Symphony Health Solutions Research Articles

Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once-every-three-months paliperidone palmitate in a real-world setting

Objectives: Since May 2015, adult patients with schizophrenia adequately treated with once monthly paliperidone palmitate (PP1M) may be transitioned to once-every-three-months paliperidone palmitate (PP3M). This study aims to describe baseline characteristics and treatment patterns of patients with schizophrenia initiated on PP3M in a real-world setting.Methods: Pharmacy and medical claims from May 2014 to September 2016 for adult patients with schizophrenia initiated on PP3M (index date) in the Symphony Health Solutions database were analyzed. The cohort consisting of all patients and the one restricted to those transitioning from PP1M as per prescribing guideline recommendations were considered. Baseline characteristics were assessed during the 12 month baseline period. PP1M treatment patterns, proportion of days covered (PDC) by mental-health-related medications, and healthcare resource utilization (HRU) patterns were evaluated for each baseline quarter. PP3M treatment patterns were assessed post-index.Results: Among the 1545 adult patients initiated on PP3M who formed the first cohort, 68.8% transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition, forming the second cohort. In both cohorts, the proportion of patients with a PDC ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased while the proportion of patients with ≥1 emergency room, inpatient, or outpatient visit decreased in baseline quarters closer to PP3M initiation. Among patients with ≥4 months of follow-up after the first dose, 85–88% had a second dose. Similarly, among those with ≥4 months of follow-up after the second dose, 87–90% received a third dose.Conclusions: Patients initiated on PP3M demonstrated decreased HRU and increased adherence in quarters closer to PP3M initiation, and were persistent on their PP3M treatment.

Real-world palbociclib dosing patterns and implications for drug costs in the treatment of HR+/HER2- metastatic breast cancer

ABSTRACTBackground: This study described real-world palbociclib dosing patterns and associated impacts on treatment costs for HR+/HER2- metastatic breast cancer (mBC) in the US.Methods: Postmenopausal women with HR+/HER2- mBC who initiated palbociclib-based therapy (initiation date = index date) between 02/03/2015 (palbociclib approval) and 02/29/2016, and continuous quarterly activity 1 year before and 6 months after the index date, were identified in the Symphony Health Solutions database. Rates of 1) dose reduction (≥25 mg dose decrease/daily), and 2) reduction or interruption (>60 day gap in continuous drug supply) were assessed using Kaplan-Meier analyses. Drug wastage cost was estimated based on overlapping days between two prescription fills: the last original dose fill and the first reduced dose fill.Results: 1,242 patients initiated palbociclib-based therapy (mean age = 62.7 years, median follow-up = 8.7 months). During the 12-month post-index period, across the first four lines, dose reduction rates were 31.9–33.7% and dose reduction/interruption rates were 63.5–80.9%. A total of 411 (33.1%) patients changed dose, among whom 128 (31.1%) experienced prescription fill overlap (average = 11.1 days). Mean potential drug wastage cost among patients with fill overlap was $5,471.Conclusions: Most patients receiving palbociclib experienced dose reduction or interruption early in treatment; the associated drug wastage may lead to considerable costs.

Abstract 4015: A comparative study of PD-L1 IHC 22C3 and 28-8 FDA-approved diagnostic assays in cancer

Abstract Background: Higher levels of PD-L1 expression at the surface of tumor cells have been associated with increased response to anti-PD-1 therapies (Santabarbara G et al. Ann Transl Med. 2016;4:215; Borghaei H et al. N Engl J Med. 2015;373:1627-1639; Brahmer J et al. N Engl J Med. 2015;373:123-135). The FDA has 2 approved tests associated with the use of these agents. The Dako PD-L1 IHC 22C3 kit is approved as a companion diagnostic for the use of pembrolizumab in the first- and second-line non-small-cell lung cancer (NSCLC) settings, where diagnostic testing is required for its use. The Dako PD-L1 IHC 28-8 kit is approved as a complementary diagnostic for nivolumab therapy in second-line NSCLC, where testing is not required for its use. NeoGenomics Laboratories stained a subset of the samples received for PD-L1 testing with both 22C3 and 28-8 on the same biopsy specimen. This dataset presents an opportunity to explore real-world concordance testing for 22C3 and 28-8 antibodies. Methods: The analysis was performed on a dataset obtained from Symphony Health Solutions describing the PD-L1 biomarker test results and annotations reported by NeoGenomics Laboratories between Oct 7, 2015, and Aug 31, 2016. A total of 5217 biomarker test results were available for 4528 patients afflicted by diverse malignancies. Concordance testing was performed on 556 unique patients that had a single 22C3/28-8 pairing collected from the same biopsy specimen. All staining was performed using the FDA-approved in vitro diagnostic assay using the 22C3 antibody or the 28-8 antibody on the Dako Link 48. Cases were reviewed and scored randomly across multiple pathologists, who received special training and certification in scoring. All statistical analyses were performed in SAS. Results: Paired biopsy specimens stained with both 22C3 and 28-8 displayed high degrees of correlation (Spearman’s correlation co-efficient = 0.97). In addition, Bland-Altman analysis revealed that the mean difference in the percentage of tumor cells positively stained for PD-L1 between the paired 22C3 and 28-8 assay findings was 0.48% [95% prediction limit (-12.41% to 13.37%)]. Across expression levels both antibodies displayed a similar probability of being interpreted as greater than one another (43 of 556 where 28-8>22C3 and 40 of 556 where 22C3>28-8), with no clear direction of a single antibody displaying greater sensitivity. When analyzed at the ≥ 1%, ≥ 5%, ≥ 10%, ≥ 25% and ≥ 50% thresholds, the overall rate of agreement was between 96.8% and 98.2% and associated with a level of agreement (Cohen’s kappa) between 0.92 and 0.96. Conclusion: Both the 22C3 and 28-8 diagnostic assays show strong agreement in a single central laboratory real-world setting. These data, in conjunction with recent findings from analytical comparability studies reported elsewhere, support the potential interchangeability of these assays for diagnostic interpretation. Citation Format: Cory Batenchuk, Maher Albitar, Sucha Sudarsanam, Vladislav Chizhevsky, Chelsea Jin, Virginia A. Burns. A comparative study of PD-L1 IHC 22C3 and 28-8 FDA-approved diagnostic assays in cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4015. doi:10.1158/1538-7445.AM2017-4015

Effects of Repository Corticotropin Injection on Medication Use in Patients With Rheumatologic Conditions: A Claims Data Study.

Background: Currently, specific studies identifying how repository corticotropin injection (RCI) is used in rheumatologic conditions are lacking. This is a first step to familiarize the trends of demographics using RCI as well as other medication use. Objective: RCI may produce anti-inflammatory as well as immune-modulatory effects. The purpose of this study is to examine the demographics of those who use RCI and the change in medication use, specifically prednisone, after RCI initiation. Method: This study used the Symphony Health Solutions (SHA) Claims database from 2008 to 2015. International Classification of Disease, Ninth Revision, codes were used to identify rheumatologic conditions including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, and polymyositis. Information including RCI dose and concomitant medication uses was also obtained. Results: A total of 2749 patients with rheumatologic conditions receiving RCI were investigated for demographic information, and a total of 1048 patients with rheumatologic conditions on RCI were examined for medication use. The use of nonsteroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs, and biologics overall decreased significantly in all 3 rheumatologic conditions except biologics in dermatomyositis/polymyositis. In addition, mean prednisone dose before and after RCI use significantly decreased one quarter (12 weeks) after RCI initiation. Conclusion: Claims-based study on RCI use indicates that RCI use might reduce use of prednisone, disease-modifying anti-rheumatic drugs, and other biologics. Further prospective study is needed.

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

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.

Underuse of Methotrexate in the Treatment of Rheumatoid Arthritis: A National Analysis of Prescribing Practices in the US.

Methotrexate (MTX) is the anchor drug in the treatment of rheumatoid arthritis (RA) due to its effectiveness, tolerability, and cost. This study examines MTX prescribing practices in the US from 2009 to 2014. Symphony Health Solutions, which covers 274 million patients in the US, was used to identify patients diagnosed with RA who were naive to MTX in 2009 and 2012. Data were collected, including medication use and doses, demographics, and medical comorbidities. Of the patients who had 5-year followup data available, oral MTX was started in 35,640 in 2009, and 44% continued taking this dose during the followup. Of the 20,041 patients who changed therapy during the study period, 87% had the addition of or switched to a biologic agent, while 13% were changed from oral to subcutaneous (SC) MTX. The mean oral dose prior to the start of a biologic agent was 15.3 ± 5 mg/week. A comparison of 2009 with 2012 showed a modest increase in the mean dose of oral MTX from 15.3 mg/week to 15.9 mg/week, as well as a small but statistically significant (P < 0.0001) increase in the use of SC MTX after failure of oral MTX from 13% to 16% of patients. MTX is underutilized in the treatment of RA with suboptimal dosing, inadequate duration of therapy, and failure to use SC administration. The comparison of MTX use between the 2009 and the 2012 cohorts demonstrates only a marginal increase in the dose of oral MTX and the use of SC MTX.

Impact of a Patient Support Program on Patient Adherence to Adalimumab and Direct Medical Costs in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, and Ankylosing Spondylitis.

AbbVie provides a free-to-patient patient support program (PSP) to assist adalimumab-treated patients with medication costs, nurse support, injection training, pen disposal, and medication reminders. The impact of these services on patient adherence to adalimumab and direct medical costs associated with autoimmune disease has not been assessed. To quantify the relationship between participation in a PSP and outcomes (adalimumab adherence, persistence, and direct medical costs) in patients initiating adalimumab treatment. A longitudinal, retrospective, cohort study was conducted using patient-level data from the PSP combined with Symphony Health Solutions administrative claims data for patients initiating adalimumab between January 2008 and June 2014. The sample included patients aged ≥ 18 years with a diagnosis of Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis who were biologic-naïve before initiation of adalimumab. Patients who enrolled in the PSP (PSP cohort) were matched to those who did not enroll (non-PSP cohort) based on age, sex, year of treatment initiation, comorbidities, diagnosis, and initiation at a specialty pharmacy. For the PSP cohort, the index date was assigned as the earliest date of PSP enrollment, and time to enrollment following adalimumab initiation was used to assign index dates for the non-PSP cohort. All patients were required to have evidence of medical and pharmacy coverage for at least 6 months before and after their first adalimumab claim and at least 12 months after their index date. Adherence (proportion of days covered during the 12 months following PSP opt-in [index date]) was compared between cohorts using t-tests. Persistence was assessed using survival analysis of discontinuation rates. Medical costs for emergency department, inpatient, physician, and outpatient visits (all-cause and disease-related) and total costs (medical plus drug costs) were compared at 12 months following the index date using t-tests. A total of 2,386 patients were included in the study and were allocated to the PSP (n = 1,199) and non-PSP (n = 1,187) cohorts. Baseline characteristics were similar between cohorts. During the follow-up period, adalimumab adherence was 14% greater in the PSP cohort than for the non-PSP cohort (67.0% vs. 58.8%; P < 0.001). The discontinuation rate for adalimumab was 14% lower in the PSP cohort compared with the non-PSP cohort (39.7% vs. 46.2%; P = 0.001). Univariate analyses showed that PSP patients had 23% lower 12-month medical costs (excluding costs for biologic treatment) than did non-PSP patients ($18,322 vs. $23,679; P = 0.003). Disease-related medical costs were 22% lower for PSP than for non-PSP patients ($8,001 vs. $10,202; P = 0.045). Total costs were 10% lower for PSP than for non-PSP patients ($35,741 vs. $39,713; P = 0.030). Patient enrollment in the PSP was associated with greater adherence, improved persistence, and reduced medical (all-cause and disease-related) and total health care costs for patients receiving adalimumab therapy. Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the abstract. All authors contributed to the development of the publication and maintained control over the final content. Rubin has received consulting fees or research support from AbbVie, Amgen, Emmi, Genentech, Ironwood, Janssen, Pfizer, Prometheus, Shire, and Takeda. Skup and Mittal are employees and stockholders of AbbVie. Chao was an employee of AbbVie at the time of the study and may hold AbbVie stock. Johnson and Davis are employees of Medicus Economics, which received payment from AbbVie to participate in this research. Study concept and design were contributed by Rubin, Mittal, Chao, and Skup, along with Davis and Johnson. Davis and Johnson took the lead in data collection, with assistance from the other authors, and data interpretation was performed by Rubin, Mittal, Chao, and Skup, with assistance from Davis and Johnson. All authors contributed to the writing and revision of the manuscript. The abstract for this study was published as Rubin DT, Skup M, Davis M, Johnson S, Chao J. Impact of AbbVie's patient support program on resource costs in Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis. J Manag Care Spec Pharm. 2015;21(Suppl 4a):S74-75 (poster presentation at Academy of Managed Care, 27th Annual Meeting and Expo; April 7-10, 2015; San Diego, CA) and as abstract 2339 in Arthritis Rheumatol. 2015;67(Suppl 10; poster presentation at American College of Rheumatology 2015 ACR/AHRP Annual Meeting; November 7-11, 2015; San Francisco, CA).

Editorial: Statins for Inflammatory Bowel Disease: Expanding the Scope of Prevention.

In addition to cholesterol depletion, statins also significantly decrease systemic inflammation as measured by C-reactive protein. In this issue of American Journal of Gastroenterology, Ungaro et al. present their results on the associations between statin prescriptions and risk of Crohn's disease (CD) and ulcerative colitis (UC). Using a national medical claims and pharmacy database created by Symphony Health Solutions LLC (SHA), they show that any use of statin is protective against diagnosis of CD and UC. The protective effect against CD appears strongest among older populations (>60 years old). These findings offer intriguing insights into inflammatory pathways that could be modulated by cholesterol lowering drugs. In addition, if replicated in other cohorts, these results provide further rationale for investigating the use of statins in broader preventive efforts, including healthy patients at risk of developing inflammatory bowel disease.

Growth in sales of custom-compounded menopause hormones

In 2002, the Women’s Health Initiative (WHI), a randomised control trial that studied oestrogen plus progestin in healthy postmenopausal women in the USA, linked the use of combined hormone therapy to high rates of heart disease, dementia, stroke, and some forms of cancer. The results sent shockwaves through the medical profession and prompted some women to switch from hormone therapies prescribed by their doctors to natural alternatives. More than a decade after the original WHI fi ndings, a series of reports—including further WHI data—has cast doubt about the initial conclusions. Researchers now believe the WHI data was skewed towards women aged 63 years or older who had begun using hormone therapy on average 10 years after the onset of the menopause. By contrast, the Kronos Early Estrogen Prevention Study and Danish research led by Louise Schierbeck have highlighted the benefi ts of hormone therapy for many young women, such as relieving menopausal symp toms and helping to prevent osteoporosis. Many doctors now think there might be a window of opportunity for women to benefi t from hormone therapy if they are aged less than 60 years and are within 10 years of starting the menopause. But some women are still concerned and confused about traditional hormone therapies. The number of prescriptions in the USA for traditional hormone therapies approved by the US Food & Drug Administration (FDA) has plunged by 61% from 93 million in 2002 to 36 million in 2012, according to fi gures from Symphony Health Solutions. By contrast, a rising number of prescriptions are fi lled for custom-compounded bioidentical hormones, which are mixed for patients by pharmacists but not regulated by the FDA. JoAnn Pinkerton, Professor of Obstetrics and Gynecology at the University of Virginia, USA, and her colleagues presented their fi ndings of an analysed survey (investigated during October and November 2014) on March 6, 2015 at the Endocrine Society’s 97th annual meeting. They estimated that between 26 million and 36 million prescriptions are fi lled for custom-compounded bioidentical hormones. Of the 483 pharmacies that responded to the survey, 69% believed the number of customcompounded prescriptions they fi ll will rise by 2016, with most predicting an increase of between 5% and 25%. “We think that when the WHI came out showing an increased risk in heart disease, dementia, and breast cancer—even though the relative risks were small and the absolute risks were even smaller—people became very concerned and discontinued their hormones,” Pinkerton told The Lancet Diabetes & Endocrinology. “Some of them went to bioidenticals because there was a lot of hype and myth that they were safer than FDA-approved therapies.” Pinkerton highlighted concerns about the scarcity of clinical data on the safety of bioidenticals and fears about the quality and monitoring of custom-compounded products. She pointed to an outbreak of meningitis in 2012 in the USA that was traced to compounded intrathecal steroids after issues with contamination. Pinkerton also cited an investigation by More magazine in 2012, during which 10 of 12 samples of a medicine called TriEst from diff erent compounding pharmacies were found to contain the wrong amounts of oestrogen and progesterone. The American College of Obstetricians & Gynecologists and the American Society for Reproductive Medicine have echoed her concerns; after testing 29 internet-ordered samples of bioidentical customcompounded hormones, they noted that 34% failed one or more standard quality tests, including potency testing, compared with less than 2% in FDAapproved drug therapies. However, the North American Menopause Society has claimed that custom-compounded products can benefi t some consumers who have allergies, or who need dosages or mixtures that are not available commercially. Heather Currie, Associate Specialist Gynaecologist at the Dumfries & Galloway Royal Infi rmary in Dumfries, UK, and Chairman-elect of the British Menopause Society, said bioidentical hormones are only just starting to be used in the UK. “They haven’t taken off just yet but we are concerned that they will do”, she told The Lancet Diabetes & Endocrinology. “Even though there may not be many pharmacies selling them, women can still buy them over the internet.” The UK’s National Institute for Health and Care Excellence, will launch a consultation on its fi rst menopause guidelines in May 2015, with the guidance expected to be published in October 2015. Currie hopes the publication of the guidelines will be an opportunity to dispel some of the myths surrounding hormone replacement therapy.

Abstract 332: Toward Big Data: Integrating Cardiovascular Registry and Claims Data to Create a Clinical Practice-based Analytical Platform

Background: There is great promise in ‘big data’ analytics that leverage multiple data sources including clinical registries and claims data, creating large, broadly distributed, and clinically detailed analytical platforms to study a range of cardiovascular topics, including practice patterns associated with optimal clinical outcomes. Objective: Describe a newly created integrated analytical platform utilizing U.S. cardiovascular registry records and healthcare claims data from real-world clinical practices. Methods: The analytical platform includes records from five American College of Cardiology (ACC) National Cardiovascular Data Registry programs and pharmacy, private practitioner and hospital claims data from Symphony Health Solutions (SHS). The NCDR registries include ≈ 650,000 patients in ACTION Registry-GWTG (acute coronary syndrome), 6.7m in CathPCI (diagnostic cardiac catheterizations and PCI), 660,000 in ICD (implantable cardioverter defibrillators), 33,000 in IMPACT (pediatric and adult congenital treatment) and 3.4m in PINNACLE (ambulatory CAD, HTN, HF and AFib). With history as early as 2003, SHS currently receives one or more pharmacy, practitioner or hospital claims annually for ≈274m patients in the U.S. All payer types are represented, including self-pay pharmacy patients. Patient inclusion criteria: 1) Data within 2006 [[Unable to Display Character: &amp;#8211;]] 2014, 2) one or more records in ≥ 1 of 5 NCDR registries, 3) one or more claims observed in ≥ 1 of 3 SHS datasets: pharmacy, private practitioner or hospital claims, 4) populated data fields enabling generation of a unique, patient-level, synthetic identifier (ID) for matching and longitudinal linkage across the registry(s) and the dataset(s). The analytical platform has been developed using a HIPAA and HITECH compliant, certified approach. Results: Over 8.7 million patients have been successfully linked between the NCDR registries and the SHS claims data. On average, 95% of patients in the registry(s) sample was also observed and matched in the SHS datasets. Conclusion: High match rates were observed between the ACC and SHS data, identifying large populations of patients with cardiovascular disease. Clinical registry data combined with longitudinal claims data will generate a ‘broad’ and ‘deep’ data platform for analytics of quality of care and outcomes.

Abstract 19139: Impact of Medical Study Publication on Cholesterol Medication Prescriptions

Introduction: The challenges of translating research findings into practice have been well demonstrated, though some high impact studies do change care delivery. It is unknown whether such trials have spillover effects onto similar but unrelated medications. Hypothesis: Cholesterol trial findings change prescriptions for both trial drugs and statins in the direction of the results, even if statins were not directly studied. Methods: The Symphony Health Solutions’ PHAST Prescription Monthly database provided retail prescriptions from 2007 to 2013. We selected 5 cholesterol trials that were all published in the New England Journal of Medicine. The trials [main drug(s) studied, result] were: ENHANCE [simvastatin/ezetimibe, negative], JUPITER [rosuvastatin, positive], ARBITER 6 HALTS [niacin, positive; ezetimibe, negative], ACCORD LIPID [fenofibrate, negative], AIM HIGH [niacin, negative]. For each trial, we performed a difference-in-differences analysis for both the main drug(s) studied and statins using anti-hypertensive drugs as the control, comparing the 1 and 12 month prescription averages after to an average of the 12 months before the trial. Results: The 12-month average study drug monthly prescriptions changed in the direction expected from the trial results for all (p&lt;0.01), except niacin post ARBITER trial. After ENHANCE, simvastatin/ezetimbe changed -533,490 (95% CI -655,008, -411,976); after JUPITER, rosuvastatin changed 337,328 (278,722, 395,934); after ARBITER, niacin changed 1,335 (-17,625, 20,294) and ezetimibe changed -185,587 (-222,697, -148,147); after ACCORD, fenofibrate changed -263,522 (-316,805, -210,238); after AIM HIGH, niacin changed -154,460 (-182,760, -126,160). Over 50% of the year change occurred in the first month after each trial, except niacin post ARBITER. The trend of increasing statin prescriptions was unperturbed by the trial results. Conclusions: Individual cholesterol trial drug prescriptions changed substantially and as expected after trial results, with the majority of the change occurring immediately after trial publication. There was no evidence for detrimental spillover effects on statin prescriptions. These results suggest that the uptake of these trial findings was appropriate.

Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer.

With the growing use of oral anticancer medications, understanding adherence patterns has become increasingly important. Abiraterone acetate (AA) is a prodrug of abiraterone, a novel androgen biosynthesis inhibitor. AA is approved for use in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer. To evaluate AA and concomitant prednisone utilization and adherence patterns for patients with prostate cancer in the United States. This study used data from 2 administrative health care claims databases--Dataset 1: Truven Health Analytics MarketScan (December 2010 to August 2012) and Dataset 2: Symphony Health Solutions' ProMetis Lx (June 2009 to March 2013). To evaluate the consistency of medication-taking behavior, adherence was measured using medication possession ratio (MPR), which was calculated as the sum of days of supply divided by the days on therapy in patients with at least 2 AA prescriptions. Additional outcomes included the proportion of patients taking prednisone, mean and median daily dose of AA, and concomitant prednisone use. Adherence was also studied by age, health care plan type, or previous recent chemotherapy subgroups. 515 patients (mean age: 72.2) and 3,228 patients (mean age: 72.2) with at least 1 AA claim were selected from Dataset 1 and Dataset 2, respectively. The mean (median) daily AA dose per person per prescription was 998.8 (1,000) mg for Dataset 1 and 994.2 (1,000) mg for Dataset 2, which is within 1% of the recommended daily dose (1,000 mg). Mean (median) MPR was 93% (98%; n = 492) in Study Population 1 and 93% (100%; n = 2,449) in Study Population 2. The mean (median) daily prednisone dose per person per prescription was similar in both datasets with 10.1 (10.0; n = 488) mg and 10.6 (10.0; n = 2,425) mg in Dataset 1 and 2, respectively. Similar adherence patterns were observed for patients in different age groups, for patients with commercial health care plans versus patients with Medicare coverage, and for patients with recent chemotherapy compared with patients without. Results from 2 observational studies reported high levels of adherence to AA dosing and administration patterns consistent with prescribing information. These findings provide useful insights into the treatment patterns in patients with prostate cancer treated with AA and can contribute to the current discussion in oncologic research and practice.

Use of Antidiabetic Drugs in the U.S., 2003–2012

To describe market trends for antidiabetic drugs, focusing on newly approved drugs, concomitant use of antidiabetic drugs, and effects of safety concerns and access restrictions on thiazolidinedione use. Nationally projected data on antidiabetic prescriptions for adults dispensed from U.S. retail pharmacies were extracted from IMS Health Vector One National and Total Patient Tracker for 2003-2012 and from Encuity Research Treatment Answers and Symphony Health Solutions PHAST Prescription Monthly for 2012. Since 2003, the number of adult antidiabetic drug users increased by 42.9% to 18.8 million in 2012. Metformin use increased by 97.0% to 60.4 million prescriptions dispensed in retail pharmacies in 2012. Among antidiabetic drugs newly approved for marketing between 2003 and 2012, the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin had the largest share with 10.5 million prescriptions in 2012. Rosiglitazone use plummeted to <13,000 prescriptions dispensed in retail or mail-order pharmacies in 2012. Concomitancy analyses showed that 44.9% of metformin use was for monotherapy. Between 33.4 and 48.1% of sulfonylurea, DPP-4 inhibitor, thiazolidinedione, and glucagon-like peptide 1 analog use was not accompanied by metformin. The antidiabetic drug market is characterized by steady increases in volume, and newly approved drugs experienced substantial uptake, especially DPP-4 inhibitors. The use of rosiglitazone has been negligible since restrictions were put in place in 2011. Further study is needed to understand why one-third to one-half of other noninsulin antidiabetic drug use was not concomitant with metformin use despite guidelines recommending that metformin be continued when other agents are added to treatment.

Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients

Background:Rivaroxaban was shown to be effective in reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF) in a randomized controlled trial setting.Objective:To assess real-world safety, effectiveness, and persistence associated with rivaroxaban and warfarin in nonvalvular AF patients.Methods:Healthcare claims from Symphony Health Solutions’ Patient Transactional Datasets from May 2011 to July 2012 were analyzed. Adult patients newly initiated on rivaroxaban or warfarin, with ≥2 AF diagnoses (ICD-9-CM: 427.31) and a CHADS2 score ≥1 during the 180 day baseline period were included. Cohorts were matched 1:4 using propensity score methods. Study outcomes were major bleeding, intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding, composite stroke and systemic embolism, and venous thromboembolism (VTE) events. Cox proportional hazard models were used to compare event and persistence rates.Results:The matched sample included 3654 rivaroxaban and 14,616 warfarin patients. Matching was adequate, with all standardized differences in patient characteristics <10%. No significant differences were observed for bleeding and composite stroke and systemic embolism outcomes, although rivaroxaban users were associated with significantly fewer VTE events (hazard ratio [HR] = 0.36, 95% confidence interval [CI]: 0.24–0.54, p < 0.0001) compared to warfarin users. Rivaroxaban was also associated with a significantly lower risk of treatment non-persistence (HR = 0.66; 95% CI: 0.60–0.72, p < 0.0001).Limitations:Claims data may have contained inaccuracies, and mortality and laboratory data were not available. Confounding may still have been possible even after propensity score matching. Early use pattern of medications may have changed over time.Conclusion:This analysis suggests that rivaroxaban and warfarin do not differ significantly in real-world rates of composite stroke and systemic embolism and major, intracranial, or GI bleeding. Rivaroxaban, however, was associated with significantly fewer VTE events and significantly better treatment persistence compared with warfarin.

FRI0558 One approach to evaluating step therapy policies for immune disorder specialty pharmaceuticals

BackgroundRheumatology practices are increasingly exposed to patient health care benefit plans that include designs such as “step therapy” (ST) policies which may affect medication choice. Managed care companies implement ST...