Emerging treatment patterns and checkpoint inhibitor (CPI) use among newly diagnosed Merkel cell carcinoma (MCC) patients in the United States veteran population.

2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 139-139
Author(s):  
Ying Zheng ◽  
Shivani Pandya ◽  
Ting Yu ◽  
Mairead Kearney ◽  
Sulena Shrestha ◽  
...  

139 Background: MCC is a rare and aggressive skin cancer with annual incidence of 2,500 in the U.S. Checkpoint inhibitors (CPIs) demonstrated durable disease response historically not seen with chemotherapy among MCC patients in clinical trials. Avelumab, a PD-L1 antibody, became the first and only approved treatment for metastatic MCC by the U.S. FDA in March 2017. This study evaluated emerging treatment patterns among MCC patients using the US Veterans Health Administration (VHA) database. Methods: This retrospective study identified newly-diagnosed MCC patients who initiated ≥1 systemic therapy from Oct. 2013 to Jan. 2018 and had continuous enrollment from ≥6 months pre-initial MCC diagnosis date until ≥2 months post-index date with follow-up until the earliest of death, disenrollment, or study end. The index date was defined as the start date of first-line (1L) systemic therapy. A subsequent line of therapy (2L) was defined by the earliest of new therapy addition, regimen switch, or a new/existing regimen after a >60-day gap from the prior cycle end. Duration of 1L therapy was evaluated among patients treated with CPIs, National Cancer Comprehensive Network (NCCN)-recommended chemotherapy (recCTs), and other chemotherapy (oCTs). The median duration of therapy was estimated using the Kaplan Meier method. Results: Of the 120 MCC patients (72% pre-2017) with 1L systemic therapy, 17%, 45%, and 38% were treated with CPIs, recCTs and oCTs, respectively. More than 75% were white men aged ≥65 years with mean baseline Charlson comorbidity index scores ≥5. Carboplatin-etoposide (56%) and cisplatin-etoposide (26%) were the most commonly-used recCTs. The median duration of 1L therapy in patients treated with CPI, recCTs and oCTs was 300, 91, and 21 days, respectively. 2L therapy was initiated in 33% of all 1L patients. Conclusions: Among 1L MCC patients, CPIs treated patients appear to be on treatment longer than both recCTs and oCTs patients. These descriptive findings provide important insights into the emerging real-world treatment patterns amongst MCC patients in the VHA population.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e21002-e21002
Author(s):  
Hemant Phatak ◽  
Shivani Pandya ◽  
Ting Yu ◽  
Mairead Kearney ◽  
Li Wang ◽  
...  

e21002 Background: The use of CPIs among patients (pts) with metastatic MCC, a rare and aggressive skin cancer, has increased since the US FDA approval of avelumab and the National Cancer Comprehensive Network (NCCN) recommendation of CPIs in 2017. Given the growing interest in understanding real-world clinical and economic outcomes associated with CPI use, this study assessed time to treatment failure (TTF), overall survival (OS), healthcare resource utilization (HRU), and costs among MCC pts receiving NCCN-recommended 1L regimens including CPIs and CT in the VHA. Methods: This is a retrospective analysis of pts with newly-diagnosed MCC who initiated 1L treatment between October 2013 and January 2018 (index date = 1L therapy start date) and had continuous enrollment from ≥6 months pre-initial MCC diagnosis date until ≥2 months post-index date (follow-up). The index date to earliest of death or subsequent line of therapy start was used as a proxy for TTF. TTF and OS were estimated using Kaplan Meier method. All-cause HRU and costs (2018 USD) per patient per month (PPPM) were evaluated during TTF or until end of follow-up, whichever occurred first. Results: Of 120 MCC pts (72% pre-2017) initiating 1L therapy, 62% received NCCN-recommended regimens, including 17% and 45% treated with CPIs and CTs. Pts receiving CPIs were on average older with higher baseline comorbidity burden. The clinical and economic outcomes of these two pt groups are summarized in the table below. Conclusions: The current descriptive non-comparative analyses provide new information on the trends in clinical and economic outcomes of MCC pts treated in the VHA. Despite higher costs, the utilization of newly-approved CPIs in 1L setting showed delayed treatment failure and reduced all-cause HRU vs. CTs. These findings require further validation in studies with larger patient cohorts and longer follow-up. [Table: see text]


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3557-3557 ◽  
Author(s):  
Shaum Kabadi ◽  
Ravi K Goyal ◽  
Saurabh P Nagar ◽  
James A Kaye ◽  
Keith L Davis ◽  
...  

Abstract Introduction: Contemporary data describing treatment patterns, adverse events (AEs) and outcomes in CLL patients in clinical practice is lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health care resource use (HCRU), and costs in patients with newly diagnosed CLL. Methods: Using a nationally representative population of privately insured patients in the US, adult patients with CLL were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL-directed treatment. Treatment patterns up to 4 lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per-patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results: Of all patients meeting the selection criteria (n=7,639; median age, 66 years), 18% (n=1,379) received a systemic therapy during study follow-up. The most common systemic therapy regimens, regardless of therapy line, were bendamustine/rituximab (BR) (32%), rituximab monotherapy (24% [including maintenance]), ibrutinib monotherapy (15%), and fludarabine/cyclophosphamide/ rituximab (FCR) (14%). Of these, BR was the most common LOT-1 regimen (28.1%), while ibrutinib was the most common regimen in LOT-2 (20.8%) and in LOT-3 (25.5%). Use of idelalisib was limited to 1.6% of all patients receiving systemic therapy; however, an increasing trend was observed as patients moved from first to fourth LOT (<1% in LOT-1, 3.1% in LOT-2, 4.7% in LOT-3, and 8.6% in LOT-4). AEs identified during the most common treatments for CLL are presented by treatment regimen in Table 1. The mean monthly all-cause and CLL-related costs, among patients treated with a systemic therapy, were $7,943 (SD=$15,757) and $5,185 (SD=$9,935), respectively. Figure 1 depicts mean monthly costs by care setting and number of AEs, among all patients. Mean (SD) monthly all-cause costs during the post-index date follow-up were $905 ($1,865) among those with no AEs, $1,655 ($5,364) among those with 1-2 AEs, $2,883 ($8,483) among those with 3-5 AEs, and $6,032 ($13,290) among those with ≥6 AEs. Conclusions: This population-based study yielded recent real-world evidence on treatment patterns, AEs, HCRU, and costs in patients enrolled in health plans in the US. Immunochemotherapy, particularly BR, remained the preferred frontline therapy for CLL, whereas ibrutinib was the preferred therapy in LOT-2 and LOT-3, during the study period. This study demonstrates that the AE burden associated with current treatment alternatives for CLL is substantial, and the management of AEs occurring during treatments may have a significant impact on the overall health care costs. Disclosures Kabadi: AstraZeneca: Employment. Goyal:RTI Health Solutions: Employment, Research Funding. Nagar:RTI Health Solutions: Employment, Research Funding. Kaye:RTI Health Solutions: Employment, Research Funding. Davis:RTI Health Solutions: Employment, Research Funding. Mato:Celgene: Consultancy; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy; Sunesis: Honoraria, Research Funding; TG Therapeutics: Research Funding; Janssen: Consultancy, Honoraria; Acerta: Research Funding; Prime Oncology: Speakers Bureau; Regeneron: Research Funding.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 43-43
Author(s):  
Amanda Wilson ◽  
Ahmed Daak ◽  
Jun Su

Introduction ITP is an autoimmune disorder characterized by platelet destruction and impaired production. Some patients with ITP are refractory or unresponsive to existing therapies, indicating significant unmet medical needs. An assessment of current real-world treatment patterns among patients with ITP should enhance understanding of the ITP disease population and current unmet need. Here we present real-world data describing the ITP population in the United States in terms of demographic and clinical characteristics and use of available ITP therapies. Methods This was a longitudinal, retrospective, observational cohort study utilizing data from the Optum® Clinformatics® claims database. Patients with newly diagnosed ITP were included; defined as patients with ≥1 inpatient claim or ≥2 outpatient claims within 90 days of ITP-related diagnosis codes (International Classification of Diseases [ICD], Ninth and Tenth Revision; ICD-9: 287.3x; ICD-10: D69.3x or D69.4x) between October 1, 2015 and March 31, 2020. The index date was the date these criteria were met. Patients were excluded if they had &lt;12 months continuous coverage or any record of thrombopoietin receptor agonist (TPO-RA) use before the index date. All patients were required to have ≥1 prescription during follow-up. Primary ITP was defined as patients who met the inclusion criteria and also had no ICD codes for secondary ITP, and no causes of secondary ITP in an identified time period prior to the index date. Here we describe clinical characteristics and medication use among newly diagnosed patients with primary ITP and the proportion of patients who went on to develop persistent (90 days to &lt;12 months) or chronic (≥12 months) ITP. Results There were 19,376 newly diagnosed patients who met inclusion criteria; 15,798 (82%) had primary ITP and 3,578 (18%) had secondary ITP. Among patients with primary ITP, median (min-max) duration of follow-up was 16 (0-55) months and 61% had ≥12 months of follow-up (median duration: 26 months). At baseline, mean (standard deviation [SD]) age was 67 (16) years and 53% of patients were male. Mean (SD) Charlson Comorbidity Index (CCI) was 0.94 (1.41) and 11% of patients fell into a CCI category ≥3. The most common comorbid conditions were hypertension (60%), cardiovascular disease (37%), diabetes (29%), and anemia (27%). The most commonly used concomitant medications were lipid-lowering medications (44%), pain medications (24%), corticosteroids (23%), and anticoagulants (11%). During follow-up, use of these medications increased (lipid-lowering medications [46%], pain medications [38%], corticosteroids [39%], and anticoagulants [15%]). The most commonly used ITP medications during follow-up were corticosteroids (33%), rituximab (3.3%), TPO-RA (2.8%), immunosuppressants (2.6%), intravenous immunoglobulin (2.5%), and immunomodulators (2.4%). There were 1935 (12%) deaths during follow-up, and 87 (0.6%) patients underwent a splenectomy. Of the patients with ≥12 months of follow-up (n=9610), 16% and 32% developed persistent ITP and chronic ITP, respectively. Among the patients with persistent/chronic ITP and ≥12 months of follow-up, 242 (5.3%) received TPO-RA during follow-up. Of these, 93% concomitantly received ≥1 additional ITP treatment-related medication (TRM), 73% of the patients who received TPO-RA and ≥1 other TRM received ≥2 additional ITP TRMs, and 68% of patients who received TPO-RA and ≥2 other TRMs received ≥3 additional ITP TRMs. Of the 242 patients with ≥12 months of follow-up and persistent/chronic ITP who received TPO-RA, 55 (23%) either received an additional TPO-RA therapy or received another newly initiated ITP-related medication ≥30 days after starting TPO-RA. Almost half of the patients with primary ITP developed persistent/chronic disease. However, only a small percentage of these patients in the Optum® Clinformatics® claims database with no history of TPO-RA use received TPO-RA during follow-up. The majority of patients treated with TPO-RA received ≥1 other ITP TRM during follow-up and nearly 1 in 4 persistent/chronic patients receiving TPO-RA required ≥1 additional TPO-RA or switched to another ITP medication. Conclusion Even with the availability of many ITP drug therapies, there is still a considerable current unmet need for effective treatments among patients with primary ITP. The authors acknowledge Rajeshwari Punekar for contributions to study design. Disclosures Wilson: Sanofi: Current Employment, Current equity holder in publicly-traded company. Daak:Sanofi: Current Employment. Su:Sanofi: Current Employment.


2019 ◽  
pp. 1-13
Author(s):  
Pradeep J. Poonnen ◽  
Jill E. Duffy ◽  
Bradley Hintze ◽  
Maulik Shukla ◽  
Thomas S. Brettin ◽  
...  

PURPOSE The Veterans Health Administration (VHA) is the largest cancer care provider in the United States, with the added challenge of serving more than twice the percentage of patients with cancer in rural areas than the national average. The VHA established the National Precision Oncology Program in 2016 to implement and standardize the practice of precision oncology across the diverse VHA system. METHODS Tumor or peripheral blood specimens from veterans with advanced solid tumors who were eligible for treatment were submitted for next-generation sequencing (NGS) at two commercial laboratories. Annotated results were generated by the laboratories and independently using IBM Watson for Genomics. Levels-of-evidence treatment recommendations were based on OncoKB criteria. RESULTS From July 2016 to June 2018, 3,698 samples from 72 VHA facilities were submitted for NGS testing, of which 3,182 samples (86%) were successfully sequenced. Most samples came from men with lung, prostate, and colorectal cancers. Thirty-four percent of samples were from patients who lived in a rural area. TP53, ATM, and KRAS were among the most commonly mutated genes. Approximately 70% of samples had at least one actionable mutation, with clinical trials identified as the recommended option in more than 50%. Mutations in genes associated with a neuroendocrine prostate cancer phenotype were expressed at increased frequency among veterans than in the general population. The most frequent therapies prescribed in response to NGS testing were immune checkpoint inhibitors, EGFR kinase inhibitors, and PARP inhibitors. CONCLUSION Clinical implementation of precision oncology is feasible across the VHA health care system, including rural sites. Veterans have unique occupational exposures that might inform the nature of the mutational signatures identified here. Importantly, these results underscore the importance of increasing clinical trial availability to veterans.


10.36469/9864 ◽  
2013 ◽  
Vol 1 (2) ◽  
pp. 174-183
Author(s):  
Lin Xie ◽  
M. Furaha Kariburyo ◽  
Juan Du ◽  
Yuexi Wang

Objective: To examine the economic burden and health care utilizations of schizophrenia in the U.S. veteran population. Methods: A retrospective database analysis was performed using the Veterans Health Administration (VHA) Medical SAS® datasets from October 1, 2008 through September 30, 2012. Patients diagnosed with schizophrenia were identified, and the initial diagnosis date was designated as the index date. A group of patients without schizophrenia of the same age, region, gender and index year were identified and matched by baseline Charlson Comorbidity Index (CCI) score, as the comparison group. Patients in both groups were required to be at least age 18 years and have continuous medical and pharmacy benefits 1 year pre- and 1 year post-index date. One-to-one propensity score matching was used to compare health care costs and utilizations during the follow-up period between the schizophrenia and comparison group patients, adjusted for baseline demographic and clinical characteristics. Results: A total of 171,086 eligible patients were identified for the schizophrenia and control cohorts. After 1:1 matching, a total of 70,045 patients were matched from each cohort with well-balanced baseline characteristics. Patients diagnosed with schizophrenia had significantly higher health care utilization in inpatient (18.12% vs. 2.30%, p&lt;0.01), emergency room (19.67% vs. 6.46%, p&lt;0.01), office (98.32% vs. 53.26%, p&lt;0.01), and outpatient visits (98.53% vs. 54.16%, p&lt;0.01). Higher health care utilizations translated into higher costs for schizophrenic patients including inpatient ($7,228 vs. $613, p&lt;0.01), pharmacy ($1,012 vs. $343, p&lt;0.01), outpatient ($3,998 vs. $1,302, p&lt;0.01), and total costs ($12,238 vs. $2,260, p&lt;0.01) relative to patients in the comparison group. Conclusion: Patients diagnosed with schizophrenia in the U.S. VHA system were associated with a substantial economic burden, compared to their matched controls.


Author(s):  
Greenberg Benjamin ◽  
Scott Kolodny ◽  
Mengru Wang ◽  
Chinmay Deshpande

Abstract Background: The current landscape and treatment patterns of disease-modifying therapy (DMT) use among pediatric patients with multiple sclerosis (MS) is not yet well understood. This study examined DMT utilization and treatment patterns among pediatric patients newly diagnosed with MS. Methods: Pediatric patients (&lt;18 years) with 2 MS diagnosis claims from January 1, 2010, to December 31, 2016, were identified from the MarketScan Commercial Database. Index date was defined as the date of first MS diagnosis and patients were followed up for 1-year post-index date. Outcomes evaluated included percentage of patients who initiated treatment after MS diagnosis, different DMTs initiated, treatment discontinuation, and switching treatment over the follow-up period. Results: Of the 182,057 newly diagnosed MS patients, 288 pediatric patients (mean age: 14 years; females: 61%) were identified. Within the first year of diagnosis, 188 patients (65.3%) did not receive any DMT. The most commonly first initiated treatments were interferons and glatiramer acetate (83%), but 28% of patients switched or discontinued from first initiated treatment within 6 months of treatment initiation. Conclusions: This study suggests that a considerable proportion of pediatric MS patients remain untreated within one year. Patients most commonly initiated injectables as their first DMT. Overall approximately 1 in 3 patients failed on therapy early. Thus, the study warrants urgency in treating these patients with currently approved treatment options.


2014 ◽  
Vol 28 (2) ◽  
pp. 385-413 ◽  
Author(s):  
Nicole Thibodeau ◽  
John Harry Evans ◽  
Nandu J. Nagarajan

SYNOPSIS Starting in 1995, the Veterans Health Administration (VHA) transformed a bureaucratic healthcare system into a performance-driven, patient-focused integrated healthcare network. The VHA's experience may offer lessons for private and public sector providers as the U.S. explores alternative healthcare delivery systems and payment methods. Similar patient-focused integrated systems are one of the hallmarks of the latest U.S. attempt to improve the quality and efficiency of healthcare delivery. The use of performance incentives to promote cooperation and innovation is also central to both the VHA and the U.S. reform. This study reviews the VHA's experience with an eye to identifying issues and potential research avenues for accounting researchers interested in the role of accounting information for control, coordination, and organizational change.


2020 ◽  
Vol 4 (6) ◽  
Author(s):  
Orna Intrator ◽  
Edward Alan Miller ◽  
Portia Y Cornell ◽  
Cari Levy ◽  
Christopher W Halladay ◽  
...  

Abstract Background and Objectives U.S. Department of Veterans Affairs Medical Centers (VAMCs) contract with nursing homes (NHs) in their community to serve Veterans. This study compares the characteristics and performance of Veterans Affairs (VA)-paid and non-VA-paid NHs both nationally and within local VAMC markets. Research Design and Methods VA-paid NHs were identified, characterized, and linked to VAMC markets using data drawn from VA administrative files. NHs in the United States in December 2015 were eligible for the analysis, including. 1,307 VA-paid NHs and 14,253 non-VA-paid NHs with NH Compare measures in 128 VAMC markets with any VA-paid NHs. Measurements were derived from the Centers for Medicare and Medicaid Services (CMS) five-star rating system, NH Compare. Results VA-paid NHs had more beds, residents per day, and were more likely to be for-profit relative to non-VA-paid NHs. Nationally, the average CMS NH Compare star rating was slightly lower among VA-paid NHs than non-VA-paid NHs (3.05 vs. 3.21, p = .04). This difference was seen in all 3 domains: inspection (3.11 vs. 3.23, p &lt; .001), quality (2.68 vs. 2.83, p &lt; .001), and total nurse staffing (3.36 vs. 3.42, p &lt; .10). There was wide variability across VAMC markets in the ratio of average star rating of VA-paid and non-VA-paid NHs (mean ratio = 0.93, interquartile range = 0.78–1.08). Discussion and Implications With increased community NH use expected following the implementation of the MISSION Act, comparison of the quality of purchased services to other available services becomes critical for ensuring quality, including for NH care. Methods presented in this article can be used to examine the quality of purchased care following the MISSION Act implementation. In particular, dashboards such as that for VA-paid NHs that compare to similar non-VA-paid NHs can provide useful information to quality improvement efforts.


2006 ◽  
Vol 1 (2) ◽  
pp. 99-105 ◽  
Author(s):  
Jonathan B. Perlin

Ten years ago, it would have been hard to imagine the publication of an issue of a scholarly journal dedicated to applying lessons from the transformation of the United States Department of Veterans Affairs Health System to the renewal of other countries' national health systems. Yet, with the recent publication of a dedicated edition of the Canadian journal Healthcare Papers (2005), this actually happened. Veterans Affairs health care also has been similarly lauded this past year in the lay press, being described as ‘the best care anywhere’ in the Washington Monthly, and described as ‘top-notch healthcare’ in US News and World Report's annual health care issue enumerating the ‘Top 100 Hospitals’ in the United States (Longman, 2005; Gearon, 2005).


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