US Commercial Insurance Claims Database Research Articles

Development and evaluation of an algorithm to link mothers and infants in two US commercial healthcare claims databases for pharmacoepidemiology research

BackgroundAdministrative healthcare claims databases are used in drug safety research but are limited for investigating the impacts of prenatal exposures on neonatal and pediatric outcomes without mother-infant pair identification. Further, existing algorithms are not transportable across data sources. We developed a transportable mother-infant linkage algorithm and evaluated it in two, large US commercially insured populations.MethodsWe used two US commercial health insurance claims databases during the years 2000 to 2021. Mother-infant links were constructed where persons of female sex 12–55 years of age with a pregnancy episode ending in live birth were associated with a person who was 0 years of age at database entry, who shared a common insurance plan ID, had overlapping insurance coverage time, and whose date of birth was within ± 60-days of the mother’s pregnancy episode live birth date. We compared the characteristics of linked vs. non-linked mothers and infants to assess similarity.ResultsThe algorithm linked 3,477,960 mothers to 4,160,284 infants in the two databases. Linked mothers and linked infants comprised 73.6% of all mothers and 49.1% of all infants, respectively. 94.9% of linked infants’ dates of birth were within ± 30-days of the associated mother’s pregnancy episode end dates. Characteristics were largely similar in linked vs. non-linked mothers and infants. Differences included that linked mothers were older, had longer pregnancy episodes, and had greater post-pregnancy observation time than mothers with live births who were not linked. Linked infants had less observation time and greater healthcare utilization than non-linked infants.ConclusionsWe developed a mother-infant linkage algorithm and applied it to two US commercial healthcare claims databases that achieved a high linkage proportion and demonstrated that linked and non-linked mother and infant cohorts were similar. Transparent, reusable algorithms applied to large databases enable large-scale research on exposures during pregnancy and pediatric outcomes with relevance to drug safety. These features suggest studies using this algorithm can produce valid and generalizable evidence to inform clinical, policy, and regulatory decisions.

The Epidemiology of Platelet-Rich Plasma Injections From 2010 to 2020 in a Large US Commercial Insurance Claims Database: A Recent Update.

The popularity of platelet-rich plasma (PRP) injections for the treatment of orthopaedic conditions has grown markedly. We sought to better define the trends in the usage of orthopaedic PRP injections across an insured US population over the past decade. The PearlDiver M91Ortho commercial administrative claims database was queried for all patients receiving PRP injections for orthopaedic conditions from 2010 through the first quarter of 2020 (Q1.2020). Trends in PRP use, reimbursement charges, demographics, joints injected, and administering physicians were assessed over time and reported as year-over-year (YOY) changes. Over the study period, 14,096 unique patients had 17,759 orthopaedic PRP injections. The number of PRP injections administered had a YOY increase of 7.1% (144 injections/year, 95% confidence interval [CI] = 89 to 199, Ptrend = 0.0009). A YOY increase of 895% was observed in total nonsurgical charges ($683,974/yr, 95% CI 441,504 to 926,444, Ptrend = 0.0009). The median age of PRP recipients increased (YOY change = +0.6 years, 95% CI 0.4 to 0.8, Ptrend = 0.0005). Injections to the elbow (YOY change = -0.8%, 95% CI -0.10% to [-0.06%], Ptrend = 0.005) and foot/ankle (YOY change = -1.0%, 95% CI -1.4% to [-0.06%], Ptrend = 0.002) decreased, whereas hip (YOY change = +0.4%, 95% CI 0.2% to 0.6%, Ptrend = 0.019), knee (YOY change = +0.9%, 95% CI 0.3% to 1.2%, Ptrend = 0.016), and spine (YOY change = +0.2%, 95% CI 0.0% to 0.4%, Ptrend = 0.033) injections increased. PRP injections given by sports medicine orthopaedic surgeons (YOY change = +0.8%, 95% CI 0.6% to 1.2%, Ptrend <0.0001) increased over time, whereas those by general orthopaedic surgeons decreased (YOY change = -0.9, 95% CI -1.2 to [-0.6%], Ptrend = 0.001). PRP injections quadrupled in prevalence from 2010 to Q1.2020, with a projected increase in annual usage in this data set of 66% by 2030. As greater evidence-based indications for PRP use are identified, more specialists and insurance providers may consider expanding their involvement in this growing field. III, retrospective cohort study.

Abstract 195: The Effect Of Phosphodiesterase-5 Inhibitors On Major Adverse Cardiovascular Events And Mortality In A Large Cohort Of Men With Erectile Dysfunction From A Nationwide Insurance Database: A Retrospective Study

Background: Phosphodiesterase type 5 inhibitor (PDE-5i) medications are effective in treating Erectile Dysfunction (ED) for tens of millions of men in the US and worldwide. The objective of this study was to determine the effect of PDE-5is on the incidence of major adverse cardiovascular events (MACE) (composite outcome of cardiovascular (CV) death, hospitalization for myocardial infarction, coronary revascularization, stroke, heart failure, or unstable angina pectoris) and all-cause death. Methods: A retrospective observational cohort study was conducted in a large US commercial and Medicare insurance claims database in men with ≥1 diagnosis of ED without prior MACE hospitalization within 1 year from Jan 2006 to Oct 2020. The exposed group had ≥1 claim for PDE-5i; the unexposed group had no claims for PDE-5i and were matched 2:1 on baseline risk variables. The primary outcome was MACE and secondary outcome was all-cause death, determined by multivariate Cox proportional hazard modeling. Death data were obtained via National Death Index linkage. Results: In this population, MACE was reduced by 13% in men exposed (n=23,816) to PDE-5is (hazard ratio (HR) 0.87; 95% Confidence Interval (CI) 0.79-0.95) vs. non-exposure (n=48,682) over mean follow up of 29 and 37 months, respectively. This was driven by reductions in coronary revascularization (HR 0.85; 0.73-0.98), heart failure (HR 0.83; 0.72-0.97), unstable angina (HR 0.78; 0.64-0.96), and CV death (HR 0.61; 0.41-0.90). PDE-5i-exposed men had a 25% reduction in all-cause death (HR 0.75; 0.65-0.87). Men without coronary artery disease but with CV risk factors at baseline showed a similar pattern. In the main study cohort, men in the highest quartile of PDE-5i exposure had the greatest reductions in MACE (HR 0.45; 0.37-0.54) and all-cause death (HR 0.51; 0.37-0.71) vs. the lowest exposure quartile. In a subgroup with baseline type 2 diabetes (n=6,305), PDE-5i exposure was associated with a lower MACE risk (HR 0.79; 0.64-0.97). All comparisons are significant at p&lt;0.05. Conclusions: In a large population of US men with ED, PDE-5i exposure was associated with reductions in MACE, CV death, and overall death risk compared to non-exposure. Risk reduction was positively correlated with PDE-5i exposure level.

Evaluation of treatment patterns, healthcare resource utilization, and costs among patients receiving treatment for cytomegalovirus following allogeneic hematopoietic cell or solid organ transplantation

Aim Management of cytomegalovirus (CMV) infection/disease in transplant recipients may be complicated by toxicities and resistance to conventional antivirals, adding to the overall healthcare burden. We characterized treatment patterns, healthcare resource utilization (HCRU), and costs to elucidate the healthcare burden associated with CMV therapies post-transplant. Materials and methods A retrospective, longitudinal cohort study of transplant recipients using data from a US commercial insurance claims database (2013–2017) was conducted. Patients with a claim for post-transplant CMV diagnosis and anti-CMV treatment (ganciclovir, valganciclovir, foscarnet, or cidofovir) were identified (Treated CMV cohort) and compared with patients with neither a claim for CMV diagnosis nor anti-CMV treatment (No CMV cohort) for outcomes including HCRU and associated costs. Allogeneic hematopoietic cell transplantation (HCT) or solid organ transplantation (SOT) recipients were analyzed separately. Anti-CMV treatment patterns were assessed in the Treated CMV cohort. Costs were evaluated among subgroups with myelosuppression or nephrotoxicity. Results Overall, 412 allogeneic HCT and 899 SOT patients were included in the Treated CMV cohorts, of which 41.7% and 52.5%, respectively, received multiple antiviral courses. Treated CMV cohorts compared with No CMV cohorts had higher mean monthly healthcare visits per patient (allogeneic HCT: 8.83 vs 6.61, SOT: 5.61 vs 4.45) and had an incremental adjusted mean monthly cost per patient differences of $8,157 (allogeneic HCT, p < .004) and $2,182 (SOT, p < .004). Among Treated CMV cohorts, HCRU and costs increased with additional CMV antiviral treatment courses. Mean monthly costs were higher for patients with than without myelosuppression or nephrotoxicity. Limitations Results may not be generalizable to patients covered by government insurance or outside the USA. Conclusions CMV post-transplant managed with conventional treatment is associated with substantial HCRU and costs. The burden remains particularly high for patients requiring multiple treatment courses for post-transplant CMV or for transplant recipients who develop myelosuppression or nephrotoxicity.

Trends in treatment patterns and costs of care among patients with advanced stage cervical cancer

BackgroundCurrent treatments for recurrent or metastatic cervical cancer (r/mCC) do not offer satisfactory clinical benefits, with most patients progressing beyond first-line (1L) treatment. With new treatments under investigation, understanding current treatment patterns, the impact of newly approved therapies, and total costs of care for r/mCC are important. MethodsA retrospective analysis of a US commercial insurance claims database to identify adult patients with r/mCC between 2015 and Q1–2020; defining 1L treatment as the first administration of systemic treatment without concomitant chemoradiation or surgery. Patient characteristics, treatment regimens, duration of therapy, and total costs of care were evaluated for each line of therapy. Results1323 women initiated 1L treatment for r/mCC (mean age, 56.1 years; mean follow-up, 16.5 months). One-third (n = 438) had evidence of second-line (2L) treatment; of these, 129 (29%) had evidence of third-line (3L) treatment. No regimen represented a majority among 2L+ treatments. The 2018 approval of pembrolizumab led to increased 2L immunotherapy use (0% in 2015, 37% in 2019/Q1–2020). However, only a small proportion of patients stayed on immunotherapy for a prolonged period. Mean per-patient-per-month total costs of care during treatment were $47,387 (1L), $77,661 (2L), and $53,609 (3L), driven primarily by outpatient costs. ConclusionsNo clear standard of care was observed in 2L+. Although immunotherapy is increasingly used in 2L+, only a small subset of patients stayed on immunotherapy for a prolonged period, suggesting a need for more therapeutic options. Better understanding of disease biology and the introduction of new therapies may address these unmet needs.

Accuracy of identifying diagnosis of moderate to severe chronic kidney disease in administrative claims data.

Prior validation studies of claims-based definitions of chronic kidney disease (CKD) using ICD-9 codes reported overall low sensitivity, high specificity, and variable but reasonable PPV. No studies to date have evaluated the accuracy of ICD-10 codes to identify a US patient population with CKD. We assessed the accuracy of claims-based algorithms to identify adults with CKD Stages 3-5 compared with laboratory values in a subset (~40%) of a US commercial insurance claims database (Optum's de-identified Clinformatics® Data Mart Database). We calculated the positive predictive value (PPV) of one or two ICD-9 (2012-2014) or ICD-10 (2016-2018) codes for CKD compared with a lab-based estimated glomerular filtration rate (eGFR) occurring within prespecified windows (±90 days, ±180 days, ±365 days) of the ICD-based CKD code(s). The study population ranged between 104 774 and 161 305 patients (ICD-9 cohorts) and between 285 520 and 373 220 patients (ICD-10 cohorts). The mean age was 74.4 years (ICD-9) and 75.6 years (ICD-10) and the median eGFR was 48 ml/min/1.73 m2 . The algorithm of two CKD codes compared with a lab value ±90 days of the first code achieved the highest PPV (PPV 86.36% [ICD-9] and 86.07% [ICD-10]). Overall, ICD-10 based codes had comparable PPVs to ICD-9 based codes and all ICD-10 based algorithms had PPVs >80%. The algorithm of one CKD code compared with laboratory value ±180 days maintained the PPV above 80% but still retained a large number of patients (PPV 80.32% [ICD-9] and 81.56% [ICD-10]). An ICD-10-based definition of CKD identified with sufficient accuracy a patient population with CKD Stages 3-5. Our findings suggest that claims databases could be used for future real-world research studies in patients with CKD Stages 3-5.

Real-world patterns of pegloticase use for treatment of gout: descriptive multidatabase cohort study

ObjectivePegloticase is used in severe refractory gout or in cases of intolerance to other urate-lowering therapies. We sought to evaluate the patterns of pegloticase use in the USA and the...

Effectiveness and safety of apixaban, low-molecular weight heparin, and warfarin among high-risk subgroups of venous thromboembolism patients with active cancer

Abstract Background Cancer-associated venous thromboembolism (VTE) carries a high risk for recurrent events and major bleeding (MB) which further increases among some high-risk subgroups of patients. Purpose This study evaluates recurrent VTE and MB among VTE patients with active cancer within 6 months of initiating apixaban, low-molecular weight heparin (LMWH), or warfarin stratified by cancer type, cancer treatment, and VTE characteristics. Methods Four US commercial insurance claims databases were pooled to identify VTE patients with active cancer (defined as ≥1 claim with cancer diagnosis [any stage] or cancer treatment [chemotherapy, radiation, and cancer-related surgery] within 6 months before to 30 days after VTE diagnosis). Patients who initiated apixaban, LMWH, or warfarin within 30 days following the first VTE event (01SEP2014–31MAR2018) were included. Treatment cohorts were balanced using stabilized inverse probability treatment weighting (IPTW). Cox proportional hazards models were used to estimate hazard ratios of recurrent VTE and MB for each subgroup stratification: metastatic diagnosis, cancer treatment, chemotherapy, upper and lower gastrointestinal (GI) cancer, and VTE event type (PE with or without deep vein thrombosis [DVT] versus DVT only). Statistical significance (P&amp;lt;0.10) of the interaction between the subgroup strata and outcomes were evaluated. Results A total of 3,393 apixaban, 6,108 LMWH, and 4,585 warfarin patients were identified with a mean follow-up of 105–166 days across cohorts. After IPTW, all patient characteristics were balanced. In the overall population, apixaban had a lower risk of recurrent VTE and MB vs. LMWH. Warfarin had a similar risk of recurrent VTE and MB vs. LMWH. Apixaban had a lower risk of recurrent VTE and a similar risk of MB vs. warfarin (Figure). Analyses stratified by metastatic diagnosis, cancer treatment, chemotherapy, VTE event type, and GI cancer show generally consistent results across the subgroups (most of the p values for interaction &amp;gt;0.10) and with the overall population. There was a significant interaction in cancer treatment strata: apixaban trended towards a lower risk of MB vs. LMWH with or without cancer treatment; however, patients without cancer treatment had a larger difference vs. patients with cancer treatment. Two significant interactions were observed in metastatic diagnosis strata: apixaban and warfarin had a lower risk of recurrent VTE vs. LMWH in patients without a metastatic diagnosis whereas apixaban and warfarin had similar risk of recurrent VTE vs. LMWH in patients with a metastatic diagnosis (Figure). Conclusion Across these high-risk subgroups of VTE cancer patients, apixaban generally had a lower risk of recurrent VTE and MB vs. LMWH and lower risk of recurrent VTE compared to warfarin. Warfarin patients generally had a similar risk of recurrent VTE and MB vs. LMWH. The findings are generally consistent with the overall population results. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Pfizer Inc. and Britstol-Myers Squibb Company.

PSU22 INFECTIONS AND REOPERATIONS AFTER HAMMERTOE SURGERY IN A NATIONWIDE US COMMERCIAL INSURANCE CLAIMS DATABASE

This study evaluated the rates of infections and reoperations after hammertoe surgery and calculated one- and two-year incremental payments associated with infections and reoperations in a nationwide US commercial insurance claims database.

Risk of Operative and Nonoperative Interventions Up to 4 Years After Roux-en-Y Gastric Bypass vs Vertical Sleeve Gastrectomy in a Nationwide US Commercial Insurance Claims Database

There are few nationwide studies comparing the risk of reintervention after contemporary bariatric procedures. To compare the risk of intervention after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). This cohort study used a nationwide US commercial insurance claims database. Adults aged 18 to 64 years who underwent a first RYGB or VSG procedure between January 1, 2010, and June 30, 2017, were matched on US region, year of surgery, most recent presurgery body mass index (BMI) category (based on diagnosis codes), and baseline type 2 diabetes. The prematch pool included 4496 patients undergoing RYGB and 8627 patients undergoing VSG, and the final weighted matched sample included 4476 patients undergoing RYGB and 8551 patients undergoing VSG. Bariatric surgery procedure type (RYGB vs VSG). The primary outcome was any abdominal operative intervention after the index procedure. Secondary outcomes included the following subtypes of operative intervention: biliary procedures, abdominal wall hernia repair, bariatric conversion or revision, and other abdominal operations. Nonoperative outcomes included endoscopy and enteral access. Time to first event was compared using multivariable Cox proportional hazards regression modeling. Among 13 027 patients, the mean (SD) age was 44.4 (10.3) years, and 74.1% were female; 13.7% had a preoperative BMI between 30 and 39.9, 45.8% had a preoperative BMI between 40 and 49.9, and 24.2% had a preoperative BMI of at least 50. Patients were followed up for up to 4 years after surgery (median, 1.6 years; interquartile range, 0.7-3.2 years), with 41.9% having at least 2 years of follow-up and 16.3% having at least 4 years of follow-up. Patients undergoing VSG were less likely to have any subsequent operative intervention than matched patients undergoing RYGB (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.72-0.89) and similarly were less likely to undergo biliary procedures (aHR, 0.77; 95% CI, 0.67-0.90), abdominal wall hernia repair (aHR, 0.60; 95% CI, 0.47-0.75), other abdominal operations (aHR, 0.71; 95% CI, 0.61-0.82), and endoscopy (aHR, 0.54; 95% CI, 0.49-0.59) or have enteral access placed (aHR, 0.58; 95% CI, 0.39-0.86). Patients undergoing VSG were more likely to undergo bariatric conversion or revision (aHR, 1.83; 95% CI, 1.19-2.80). In this nationwide study, patients undergoing VSG appeared to be less likely than matched patients undergoing RYGB to experience subsequent abdominal operative interventions, except for bariatric conversion or revision procedures. Patients considering bariatric surgery should be aware of the increased risk of subsequent procedures associated with RYGB vs VSG as part of shared decision-making around procedure choice.

Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases

Safety and Effectiveness of Apixaban, LMWH, and Warfarin Among Venous Thromboembolism Patients with Active Cancer: A Retrospective Analysis Using Four US Claims Databases

Safety and Effectiveness of Apixaban, LMWH and Warfarin Among Venous Thromboembolism (VTE) Patients with Active Cancer: A Subgroup Analysis of VTE Risk Scale

Safety and Effectiveness of Apixaban, LMWH and Warfarin Among Venous Thromboembolism (VTE) Patients with Active Cancer: A Subgroup Analysis of VTE Risk Scale

Association of the extent of therapy with prostate cancer in those receiving testosterone therapy in a US commercial insurance claims database.

Conflicting evidence remains in the association of testosterone therapy (TTh) with prostate cancer (PCa). This inconsistency maybe due, in part, to the small sample sizes from previous studies and an incomplete assessment of comorbidities, particularly diabetes. We investigated the association of PCa with TTh (injection or gel) and different TTh doses and determined whether this association varies by the presence of diabetes at baseline in a large, nationally representative, commercially insured cohort. We conducted a retrospective cohort study of 189491 men aged 40-60years old in the IBM MarketScan® Commercial Database, which included 1424 PCa cases diagnosed from 2011 to 2014. TTh was defined using CPT codes from inpatient and outpatient, and NDC codes from pharmacy claims. Multivariable adjusted Cox proportional hazards models were used to compute hazard ratios for patients with incident PCa. We found a 33% reduced association of PCa after comparing the highest category (>12) of TTh injections with the lowest (1-2 injections) category (HR=0.67, 95% CI: 0.54-0.82). Similar statistical significant inverse association for PCa was observed for men who received TTh topical gels (>330 vs 1- to 60-days supply). Among nondiabetics, we found significant inverse association between TTh (injection and gel) and PCa, but a weak interaction between TTh injections and diabetes (P=.05). Overall, increased use of TTh is inversely associated with PCa and this remained significant only among nondiabetics. These findings warrant further investigation in large randomized placebo-controlled trials to infer any health benefit by TTh.

Risk of Developing Additional Immune-Mediated Manifestations: A Retrospective Matched Cohort Study.

IntroductionImmune-mediated inflammatory diseases (IMIDs) cause significant impairment in quality of life. Although they share similar genetic factors, environmental precipitants, and pathophysiological mechanisms, there is little evidence on the risk of developing subsequent IMIDs after an initial IMID diagnosis. We sought to assess the risk of developing subsequent IMIDs among patients diagnosed with an initial IMID.MethodsThis retrospective matched cohort study used a large US commercial health insurance claims database (01/01/2006–09/30/2015). The risks of developing secondary IMIDs among patients aged 18–64 years with a diagnosis of one of nine IMIDs of interest (ankylosing spondylitis, celiac disease, hidradenitis suppurativa [HS], inflammatory bowel disease, lupus, psoriatic arthritis [PsA], psoriasis, rheumatoid arthritis, and uveitis) as identified from diagnosis codes on medical claims were compared with up to 1000 matched controls without the primary IMID using Cox proportional hazards models.ResultsAcross the nine IMIDs of interest, there were 398,935 unique case patients matched to 256,795,796 non-unique control patients. Case patients with an initial IMID had higher risks of developing each, any one, and any two of the other eight secondary IMIDs compared to their matched controls. Hazard ratios [95% confidence intervals] for the risk of developing any one secondary IMID ranged from 5.4 [5.0, 5.8] (initial IMID: HS) to 62.2 [59.9, 64.6] (initial IMID: PsA), and hazard ratios for developing any two secondary IMIDs ranged from 3.0 [2.3, 3.8] (HS) to 75.2 [69.3, 81.7] (PsA).ConclusionsThis study demonstrates that the risk of developing a second IMID is significantly higher for individuals who have already experienced a first IMID in a large and contemporary US claims database. Certain pairs of IMIDs co-occur more frequently than others. The risk of developing subsequent IMIDs may be an important consideration for clinicians when selecting treatment strategies.FundingAbbvie.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-00964-z) contains supplementary material, which is available to authorized users.

Incidence and prevalence of neuroendocrine tumors of the lung: analysis of a US commercial insurance claims database

BackgroundAs reported in Surveillance, Epidemiology, and End Results (SEER) data, US incidence and prevalence of neuroendocrine tumors (NET) has increased over recent years. The study objective was to update incidence and prevalence information for lung NET using administrative claims.MethodsThis descriptive epidemiological study used 2009–2014 data from 2 US claims databases: MarketScan and PharMetrics. Patients (18–64 years old) had ≥1 inpatient or ≥ 2 outpatient claims with NET of bronchus or lung, identified by International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes. Prevalence was number of lung NET patients divided by number of enrollees/year. Incidence was number of patients with a first observed NET diagnosis who were disease-free for 2 years prior, divided by number of enrollees. Age and gender adjustments performed.ResultsThe annual number of patients with lung NET identified from 2009 to 2014 ranged from 435 to 796 (MarketScan) and 419–648 (PharMetrics). In MarketScan, there was a 7.4% (95%CI 2.1–13.0; p = 0.027) annual percent change (APC) in the age-adjusted incidence for males and 6.8% (− 0.2–14.3; 0.052) for females. In PharMetrics, APC was − 2.9% (− 13.8–9.4; 0.395) for males; 14.7% (− 12.9–51.2; 0.165) for females. In MarketScan, APC in age-adjusted prevalence for males was 9.9% (4.7–15.3; 0.006); 16.2% (11.4-21.1; <.001) for females. For PharMetrics, APCs were 9.5% (2.3–17.2; 0.021) for males; 16.3% (9.6–23.5; 0.002) for females.ConclusionsFrom 2009 to 2014 there was a statistically significant increase in age-adjusted lung NET incidence for males in MarketScan, and a statistically significant increase in age-adjusted prevalence for both genders in PharMetrics. Incidence and prevalence changes, to the extent they exist, may be due to better diagnostic methods, increased awareness of NET among clinicians and pathologists, and/or an actual increase in US disease occurrence. Differences in rates across databases are difficult to explain. These results suggest the need for awareness of the clinically effective and safe treatment options available for lung NET patients among healthcare providers.

Medical therapies for heavy menstrual bleeding in women with uterine fibroids: a retrospective analysis of a large commercially insured population in the USA

To report patterns and patient characteristics associated with initiation of and persistence with medical therapies for uterine fibroid-related heavy menstrual bleeding. Retrospective cohort study. US commercial insurance claims database. 41561 women aged 18-54years with uterine fibroids and heavy menstrual bleeding who initiated medical therapies from January 2000 through December 2013. Multinomial logistic regression was used to assess patient characteristics associated with initiation and persistence. Cox proportional hazards regression was used on propensity score-matched cohorts to examine change from index medication. Initiation of and persistence with four first-line medical therapies: short- and long-acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid. Most women (79.4%) took short-acting reversible contraceptive steroids as first-line therapy (index medication), whereas 9.5%, 8.5%, and 2.7% used long-acting reversible contraceptive steroids, leuprolide acetate, and tranexamic acid, respectively. During follow-up, 16594 women (39.9%) switched to nonindex medication (18.4%) or procedural treatment (81.6%). In comparison with women taking short-acting steroids, those receiving long-acting steroids were less likely to switch [hazard ratio (HR) 0.84, 95% CI 0.79-0.91], whereas women taking leuprolide acetate (HR 2.44, 95% CI 2.27-2.62) or tranexamic acid (HR 1.44, 95% CI 1.26-1.65) were more likely to switch. Older age, emergency department visits, anaemia, and inflammatory disease diagnoses at baseline were associated with increased probability of discontinuing the index medication or switching to another therapy. Women with uterine fibroid-related heavy menstrual bleeding were more likely to persist with their initial therapy of long-acting reversible contraceptive steroid compared with other medical options. 80% women with fibroid-related heavy menstrual bleeding use SARC, but LARC users are more persistent.

Cardiovascular Burden and Medication Use Among Patients With Idiopathic Pulmonary Fibrosis

SESSION TITLE: Evaluation and Treatment of ILD SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM PURPOSE: Patients with idiopathic pulmonary fibrosis (IPF) often have a number of cardiovascular risk factors and comorbidities and take a variety of related concomitant medications. The objective of this analysis was to describe the type and prevalence of specific cardiovascular risk factors/comorbidities and related medication use in patients with IPF. METHODS: We conducted a descriptive cross-sectional analysis using a large US commercial insurance claims database to identify a cohort of patients with IPF between 2009 and 2011. We included patients with ≥ 1 inpatient claim or ≥ 2 outpatient claims with IPF (ICD-9-CM code 516.3) as one of the listed diagnoses and continuous enrollment during the identification (ID) year. Patients who had another type of interstitial lung disease after their last IPF claim in the ID year were excluded. Measures that were reported in the ID year included age, sex, health plan, usual physician specialty and cardiovascular risk factors/comorbidities and related medication use (over-the-counter medications such as aspirin were not captured). We generated descriptive results for the combined and individual ID years. RESULTS: We identified 3619 patients with IPF from 2009 to 2011: 1191 in 2009, 1292 in 2010 and 1136 in 2011. Mean (standard deviation) age was 70.4 (11.0) years, 50.5% were women, 62.6% had Medicare coverage and 49.5% received usual IPF care from a pulmonologist. Cardiovascular risk factors/comorbidities were common among patients with IPF, with ischemic heart disease being the most prevalent condition (35.7%) followed by congestive heart failure (26.8%), cerebrovascular disease (15.7%), peripheral vascular disease (11.0%), diabetes with chronic complications (9.4%), pulmonary hypertension (8.6%) and myocardial infarction (7.3%). Use of cardiovascular-related medication was evident for three-quarters of patients (74.6%): anti-hyperlipidemics (46.8%), diuretics (37.6%), renin-angiotensin inhibitors (35.5%), beta blockers (33.0%), calcium channel blockers (24.3%), anti-thrombotic agents (23.2%), anti-diabetic agents (21.6%), nitrates (9.3%), smoking cessation drugs (4.3%), anti-arrhythmic agents (3.5%) and pulmonary hypertension agents (3.0%). Results by ID year showed similar patterns. CONCLUSIONS: Cardiovascular risk factors/comorbidities and related medication use were highly prevalent among patients with IPF. These considerations should be taken into account in the overall management of patients with IPF. CLINICAL IMPLICATIONS: It is important to assess cardiovascular risk factors/comorbidities and concomitant use of related medications in the management of patients with IPF. DISCLOSURE: Karina Raimundo: Employee: Genentech, Inc. Michael Broder: Employee: Partnership for Health Analytic Research, LLC, paid by Genentech Eunice Chang: Employee: Partnership for Health Analytic Research, LLC, paid by Genentech Sheila Reddy: Employee: Partnership for Health Analytic Research, LLC, paid by Genentech Elya Papoyan: Employee: Partnership for Health Analytic Research, LLC, paid by Genentech John Stauffer: Employee: Genentech, Inc. No Product/Research Disclosure Information

Trends and Determinants of Oral Anti-Diabetic Initiation in Youth with Suspected Type 2 Diabetes.

ObjectiveTo evaluate trends and identify predictors of treatment initiation of oral anti-diabetic drugs (OAD) in youth.Patients and MethodsWe identified a select population of children, ages 8–18 years, with at least 13 months of continuous health plan coverage within the years 2001–2012 in a large US commercial insurance claims database. New use of an OAD was defined as the first claim for an outpatient dispensing following a 12-month wash out period. Treatment incidence was estimated monthly over the study period, and stratified by age, gender, geographic region, and provider specialty.ResultsThe median size of the source population during the study period was 2.2 million children. A total of 13,824 initiators (mean monthly incidence of 4.6 (95% CI = 3.6, 5.5) per 100,000 youths) were identified. Initiators were more likely to be females, age 15–18, from the southern region, and have visited a family practitioner (versus a general pediatrician) prior to initiation. Time trends demonstrate a 43% increase in initiation from 2002–2012, with a gradual decrease starting from early 2008.ConclusionIncidence of filled OAD medications in youth increased over time, especially for patients treated by family practitioners. Additional research is needed into factors influencing prescribing by family practitioners and pediatricians.

Lower 30-day readmission rates with roflumilast treatment among patients hospitalized for chronic obstructive pulmonary disease.

BackgroundFew data exist related to the impact of roflumilast on health care utilization. This retrospective study estimated 30-day hospital readmission rates between patients who did and did not use roflumilast among those with COPD hospitalizations.MethodsData were from MarketScan, a large US commercial health insurance claims database. Patients aged ≥40 years with at least one hospitalization for COPD between 2010 and 2011 were included. The roflumilast group included patients who used roflumilast within 14 days after the first hospitalization (index), while the comparison group (non-roflumilast) included patients who did not use roflumilast during the study period. Continuous enrollment for at least 6 months before and 30 days after the index date was required. The 30-day hospitalization rate was calculated after the index hospitalization. Conditional logistic regression with propensity score 1:3 matching was employed to assess the difference in 30-day hospital readmission rates between the roflumilast and non-roflumilast groups, adjusting for baseline characteristics, comorbidity, health care utilization, and COPD medication use within 14 days after the index date.ResultsA total of 15,755 COPD patients met the selection criteria, ie, 366 (2.3%) in the roflumilast group and 15,389 (97.7%) in the non-roflumilast group. The mean (± standard deviation) age was 71±12.5 years and 52% were female. After propensity score matching, all-cause 30-day hospitalization rates were 6.9% and 11.1% in the roflumilast and non-roflumilast groups, respectively. COPD-related 30-day hospitalization rates were 6.3% and 9.2% in the roflumilast and non-roflumilast groups, respectively. Conditional logistic regression identified a significantly lower likelihood of all-cause 30-day readmission (odds ratio 0.59, 95% confidence interval 0.37–0.93, P=0.023) for roflumilast patients relative to non-roflumilast patients.ConclusionThis study showed, in a real-world setting, that use of roflumilast was associated with a lower rate of hospital readmission within 30 days among patients hospitalized for COPD.

Treatment Patterns Among Patients with Myelodysplastic Syndromes: Observations of 1st-Line Therapy, Discontinuation and the Need of Additional Therapies

Background: The myelodysplastic syndromes (MDS) include a group of hematopoietic malignancies that typically affect older individuals. Healthcare claims data have not been previously used to describe treatment patterns of MDS patients who progressed while on, failed to respond to, or became intolerant to hypomethylating agents (HMA; azacitidine [AZA] and decitabine [DEC]) and were eligible for 2nd-line therapy.Methods: We conducted a retrospective cohort study using a US commercial health insurance claims database. The database contained adjudicated pharmacy and medical claims on 13 million annual lives submitted by providers, healthcare facilities, and pharmacies and included data on physician visits, medical procedures, hospitalizations, dispensed drugs, and performed tests. We identified patients with MDS (ICD-9-CM diagnosis code 238.7x) who were using an HMA in the identification (ID) period (1/1/2009–12/31/2011). The index date was the date on which the patient had used the same HMA for > 7 months, discontinued HMA treatment for ≥ 2 months, or switched to another HMA. Patients were defined as eligible for 2nd-line therapy after reaching the index date and were followed for ≥ 6 months after they became candidates for 2nd-line treatment until the end of enrollment or study end (12/31/2012).We examined treatment use patterns from 1/1/2008 to the index date. MDS-specific chemotherapy included AZA, DEC, and lenalidomide (LEN). We defined AZA or DEC cycles as continuous treatment periods without a gap of >7 days, and the gap between observed cycles could not be ≥ 60 days. Hematologic supportive care agents included erythropoiesis-stimulating agents (ESA), growth factors (ie, granulocyte and granulocyte-macrophage colony-stimulating factors), and blood transfusions.Results: Of 38,702 patients diagnosed with MDS in the ID period, we identified 1,366 who used an HMA. Three hundred eighty-six (96.0%) patients had a cytopenia potentially associated with HMA use, including anemia (92.8%), neutropenia (53.0%), and thrombocytopenia (52.7%). Of this group, 402 patients were eligible for 2nd-line MDS therapy: 283 (70.4%) had used AZA, 123 (30.6%) DEC, and 16 (4.0%) LEN. Patients averaged 6.1 HMA treatment cycles (6.4 for AZA, 5.4 for DEC) prior to being considered potential candidates for 2nd-line therapy. One hundred ninety-three (48.0%) patients had “early” discontinuation, defined as <5 treatment cycles before stopping or switching among HMAs. The proportions of patients who discontinued either AZA or DEC early were similar (47.1% vs. 50.0%). Among all 402 patients eligible for 2nd-line therapy, 320 (79.6%) received at least 1 hematologic supportive care agent: 208 (51.7%) received transfusions, 206 (51.2%) ESA, and 170 (42.3%) growth factors. Furthermore, among those eligible for 2nd-line therapy, 367 specifically switched to another HMA or did not have HMA treatment for 2 months. In this group, the rate of early discontinuation was 52.6%.Conclusions: About half of patients completed < 5 HMA treatment cycles before discontinuation. AZA was used more often than DEC as 1st-line MDS therapy. These data suggest that a significant number of patients treated with AZA and DEC discontinue and become candidates for 2nd-line MDS therapy. The clinical reasons for early HMA discontinuation warrant further investigation; effective 2nd-line therapies for these patients are needed. [Display omitted] DisclosuresMukherjee:Partnership for Health Analytic Research (PHAR): Consultancy, I was paid as a consultant for my expert opinion while developing the analysis Other. Cogle:Partnership for Health Analytic Research (PHAR): Consultancy, I was paid as a consultant for my expert opinion while developing the analysis Other. Bentley:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Broder:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Chang:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other. Lawrence:Onconova Therapeutics, Inc.: Employment. McKearn:Onconova Therapeutics, Inc.: Employment. Megaffin:Onconova Therapeutics, Inc.: Employment. Percy:Onconova Therapeutics, Inc.: Employment. Petrone:Onconova Therapeutics, Inc.: Employment, Stock Options Other. Sun:Partnership for Health Analytic Research (PHAR): Employment, I am an employee of PHAR, LLC, which was paid by Onconova Therapeutics to conduct the analyses described in this abstract. Other.