Rosacea Treatment Satisfaction: Matching Adjusted Indirect Treatment Comparison Analysis of Metronidazole Gel or Cream vs Azelaic Acid Foam.

OBJECTIVE: To assess differences in patient-reported treatment side effects and concerns associated with azelaic acid 15% foam (AAF) vs metronidazole cream (MC) and metronidazole gel (MG). METHODS: This study used matching-adjusted indirect comparison (MAIC) to compare patient-reported outcomes from survey data evaluating rosacea treatments. Outcomes of interest included percentages of patients reporting concerns and side effects and measures of importance of the concerns and tolerability of the side effects. Patients in each analysis (MG vs AAF and MC vs AAF) were matched using stabilized inverse propensity scores. RESULTS: When compared to AAF, MG-treated patients more frequently reported concerns with treatment efficacy (54% vs 4%), application (7% vs 3%), and treatment side effects. MC-treated patients more frequently reported concerns with treatment efficacy (61% vs 5%) and dryness (8% vs 5%). AAF-treated patients more frequently reported concerns with cost of treatment compared with MG (7% vs 1%) and MC (9% vs 4%). Among patients reporting concerns, level of importance associated with these concerns was similar for AAF-treated patients compared with MG- and MC-treated patients. When compared to AAF-treated patients, MG-treated patients more frequently reported side effects of dryness (26% vs 15%) and uneven skin tone (3% vs 0%), and MC-treated patients more frequently reported side effects of burning (7% vs 3%), itching (7% vs 5%), and redness (7% vs 5%). MG- and MC-treated patients indicated greater intolerance for reported side effects than AAF-treated patients. CONCLUSIONS: MG- and MC-treated patients more frequently reported treatment concerns and side effects than AAF-treated patients, and tolerability of those side effects was higher for patients treated with AAF. While treatment cost is a more frequent concern in patients treated with AAF, these patients less frequently reported concerns with treatment efficacy and reported similar or greater tolerance to side effects than patients treated with either MC or MG. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.3679.

Evaluation of treatment patterns and survival among patients with diffuse large B-cell lymphoma in the USA.

AIM: To evaluate treatment patterns of diffuse large B-cell lymphoma (DLBCL). PATIENTS & METHODS: First-line and relapsed/refractory treatment patterns and survival outcomes following first-line therapy in adult patients newly diagnosed with DLBCL were evaluated. RESULTS: A total of 1436 DLBCL patients initiated treatment and mainly received a combination regimen versus monotherapy (92.1 vs 7.9%). Patients who received monotherapy were older with more comorbidities and had shorter progression-free survival than patients receiving combination therapy (median: 31.3 vs 55.8 months). In the second-line setting (n = 164), rituximab-based combination regimens were most common; 25% underwent stem cell transplantation, and were younger with fewer comorbidities. CONCLUSION: These results illustrate the need for new treatment options for patients unable to tolerate initial combination therapy and transplant-ineligible patients who require salvage therapy.

Economic burden of patients with diffuse large B-cell and follicular lymphoma treated in the USA.

AIM: Evaluate healthcare costs and utilization of treated diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients. MATERIALS & METHODS: Adults with newly diagnosed DLBCL and FL between 1 January 2008 and 31 October 2015 were identified in the Optum™ claims database. Healthcare costs and utilization were assessed from diagnosis date until end of follow-up. RESULTS: A total of 1267 DLBCL- and 1595 FL-treated patients were identified. Mean per-patient, per-month cost during follow-up was US$11,890 for DLBCL and US$10,460 for FL. Healthcare costs and utilization decreased from year 1 to 2 following diagnosis, due to a decrease in chemotherapy services, inpatient admissions and other outpatient services. CONCLUSION: The economic burden of treated DLBCL and FL is considerable, especially in the first year following diagnosis.

The Validity of the Interpersonal Theory of Suicide in Adolescence: A Review.

Adolescence, when suicidal ideation and behaviors often begin, might offer an important window to understand the causes and prevent the progression of suicide phenomena. The need for frameworks to organize the fragmented field has been noted, but few studies are theoretically driven. An important recent contribution to understanding suicidality is Joiner's (2005) Interpersonal-Psychological Theory of Suicide (IPTS). This article reviews the evidence for the applicability of the IPTS in adolescence. Seventeen studies of adolescents that specifically tested or interpreted findings in the light of Joiner's theory or the IPTS were located. In addition, several recent reviews of the literature on suicidality in adolescence covered information relevant to the IPTS. There is some support for the theory in adolescence, particularly with regard to its most novel component, the association between acquired capability and suicide attempt. In summary, we find this theory to be a promising heuristic to organize the disparate studies in suicide research. Future challenges and directions for researchers seeking to test and elaborate the applicability of the IPTS in adolescence include: adaptations of instruments to the developmental stage, capturing of imminent risk, and consideration of whether the current model is underspecified. Age might moderate adult findings that give impulsivity an indirect role in suicide attempts.

Surgical Resection Preferences and Perceptions among Medical Oncologists Treating Liver Metastases from Colorectal Cancer.

BACKGROUND: Liver resection is a key therapeutic strategy to improve survival in patients with colorectal cancer liver metastases. Underutilization may negatively affect outcomes. Using a Web-based survey and standardized imaging scenarios, this study assessed medical oncologists' (MOs) perceptions of resectability, preferences for chemotherapy sequencing, and referral for surgical consultation in a static patient profile of good performance status and no extrahepatic spread but varying bulk and distribution of disease. METHODS: A total of 190 US-based MOs were surveyed. A single patient profile was created and combined with 10 different sets of liver computed tomographic images displaying a broad spectrum of metastases. Assessments of resectability and ranking were compared with the results obtained from an expert panel of 3 hepatic surgeons. RESULTS: The expert hepatic surgeons designated 8 scans resectable, 1 borderline resectable/convertible, and 1 unresectable. In the 8 resectable cases, 34.4 % of MOS perceived the case to be initially resectable, 41.7 % potentially resectable after chemotherapy response, and 23.9 % unresectable. Increasing number of lesions, larger tumor diameter, and bilateral disease were associated with lower resectability perception (P < 0.01). Among those cases considered resectable by MOs, they preferred initial resection (54.2 %) over neoadjuvant chemotherapy (38.4 %). Initial referral for surgical consultation was generally favored only for cases considered initially resectable by MOs. CONCLUSIONS: This study confirms both potential discrepancies between MOs' and hepatic surgeons' perception of resectability and underutilization of early surgical consultation for patients with potentially resectable colorectal cancer liver metastases and underscores the importance of an evaluation that includes an experienced hepatic surgeon.

Real-World Assessment of Interventional Treatment Timing and Outcomes for Varicose Veins: A Retrospective Claims Analysis.

PURPOSE: To evaluate the impact of delaying interventional treatment on varicose vein disease progression, complications, and health care costs in a real-world setting. MATERIALS AND METHODS: This was a retrospective analysis of adults diagnosed with varicose veins between January 2008 and June 2010. Patients were followed for 2 years after diagnosis and categorized into three cohorts based on the timing of interventional therapy: early (≤ 2 mo), intermediate (> 2 mo but ≤ 6 mo), and late (> 6 mo). Disease progression and all-cause health care costs were evaluated. RESULTS: A total of 44,206 patients were included, with 43% classified as receiving early interventional therapy, 33% as intermediate, and 24% as late. Early interventional treatment was associated with lower disease progression rates (29.2%) compared with intermediate (42.5%; P < .0001) and late treatment (52.2%; P < .0001). Also, early interventional treatment was associated with lower costs ($17,564) than intermediate ($17,923; P > .05) and late treatment ($18,399; P < .05). Each 30-day delay in treatment initiation was associated with a 7% higher risk of disease progression (P < .0001) and a 1% increase in costs (P < .0001). CONCLUSIONS: Findings suggest that early initiation of interventional varicose vein treatment was significantly associated with a decreased risk of disease progression and costs.

Evaluating treatments and corresponding costs of prostate cancer patients treated within an inpatient or hospital-based outpatient setting.

AIM: To describe treatments and cost of care for prostate cancer (PCa) in hospital-based outpatient and inpatient settings. METHODS: Hospital encounters associated with PCa (ICD-9 codes 185, 233.4) and PCa-related treatment in a hospital claims database were included. RESULTS: There were 211,440 encounters for PCa between January 2006 and December 2010 (88,151 inpatient and 123,289 outpatient). Average cost per inpatient stay was US$12,286 versus US$4364 per outpatient visit. Most common treatment during an inpatient stay and outpatient visit was surgery (57%) and radiation (76%), respectively. A total of 80% of outpatient visits and 69.9% inpatient stays were associated with a single treatment; remaining encounters were associated with ≥2 treatments. CONCLUSION: Costs are consistent with previous estimates; however, multimodal therapy is an emerging trend that may be related to greater costs in the future which may also be a challenge for hospital decision makers.

Early symptom improvement and discontinuation of 5-α-reductase inhibitor (5ARI) therapy in patients with benign prostatic hyperplasia (BPH).

BACKGROUND: Pharmacological treatment options for benign prostatic hyperplasia (BPH) commonly include α-blocker (AB) and 5-α-reductase inhibitor (5ARI) agents, which have separate but important attributes that carry clinical implications in terms of improvement of lower-urinary tract symptoms (LUTS) and clinical disease progression. OBJECTIVES: This study hypothesized that administering AB therapy concomitantly with newly started 5ARI treatment would reduce the likelihood of 5ARI discontinuation through early symptom improvement. METHODS: This retrospective analysis of the PharMetrics Integrated Medical and Pharmaceutical Database included men aged ≥50 years with ≥1 medical claim of BPH diagnosis and ≥1 prescription claim of a 5ARI with or without an AB. Patients initiating 5ARI monotherapy were propensity score matched with patients initiating combination AB + 5ARI therapy (1:1), with 5ARI time to discontinuation (30-day gap in treatment) compared between groups utilizing survival analysis techniques. The percentage of patients adherent to 5ARI therapy based on medication possession ratio (MPR) was assessed. RESULTS: After 180 days of follow-up, 61.7% of the combination therapy arm versus 59.2% of the monotherapy arm remained on therapy. Combination therapy patients were 10% less likely to discontinue 5ARI treatment (hazard ratio = 0.904; P = .006) and were more likely to be adherent when adherence was defined as MPR ≥70% and ≥75%. CONCLUSIONS: Based on an assessment of claims data, initiating AB with 5ARI therapy is associated with a lower rate of 5ARI discontinuation compared with 5ARI monotherapy. Early symptom relief from AB therapy may contribute to a lower discontinuation rate for concomitant 5ARI therapy.

Real-world treatment utilization and economic implications of lupus nephritis disease activity in the United States.

BACKGROUND: Lupus nephritis (LN) is a common and severe complication of systemic lupus erythematosus (SLE), with approximately 40% of patients with SLE developing LN. Even with treatment, 10%-30% of patients will progress to end-stage renal disease (ESRD). Although many studies have assessed the clinical value of low disease activity in LN, the economic implications are less defined. OBJECTIVE: To evaluate treatment utilization and health care costs associated with active disease, low disease activity, and ESRD in patients with LN. METHODS: A retrospective analysis of Optum pharmacy and medical claims data from 2015 to 2019 was performed and included patients with a diagnosis of SLE (International Classification of Diseases, Ninth Revision or Tenth Revision codes 710.0 or M32, respectively) and additional prespecified criteria for LN. Total health care payer costs for medical and pharmacy services and treatment utilization for commonly prescribed medications were determined for periods of low disease activity, active disease, or ESRD. RESULTS: A total of 21,251 patients (mean age 60.3 years; 87% female; 55% White patients and 18% Black patients) with a mean follow-up period of 30.6 months were included; the majority of patients had active disease (67.3%), followed by low disease activity (51.3%), and ESRD (10.5%). Glucocorticoids were used 2 times more often and mycophenolate mofetil was used 4 times more often in patients with active disease vs low disease activity. Glucocorticoids, mycophenolate mofetil, and tacrolimus were more commonly used in patients with ESRD vs those with low disease activity. Mean medical costs were $4,777 per month in active disease and $18,084 per month in ESRD vs $2,523 per month in low disease activity. CONCLUSIONS: Treatment burden and costs are high for patients with active disease and ESRD in LN. Treatments that allow patients to achieve and maintain low disease activity may help improve patient outcomes and reduce medication use and overall health care costs. DISCLOSURES: Maria Dall'Era and Kenneth Kalunian are consultants of Aurinia Pharmaceuticals. Eric Turowski, Vanessa Birardi, Neil Solomons, Simrat Randhawa, and Paola Mina-Osorio are employees and stockholders of Aurinia Pharmaceuticals. Michael Eaddy is a former employee of Xcenda, LLC. Augustina Ogbonnaya and Eileen Farrelly are employees of Xcenda, LLC, which was contracted by Aurinia Pharmaceuticals to assist in the conduct of this study and the writing of this manuscript. Aurinia Pharmaceuticals provided funding for this study and the preparation of the manuscript. Aurinia Pharmaceuticals had a role in writing the report and decision to submit for publication.

Adherence to 5-alpha reductase inhibitor therapy for benign prostatic hyperplasia: clinical and economic outcomes.

OBJECTIVE: Our goal was to quantify relationships between adherence to 5-alpha reductase inhibitors (5-ARIs), the risk of acute urinary retention (AUR) and prostate surgery, and medical costs related to patients with benign prostatic hyperplasia (BPH). METHODS: Claims recorded over a period of 6.5 years in a nationwide managed care database were analyzed. We conducted time-to-event multivariate analysis to evaluate relationships between adherence (medication possession ratio [MPR] thresholds of 70% or higher, 75% or higher, and 80% or higher), persistence (length of therapy), and the risk of AUR and surgery. We compared mean monthly BPH-related medical costs in patients with MPRs at or above thresholds and those with MPRs below thresholds and determined changes in BPH-related costs associated with 30-day increments of therapy. RESULTS: In AUR analyses (N = 17,293), meeting or exceeding MPR thresholds was associated with a reduced likelihood of AUR for 70% (hazard ratio [HR], 0.380), 75% (HR, 0.613), and 80% (HR, 0.519) (P < 0.05 for all). In prostate surgery analyses (N = 17,739), the likelihood of surgery was reduced with MPR thresholds of 70% or above (HR, 0.294), 75% or above (HR, 0.542), and 80% or above (HR, 0.436) (P < 0.05 for all). A longer duration of therapy was associated with a reduced likelihood of AUR (HR, 0.860) and surgery (HR, 0.884) (P < 0.05 for both). In both populations, adherence and persistence were also associated with significantly decreased BPH-related medical costs. CONCLUSION: In patients with BPH who received 5-ARI therapy, greater adherence and persistence were associated with significantly reduced risks of AUR and prostate surgery and with significantly lower medical costs. Maximizing adherence may enable patients to realize the potential long-term benefits of 5ARIs.

How patient cost-sharing trends affect adherence and outcomes: a literature review.

OBJECTIVE: We sought to assess the relationship between patient cost sharing; medication adherence; and clinical, utilization, and economic outcomes. METHODOLOGY: We conducted a literature review of articles and abstracts published from January 1974 to May 2008. Articles were identified using PubMed, Ovid, medline, Web of Science, and Google Scholar databases. The following terms were used in the search: adherence, compliance, copay, cost sharing, costs, noncompliance, outcomes, hospitalization, utilization, economics, income, and persistence. RESULTS: We identified and included 160 articles in the review. Although the types of interventions, measures, and populations studied varied widely, we were able to identify relatively clear relationships between cost sharing, adherence, and outcomes. Of the articles that evaluated the relationship between changes in cost sharing and adherence, 85% showed that an increasing patient share of medication costs was significantly associated with a decrease in adherence. For articles that investigated the relationship between adherence and outcomes, the majority noted that increased adherence was associated with a statistically significant improvement in outcomes. CONCLUSION: Increasing patient cost sharing was associated with declines in medication adherence, which in turn was associated with poorer health outcomes.

Benign prostatic hyperplasia: racial differences in treatment patterns and prostate cancer prevalence.

OBJECTIVE: • To compare prostate cancer, prostate-related surgery and acute urinary retention rates, as well as associated healthcare resource use over 11 years in African American and Caucasian men with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: • The BPH-related medical and surgical charges and events were determined for 398 African American men and 1656 Caucasian men followed for a mean of 10.2 years within a health maintenance organization. • Racial differences in clinical outcomes were evaluated using time-to-event analysis, stratifying results by baseline prostate-specific antigen (PSA) values. RESULTS: • Risk of a prostate cancer diagnosis was 2.2 times greater in African American than Caucasian men (95% CI 1.48-3.35, P < 0.001) in analyses adjusting for serum PSA level. • Although African Americans were more likely to receive medical therapy for symptoms of BPH than Caucasians (43.5% vs 37.2%, respectively; P= 0.029), there were no clinically meaningful differences with respect to subsequent acute urinary retention or BPH-related surgery between them, or BPH-related medical charges (US $407 vs US $405 per month). CONCLUSION: • As evidenced by this analysis of 'real-world' clinical practice, African Americans with BPH have a much greater risk of developing prostate cancer than similar Caucasian men highlighting the need for education and early detection in this population.

Clinical and economic impact of early versus delayed 5-alpha reductase inhibitor therapy in men taking alpha blockers for symptomatic benign prostatic hyperplasia.

BACKGROUND AND OBJECTIVE: Recent clinical trials indicate that combining an alpha blocker for rapid symptom improvement and a 5-alpha reductase inhibitor (5-ARI) to reduce the risk of clinical progression of benign prostatic hyperplasia (BPH) may be an optimal approach to management; however, few studies have evaluated the effect of combination therapy on clinical progression in a real-world setting. The purpose of our study was to assess the clinical and economic impact of early versus delayed 5-ARI therapy in patients treated with an alpha blocker for BPH. MATERIALS AND METHODS: A retrospective database analysis included men 50 years of age and older who were treated for BPH between 2003 and 2007. Clinical outcomes were evaluated for patients using 5-ARIs early (within 30 days of starting an alpha blocker) compared with those using delayed 5-ARI therapy (between 30 and 180 days after starting an alpha blocker). We assessed the likelihood of clinical progression (defined as the occurrence of acute urinary retention or prostate surgery) for each group over a one-year period following the start of alpha-blocker therapy. DATA SOURCE: The MarketScan Database, which was used to identify patients, contains medical and pharmacy claims data obtained directly from Medicare and commercial health plans and employers, representing 18 to 20 million lives annually. RESULTS: Of 8,617 men included in the analysis, 64.5% began 5-ARI therapy within 30 days of alpha-blocker therapy (the early cohort). These patients were less likely than those receiving delayed 5-ARI treatment to have clinical progression (12.8% vs. 17.4% respectively; P < 0.0001), acute urinary retention (10.2% vs. 13.8%, P < 0.0001), and prostate surgery (5% vs. 7%, P = 0.0002). The early group also incurred lower BPH-related medical costs ($572 vs. $730, P < 0.0001). Even though BPH-related pharmacy costs were significantly higher ($1,137 vs. $1,263, P = 0.0313), their total BPH-related costs were lower ($1,834 vs. $1,867, P = 0.0068). CONCLUSION: These results suggest that early 5-ARI therapy for men with symptomatic BPH who receive an alpha blocker may significantly reduce the risk of clinical progression (i.e., acute urinary retention or prostate surgery) over the next 12 months as well as lower BPH-related medical costs and BPH-related total costs.

Hospital Readmissions and Mortality Among Intubated and Mechanically Ventilated Adult Subjects With Pneumonia Due to Gram-Negative Bacteria.

BACKGROUND: Ventilator-associated pneumonia (VAP) is one of the most common hospital-acquired infections in ICUs and is associated with significant morbidity and mortality. Gram-negative bacteria cause 55-85% of hospital-acquired pneumonia and are associated with increased mortality. METHODS: This study sought to describe mortality rates and 30-d readmission rates among intubated and mechanically ventilated subjects with Gram-negative pneumonia and to explore associated risk factors for mortality and rehospitalization using data from the 2013 Healthcare Cost and Utilization Project (HCUP) National Readmission Database. The study sample included adults age ≥ 18 y who were hospitalized with invasive, continuous mechanical ventilation; were discharged between February 1, 2013, and November 30, 2013; and had a primary or secondary diagnosis of Gram-negative bacterial pneumonia. Logistic regression was used to identify subject characteristics significantly associated with mortality and readmissions. RESULTS: Using the HCUP projected sample of 32,683 intubated and mechanically ventilated subjects with Gram-negative pneumonia, the mortality rate during the index hospitalization was 24.3%. More than one fifth of subjects (22.9%) who survived the index hospitalization were readmitted within 30 d of discharge. Among subjects with readmissions, 18% occurred within 3 d of discharge, 39% occurred within 7 d of discharge, and 65% occurred within 14 d of discharge. Subjects with prior hospitalization within 30 d of the index hospitalization had a higher risk of readmission with an odds ratio of 1.70 (95% CI 1.48-1.94). CONCLUSIONS: Mortality was high and readmissions were substantial among intubated and mechanically ventilated subjects with Gram-negative pneumonia.

Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis.

PURPOSE: Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis. PATIENTS AND METHODS: Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician's impression of change. RESULTS: Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively. CONCLUSION: This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.

The real-world economic impact of home-based video electroencephalography: the payer perspective.

Aims: Electroencephalography (EEG) is an established method to evaluate and manage epilepsy; video EEG (VEEG) has significantly improved its diagnostic value. This study compared healthcare costs and diagnostic-related outcomes associated with outpatient vs inpatient VEEG among patients with epilepsy in the US. Materials and methods: This study used Truven MarketScan Commercial and Medicare Supplemental claims databases. Patients with a VEEG between July 1, 2013 and December 31, 2016 were identified. Index event was the first VEEG claim, which was used to determine inpatient and outpatient cohorts. Continuous health plan enrollment 6 months pre- and 12 months post-index VEEG was required. Primary outcomes were costs during the index event and 12 months post index. A generalized linear model with gamma distribution and a log link was used to estimate adjusted index and post-index costs. Results: Controlling for baseline differences, epilepsy-related cost of index VEEG was significantly lower for the outpatient ($4,098) vs the inpatient cohort ($13,821; p < 0.0001). The cost differences observed at index were maintained in the post-index period. The 12-month post-index epilepsy-related costs were lower in the outpatient cohort ($6,114 vs $12,733, p < 0.0001). Time from physician referral to index VEEG was significantly shorter in the outpatient cohort (30.6 vs 42.5 days). Patients in the inpatient cohort were also more likely to undergo an additional subsequent follow-up inpatient VEEG (p < 0.0001). Limitations: Administrative claims data have limitations, including lack of data on clinical presentation, disease severity, and comprehensive health plan information. Generalizability may be limited to a US insured population of patients who met study criteria. Conclusions: Index VEEG was less costly in an outpatient vs inpatient cohort, and costs were lower during the follow-up period of 12 months, suggesting that outpatient VEEG can be provided to appropriate patients as a less costly option. There were fewer follow-up tests in the outpatient cohort with similar pre- and post-index diagnoses.

Real-world treatment patterns and outcomes of patients with small cell lung cancer progressing after 2 lines of therapy.

OBJECTIVES: To evaluate treatment patterns, physician-assessed overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) among third-line (3L)-plus small cell lung cancer (SCLC) patients. MATERIALS AND METHODS: Retrospective analysis of a United States (US)-based community oncology electronic medical record (EMR) database was conducted. Target sample included SCLC patients ≥18 years of age whose disease progressed after at least 2 prior treatments. Treatment patterns captured systemic therapy and best supportive care (BSC) in 3L, fourth-line (4L), and fifth-line (5L) settings. ORR, PFS, and OS were evaluated for each line of systemic therapy and OS was also evaluated for BSC. RESULTS: 334 3L SCLC patients received systemic therapy (n = 249) or BSC (n = 85). Mean age (standard deviation [SD]) was 63.7 (9.5), with 72% having extensive disease at initiation of first-line therapy. Of 3L patients, 41% and 12% went on to 4L and 5L, respectively. ORR for systemic therapy in 3L and 4L averaged around 21% while 5L was 12%. Median PFS in 3L systemic therapy was 2.3 months (95% confidence interval [CI]: 1.9, 2.5), which decreased in 4L and 5L. Median OS for 3L systemic therapy was 4.4 months (95% CI: 4.0, 5.5), with 6- and 12-month survival rates of 37% and 11%, respectively. In contrast, median OS for 3L BSC was 0.9 months (95% CI: 0.6, 1.2), with 9% survival rate at 6 months. CONCLUSION: Current treatments utilized in the 3L-plus setting yield limited survival benefit. Furthermore, patients left untreated and placed on BSC typically live less than 1 month. New therapeutic options are thus needed for these patients, where no approved options exist.

Treatment Patterns and Costs of Chronic Inflammatory Demyelinating Polyneuropathy: A Claims Database Analysis.

BACKGROUND: Corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIG) have been standard-of-care treatments for chronic inflammatory demyelinating polyneuropathy (CIDP) for more than 2 decades. Despite guideline recommendations for best clinical practices, heterogeneity in patient presentation and the course of treatment for CIDP remains. There is limited literature regarding the real-world treatment patterns of and costs associated with CIDP. OBJECTIVE: To analyze and describe the real-world treatment patterns of and economic burden associated with CIDP. METHODS: This retrospective cohort study evaluated the treatment patterns and CIDP-related healthcare costs over a 2-year follow-up period for patients with newly diagnosed CIDP who had commercial insurance, using claims data from the IMS LifeLink PharMetrics Plus Claims database between 2009 through 2014. Treatment-naïve patients with newly diagnosed CIDP were evaluated for 2 years postdiagnosis, which captured the treatments used and the resource utilization. The patients were defined as receiving active CIDP therapy (ie, IVIG, immunosuppressants, oral or intravenous steroids, or plasma exchange) or active surveillance. RESULTS: Of the 525 patients identified with newly diagnosed CIDP, 55.2% of patients were prescribed only steroid therapy, and 25.3% of patients were prescribed an IVIG therapy during the 2-year follow-up. The median time to the initial treatment was shortest for patients receiving plasma exchange alone (0.03 months) or in combination with a steroid (0.03 months), followed by IVIG plus another therapy (0.53 months), and then IVIG alone (0.71 months). Initiating therapy with steroids alone took the longest mean time (6.51 months) to start the treatment. The median length of time to receive therapy was longest for the steroid plus plasma exchange cohort (21.8 months), followed by the steroid plus immunosuppressant cohort (10.1 months), and the 2 IVIG cohorts (9.04 months for IVIG alone and 9.82 months for IVIG plus another therapy). The mean total CIDP-specific 2-year follow-up costs were highest for the cohort that received IVIG alone ($119,928) or with an additional therapy ($133,334) and lowest for patients who received active surveillance ($3723) or steroids alone ($3101). CONCLUSIONS: Steroid therapy was initiated later and resulted in a shorter duration of treatment than other treatment options for patients with CIDP, which may reflect diagnostic uncertainty, disease severity or remission, therapeutic challenge to determine diagnosis, or the side-effect profile of steroids. The use of steroids alone was the most common prescribed treatment for CIDP. Further research is needed to understand the rationale for treatment decisions in this patient population and their potential impact on patients and health plans.

Cost differential of immuno-oncology therapy delivered at community versus hospital clinics.

OBJECTIVES: The site of cancer care delivery has been shown to be associated with the total cost of care. The magnitude of this effect in patients receiving expensive immuno-oncology (I-O) therapies has not been evaluated. We evaluated cost differentials between community-based and hospital-based outpatient clinics among patients receiving I-O therapies. STUDY DESIGN: This was a retrospective analysis utilizing Truven MarketScan Commercial and Supplemental Medicare claims databases. METHODS: Cost data for 3135 patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, bladder cancer, renal cell carcinoma, or melanoma who received pembrolizumab, nivolumab, and/or ipilimumab between January 1, 2015, and February 14, 2017, were analyzed as cost per patient per month (PPPM). Patients treated within a community setting were matched 2:1 with those treated at a hospital clinic based on cancer type, specific I-O therapy, receipt of radiation therapy, evidence of metastatic disease, gender, age, and evidence of surgery in the preindex period. RESULTS: Mean (SD) total (medical plus pharmacy) PPPM cost was significantly lower for patients treated in a community- versus hospital-based clinic ($22,685 [$16,205] vs $26,343 [$22,832]; P <.001). Lower PPPM medical cost in the community versus hospital setting ($21,382 [$15,667] vs $24,831 [$22,102]; P <.001) was the major driver of this cost differential. Lower total cost was seen regardless of cancer type or I-O therapy administered. CONCLUSIONS: Treatment with I-O therapies in community practice is associated with a lower total cost of care compared with that in hospital-based outpatient practices. With the expanding indications of these agents, future research is needed.

Cost analysis of COPD exacerbations and cardiovascular events in SUMMIT.

OBJECTIVES: The Study to Understand Mortality and Morbidity in COPD (SUMMIT) trial compared the efficacy of once-daily fluticasone furoate/vilanterol (FF/VI) with placebo, FF monotherapy, and VI monotherapy on mortality in patients with moderate chronic obstructive pulmonary disease (COPD) and a history/increased risk of cardiovascular (CV) disease. We conducted a post hoc economic analysis using data from SUMMIT to evaluate the economic benefits of treating these patients with COPD and CV risk. STUDY DESIGN: Patients (aged 40-80 years, with ≥10 pack-years' smoking history and a risk of CV events) were randomized (1:1:1:1) to receive placebo, FF 100 mcg, VI 25 mcg, or FF/VI 100 mcg/25 mcg. METHODS: This was a post hoc economic analysis to assess the rates and associated costs of the composite end point (acute COPD exacerbations and revascularization/CV composite events) in the SUMMIT trial from a US healthcare payer perspective. RESULTS: Overall, 16,485 patients were evaluated; of these, 5246 (31.8%) experienced an on-treatment composite end point event (28.5% experienced a COPD exacerbation, 4.2% experienced a CV event, and 2.0% underwent a revascularization procedure). The mean estimated 1-year on-treatment combined end point cost was highest for placebo and lowest for FF/VI ($4220 vs $3482, respectively). The reductions in cost versus placebo were significant for all active treatments (P <.0001). The likelihood of experiencing an on-treatment combined end point event was lower for patients treated with FF/VI versus placebo (hazard ratio, 0.81; P <.001). CONCLUSIONS: One-year combined end point event costs were significantly lower for all active treatments versus placebo. Clinicians and payers may be able decrease costs by effectively managing patients' COPD in those with CV risk.