Real-world adherence and treatment discontinuation with trifluridine/tipiracil (FTD-TPI) compared with regorafenib (REG) for the treatment of metastatic colorectal cancer (mCRC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15000-e15000
Author(s):  
Anuj K. Patel ◽  
Mei Sheng Duh ◽  
Victoria E. Barghout ◽  
Mihran Ara Yenikomshian ◽  
Yongling Xiao ◽  
...  

e15000 Background: FTD-TPI and REG both prolong survival in refractory mCRC. Both agents have the benefit of oral administration but with distinct side effect profiles. This study aims to compare real-world treatment patterns following initiation of FTD-TPI or REG for mCRC in a large, nationally representative US claims database. Methods: Retrospective data from 10/2014 to 7/2016 from the US Symphony Health Solutions’ Integrated Dataverse (IDV®) database were analyzed for patients (pts) receiving FTD-TPI or REG. The index date was the date of first FTD-TPI or REG prescription. Pts were included if: 1) age ≥18 years old, 2) ≥1 CRC diagnosis, 3) no diagnosis of gastric cancer or gastrointestinal stromal tumor, and 4) continuous clinical activity for ≥3 months before and after index date. The observation period spanned from index date to end of data, end of continuous clinical activity, or switch to another mCRC treatment. Medication adherence was assessed by medication possession ratio (MPR), with MPR ≥80% as the defined threshold for adherence, as well as by proportion of days covered (PDC) at 3 months. Between treatment groups, binary endpoints were compared using Chi-square tests and mean and median time to treatment discontinuation (TTD) were compared using t-test and Wilcoxon test, respectively. Results: The study population consisted of 1,630 FTD-TPI pts and 1,425 REG pts. Mean ± standard deviation (SD) age of FTD-TPI pts was 61 ± 11 and REG pts was 63 ± 11 (p < 0.01). Mean ± SD length of observation period in days was 161 ± 59 for FTD-TPI pts and REG pts was 212 ± 113 (p < 0.01). 84% of FTD-TPI and 74% of REG pts reached MPR ≥80% (p < 0.01). FTD-TPI pts had higher mean PDC (71% vs 59%, p < 0.01) than REG pts. Mean and median TTD were significantly longer for FTD-TPI than REG pts (mean: 101 vs. 88 days, p < 0.01; median: 97 vs. 69 days, p < 0.01). Conclusions: In this analysis of real-world medication utilization for mCRC pts, those pts started on FTD-TPI had significantly higher medication adherence and longer TTD than those on REG.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 666-666
Author(s):  
Anuj K. Patel ◽  
Mei Sheng Duh ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Yongling Xiao ◽  
...  

666 Background: FTD/TPI and REG both prolong survival in refractory mCRC and have similar indications with different side effect profiles. This study compares real-world treatment patterns with FTD/TPI and REG for mCRC in a large, representative US claims database. Methods: Retrospective data from 10/2014 to 7/2016 from the US Symphony Health Solutions’ Integrated Dataverse (IDV®) database were analyzed for patients receiving FTD/TPI or REG. The index date was the date of first FTD/TPI or REG prescription. Patients were included if: 1) age ≥18 years old, 2) ≥1 CRC diagnosis, 3) no diagnosis of gastric cancer or gastrointestinal stromal tumor, and 4) continuous clinical activity for ≥3 months before and after index date. The observation period spanned from index date to end of data, end of continuous clinical activity, or switch to another mCRC treatment. Adherence was assessed using medication possession ratio (MPR) ≥0.80 and proportion of days covered (PDC) ≥0.80 at 3 months. Compliance was assessed using time to discontinuation over the observation period using allowable gaps of 45, 60, or 90 days. Patients who never discontinued therapy were censored at the end of the observation period. Outcomes were compared between FTD/TPI and REG using multivariate logistic regression and Cox proportional hazards models, adjusting for demographic and clinical baseline characteristics. Results: A total of 1,630 FTD/TPI patients and 1,425 REG patients were identified. Mean ± standard deviation (SD) age of FTD/TPI patients was 61.0 ± 11.0 compared to 62.8 ± 10.9 for REG patients (p < 0.001). FTD/TPI patients were 80% more likely to have a MPR ≥0.80 compared to those on REG (Odds Ratio [OR] = 1.80, p < 0.001) and more than twice as likely to have a PDC ≥0.80 (OR = 2.66, p < 0.001) at 3 months. FTD/TPI patients were 37% less likely to discontinue their treatment compared to those on REG when using gaps of 60 days (Hazard Ratio = 0.63, p < 0.001). Similar results were found with 45 and 90 days. Conclusions: In this retrospective study of mCRC patients, patients on FTD/TPI were significantly more likely to adhere and comply with therapy compared to those on REG.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029862 ◽  
Author(s):  
Seung Jae Kim ◽  
Oh Deog Kwon ◽  
BeLong Cho ◽  
Seung-Won Oh ◽  
Cheol Min Lee ◽  
...  

ObjectivesWe tried to clarify, by using representative national data in a real-world setting, whether single-pill combinations (SPCs) of antihypertensives actually improve medication adherence.DesignA nationwide population-based study.SettingWe used a 2.2% cohort (n=1 048 061) of the total population (n=46 605 433) that was randomly extracted by National Health Insurance of Korea from 2008 to 2013.ParticipantsWe included patients (n=116 677) who were prescribed with the same antihypertensive drugs for at least 1 year and divided them into groups of angiotensin II receptor blocker (ARB)-only, calcium channel blocker (CCB)-only, multiple-pill combinations (MPCs) and SPCs of ARB/CCB.Primary outcome measuresMedication possession ratio (MPR), a frequently used indirect measurement method of medication adherence.ResultsAdjusted MPR was higher in combination therapy (89.7% in SPC, 87.2% in MPC) than monotherapy (81.6% in ARB, 79.7% in CCB), and MPR of SPC (89.7%, 95% CI 89.3 to 90.0) was higher than MPR of MPC (87.2%, 95% CI 86.7 to 87.7) (p<0.05). In subgroup analysis, adherence of SPC and MPC was 92.3% (95% CI 91.5 to 93.0) vs 88.1% (95% CI 87.1 to 89.0) in those aged 65–74 years and 89.3% (95% CI 88.0 to 90.7) vs 84.8% (95% CI 83.3 to 92.0) in those ≥75 years (p<0.05). According to total pill numbers, adherence of SPC and MPC was 90.9% (CI 89.8 to 92.0) vs 85.3% (95% CI 84.1 to 86.5) in seven to eight pills and 91.2% (95% CI 89.3 to 93.1) vs 82.5% (95% CI 80.6 to 84.4) in nine or more (p<0.05). The adherence difference between SPC and MPC started to increase at five to six pills and at age 50–64 years (p<0.05). When analysed according to elderly status, the adherence difference started to increase at three to four pills in the elderly (≥65 years) and at five to six in the non-elderly group (20–64 years) (p<0.05). These differences all widened further with increasing age and the total medications.ConclusionSPC regimens demonstrated higher adherence than MPC, and this tendency is more pronounced with increasing age and the total number of medications.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S872-S872
Author(s):  
Julie Priest ◽  
Rachel Bhak ◽  
Maral DerSarkissian ◽  
Cindy Garris ◽  
Alan Oglesby ◽  
...  

Abstract Background This study compared yearly and longer term antiretroviral (ARV) adherence among HIV patients overall and by single-tablet regimens (STRs) vs. multi-tablet regimens (MTRs). Methods A retrospective study using Optum Clinformatics US-based claims data was conducted. Patients with an HIV-1 diagnosis during 2011–2017, age ≥ 18 years at index (date of first complete ARV regimen during the study period), and continuous enrollment for ≥ 3 months before index (baseline) and ≥ 12 months after index (observation) were included. MTRs were required to be comprised of 3 or more agents across at least 2 classes. Adherence was measured as the proportion of days covered (PDC) and compared using a Chi-square test. PDC was examined in the 1-year observation period for the overall analysis, and each year following index among patients with at least 4 years of continuous data. A subgroup analysis was conducted among patients with index during 2014–2016 to evaluate modern ARV adherence. Results Among the 15,153 included patients, median age was 45 years, the majority were male (88%), and 53% were in the South. At baseline, 58% (n = 8,715) were receiving an STR and 43% (n = 6,438) an MTR. Compared with STR patients, MTR patients had higher prevalence of hyperlipidemia (36% vs. 29%), cardiovascular disease (27% vs. 21%), and hypertension (25% vs. 20%). During year 1, the proportion of patients with PDC ≥ 0.90 was 63% overall (Table 1), and greater for STR than MTR (67% vs. 58%, P < .001). Among patients with at least 4 years of observation, PDC ≥ 0.90 decreased over time (from 67% in year 1 to 53% in year 4). In the subgroup of patients with index during 2014–2016 (Table 2), similar but slightly worse trends were observed, with PDC ≥ 0.90 for 57% of patients overall, and decreasing over time for those patients with at least 3 years of observation (59% in year 1 to 42% in year 3). Conclusion Adherence in this population of patients with HIV showed room for improvement in the first year of observation overall and in the modern ARV era, with those receiving STRs having higher adherence when compared with those receiving MTRs. For the patients with 4 years of follow-up, adherence tended to decrease year on year. Maintaining high rates of ARV adherence is a critically important aspect of therapy for patients with HIV. Disclosures All authors: No reported disclosures.


2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Ikuko Tanaka ◽  
Masayo Sato ◽  
Tomoko Sugihara ◽  
Douglas E. Faries ◽  
Shuko Nojiri ◽  
...  

Adherence and persistence with osteoporosis treatments are essential for reducing fracture risk. Once-daily teriparatide is available in Japan for treating osteoporosis in patients with a high risk of fracture. The study objective was to describe real-world adherence and persistence with once-daily teriparatide 20 μg during the first year of treatment for patients who started treatment during the first eight months of availability in Japan. This prescription database study involved patients with an index date (first claim) between October 2010 and May 2011, a preindex period ≥6 months, and a postindex period ≥12 months and who were aged >45 years. Adherence (medication possession ratio (MPR)) and persistence (time from the start of treatment to discontinuation; a 60-day gap in supply) were calculated. A total of 287 patients started treatment during the specified time period; 123 (42.9%) were eligible for inclusion. Overall mean (standard deviation) adherence was 0.702 (0.366), with 61.0% of patients having high adherence (MPR > 0.8). The percentage of patients remaining on treatment was 65.9% at 180 days and 61.0% at 365 days. Our findings suggest that real-world adherence and persistence with once-daily teriparatide in Japan are similar to that with once-daily teriparatide in other countries and with other osteoporosis medications.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Chia-Chen Kao ◽  
Hui-Min Hsieh ◽  
Daniel Yu Lee ◽  
Kun-Pin Hsieh ◽  
Shwu-Jiuan Sheu

AbstractWe aim to investigate the role of medication adherence history in treatment needed diabetic retinopathy (TNDR). We conducted a retrospective nested case–control study using 3 population-based databases in Taiwan. The major one was the 2-million-sample longitudinal health and welfare population-based database from 1997 to 2017, a nationally representative random sample of National Health Insurance Administration enrolled beneficiaries in 2010 (LHID2010). The national death registry and national cancer registry were also checked to verify the information. The outcome was defined as the TNDR. The Medication possession ratio (MPR) was defined as the ratio of total days of diabetes mellitus (DM) medication supply divided by total observation days. MPR ≥ 80% was proposed as good medication adherence. The association of MPR and the TNDR was analyzed. Other potential confounders and MPR ratio were also evaluated. A total of (n = 44,628) patients were enrolled. Younger aged, male sex and patients with less chronic illness complexity or less diabetes complication severity tend to have poorer medication adherence. Those with severe comorbidity or participating pay-for-performance program (P4P) revealed better adherence. No matter what the characteristics are, patients with good MPR showed a significantly lower likelihood of leading to TNDR after adjustment with other factors. The protection effect was consistent for up to 5 years. Good medication adherence significantly prevents treatment needed diabetic retinopathy. Hence, it is important to promote DM medication adherence to prevent risks of diabetic retinopathy progression, especially those who opt to have low medication adherence.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5073-5073
Author(s):  
Stephen J. Freedland ◽  
Neeraj Agarwal ◽  
Krishnan Ramaswamy ◽  
Rickard Sandin ◽  
Dave Russell ◽  
...  

5073 Background: Several randomized controlled trials have shown that adding docetaxel or novel hormonal therapy (NHT) to androgen deprivation therapy (ADT) improves survival in mCSPC patients. This study aimed to evaluate the real-world utilization of advanced therapies over time and to provide data on utilization patterns among racial minorities that are often under-represented in clinical trials. Methods: This was a retrospective analysis of a Medicare database (Jan 2009-Dec 2018). Adult men with ≥1 claim for prostate cancer (PC) who initiated ADT (index date) within 90 days prior to or any time after a metastasis diagnosis were included. The first-line (1L) treatment was grouped by PC drugs prescribed within 30 days prior to and 120 days after the index date, in 4 categories: ADT alone, ADT + first-generation anti-androgen (AA; ≥90 days to avoid capturing AA for flare control), ADT + docetaxel, and ADT + NHT (abiraterone, apalutamide, and enzalutamide). The 1L treatment distributions were described over time and stratified by race. Results: A total of 35,195 patients with mCSPC were included in the study, with a mean (SD) age of 76.5 (7.9) years. 11.8% were Black, 5.3% Hispanic, and 78.5% White. 76.4% received ADT alone as 1L treatment, 14.3% ADT + AA, 4.8% ADT + docetaxel, and 4.5% ADT + NHT. While the proportion of patients treated with ADT alone and ADT + AA slowly decreased over time, the utilization of ADT + docetaxel increased since 2015 and the utilization of ADT + NHT increased since 2017 (Table). After the emergence of NHTs for treatment of mCSPC in 2017, treatment intensification with ADT + NHT was numerically lower for Black than White patients. Data from before 2017 also suggest a similar lower use of ADT + AA in Black patients (Table). Survival analysis across treatment cohorts and race are ongoing. Conclusions: In this large and nationally representative sample of mCSPC patients, less than one-third of patients received treatment intensification by 2018, possibly due to patient/disease characteristics, provider awareness or therapeutic inertia, or cost. Importantly, the data showed less frequent treatment intensification in Black vs White patients. Further study is required to elucidate underlying reasons for this disparity.[Table: see text]


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 265-265
Author(s):  
Marie-Helene Lafeuille ◽  
Amanda M. Grittner ◽  
Patrick Lefebvre ◽  
Lorie Ellis ◽  
R. Scott McKenzie

265 Background: Two oral agents have recently been approved for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC): abiraterone acetate (AA) combined with prednisone (P) for treatment of patients with mCRPC and enzalutamide (ENZ) for patients with mCRPC previously treated with docetaxel. Although corticosteroid (CS) co-administration is not required in ENZ prescribing information, 48% of ENZ-treated patients receive CS according to a large phase III clinical trial. To date, real world CS utilization patterns in AA- and ENZ-treated patients has not been reported. Methods: ProMetis Lx administrative claims data covering multiple health plans were used to identify patients with ≥1 PC diagnosis (ICD-9 185, V10.46) during ≥6 months of claims activity before the first AA or ENZ claim (index date). The proportion of patients receiving CS (identified by NDC codes) during AA or ENZ treatment (observation period-defined as first to end of last AA or ENZ prescription) was reported using descriptive statistics. Additionally, dosing and medication possession ratio (MPR) were calculated for the subset of patients receiving P. Results: A total of 3,228 AA-treated and 675 ENZ-treated PC patients were identified. Baseline comorbidities patterns were similar between treatment groups for hypertension (AA 55%, ENZ 56%), diabetes (25% both groups), and cardiovascular disease (28% both groups). The mean (SD) observation period for AA-treated patients was 142 (133) days and for ENZ-treated patients was 74 (46) days. CS use, P dose and P MPR are described in the following table. Conclusions: CS use was common in PC patients prior to and during treatment with AA and ENZ. While this data set may underreport CS use, patterns of CS use are consistent with clinical trial data. Further research based on data with longer follow-up and additional observational datasets is warranted. [Table: see text]


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 11-11
Author(s):  
Anuj K. Patel ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Guillaume Germain ◽  
Philippe Jacques ◽  
...  

11 Background: Adherence to oral chemotherapies is a critical but difficult to measure factor in the care of patients with advanced cancer. FTD/TPI and REG have both demonstrated prolonged survival in patients with refractory mCRC, but with notably different side effect profiles. This study utilizes real-world data to assess adherence and discontinuation of patients treated with FTD/TPI or REG and explore the effect of sequencing on adherence. Methods: Adults diagnosed with mCRC were identified using the nationally representative IQVIA Real-World Data Adjudicated Claims – US database (10/2014–07/2017). The first dispensing date of FTD/TPI or REG (if after FTD/TPI approval [10/2015]) was defined as the index date and the 3 months before as the baseline period. The observation period spanned from the index to the earliest date of a switch to another mCRC agent, end of continuous enrollment, or end of data availability. Medication possession ratio (MPR), proportion of days covered (PDC) at 3 months, and discontinuation (i.e., allowable gap≥45 days) were compared. Logistic (odds ratio [OR]) and Cox proportional hazards (hazard ratio [HR]) regressions, adjusting for baseline characteristics, were used to compare adherence and discontinuation, respectively. A subgroup analysis was conducted among switchers (FTD/TPI to REG vs REG to FTD/TPI). Results: A total of 469 FTD/TPI and 311 REG users were identified. FTD/TPI users had higher compliance with an MPR ≥ 80% (OR = 2.47; p < 0.001) and PDC ≥ 80% (OR = 2.77; p < 0.001). FTD/TPI users had lower risk of discontinuation (HR = 0.76; p = 0.006). Among switchers (96 FTD/TPI to REG; 83 REG to FTD/TPI), those switching from FTD/TPI to REG were more likely to have an MPR ≥ 80% (OR = 2.91; p < 0.001) and PDC ≥ 80% (OR = 4.60; p < 0.001) compared to REG to FTD/TPI switchers. Additionally, FTD/TPI to REG switchers had a lower risk of first treatment discontinuation (HR = 0.66; p = 0.009). Conclusions: In this study, FTD/TPI users had significantly higher compliance, lower discontinuation rate, and switchers treated first with FTD/TPI had better compliance, demonstrating that claims data can provide insight into oral chemotherapy adherence patterns in mCRC.


2016 ◽  
Vol 6 (6) ◽  
pp. 355-368 ◽  
Author(s):  
Martha Sajatovic ◽  
Daisy Ng-Mak ◽  
Caitlyn T. Solem ◽  
Fang-Ju Lin ◽  
Krithika Rajagopalan ◽  
...  

Background: The aim of this study was to describe dosing patterns and medication adherence among bipolar patients who initiated lurasidone in a real-world setting. Methods: Adult bipolar patients who initiated lurasidone between 1 November 2010 and 31 December 2012 (index period) with 6-month pre- and post-index continuous enrollment were identified from the IMS RWD Adjudicated Claims US database. Patients were grouped by starting lurasidone daily dose: 20 mg (7.1%), 40 mg (62.2%), 60–80 mg (28.7%), and 120–160 mg (2.1%). Patient characteristics were compared across doses using Cochran–Armitage trend tests. Multivariable ordinal logistic regression assessed the association between initial lurasidone dose and patient characteristics. Medication adherence was measured using medication possession ratio (MPR). Results: Of 1114 adult bipolar patients (mean age 40.6 years, 70.6% female), 90% initiated lurasidone at 40 mg or 80 mg/day (mean 51.9 mg/day). Of these, 16.2% initiated lurasidone as monotherapy. Mean lurasidone maintenance dose was 55.2 mg/day and mean MPR was 0.53 [standard deviation (SD) = 0.34] over the 6-month follow up. Substance use, hyperglycemia, obesity, and prior antipsychotic use were associated with higher initial lurasidone doses ( p < 0.05). Odds of a 20 mg/day increase in initial lurasidone dose was 1.6-times higher for patients with substance use [95% confidence interval (CI): 1.16−2.24], 2.6-times higher with hyperglycemia problems (95% CI: 1.15−5.83), 1.7-times higher with obesity (95% CI: 1.05−2.60), and 1.3 (95% CI: 1.01−1.78) and 1.8-times higher (95% CI: 1.17−2.86) with prior use of second- and first-generation antipsychotics, respectively. Conclusions: This real-world analysis of bipolar patients indicated that 40 mg or 80 mg/day were the most common starting doses of lurasidone. A majority of patients used concomitant psychiatric medications (polypharmacy). Higher doses of lurasidone were prescribed to patients with comorbidities or prior antipsychotic use. Adherence to lurasidone was comparable to or better than antipsychotic adherence reported in bipolar disorder literature.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 204-204
Author(s):  
M. Lafeuille ◽  
M. Senbetta ◽  
R. S. McKenzie ◽  
P. Lefebvre

204 Background: In metastatic prostate cancer (MPC) patients, treatment options include hormonal therapies, chemotherapy, and radiotherapy. This study quantifies the real-world healthcare resource utilization of MPC patients. Methods: Health insurance claims from 40 self-insured companies across the US (Employer [E]; 01/1999-02/2009), and from the Medicare 5% ([M]; 1999-2008) databases were analyzed. Patients with a metastasis diagnosis (ICD-9: 196-199) following 2 prostate cancer diagnoses (ICD-9: 185, V10.46) within 365 days were identified. Patients with other malignant diagnoses at baseline, defined as 365 days prior to metastasis diagnosis (index date), were excluded. Patients were evaluated for baseline medical history and for chemotherapy, hormonal agents, radiation, and corticosteroids utilization during both baseline and observation periods. Hospitalization rates and prostate cancer-related procedures post index date were also reported. Results: The study population comprised 11,725 patients (E: 3,227; M: 8,498). Mean age (SD) was 72.8 (10.2) in Employer and 78.1 (7.7) in Medicare. Mean observation period (SD) was 803 (753) days in Employer and 9.2 (8.2) quarters in Medicare. During the baseline period, chemotherapy, hormonal agents, radiation therapy, and corticosteroids were administered to 5%, 52%, 9%, and 21% of Employer, and 2%, 45%, 8%, and 12% of Medicare patients respectively, whereas these interventions increased to 22%, 55%, 39%, and 46% for Employer, and to 21%, 50%, 33%, and 29% for Medicare during the observation period. A total of 66% Employer and 79% Medicare patients were hospitalized post index date. Most patients (E: 92%; M: 98%) had prostate cancer-related procedures, including prostate specific-antigen testing (E: 39%; M: 80%), computerized axial tomography scan (E: 72%; M: 81%), prostate biopsy (E: 47%; M: 54%), X-ray (E: 11%; M: 64%), bone scan (E: 56%; M: 60%), and magnetic resonance imaging scan (E: 35%; M: 37%). Conclusions: This observational study describes real-world utilization patterns in patients with advanced prostate cancer. [Table: see text]


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