This study assessed underuse of treatment with hypomethylating agents (HMAs) among patients with newly diagnosed myelodysplastic syndromes with refractory anemia with excess blasts. Of 1190 patients from the Surveillence, Epidemiology, and End Results-Medicare database, 526 (44%) did not use HMAs and 295 (25%) were non-persistent HMA users, whereas 369 (31%) were persistent HMA users. Several clinical and demographic factors were associated with HMA underuse. Background: Recent data suggest significant underutilization of hypomethylating agents (HMAs) that are recommended treatments for patients with myelodysplastic syndromes (MDS) with refractory anemia with excess blasts (RAEB). The study objective was to assess the degree of HMA use and predictors of HMA underuse in this population. Patients and Methods: This was a retrospective study including patients diagnosed with the RAEB form of MDS between January 2011 and December 2015 using the Surveillance, Epidemiology, and End Results-Medicare linked database. Patients were excluded if they had < 1 year of continuous enrollment before diagnosis or received stem cell transplant or lenalidomide during the follow-up period. HMA non-peristence was defined as use of < 4 cycles (3-10 HMA days/28 days) of HMAs or a gap of 90 days between consecutive cycles. Patients were characterized as HMA never-users, HMAepersistent users, and HMAenon-persistent users. Descriptive statistics were used to summarize patient characteristics. Multivariable logistic regression was used to assess predictors of HMA underuse and persistence. Results: Of the 1190 patients, 526 (44%) were never-users, 295 (25%) were non-persistent users, and 369 (31%) were persistent users. Age at diagnosis (eg, 66-70 years vs. 80 years; odds ratio [OR], 2.36; 95% confidence interval [CI], 1.56-3.56), marital status (single vs. married; OR, 0.67; 95% CI, 0.51-0.89), National Cancer Institute comorbidity index ( 3 vs. 0-1; OR, 0.62; 95% CI, 0.46-0.83), and performance status (poor vs. good; OR, 0.67; 95% CI, 0.51-0.87) were significantly associated with HMA underuse. Conclusion: Several demographic and clinical factors were associated with underuse of HMAs. There is need for a better understanding of suboptimal HMA use and its relationship with clinical response.
This study assessed medical costs of early discontinuation of hypomethylating agents (HMAs) in patients with refractory anemia with excess blasts subgroup of myelodysplastic syndromes using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database (2010)(2011)(2012)(2013)(2014)(2015)(2016). Patients discontinuing HMAs before the recommended time frame required to elicit clinical response may experience suboptimal outcomes and incur higher healthcare costs, thus pointing to the potential benefit of treatment continuity as per guidelines. Background: Suboptimal use of hypomethylating agents (HMAs) among higher-risk myelodysplastic syndrome (HR-MDS) patients can translate into worse health outcomes and economic burden. We estimated the direct medical costs associated with HMA treatment nonpersistence among HR-MDS patients. Patients and Methods: Using the Surveillance, Epidemiology, and End ResultseMedicare linked database, a retrospective cohort of patients diagnosed with refractory anemia with excess blasts (RAEB), a diagnosis that substantially overlaps with HR-MDS, between January 2011 and December 2015 was analyzed. Patients who had 1 year of continuous Medicare enrollment before diagnosis and who did not receive stem cell transplant or lenalidomide in the follow-up period were included. Patients receiving HMAs were stratified into HMA persistent (4 HMA cycles) and HMA nonpersistent (<4 cycles or a gap of 90 days between cycles) groups. Healthcare resource use and costs during the follow-up period were reported descriptively as total and per patient per month (PPPM). Weighted generalized linear models (GLM) were used to compare estimated healthcare resource use and costs between HMA groups. Results: Among the 664 patients with RAEB, 295 (44.4%) were HMA nonpersistent and 369 (55.6%) HMA persistent. On the basis of weighted GLM analysis, the HMA nonpersistent group incurred significantly (P < .05
Objectives: To evaluate hypomethylating agent (HMA) persistence in patients with myelodysplastic syndromes (MDS), and examine its association with healthcare resource utilization (HRU) and progression to acute myeloid leukemia (AML). Methods: A total of 2,400 adults diagnosed with MDS initiating HMAs were included from IBM MarketScan databases during 1/1/2011-3/31/2018. The index date was HMA initiation following MDS diagnosis. Patients were classified according to their persistence status by the end of a fixed 'landmark period' of 4 months post-index. Results: Median persistence to HMAs was 5.6 months (95% CI: 5.2, 6.1); HMA non-persistence increased with time. Non-persistent patients had a significantly higher non-HMA-related HRU burden than persistent patients [adjusted incidence rate ratios, outpatient visits: 1.12 (95% CI: 1.10, 1.14); inpatient visits: 1.48 (95% CI: 1.30, 1.69); emergency department visits 1.30 (95% CI: 1.12, 1.50); all p-values < 0.001]. All-cause and HMA-related outpatient visits were lower among non-persistent patients, likely because of fewer HMA administration-related visits. The incidence rate of AML was numerically, although not significantly, higher in non-persistent patients, when starting follow-up at the end of the landmark period. When follow-up began at the index date, non-persistent patients had a significantly higher rate of AML [adjusted hazard ratio, 1.88 (95% CI: 1.53, 2.32); p-value < 0.001]. Conclusions: HMA non-persistence, which increased over time, was associated with significantly higher non-HMA-related HRU, and numerically higher AML progression in MDS patients initiating HMAs. Future studies should evaluate predictors of HMA non-persistence in this patient population.
e15070 Background: Trifluridine/tipiracil (FTD/TPI) was recently approved for the treatment of third-line or later (3L+) metastatic colorectal cancer (mCRC). The objective of this study was to develop a payer-perspective budget impact model to estimate the 1-year budgetary consequences of adding FTD/TPI to a health plan’s formulary when a portion of the eligible mCRC patients who are currently treated with regorafenib are treated with FTD/TPI. Methods: The baseline annual budget for treating 3L+ mCRC patients, including pharmacy, administration, monitoring, and adverse-event (AE) costs, and excluding FTD/TPI, was estimated. Pharmacy costs were calculated using wholesale acquisition costs, and all other costs, AE rates, dosing administration, and monitoring guidelines were obtained from publically available sources. The model assumes that all treatment costs were incurred over 1 year, all AEs were mutually exclusive, and 30% of serious AEs (grades 3 and 4) were treated on an inpatient basis. Medication costs associated with outpatient AE management were not included. Using a regorafenib replacement strategy which pulls FTD/TPI market share from regorafenib, the projected annual budget was calculated assuming 30.5% adoption by FTD/TPI. Results: Of the hypothetical population of 1 million, approximately 107 were mCRC patients eligible for receiving 3L+ treatment. A net saving of $230,949 (−6.3%) in total costs was achieved when FTD/TPI therapy was included on total costs of $3,412,713, with the greatest savings in medication (−7.7%) and AE management costs (−0.3%). The reduction in cost per treated patient per year was $2150.12, and the net budget impact was −$0.02 (−6.3%) per member per month. Conclusions: Inclusion of FTD/TPI therapy in the model resulted in net savings in medication, AE management, and total costs, and costs per treated patient per year. These data suggest potential savings if FTD/TPI is added to a health plan formulary for the 3L+ treatment of mCRC patients. Sponsorship: Taiho Oncology, Inc. Editorial Assistance: Complete HealthVizion.
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