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First-line (1L) maintenance avelumab prolonged overall survival (OS) in patients with advanced urothelial carcinoma (aUC) in JAVELIN Bladder 100. OS was measured from maintenance initiation in patients with disease control following 1L platinum-based therapy (PBT). The OS impact of maintenance for the 1L PBT-treated population is unknown since it was not measured from 1L initiation, nor can it be benchmarked with other 1L therapies. To characterize the OS impact of maintenance avelumab, we used an oncology simulation model to estimate the OS of maintenance-eligible and -ineligible patients with aUC from 1L PBT initiation. We developed a simulated cohort of 1L PBT-treated patients with aUC, including those who did and did not receive maintenance avelumab. Eligibility was assessed at 5.6 months post 1L PBT initiation based on the JAVELIN trial design. Among the 1L-treated population, 58% (95% credible interval [CrI] 49-67%) were projected to be eligible (calculated from contemporary phase 3 trials); of those, 85% were assumed to receive maintenance. The model estimated median OS (mOS) among a maintenance-ineligible simulated cohort which when combined with the maintenance-eligible cohort yielded an estimated OS in the overall maintenance- intended population from 1L PBT initiation. Approximately half of the modeled 1L PBT-treated population received maintenance. Estimated mOS was 10.1 months (95% CrI 7.5-13.5) for the maintenance-ineligible cohort, 29.3 months (95% CrI 24.8-33.9) for the maintenance-eligible, received maintenance cohort, and 15.9 months (95% CrI 13.2-19.1) in the overall maintenance-intended, 1L PBT-treated population, including those eligible and ineligible for maintenance. The model shows that maintenance avelumab has a modest impact on OS in the overall 1L PBT-treated population of patients with aUC. While maintenance avelumab improves OS for eligible patients, a large proportion of the maintenance-intended population may not receive maintenance due to ineligibility or physician/patient choice.

Objective: We demonstrate a new model framework as an innovative approach to more accurately estimate and project prevalence and survival outcomes in oncology. Methods: We developed an oncology simulation model (OSM) framework that offers a customizable, dynamic simulation model to generate population-level, country-specific estimates of prevalence, incidence of patients progressing from earlier stages (progression-based incidence), and survival in oncology. The framework, a continuous dynamic Markov cohort model, was implemented in Microsoft Excel. The simulation runs continuously through a prespecifed calendar time range. Time-varying incidence, treatment patterns, treatment rates, and treatment pathways are specifed by year to account for guideline-directed changes in standard of care and real-world trends, as well as newly approved clinical treatments. Patient cohorts transition between defined health states, with transitions informed by progression-free survival and overall survival as reported in published literature. Results: Model outputs include point prevalence and period prevalence, with options for highly granular prevalence predictions by disease stage, treatment pathway, or time of diagnosis. As a use case, we leveraged the OSM framework to estimate the prevalence of bladder cancer in the United States. Conclusion: The OSM is a robust model that builds upon existing modeling practices to offer an innovative, transparent approach in estimating prevalence, progression-based incidence, and survival for oncologic conditions. The OSM combines and extends the capabilities of other common health-economic modeling approaches to provide a detailed and comprehensive modeling framework to estimate prevalence in oncology using simulation modeling and to assess the impacts of new treatments on prevalence over time. Keywords: epidemiology, Markov, modeling, oncology, OSM, prevalence

Background Adherence and persistence to therapy, or how well a patient follows provider directions on frequency and time to discontinuation of prescribed medications, is associated with positive health outcomes, including decreased healthcare costs and patient mortality. A clear literature gap exists assessing adherence and persistence to antidepressants (ADs) in the major depressive disorder (MDD) population at clinically relevant time points and at the therapeutic class level. Objective This study assessed adherence and persistence to specific ADs, therapeutic classes, and AD therapy overall at multiple time points among US individuals from commercial, Medicare supplemental, and Medicaid insurance plans. Methods Patients with MDD without AD or MDD claims in the prior 6 months who initiated therapy in 2003–2014 with a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic AD (TCA), monoamine oxidase inhibitor (MAOI), or other AD were identified using MarketScan ® databases. These databases contain information on diagnoses, billing codes, and dates of service. Adherence (proportion of days covered) and persistence (days until a 30-day gap in therapy) were calculated to AD medication, AD therapeutic class, and AD therapy overall over the first 3, 6, 9, and 12 months from the index prescription date. Multivariable logistic regression estimated the adjusted odds ratios (ORs) of adherence to initial AD medication comparing AD therapeutic classes. Results For 527,907 patients, adherence to initial AD medication decreased over 3, 6, 9, and 12 months (41, 31, 24, and 21%, respectively). Similar patterns were observed for adherence to initial AD therapeutic class, AD therapy overall, and all three persistence calculations. The odds of adherence to SNRIs versus SSRIs were 20–27% greater at 3, 6, 9, and 12 months (ORs 1.20, 1.23, 1.25, 1.27, respectively; p -values all <0.0001). Similar or significantly lower odds of adherence were demonstrated for other classes versus SSRIs at 3, 6, 9, and 12 months [ORs for other ADs 0.80, 0.77, 0.74, 0.72, respectively ( p -values all <0.0001); ORs for TCAs 0.46, 0.45, 0.47, 0.49, respectively ( p -values all <0.0001); ORs for MAOIs 1.13, 1.0, 0.77, 0.69, respectively ( p -values all >0.05)]. Conclusion We found low adherence and persistence to ADs in the MDD population. Within the limitations of the insurance claims data we analysed, our results suggest that adherence may differ based on therapeutic class, as patients initiating SNRI therapy appeared to have a higher likelihood of adherence versus SSRIs over the year assessed, while the odds of adherence appeared similar or lower for other classes versus SSRIs. Further prospective research is needed to confirm these findings and determine additional drivers of these apparent differences by AD therapeutic class.

Abstract Background Although there is evidence that anti-tumor necrosis factor (TNF) utilization earlier in the inflammatory bowel disease (IBD) course and before the onset of disease-related complications leads to improved patient outcomes, the health care costs and utilization impact have not been well defined. This study assessed differences in health care utilization and costs among patients with IBD treated with anti-TNFs. Methods Patients with a diagnosis of ulcerative colitis (UC) or Crohn disease (CD) between January 1, 2001, and December 31, 2014, were identified from a claims database. Patients were required to have ≥1 claim for a 5-aminosalicylic acid, corticosteroid, or immunomodulator after the IBD diagnosis and ≥1 anti-TNF drug claim after the first IBD treatment. Complication and noncomplication cohorts were identified based on disease-related complications and IBD-related hospitalizations or emergency department visits for 6 months before anti-TNF initiation. Generalized linear models were used to compare health care costs and utilization for the 12 months after anti-TNF initiation (follow-up). Results The study included 6329 patients with CD and 4451 patients with UC. In patients with CD with complications, >33.7% had intestinal strictures and 6% had enteroenteric fistula before anti-TNF treatment. Patients with CD with complications incurred significantly higher IBD-related and all-cause health care costs during follow-up, and patients with UC experienced the same trends. Conclusions These results suggest that anti-TNF treatment after, rather than before, a patient develops complications leads to a higher economic burden. However, these findings could also result from patients with more severe disease having early complications that are more difficult to treat.

Abstract #1066 Objective: Hypothyroidism requires patients to be adherent to lifelong thyroid hormone replacement therapy with levothyroxine, as indicated by a number of guidelines. Conclusion: Adherence to thyroid hormone replacement remains to be a concern among hypothyroid patients treated with levothyroxine.

Methods: Retrospective claims analysis was conducted using Optum Clinformatics™ Data Mart database which includes medical and pharmacy claims for over 67 million commercial/Medicare insured US patients. Odds of having TSH labs out of range was calculated using logistic regression controlling for insurance type, Charlson comorbidity index score, year of index date, and type of diagnosing physician (endocrinologist vs other).