Cost-effectiveness of edoxaban versus rivaroxaban for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in the US.

BACKGROUND: Understanding the value of new anticoagulation therapies compared with existing therapies is of paramount importance in today's cost-conscious and efficiency-driven health care environment. Edoxaban and rivaroxaban for stroke prevention in nonvalvular atrial fibrillation (NVAF) patients with CHADS2 scores ≥2 have been evaluated in pivotal trials versus warfarin. The relative value of edoxaban versus rivaroxaban would be of interest to health care stakeholders and patients who prefer a once-daily treatment option for long-term stroke prevention in NVAF. OBJECTIVE: To evaluate the relative cost-effectiveness of two once-daily regimens of novel oral anticoagulation therapy - edoxaban (60 mg/30 mg dose-reduced) versus rivaroxaban (20 mg/15 mg dose-reduced) - for stroke prevention in NVAF patients from a US health-plan perspective. MATERIALS AND METHODS: A Markov model simulated lifetime risk and treatment of stroke, systemic embolism, major bleeding, clinically relevant nonmajor bleeding, myocardial infarction, and death in NVAF patients treated with edoxaban or rivaroxaban. Efficacy and safety data were derived from a network meta-analysis that utilized data from patients enrolled in ENGAGE AF-TIMI 48 and ROCKET-AF. Health care cost and utility data were obtained from published sources. Incremental cost-effectiveness ratios of $150,000 per quality-adjusted life year (QALY) gained were used as thresholds for "highly cost-effective", "cost-effective", and "not cost-effective" treatment options, respectively, as per American Heart Association/American College of Cardiology guidelines. RESULTS: Edoxaban was dominant relative to rivaroxaban, such that it was associated with lower total health care costs and better effectiveness in terms of QALYs in the base-case analysis. Results were supported by probabilistic sensitivity analyses that showed edoxaban as either dominant or a highly cost-effective alternative (incremental cost-effectiveness ratio <$50,000) to rivaroxaban in 88.4% of 10,000 simulations. CONCLUSION: Results of this study showed that the once-daily edoxaban (60 mg/30 mg dose-reduced) regimen is a cost-saving or highly cost-effective treatment relative to rivaroxaban (20 mg/15 mg dose-reduced) for stroke prevention in NVAF patients with CHADS2 ≥2.

Analysis of Adherence, Persistence, and Surgery Among Endometriosis Patients Treated with Leuprolide Acetate Plus Norethindrone Acetate Add-Back Therapy.

BACKGROUND: Endometriosis affects over 10 million women in the United States. Depot leuprolide acetate (LA), a gonadotropin-releasing hormone agonist, has been used extensively for the treatment of women with endometriosis but is associated with hypoestrogenic symptoms and bone mineral density loss. The concomitant use of add-back therapies, specifically norethindrone acetate (NETA), can alleviate these adverse effects. OBJECTIVE: To compare adherence to and persistence with LA treatment and time to endometriosis-related surgery among women treated with NETA and women treated with LA plus other add-back therapies or LA only. METHODS: This retrospective analysis was conducted using Truven Health MarketScan Commercial Claims and Encounters Database. Women with a diagnosis of endometriosis (ICD-9-CM code 617.xx) who initiated LA (index date) in 2005-2011 were selected for inclusion. Additional requirements were 12 months of continuous enrollment pre- and post-index and no evidence of endometriosis-related surgeries pre-index or up to 30 days post-index; no pre-index use of estrogen or noncontraceptive hormones; and no diagnoses of uterine fibroids, malignant neoplasms, infertility, or pregnancy. Patients were characterized as using NETA; other add-back therapies (estrogens, progestins, or estrogen-progestin combinations); or no add-back therapy. Adherence to and persistence with LA were measured over the 6 months following the index date using outpatient medical and pharmacy claims. Patients were considered adherent if their proportion of days covered was greater than or equal to 0.80. Persistence was operationalized as time to discontinuation, defined as a continuous gap of > 60 days without LA on hand. Time to endometriosis-related surgery (laparotomy, laparoscopy, excision/ablation/fulguration, oophorectomy, and hysterectomy) was measured over the 12 months following the index date. Surgeries were identified from inpatient and outpatient medical claims using procedure codes. Outcomes were compared among cohorts using multivariable logistic and Cox proportional hazards regression models controlling for demographics and baseline clinical characteristics. RESULTS: The final sample included 3,114 women, with a mean age of 36.9 years. The majority of women used LA only with no add-back therapy (n = 1,963, 63.0%), while 15.1% (n = 470) used NETA, and 21.9% (N = 681) used other add-back therapies. During the 6-month follow-up, more patients in the LA plus NETA cohort were adherent to LA therapy compared with LA only (47.2% vs. 31.5%, P < 0.001), and fewer patients discontinued (37.9% vs. 59.6%, P < 0.001). Additionally, fewer patients underwent endometriosis-related surgery in the 12 months after LA initiation in the LA plus NETA cohort (12.6% vs. 16.9%, P = 0.021). In multivariable models, women who initiated LA plus NETA or LA plus other add-back therapies had a higher likelihood of being adherent to LA than LA only patients (OR = 1.91, 95% CI = 1.55-2.36 and OR = 1.95, 95% CI = 1.63-2.34) and lower likelihood of LA discontinuation (HR = 0.54, 95% CI = 0.46-0.63 and HR = 0.59, 95% CI = 0.52-0.68). NETA patients had a lower surgery rate in the 12-month post-index period compared with other add-back patients (HR = 0.68, 95% CI = 0.50-0.93) or LA only patients (HR = 0.69, 95% CI = 0.52-0.92). CONCLUSIONS: For women with endometriosis, treatment with LA and concomitant add-back therapies was associated with better adherence to and persistence with LA over the 6 months following initiation, compared with treatment with LA only. The increased adherence and persistence to LA may translate into decreased need for surgical intervention, although fewer endometriosis-related surgeries were only observed in the 12 months following LA initiation for patients using concomitant NETA add-back therapy. These results support an increased and earlier use of NETA add-back therapy among women who initiate LA. DISCLOSURES: This study was funded by AbbVie, which also markets the endometriosis drugs Lupron and Lupaneta Pack. AbbVie participated in the study design, research, data collection, analysis and interpretation, writing, review, and approval of this publication. Soliman and Castelli-Haley are employees of AbbVie and may own AbbVie stock or stock options. Bonafede and Farr are employees of Truven Health Analytics, which received a research contract to conduct this study with and on behalf of AbbVie. Winkel is a clinical professor in the Department of Obstetrics and Gynecology at Georgetown University in Washington, DC, and has served in a consulting role on research to AbbVie for this project. An earlier version of the current research was presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 20th Annual International Meeting; Philadelphia, PA; May 2015. All authors participated in data analysis and interpretation and contributed to the development of the manuscript.

Healthcare Costs Among Adults with Type 2 Diabetes Initiating DPP-4 Inhibitors.

INTRODUCTION: Oral antidiabetes medications, including dipeptidyl peptidase-4 inhibitors (DPP-4is) saxagliptin and sitagliptin, are used for the treatment of type 2 diabetes (T2D). The study objective was to compare all-cause and diabetes-related costs following initiation of saxagliptin or sitagliptin. METHODS: Patients aged ≥ 18 years initiating saxagliptin or sitagliptin between January 1, 2009 and January 31, 2012 in the Truven Health MarketScan Commercial and Medicare Supplemental databases were identified. Patients were required to have continuous enrollment for ≥ 365 days before and ≥ 365 days after the index date (date of the first saxagliptin or sitagliptin claim). Additionally, patients were required to have a claim with a T2D diagnosis (ICD-9-CM 250.×0, 250.×2) and no claims for a DPP-4i medication before the index date. All-cause and diabetes-related medical costs and total costs (including pharmacy costs) were captured over the 1-year follow-up period. Generalized linear models with log link and gamma distribution were fit to compare costs between the two cohorts using cost ratios, controlling for patient baseline characteristics. Recycled prediction methods were used to generate adjusted predicted costs and confidence intervals. RESULTS: The final sample comprised 3354 saxagliptin initiators and 26,895 sitagliptin initiators. The average age of saxagliptin and sitagliptin initiators was 57 years and just over 50% were males. After adjusting for baseline characteristics, saxagliptin patients had significantly lower average all-cause medical costs (cost ratio = 0.901, P < 0.001; predicted mean costs: $8687 vs. $9646) compared with sitagliptin patients over the 1-year follow-up. Findings were consistent for diabetes-related medical costs (cost ratio = 0.890, P < 0.001; predicted mean costs: $2180 vs. $2450). Total costs were also lower for saxagliptin initiators (cost ratio = 0.950, P = 0.002; predicted mean costs: $13,911 vs. $14,651) over the 1-year follow-up period. CONCLUSION: Initiation of treatment with saxagliptin was associated with lower medical costs over 1 year compared with initiation of sitagliptin among adults with T2D. FUNDING: AstraZeneca.

Clinical and Economic Outcomes Associated With the Timing of Initiation of Basal Insulin in Patients With Type 2 Diabetes Mellitus Previously Treated With Oral Antidiabetes Drugs.

PURPOSE: In patients with type 2 diabetes mellitus (T2DM) not achieving glycemic targets using oral antidiabetes drugs (OADs), studies suggest that timely insulin initiation has clinical benefits. Insulin initiation at the early versus late stage of disease progression has not been explored in detail. This retrospective database analysis investigated clinical and economic outcomes associated with the timing of insulin initiation in patients with T2DM treated with ≥1 OAD in a real-world US setting. METHODS: This study linked data from the Truven Health MarketScan(®) Commercial database, Medicare Supplemental database, and Quintiles Electronic Medical Records database. A total of 1830 patients with T2DM were included. Patients were grouped according to their OAD use before basal insulin initiation (1, 2, or ≥3 OADs) as a proxy for the timing of insulin initiation. Clinical and economic outcomes were evaluated over 1 year of follow-up. FINDINGS: During follow-up the 1 OAD group, compared with the 2 and ≥3 OADs groups, had a greater reduction in glycosylated hemoglobin A1c (-1.7% vs -1.0% vs -0.9%, respectively; P < 0.0001), greater achievement of glycemic target (38.2% vs 26.7% vs 19.6%, respectively; P < 0.0001), and a lower incidence of hypoglycemia (2.7% vs 6.6% vs 5.0%, respectively; P = 0.0002), with no difference in total health care costs ($21,167 vs $21,060 vs $20,133, respectively). IMPLICATIONS: This study shows that early insulin initiation (represented by the 1 OAD group) may be clinically beneficial to patients with T2DM not controlled with OADs, without adding to costs. This supports the call for timely initiation of individualized insulin therapy in this population.

Persistence, adherence, and all-cause healthcare costs in atazanavir- and darunavir-treated patients with human immunodeficiency virus in a real-world setting.

OBJECTIVES: Atazanavir (ATV) and darunavir (DRV) are protease inhibitors approved for HIV treatment in combination with ritonavir (/r). The objectives of this study were to compare persistence (time to treatment discontinuation/modification), adherence, and healthcare costs among patients with human immunodeficiency virus (HIV) initiating ATV/r or DRV/r. METHODS: This retrospective cohort study used commercial and Medicaid administrative insurance claims data. Patients initiating ATV/r or DRV/r from 2006-2013 with continuous enrollment for ≥6 months before and ≥3 months after initiation were included. Patients were followed from initiation until discontinuation/modification (≥30 day gap in ATV or DRV or initiation of a new antiretroviral medication), during which time adherence (proportion of days covered [PDC], with PDC ≥80% or 95% considered adherent) and per-patient per-month (PPPM) total healthcare costs were measured. DRV/r patients were propensity score matched to ATV/r patients at a 1:1 ratio to achieve balance on potentially confounding demographic and clinical factors. Commercial and Medicaid samples were analyzed separately, as were antiretroviral (ART)-naïve and experienced patients. RESULTS: The final samples comprised 2988 commercially-insured and 1158 Medicaid-insured patients. There were no significant differences in hazards of discontinuation/modification between the ATV/r or DRV/r cohorts. With respect to odds of being adherent, the only marginally significant result was comparing odds of achieving PDC ≥80% among ART-naïve Medicaid patients, which favored ATV/r. All other adherence comparisons were not significant. Although ATV/r cohorts tended to have lower PPPM costs, the majority of these differences were not statistically significant. CONCLUSIONS: Patients with HIV treated with either ATV/r or DRV/r had similar time to treatment discontinuation/modification, adherence, and monthly healthcare costs. Results were similar across the pre-specified sub-groups. These findings are useful not only as an insight into clinical practice, but also as a resource for healthcare providers and payers evaluating treatment options for HIV+ individuals.

The impact of persistence with therapy on inpatient admissions and emergency room visits in the US among patients with multiple sclerosis.

OBJECTIVE: Disease-modifying therapy (DMT) for multiple sclerosis (MS) can reduce relapses and delay progression; however, poor adherence and persistence with DMT can result in sub-optimal outcomes. The associations between DMT adherence and persistence and inpatient admissions and emergency room (ER) visits were investigated. METHODS: Patients with MS who initiated a DMT in a US administrative claims database were followed for 1 year. Persistence to initiated DMT was measured as the time from DMT initiation to discontinuation (a gap of >60 days without drug 'on hand') or end of 1-year follow-up. Adherence to initiated DMT was measured during the persistent period and was operationalized as the medication possession ratio (MPR). Patients with an MPR <0.80 were considered non-adherent. Claims during the 1-year follow-up period were evaluated for the presence of an all-cause inpatient admission or an ER visit. Adjusted odds ratios (AORs) for inpatient admission or ER visit comparing persistent vs non-persistent and adherent vs non-adherent patients were estimated using logistic regression models adjusted for patient characteristics. RESULTS: The final sample included 16,218 patients. During the 1-year follow-up period, 35.3% of patients discontinued their initiated DMT and 13.9% were not adherent while on therapy. During that same period, 10.0% of patients had an inpatient admission and 24.9% had an ER visit. The likelihoods of inpatient admission and ER visit were significantly decreased in persistent patients (AOR [95% CI] = 0.50 [0.45, 0.56] and 0.65 [0.60, 0.69], respectively) and in adherent patients (AOR [95% CI] = 0.83 [0.71, 0.97] and 0.86 [0.77, 0.95], respectively). CONCLUSIONS: Persistence and adherence with initiated DMT are associated with decreased likelihoods of inpatient admission or ER visit, which may translate to improved clinical outcomes.

Clinical and Economic Burden of Antineutrophil Cytoplasmic Antibody-associated Vasculitis in the United States.

OBJECTIVE: To describe the prevalence of major relapse and healthcare costs among patients with granulomatosis with polyangiitis (GPA); to find patients with microscopic polyangiitis (MPA) in administrative databases, because no MPA diagnosis code exists; and to describe the clinical and economic burden associated with MPA. METHODS: Adults (≥ 18 yrs) with ≥ 2 diagnoses of GPA [International Classification of Diseases-9-Clinical Modification (ICD-9-CM 446.4)] during 2009-2013 were extracted from the Truven Health MarketScan Commercial and Medicare Supplemental databases. Evidence of major relapse (based on the Birmingham Vasculitis Activity Score) and healthcare costs were collected during 12-month and 24-month followup periods. Adults with ≥ 2 diagnoses of unspecified arteritis (ICD-9-CM 447.6) were found as potential patients with MPA and additional criteria based on clinical input were applied to refine the sample. Major relapse-associated conditions and healthcare costs in the 6 months pre- and post-diagnosis were measured. Costs were inflated to 2013 US$. RESULTS: A total of 2784 patients with GPA were found and 18.7% experienced a major relapse in the 12-month followup period. The patients with a major relapse incurred higher average all-cause (12-month: $88,065 vs $30,682; p < 0.0001) and GPA-related costs (12-month: $61,636 vs $15,748; p < 0.0001) than patients without a relapse. Trends were consistent over the 24-month followup period. There were 612 incident patients with MPA. Following MPA diagnosis, healthcare costs nearly doubled ($30,166 vs $56,642; p < 0.0001). CONCLUSION: In a real-world setting, patients with GPA who experience major relapse have higher economic burden, compared to patients without a relapse. MPA diagnosis was associated with nearly a 2-fold increase in healthcare costs.

Comparison of Healthcare Costs Between Rheumatoid Arthritis Patients Treated with Infused Biologics After Switching from Another Biologic.

INTRODUCTION: While there is a substantial body of literature on the comparative healthcare costs of biologics used to treat rheumatoid arthritis (RA), nearly all of these investigations have been exclusively focused on anti-tumor necrosis factor-α (anti-TNF) agents in the setting of first-line biologic treatment. This study compared healthcare costs between RA patients treated with infused biologics after previously using at least one other biologic agent. METHODS: Using a large US administrative claims dataset, adult RA patients initiating an infused biologic (abatacept, infliximab, tocilizumab) between January 1, 2010 and January 1, 2012 (initiation = index) were identified. Rituximab was excluded because of unique dosing intervals, which make it difficult to determine treatment discontinuation using a claims database. Patients were required to have used one or more other biologic (infused or injected) at any time before index. Patients could contribute multiple observations to the dataset; one for each infused biologic they initiated between January 1, 2010 and January 1, 2012. A 6-month period before index was used to measure patient characteristics. A variable-length follow-up period after index was used to measure per-patient per-month (PPPM) healthcare costs, including biologic costs, RA-related healthcare costs, and all-cause healthcare costs. Generalized estimating equations models compared healthcare costs between the biologic agents, adjusting for patients' demographics and clinical characteristics. RESULTS: The sample comprised 3,771 infused biologic initiations (abatacept = 1,759; infliximab = 922; tocilizumab = 1,090); the mean age of participants was 55 years, 82 % were female, and the median follow-up ranged from 251 to 280 days. Compared with other patients, patients treated with tocilizumab had significantly lower (all P < 0.05) PPPM biologic costs (abatacept = $2,597, infliximab = $3,141, tocilizumab = $1,894), RA-related healthcare costs (abatacept = $2,929, infliximab = $3,598, tocilizumab = $2,236), and all-cause healthcare costs (abatacept = $3,735, infliximab = $4,600, tocilizumab = $3,042). CONCLUSIONS: Among RA patients treated with infused biologics after previously using at least one other biologic, patients treated with tocilizumab had the lowest real-world healthcare costs, largely driven by lower costs directly related to biologic treatment. Such biologic-related cost differences may be driven by variations in real-world treatment patterns (e.g., dose, escalation, treatment frequency).

Characteristics and comprehensiveness of adult HIV care and treatment programmes in Asia-Pacific, sub-Saharan Africa and the Americas: results of a site assessment conducted by the International epidemiologic Databases to Evaluate AIDS (IeDEA) Collaboration.

INTRODUCTION: HIV care and treatment programmes worldwide are transforming as they push to deliver universal access to essential prevention, care and treatment services to persons living with HIV and their communities. The characteristics and capacity of these HIV programmes affect patient outcomes and quality of care. Despite the importance of ensuring optimal outcomes, few studies have addressed the capacity of HIV programmes to deliver comprehensive care. We sought to describe such capacity in HIV programmes in seven regions worldwide. METHODS: Staff from 128 sites in 41 countries participating in the International epidemiologic Databases to Evaluate AIDS completed a site survey from 2009 to 2010, including sites in the Asia-Pacific region (n=20), Latin America and the Caribbean (n=7), North America (n=7), Central Africa (n=12), East Africa (n=51), Southern Africa (n=16) and West Africa (n=15). We computed a measure of the comprehensiveness of care based on seven World Health Organization-recommended essential HIV services. RESULTS: Most sites reported serving urban (61%; region range (rr): 33-100%) and both adult and paediatric populations (77%; rr: 29-96%). Only 45% of HIV clinics that reported treating children had paediatricians on staff. As for the seven essential services, survey respondents reported that CD4+ cell count testing was available to all but one site, while tuberculosis (TB) screening and community outreach services were available in 80 and 72%, respectively. The remaining four essential services - nutritional support (82%), combination antiretroviral therapy adherence support (88%), prevention of mother-to-child transmission (PMTCT) (94%) and other prevention and clinical management services (97%) - were uniformly available. Approximately half (46%) of sites reported offering all seven services. Newer sites and sites in settings with low rankings on the UN Human Development Index (HDI), especially those in the President's Emergency Plan for AIDS Relief focus countries, tended to offer a more comprehensive array of essential services. HIV care programme characteristics and comprehensiveness varied according to the number of years the site had been in operation and the HDI of the site setting, with more recently established clinics in low-HDI settings reporting a more comprehensive array of available services. Survey respondents frequently identified contact tracing of patients, patient outreach, nutritional counselling, onsite viral load testing, universal TB screening and the provision of isoniazid preventive therapy as unavailable services. CONCLUSIONS: This study serves as a baseline for on-going monitoring of the evolution of care delivery over time and lays the groundwork for evaluating HIV treatment outcomes in relation to site capacity for comprehensive care.

Retrospective analysis of long-term adherence to and persistence with DPP-4 inhibitors in US adults with type 2 diabetes mellitus.

INTRODUCTION: Patients with type 2 diabetes mellitus (T2DM) must remain adherent and persistent on antidiabetic medications to optimize clinical benefits. This analysis compared adherence and persistence among adults initiating dipeptidyl peptidase-4 inhibitors (DPP-4is), sulfonylureas (SUs), and thiazolidinediones (TZDs) and between patients initiating saxagliptin or sitagliptin, two DPP-4is. METHODS: This retrospective cohort study utilized the US MarketScan(®) (Truven Health Analytics, Ann Arbor, MI, USA) Commercial and Medicare Supplemental health insurance claims databases. Adults aged ≥18 years with T2DM who initiated a DPP-4i, SU, or TZD from January 1, 2009 to January 31, 2012 were included. Patients must have been continuously enrolled for ≥1 year prior to and ≥1 year following initiation. Adherence was measured using proportion of days covered (PDC), with PDC ≥ 0.80 considered adherent. Persistence was measured as time to discontinuation, defined as last day with drug prior to a 60+ days gap in therapy. Multivariable logistic regression and Cox proportional hazards models compared the outcomes between cohorts, controlling for baseline differences. RESULTS: The sample included 238,372 patients (61,399 DPP-4i, 134,961 SU, 42,012 TZD). During 1-year follow-up, 47.3% of DPP-4i initiators, 41.2% of SU initiators, and 36.7% of TZD initiators were adherent. Adjusted odds of adherence were significantly greater among DPP-4i initiators than SU (adjusted odds ratio [AOR] = 1.678, P < 0.001) and TZD initiators (AOR = 1.605, P < 0.001). During 1-year follow-up, 55.0% of DPP-4i initiators, 47.8% of SU initiators, and 42.9% of TZD initiators did not discontinue therapy. Adjusted hazards of discontinuation were significantly greater for SU (adjusted hazard ratio [AHR] = 1.390, P < 0.001) and TZD initiators (AHR = 1.402, P < 0.001) compared with DPP-4i initiators. Saxagliptin initiators had significantly better adherence (AOR = 1.213, P < 0.001) compared with sitagliptin initiators, and sitagliptin initiators had significantly greater hazard of discontinuation (AHR = 1.159, P < 0.001). Results were similar over a 2-year follow-up. CONCLUSIONS: US adults with T2DM who initiated DPP-4i therapy, particularly saxagliptin, had significantly better adherence and persistence compared with patients who initiated SUs or TZDs.

Price elasticity and medication use: cost sharing across multiple clinical conditions.

BACKGROUND: To address the impact that out-of-pocket prices may have on medication use, it is vital to understand how the demand for medications may be affected when patients are faced with changes in the price to acquire treatment and how price responsiveness differs across medication classes.  OBJECTIVE: To examine the impact of cost-sharing changes on the demand for 8 classes of prescription medications. METHODS: This was a retrospective database analysis of 11,550,363 commercially insured enrollees within the 2005-2009 MarketScan Database. Patient cost sharing, expressed as a price index for each medication class, was the main explanatory variable to examine the price elasticity of demand. Negative binomial fixed effect models were estimated to examine medication fills. The elasticity estimates reflect how use changes over time as a function of changes in copayments. RESULTS: Model estimates revealed that price elasticity of demand ranged from -0.015 to -0.157 within the 8 categories of medications (P less than 0.01 for 7 of 8 categories). The price elasticity of demand for smoking deterrents was largest (-0.157, P less than 0.0001), while demand for antiplatelet agents was not responsive to price (P greater than 0.05). CONCLUSIONS: The price elasticity of demand varied considerably by medication class, suggesting that the influence of cost sharing on medication use may be related to characteristics inherent to each medication class or underlying condition.

Comparison between guideline-preferred and nonpreferred first-line HIV antiretroviral therapy.

OBJECTIVES: To compare antiretroviral therapy (ART) adherence and persistence and total healthcare expenditures in Medicaid-insured patients with human immunodeficiency virus (HIV) initiating preferred or nonpreferred first-line ART based on March 2012 HHS HIV treatment guidelines. STUDY DESIGN: Retrospective observational study using Medicaid administrative healthcare claims from 15 states. METHODS: Subjects were HIV patients 18 to 64 years who initiated first-line HIV-related ART between January 1, 2007, and September 30, 2011, with continuous enrollment for 6 months prior to and at least 3 months following ART initiation. Patients were classified as having initiated preferred or nonpreferred ART based on March 2012 HHS HIV treatment guidelines. Outcomes were: ART adherence (proportion of days covered dichotomized at ≥80% and ≥95%), time to ART nonpersistence, and per patient per month (PPPM) total healthcare expenditures. Outcomes were evaluated using multivariable regressions. RESULTS: Sample included 1979 patients initiating preferred ART regimens and 1614 patients initiating nonpreferred ART; overall mean age was 41 years; 48% of subjects were female. In the multivariable analyses, patients initiating preferred ART regimens had significantly greater odds of adherence ≥80% (odds ratio [OR], 1.38; 95% CI, 1.07-1.77) and adherence ≥95% (OR, 1.26; 95% CI, 1.05-1.51), and a significantly lower hazard of nonpersistence (HR, 0.48; 95% CI, 0.44-0.52). PPPM total healthcare expenditures were numerically lower for patients initiating preferred ART regimens (-$341; 95% CI, -$888 to $255) but the difference was not deemed significant. CONCLUSIONS: This study reinforces the value of HHS recommendations for first-line ART. The potential impact of these findings will grow as more HIV patients become Medicaid-eligible under the Patient Protection and Affordable Care Act.

Real-world impact of comparative effectiveness research findings on clinical practice.

OBJECTIVES: Unprecedented funding for comparative effectiveness research (CER) to help provide better evidence for decision making as a way to lower costs and improve quality is under way. Yet how research findings are adopted and applied will impact the nation's return on this investment. We examine the relationship between the publication of findings from 4 seminal CER trials, the release of subsequent clinical practice guidelines (CPGs), and utilization trends for associated surgical interventions, diagnostic interventions, or medications. STUDY DESIGN: Retrospective, observational study. METHODS: Using a large national administrative claims database, we examined time series utilization trends before and after publication of findings from 4 CER trials published within the last decade. RESULTS: We found no clear pattern of utilization in the first 4 quarters after publication. However, we found that results for 2 of the studies were in concert with the release of CPGs and publication of study results. The trend in intensive statin therapy rose rapidly starting at the end of 2007, while the trend in standard therapy remained relatively constant (PROVE-IT). And, 9 months after trial publication, breast magnetic resolution imaging (MRI) utilization rates rose 43.2%, from 0.033 to 0.048 per 100 enrollees (Mammography With MRI). CONCLUSIONS: Our analysis of 4 case studies supports the call others have made to translate and disseminate CER findings to improve application of research findings to clinical practice and the need for continued development and dissemination of CPGs that serve to synthesize research findings and guide practitioners in clinical decision making. Further research is needed to determine whether these findings apply to different medical topics.

Patterns and correlates of linkage to appropriate HIV care after HIV diagnosis in the US Medicaid population.

BACKGROUND: Timely linkage to appropriate care after human immunodeficiency virus (HIV) diagnosis is critical to optimizing patient outcomes. Medicaid is the largest source of health care coverage for patients with HIV in the United States, yet no studies of linkage to appropriate HIV care have focused solely on the Medicaid population. METHODS: This is a retrospective study using Medicaid claims data from 15 states. Study sample comprised patients aged 18 to 64 years with 1 or more HIV tests between January 1, 2003, to May 1, 2010, followed or accompanied by HIV diagnosis. The "Test Index" corresponded to the HIV test that was temporally proximate to first HIV diagnosis. Study end point was linkage to appropriate HIV care, defined as receipt of CD4 and viral load tests as per US treatment guidelines. Time-to-event analyses characterized patterns and correlates of linkage to appropriate care. RESULTS: This study included 6684 patients, with a mean age of 35 years, 70% female, and 47% black race. Overall, 21.0% of patients linked to appropriate care within 1 year of the Test Index and 26.4% within 5 years. Compared with whites, blacks had a significantly shorter time to linkage to HIV appropriate care (hazard ratio, 2.034; P < 0.001). CONCLUSIONS: These findings in Medicaid patients newly diagnosed with HIV contrast with prior research show disparities in access to HIV care favoring whites. Overall, the proportion of patients who linked to appropriate HIV care was very low given the availability of effective treatment, suggesting a need for more effective interventions promoting timely linkage to appropriate care after diagnosis.

Combination therapy patterns and predictors of ADHD in commercially insured and Medicaid populations.

OBJECTIVES: Several stimulant and nonstimulant medications are used alone or in combination to treat attention-deficit/hyperactivity disorder (ADHD). Little is known about the current prevalence and predictors of combination therapy. This analysis describes ADHD medication use focusing on combination versus monotherapy. METHODS: Health insurance claims from the Truven Health MarketScan® Commercial Database and Multi-State Medicaid Database were analyzed for patients with an ADHD diagnosis (International Classification of Diseases, Ninth Revision codes 314.0x). Patients included were aged ≥ 6 years as of January 2010, continuously enrolled from July 2009 through December 2010, and had a claim for an ADHD medication in 2010. Medication use was measured in treatment months during 2010. Baseline demographic and clinical predictors of combination therapy (> 1 ADHD medication class in the same month) involving atomoxetine, long-acting stimulants, and α2-adrenergic agonists were explored using logistic regression, with generalized estimating equations to account for within-patient correlation between months. RESULTS: Commercially insured patients with ADHD (N = 211 226) were primarily aged 6 to 17 years (58.4%) and male (61.5%). Attention-deficit/hyperactivity disorder with hyperactivity was present in 15.8% of these patients. Combination therapy was used in 10.3% of 1 125 119 treatment months. Short-acting stimulants and α2-adrenergic agonists had the highest combination use (45.3% and 54.0%, respectively). Patients with ADHD insured through Medicaid (N = 125 104) were primarily aged 6 to 17 years (94.4%) and male (69.5%). Hyperactivity was present in 39.7% of these patients. Combination therapy was used in 24.0% of 721 986 treatment months. Short-acting stimulants, α2-adrenergic agonists, and intermediate-acting stimulants had the highest combination use (70.0%, 63.8%, and 51.8%, respectively). In multivariate models for both data sources, female patients were less likely to use combination therapy. Patients with hyperactivity were more likely to use combination therapy. Tics/Tourette's syndrome was associated with combination therapy for atomoxetine and long-acting stimulants. CONCLUSION: In commercially insured and Medicaid ADHD populations, combination therapy rates differed by medication class, as did the demographic and clinical characteristics statistically significantly associated with combination therapy. This suggests that these medications may be used differently in clinical practice.