in weeks 1-4 and once every 4 weeks in weeks 5-24) were obtained from CMS Physician Fee Schedule (July 2015 release) and Clinical Laboratory Fee Schedule (January 2015 release).Cost of BREs (ie, cost for treating bleeding events and/or cost for rescue therapy) was derived on the basis of incidence rates of BRE (0.128 per patient-week for non-responder and 0.031 per patient-week for responder, calculated from data reported in Weitz et al, Curr Med Res Opin, 2012) and average treatment cost per BRE ($6,006, in inflation-adjusted June 2015 $) estimated from BREs identified during 2007-2013 in a study of a large US administrative healthcare claims database (Cetin et al, Blood, 2014).Cost per response was computed as total cost (summation of all the cost items aforementioned) divided by overall platelet response rate.Results:The cost per response results by treatment strategy are summarized in the Table. Compared to the "watch and rescue" strategy, use of any of the two TPO-RAs is associated with a fewer number of BREs, a lower cost for treating BREs, and a lower cost per response. Cost per response estimates of the two TPO-RAs are broadly comparable, with romiplostim associated with lower cost per response than eltrombopag.Conclusion:In non-splenectomized adults with chronic ITP, the use of TPO-RAs represents an efficient way in achieving treatment success, with lower cost per treatment success than the "watch and rescue" strategy.Table 1Cost per Response by Treatment Strategy (time horizon: 24 weeks; 2015 $)RomiplostimEltrombopag"Watch and rescue"Drug acquisition cost$44,321$37,0330Drug administration cost$60000Physician visit and platelet count monitoring cost$711$711$711Liver function monitoring cost0$770Average number of BREs1.031.402.74Cost of BREs$6,164$8,418$16,464Total cost$51,796$46,239$17,175Overall response rate87.8%71.8%14.5%Cost per response$58,990$64,432$118,314 DisclosuresLi:Amgen, Inc.: Employment, Equity Ownership. Sharma:Amgen Inc.: Employment, Other: stock ownership. Zhang:Amgen Inc.: Other: Internship. Campioni:Amgen Inc.: Employment, Other: stock ownership. Fust:Amgen Inc.: Consultancy, Research Funding; Optum: Employment. Lin:Amgen Inc.: Employment, Other: stock ownership. Parthan:Optum: Employment; Amgen Inc.: Consultancy, Research Funding. Wang:Amgen Inc.: Employment, Other: stock ownership. Zur:Optum: Employment; Amgen Inc.: Consultancy, Research Funding. Cetin:Amgen, Inc: Employment, Equity Ownership. Eisen:Amgen Inc: Employment, Other: stock ownership.

Role of pharmacoepidemiology studies in addressing pharmacovigilance questions: a case example of pancreatitis risk among ulcerative colitis patients using mesalazine.

PurposeWell-designed pharmacoepidemiology studies address several limitations of postmarketing spontaneous reports in regard to signal evaluation. This study evaluated a signal of disproportionate reporting of acute pancreatitis cases observed in patients with ulcerative colitis (UC) treated with MMX Multi Matrix System® (MMX®) mesalazine and demonstrated how inherent limitations of postmarketing reports were overcome.MethodsAdults with UC who were new users of MMX mesalazine or another branded mesalazine (controlled-release, delayed-release, or extended-release mesalazine; balsalazide disodium; olsalazine sodium; sulfasalazine; or sulfasalazine delayed-release) were identified from a large US administrative healthcare claims database. Acute pancreatitis incidence rates were compared between patients on MMX mesalazine versus comparator therapies. Propensity scores were used to match patients on MMX mesalazine with patients on comparator drugs to achieve a balance of baseline patient factors.ResultsCrude incidence rates [95 % confidence interval (CI)] of acute pancreatitis among patients on MMX mesalazine were similar to those of patients on comparator therapies [8.55 (5.54–13.21) vs 10.05 (7.54–13.41) per 1000 person-years]; the resulting incidence rate ratio (IRR) was [0.85 (0.48–1.47)]. Propensity score-matching had little influence on the IRR [0.84 (0.46–1.55)]; nor did further adjustment by demographic characteristics, daily dose, and causes of acute pancreatitis [0.76 (0.41–1.43)].ConclusionFindings of no increase in pancreatitis risk with MMX mesalazine demonstrate the value of pharmacoepidemiology studies for evaluating a drug’s postmarket safety profile when confronted with spontaneous reporting data suggestive of a safety issue.Electronic supplementary materialThe online version of this article (doi:10.1007/s00228-014-1660-7) contains supplementary material, which is available to authorized users.

Pneumocystis pneumonia incidence in metastatic solid tumor and lymphoma patients from an administrative health care claims database.

e12500 Background: Pneumoncystis jiroveci pneumonia (PJP) causes severe, often life-threatening illness in immunocompromised patients, including patients with cancer. PJP incidence estimates have been reported for several different cancer types based on case series from single institutions. In order to obtain incidence estimates from a larger pool of patients, we studied PJP claims among patients with metastatic solid tumors (MSTs) or lymphomas in a large administrative healthcare claims database. Methods: Adults diagnosed with MSTs or lymphomas between January 1999-September 2011 were identified in the MarketScan commercial, Medicare supplemental and Medicaid databases based on ICD-9 diagnosis codes. First PJP after cancer diagnosis was defined by PJP ICD-9 code (136.3) associated with an inpatient hospital stay of at least 1 day. Patients with a PJP claim before their cancer diagnosis were excluded. PJP incidence proportions and rates (with 95% CIs) were calculated by age group, sex, HIV status, and tumor type. Results: There were 158 PJP cases (0.04%) among 392,369 HIV-negative MST patients, an incidence rate of 3.0/10,000 pt-yrs (95% CI 2.6-3.5). Incidence rates by metastatic cancer type were 6.8/10,000 pt-yrs for lung, 5.4/10,000 pt-yrs for pancreas, 4.1/10,000 pt-yrs for prostate, 3.0/10,000 pt-yrs for breast, and 0.9/10,000 pt-yrs each for colorectal and ovary. There were 337 PJP cases (0.21%) among 162,799 HIV-negative lymphoma patients, an incidence rate of 9.4/10,000 pt-yrs (95% CI 8.5-10.5). Incidence was higher among males compared to females in both MST and lymphoma patients. PJP incidence rates in HIV-positive patients were approximately 14 times higher than in HIV-negative patients. Conclusions: PJP is a rare occurrence among patients with MSTs or lymphomas. In this analysis of a large administrative healthcare claims database, PJP incidence was higher among lymphoma patients compared to MST patients. Incidence estimates were lower than reports from institutional case series, but patterns of occurrence were consistent in terms of higher incidence in patients with lymphomas or HIV. Differences in incidence by tumor type were also observed among MST patients.