scholarly journals Examining the Prevalence of Previously Recorded Phenotypically Related Diagnoses Among Fee-for-Service Medicare Enrollees Newly Diagnosed with Mendelian Conditions

Author(s):  
William B. Weeks ◽  
Grace Huynh ◽  
Stacey Y. Cao ◽  
Jeremy Smith ◽  
Chaitanya Bangur ◽  
...  
Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3492-3492
Author(s):  
Anne Shah ◽  
Allison Petrilla ◽  
Mayvis Rebeira ◽  
Joseph Feliciano ◽  
Thomas W. LeBlanc ◽  
...  

Background: Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of lymphoid malignancies characterized by a clinically aggressive course with poor prognosis. A majority of PTCL patients are ≥60 years of age and typically present with advanced stage disease and multiple comorbidities. There remains no consensus standard of care for patients with most PTCL subtypes. Multi-agent chemotherapy, consisting of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP with etoposide (CHOEP), are guideline recommended options for nodal subtypes. Limited contemporary real-world data exist on the treatment patterns and overall survival (OS) of PTCL patients treated with CHOP or non-CHOP regimens in the United States before the FDA approval of brentuximab vedotin in combination with chemotherapy in November 2018 based on the ECHELON-2 trial. Objective: To evaluate treatment patterns and OS prior to the approval of brentuximab vedotin among Medicare Fee-for-Service (FFS) beneficiaries newly diagnosed with PTCL. Methods: The 100% sample of Medicare FFS claims (Parts A/B/D) was used to identify patients aged ≥65 years with ≥1 inpatient or ≥2 distinct outpatient diagnosis claims for PTCL (index event) from January 2011 to December 2017. Patients were required to have a least 6 months prior and 12 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or the end of the study period, whichever occurred first. OS, defined as the time from initial episode or treatment start date to the validated date of death, was measured using the Kaplan-Meier method; patients without a death date were assumed to be alive at the time of analysis and were censored. Results: A total of 2551 Medicare FFS beneficiaries with a PTCL diagnosis met study criteria and were included for analysis. The majority of patients were white (86.9%), over half were male (52.9%), and mean age was 75 years. Patients had multiple comorbidities at diagnosis (Charlson Comorbidity Index (CCI) score 4.47), including hypertension (77.3%), diabetes (32.9%), and chronic obstructive pulmonary disease (28.1%). Among the 2551 patients in the study cohort, 62.4% (n=1593 of 2551) received at least one identifiable drug regimen; 25.5% of treated patients received CHOP (n=407), 3.1% CHOEP (n=50) and 71.2% (n=1134) other regimens. Of patients treated with other regimens, 37.7% (n=427) received steroids only, 22.4% (n=254) steroids with unidentifiable chemotherapy, 6.9% (n=78) cyclophosphamide, 6.2% (n=70) methotrexate, 4.6% (n=52) brentuximab vedotin, 3.6% (n=41) bendamustine, 3.5% (n=40) romidepsin, and 15.2% (n=172) other therapy combinations. Among patients who were treated with CHOP, 16.6% (n=66) received an identifiable second line of therapy (LoT), 48.7% (n=194) an unidentifiable second LoT, and the remainder (34.7%, n=138) had no evidence of further anti-cancer treatment. The median time from CHOP initiation to a subsequent LoT was 5.6 months. The mean baseline CCI score for patients treated with CHOP was 4.33 (±2.93) compared with 4.76 (±2.97) for patients treated with other therapies (p=0.0118). In patients receiving an identifiable first LoT, median OS among CHOP and non-CHOP recipients was 4.8 years (95% CI 3.0-6.1) and 4.4 years (95% CI 3.0-4.9), respectively (Table). The 5-year OS estimate was 49% in patients receiving CHOP compared with 46% for non-CHOP recipients. Conclusions: Fewer than 30% of Medicare beneficiaries newly diagnosed with PTCL were treated with intensive chemotherapy as first LoT. Acknowledging a possible selection bias for more fit PTCL patients receiving CHOP, this group had increased OS compared with patients receiving non-CHOP therapy. However, the 5-year OS across all cohorts was less than 50%. New therapies such as brentuximab vedotin may fill the need for PTCL Medicare beneficiaries who may not be able to tolerate CHOP or CHOP-based regimens. Disclosures Shah: Avalere Health, An Inovalon Company: Employment. Petrilla:Avalere Health, An Inovalon Company: Employment. Rebeira:Seattle Genetics: Employment. Feliciano:Seattle Genetics: Employment, Equity Ownership. LeBlanc:Astra Zeneca: Consultancy, Research Funding; Duke University: Research Funding; Jazz Pharmaceuticals: Research Funding; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; NINR/NIH: Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Research Funding; CareVive: Consultancy; Celgene: Honoraria; Flatiron: Consultancy; American Cancer Society: Research Funding; Heron: Membership on an entity's Board of Directors or advisory committees; Medtronic: Membership on an entity's Board of Directors or advisory committees; Pfizer Inc: Consultancy. Lisano:Seattle Genetics, Inc.: Employment, Equity Ownership.


2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 5-5
Author(s):  
Catherine R. Fedorenko ◽  
Karma L. Kreizenbeck ◽  
Laura Panattoni ◽  
Julia Rose Walker ◽  
Mikael Anne Greenwood-Hickman ◽  
...  

5 Background: As payers move from fee-for-service to episode-based reimbursement, there is a need for oncology providers to accurately measure in- and out-of-system resource use and cost for patients under their care. Medicare assigns management of a patient to only one provider, yet delivery systems may assume contractual responsibility for a patient with cancer’s entire episode costs, including care received outside of their system. Accordingly, the goal of this study was to estimate OOS care for patients with breast, colorectal (CRC), and non-small cell lung cancer (NSCLC). Methods: Cancer registry records for patients with breast, CRC, or NSCLC diagnosed in Western Washington State from January 2007 to June 2016 were linked with claims from two regional commercial insurers. The analysis focused on initial treatment phase: first day of treatment (surgery, radiation, chemotherapy) through the first 4-month gap in treatment. Patients were assigned an oncology provider group by identifying the clinic Tax ID Number (TIN) with the most Evaluation & Management (E&M) claims with a cancer diagnosis. Claims were considered in system if the TIN matched the assigned clinic. Costs included claims paid to all providers (adjusted to 2016 dollars). Results: The study included 7,686 newly diagnosed patients with breast, CRC, or NSCLC. The average cost for the initial treatment phase was $61,147/patient (SD $75,432, median $35,750). Nearly 31% of claims paid (mean $18,684, SD $32,649) were out of system. Among OOS costs, 24% were for inpatient care, 68% were for outpatient care, and 8% were for outpatient pharmacy. Conclusions: Among newly diagnosed patients with breast, CRC, or NSCLC, approximately 1/3 of costs for the initial treatment period stemmed from OOS care. Developing best practices for the reporting and management of OOS will be critical for organizations to succeed under episode-based reimbursement plans.[Table: see text]


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 38-38
Author(s):  
Shuling Li ◽  
Julia T Molony ◽  
Karynsa Cetin ◽  
Jeffrey S Wasser ◽  
Ivy Altomare

Abstract Background: ITP is a rare disorder characterized by low platelet counts and a tendency toward increased bleeding and bruising. Several studies have shown that ITP incidence increases with age. Elderly ITP patients may have a higher risk of bleeding and their disease management can be challenging due to increased burden of other health problems. However, little information is available regarding rates of BREs in elderly ITP patients. As the population ages, understanding the frequency of bleeding events and/or use of ITP therapy to treat or prevent bleeding in routine clinical practice could provide insights into the real-world burden of this disease in elderly patients. Methods: Using Medicare 20% sample data 2007-2012, we identified elderly Medicare fee-for-service (FFS) enrollees newly diagnosed with primary ITP (ICD-9-CM diagnosis code 287.31) at age ≥67 years (to ensure ≥2 years of Medicare FFS enrollment before their first claim with an ITP code to determine study eligibility), between January 1, 2009, and September 30, 2012. BREs were defined as ≥1 bleeding event (of any severity) and/or use of ITP therapies commonly considered for rescue or emergency therapy (platelet transfusion, intravenous immunoglobulin [IVIg], anti-D, or IV steroids). Claims with relevant codes with dates of service separated by ≤3 days were considered a single BRE. The rate of BREs (per person-year) was calculated for all BREs and by event type incorporated into BREs for the ITP cohort overall and stratified on ITP phase (newly diagnosed: 0 to <3 months; persistent: 3-12 months; chronic: >12 months). ITP phase was defined based on ITP disease duration, which was calculated as the time between initial ITP diagnosis and last ITP claim. Patients were followed from ITP diagnosis until the last ITP claim (end of ITP duration), death, disenrollment from FFS coverage, or December 31, 2012, whichever came first. Results: We identified 3007 elderly patients with primary ITP (mean [SD] age: 79.6 [7.5] years; 55% female) in the database of 12.8 million enrollees. The median (IQR) ITP duration was 6 (1, 17) months; 37%, 30%, and 34% of patients had ITP duration <3, 3-12, and >12 months, respectively. During 2687 person years follow-up, 1806 patients (60%) experienced at least one BRE for a total of 6305 BREs; 42% were bleeding events only, 50% were therapy only, and 8% were both. BRE rates (95% CI) per person year were 2.35 (2.29-2.41) for any BREs and 0.99 (0.95-1.03), 1.18 (1.14-1.22), and 0.18 (0.16-0.20) for BREs with bleeding only, therapy only, and both, respectively. The most common bleeding types were gastrointestinal hemorrhage, hematuria, epistaxis, and ecchymoses. Intracranial hemorrhage was reported in 107 patients (3.6%). Newly diagnosed patients had higher BRE rates (Table). Table.Newly diagnosed ITP (n=3007)Persistent ITP (n=1907)Chronic ITP (n=1010)BREsCountRate per person year (95% CI)CountRate per person year (95% CI)CountRate per person year (95% CI)All24474.46 (4.28,4.63)21962.05 (1.96,2.14)16621.56 (1.49,1.64)With bleeding only10871.98 (1.86,2.10)8350.78 (0.73,0.83)7330.69 (0.64,0.74)With therapy only10221.86 (1.75,1.98)12621.18 (1.11,1.24)8840.83 (0.78,0.88)With both bleeding and therapy3380.62 (0.55,0.68)990.09 (0.07,0.11)450.04 (0.03,0.05) Conclusion: We provided current real-world estimates of BRE rates in elderly patients with ITP. About 60% of ITP patients experienced at least one BRE, and half of all BREs were defined by therapy use alone. This demonstrates the importance of examining both bleeding and use of rescue or emergency ITP therapy in the assessment of disease burden in elderly patients with ITP. Disclosures Cetin: Amgen, Inc: Employment, Equity Ownership. Wasser:Amgen, Inc: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Altomare:Amgen Inc.: Consultancy, Honoraria.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4049-4049
Author(s):  
Erin M. Sullivan ◽  
Jenna Cohen ◽  
Chelsea Norregaard ◽  
Uyen Nguyen ◽  
Chris Sloan ◽  
...  

Abstract Systemic mastocytosis (SM) is a rare mast cell disease driven by the KIT D816V mutation in which mast cells accumulate in ≥1 tissues or organs resulting from clonal proliferation of abnormal mast cells in one or more extracutaneous organs. Most forms of SM are non-advanced (non-AdvSM). To date, the economic burden of non-AdvSM has not been well-studied among Medicare patients. This study compared direct healthcare resource utilization (HCRU) and healthcare costs in Medicare beneficiaries with non-AdvSM and a matched cohort without SM. This study used Centers for Medicare and Medicaid Services-sourced 100% Medicare Fee for Service (FFS) claims (Parts A/B/D) and identified newly diagnosed non-AdvSM patients who had ≥2 medical claims for SM (ICD-10-CM Dx codes: D47.02 OR C94.30 OR C94.31 OR C94.32 OR C96.21) between 1/1/2017 and 12/31/2018. Patients were classified as non-AdvSM using a claims-based algorithm. The index date was the date of first observed SM diagnosis. Continuous enrollment in Medicare Parts A/B/D for 12 months pre- and post-index was required. Non-AdvSM patients were direct matched (1:1) on age, sex, race, index year, Medicare-Medicaid dual eligibility, and Charlson Comorbidity Index score to a non-SM control cohort. HCRU and costs were assessed during the 12 months pre- and post-index. Medical costs are reported in 2021 US dollars. Post match, there were 333 non-AdvSM and 333 non-SM patients. Mean [SD] age of the non-AdvSM cohort was 67.3 [11.7] and 67.8 [13.3] years for the control cohort. Over 25% of patients were &lt;65 years of age at index and originally qualified for Medicare with a disability. Most (76%) patients were female, and 94% were White. During the 12-month pre-index period, non-AdvSM patients had more specialist physician office visits per patient (mean [SD]: 15 [15]) compared to non-SM patients (10 [13]; p&lt;0.01). Non-AdvSM patients vs. controls had higher prevalence of asthma (29% vs. 15%, p&lt;0.0001) and any malignancy (43% vs. 15%, p&lt;0.0001) and lower prevalence of hypertension (58% vs. 68%, p=0.0103), diabetes with and without complications (19% vs. 34%; 8% vs. 15%; both p&lt;0.0001), and renal disease (7% vs. 11%, p=0.0439). Non-AdvSM patients were also higher utilizers of corticosteroids (64% vs. 54%, p=0.0094), epinephrine auto-injectors (31% vs. 1%, p&lt;0.0001), and omalizumab (6% vs. 0%, p&lt;0.0001) compared to non-SM patients. Total (Parts A/B/D) healthcare costs in the 12-month follow up period were almost one-third higher for non-AdvSM patients than for non-SM controls (mean [SD]: $40,250, [$54,563] vs. $30,013 [$51,235]; p=0.0128). Pharmacy (Part D only) expenditures were also significantly higher ($13,938[$38,367] vs. $5,745 [$17,213], p=0.0004) and accounted for a greater proportion (34.6% vs. 19.1%) of total costs for non-AdvSM patients vs. non-SM patients. Non-AdvSM patients were high utilizers of physician office visits post-index compared to non-SM controls; more non-AdvSM patients had ≥1 oncology/hematology visit (36.9% vs. 12.9%; p&lt;0.0001), or allergy/immunology visit (47.2% vs. 3.9%; p&lt;0.0001) and mean [SD] visits per patient were higher among non-AdvSM patients (3.4 [11.8] vs. 1.3 [6.4] oncology/hematology, p=0.0049; 3.3 [9.5] vs. 0.2 [1.7] allergy/immunology, p&lt;0.0001). Approximately 40% of non-AdvSM patients filled ≥1 prescription for an epinephrine auto-injector compared with &lt;3% in non-SM patients (p&lt;0.0001). More non-AdvSM patients had prescriptions for H1 antihistamines (13.8% vs. 5.4%, p=0.0002), oral and systemic corticosteroids (39.0% vs. 27.9%, p&lt;0.0001; 51.7% vs. 32.1%, p=0.0079, respectively), leukotriene antagonists (40.5% vs. 8.7%; p&lt;0.0001), and omalizumab (6.9% vs. 0.0%, p&lt;0.0001). Compared to a matched cohort of non-SM Medicare FFS patients, non-AdvSM Medicare patients had 30% higher mean per patient total healthcare expenditures ($40,250 vs. $30,013), driven by more prescription drug use and higher utilization of outpatient resources, specifically visits to oncologists/hematologists and allergists/immunologists. Notably, this analysis does not represent the HCRU and costs of the most severe SM patients. Further research to understand the basis of the higher proportion of non-AdvSM patient in this analysis who were &lt;65 years and qualified for Medicare with a disability (vs. 14% in all of Medicare), and the corresponding long-term medical costs among these patients is warranted. Disclosures Sullivan: Blueprint Medicines: Current Employment, Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Cohen: Blueprint Medicines: Current Employment, Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months. Norregaard: Blueprint Medicines: Current Employment, Current equity holder in publicly-traded company. Nguyen: Blueprint Medicines: Current Employment. Sloan: Blueprint Medicines: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Petrilla: Blueprint Medicines: Other: Allison Petrilla is an employee of Avalere Health, which received consulting fees from Blueprint Medicines for this study.. Silverstein: Blueprint Medicines: Other: Alison Silverstein is an employee of Avalere Health, which received consulting fees from Blueprint Medicines for this study.. Murunga: Blueprint Medicines: Other: Anne Murunga is an employee of Avalere Health, which received consulting fees from Blueprint Medicines for this study.. Schinkel: Blueprint Medicines: Other: Jill Schinkel is an employee of Avalere Health, which received consulting fees from Blueprint Medicines for this study..


2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 278-278
Author(s):  
Anik Patel ◽  
Aurelien Jamotte ◽  
Tara Matsuda ◽  
Partha Manas Das ◽  
Ehab Elkhouly ◽  
...  

278 Background: The number of targeted therapies approved for treatment of mNSCLC has increased over the past 5 years. Strategies to identify eligible patients with actionable mutations for targeted therapy include simultaneous testing of ≥ 2 genes via next generation sequencing (NGS) or multiple simultaneous gene testing (MSGT) and sequential single gene testing (SSGT). Current clinical practice guidelines strongly recommend broad molecular profiling in all patients for the simultaneous assessment of multiple genes, including EGFR, ALK and ROS1, that may have potential roles in cancer development. Limited real-world (RW) evidence is available describing the uptake of these strategies and receipt of targeted therapy. Methods: Medicare beneficiaries age 65 years or older, newly diagnosed with mNSCLC and tested for mutations of interest in mNSCLC (ALK, EGFR, ROS1, BRAF, HER2, KRAS, MET, NTRK, RET) from July 2014 - June 2018 were identified using Medicare FFS claims (100% sample) linked to biomarker results in PROGNOS NSCLC Explorer. Patients were followed from date of first metastatic diagnosis and stratified by line of therapy, testing strategy, and year of mNSCLC diagnosis. Those testing positive for an actionable biomarker were identified and then segmented by timing of receipt of a subsequent targeted therapy. Results: 12,272 beneficiaries met inclusion criteria: median age: 75 years, 51% were female, 86% white. Among mNSCLC patients with at least one biomarker test result, EGFR and ALK mutation status were the most commonly tested and reported in 85% and 63% respectively. Overall, 1540 (12.5%) tested positive for EGFR, ALK or ROS1. The relative use of NGS or MSGT vs. SSGT for biomarker testing increased over time, from 63% in 2014 to 80% in 2018. During this period, 789 patients were identified as having at least one positive biomarker test result prior to initiating 1L therapy: 635 were identified via NGS or MSGT while 154 were identified via SSGT. Despite a positive test for mutations of interest, only 292 patients received a targeted drug at 1L. Conclusions: This RW study of mNSCLC patients demonstrates an increasing trend to test patients for multiple biomarkers at once via NGS or other MSGT methods. The number of patients receiving appropriate targeted therapies was low, suggesting the need to address the barriers to administration of guideline-recommended therapy.


2020 ◽  
Vol 8 (1) ◽  
pp. e001328
Author(s):  
Tze-Woei Tan ◽  
David G Armstrong ◽  
Kirsten C Concha-Moore ◽  
David G Marrero ◽  
Wei Zhou ◽  
...  

IntroductionThis study aimed to examine the association of race and ethnicity on the risk of lower extremity amputations among Medicare beneficiaries with diabetic foot ulcers (DFUs) and diabetic foot infections (DFIs).Research design and methodsA retrospective study included 2011–2015 data of a 5% sample of fee-for-service Medicare beneficiaries with a newly diagnosed DFU and/or DFI. The primary outcome was the time to the first major amputation episode after a DFU and/or DFI were identified using the diagnosis and procedure codes. We used multivariable Cox proportional hazards models to estimate the risk of time to the first major amputation across races, adjusting for sociodemographic and health status factors. Adjusted hazard ratios (aHRs) with a 95% CI were reported.ResultsAmong 92 929 Medicare beneficiaries newly diagnosed with DFUs and/or DFIs, 77% were whites, 14.3% African Americans (AAs), 3.3% Hispanics, 0.7% Native Americans (NAs), and 4.0% were other races. The incidence rates of major amputation were 0.02 person-years for NAs, 0.02 person-years for AAs, 0.01 person-years for Hispanics, 0.01 person-years for other races, and 0.01 person-years for whites (p<0.05). Multivariable analysis showed that AAs (aHR=1.9, 95% CI 1.7 to 2.2, p<0.0001) and NAs (aHR=1.8, 95% CI 1.3 to 2.6, p=0.001) were associated with an increased risk of major amputation compared with whites. Beneficiaries with DFUs and/or DFIs diagnosed by a podiatrist or primary care physician (aHR=0.7, 95% CI 0.6 to 0.8, p<0.0001, specialists as reference) or at an outpatient visit (aHR=0.3, 95% CI 0.3 to 0.3, p<0.0001, inpatient stay as reference) were associated with a decreased risk of major amputation.ConclusionsRacial and ethnic disparities in the risk of lower extremity amputations appear to exist among fee-for-service Medicare beneficiaries with diabetic foot problems. AAs and NAs with DFUs and/or DFIs were associated with an increased risk of major amputations compared with white Medicare beneficiaries.


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