Provider perceptions of barriers to biosimilar utilization in community oncology practices.

BACKGROUND: Biosimilars reduce the burden of cost on patients and payers, and so doing, increase access to life-saving care. However, biosimilar uptake in the US has been inconsistent. OBJECTIVES: This study assessed provider perceptions of barriers to biosimilar use and their relationships to utilization rates in a large, national oncology network and examined if perceptions differed by demographic and practice characteristics. METHODS: A 28-item survey was administered to 400 network physicians, pharmacists, nurses, and administrators, spanning 25 provider groups, and measured 1) barriers to use categorized into 4 subscales-payer-related, provider-related, operational, and patient-related, using a Likert scale ranging from Never (1) to Always (5); and 2) demographic and practice characteristics. Utilization rates were assessed using aggregated patient-level drug administration data found in the electronic health record system. Descriptive and inferential statistics were used to describe responses and assess relationships between variables. RESULTS: A total of 46 responses were analyzed, with a response rate of 11.5%. Most respondents were female (55.6%), physicians (52.2%), with over 6 years of experience (67%). A majority worked in practices participating in the Oncology Care Model (86.7%) and received continuing education on biosimilars (84.8%). Overall scale score was moderately low (mean=2.31), indicating low levels of perceived barriers. The lowest subscale score was operational barriers (mean=2.21), while payer-related barriers was the highest (mean=2.78). Perceptions of barriers did not differ based on demographic and practice characteristics. The average biosimilar utilization rate was 66.2%, with practices in the West administering biosimilars most frequently (71.8%). Utilization was not impacted by perceptions of barriers. CONCLUSION: Perceived barriers to biosimilar utilization were not common and not associated with utilization. Infrequent impediments to utilization may be associated with network-wide emphasis on continuing education and a value-based care environment. Future research should consider other practice- and patient-level factors that may impact biosimilar utilization.

Association Between Persistence with Oral Atypical Antipsychotic Medications and Hospital and Emergency Department Utilization in Medicaid Patients with Schizophrenia.

Purpose: To examine 1-year persistence with oral atypical antipsychotics (OAAPs) for Medicaid patients with schizophrenia and assess the association between OAAP persistence and hospital and emergency department (ED) resource utilization. Patients and Methods: Using 2016-2020 multi-state Medicaid claims data, this retrospective study followed patients diagnosed with schizophrenia for 12 months after initiating OAAP therapy. Patients started on an OAAP with no evidence of antipsychotic use in the previous 6 months were included if they had a diagnosis of schizophrenia, were not dually enrolled in Medicaid and Medicare, did not switch to a long-acting injectable antipsychotic, and were continuously eligible 6 months before and 12 months after the initial OAAP prescription (index date). OAAP persistence was measured allowing for a <60-day gap. All-cause and schizophrenia-related inpatient and emergency department (ED) resource utilization during the follow-up period were compared between OAAP persistent and non-persistent groups. Results: The study sample of 13,007 had an average age of 39.1 years and 57.0% were male. Patients were persistent with their index OAAP for 135 days on average and 73.1% had a ≥60-day gap in antipsychotic therapy post-index. While 32.8% and 28.6% of patients who did not persist with their index OAAP restarted the index OAAP or switched to a different OAAP medication later in the year, respectively, a larger proportion (38.6%) had no further OAAP prescriptions. After adjustment for demographic and clinical variables, compared to non-persistent patients, persisting with OAAPs was significantly associated with fewer all-cause and schizophrenia-related hospitalizations (Incidence Rate Ratio [IRR]=0.742, p<0.001; IRR=0.823, p<0.001; respectively) and ED visits (IRR=0.759, p<0.001; IRR=0.773, p<0.001; respectively). Conclusion: Non-persistence with OAAP medication is common among patients with schizophrenia and associated with negative outcomes including increased utilization of hospital and ED resources. Patient-centered interventions that improve antipsychotic persistence should be implemented to facilitate optimal outcomes in this population.

One-Year Medication Treatment Patterns, Healthcare Resource Utilization, and Expenditures for Medicaid Patients with Schizophrenia Starting Oral Atypical Antipsychotic Medication.

Oral atypical antipsychotic (OAAP) medications are the most commonly prescribed treatment for the management of schizophrenia symptoms. This retrospective study, using Medicaid claims data (2016-2020), followed patients for 12 months after initiating OAAP therapy. Study outcomes included OAAP adherence, switching, augmentation, healthcare resource utilization (HRU), and expenditures. All-cause and schizophrenia-related HRU and expenditures were compared between adherent and nonadherent cohorts. Among 13,007 included patients (39.1 ± 12.8 years of age, 57.0% male, 36.1% Black, 31.8% White, 9.7% Hispanic), 25.7% were adherent to OAAPs (proportion of days covered [PDC] ≥ 0.8). During the 1-year follow-up period, Black individuals were in possession of an OAAP for an average of 166 days compared to 198 and 202 days for White and Hispanic patients, respectively. Approximately 16% of patients switched OAAP medications and 3.2% augmented therapy with an OAAP added to their index medication. Nearly 40% of patients were hospitalized during follow-up and 68.4% had emergency department (ED) visits. A greater proportion of nonadherent patients had all-cause inpatient (41.7% vs. 34.1%, p < 0.001) and ED visits (71.7% vs. 58.8%, p < 0.001) compared to adherent patients. Annual total healthcare expenditures were $21,020 per patient; $3481 higher for adherent versus nonadherent patients. Inpatient expenditures comprised 44.6% and 30.6% of total expenditures for nonadherent and adherent patients, respectively. Hospitalized patients' total expenditures were $23,261 higher compared to those without a hospitalization. Adherence to OAAP medication is suboptimal and associated with increased utilization of costly hospital and ED resources. Efforts to improve therapies and increase medication adherence could improve clinical and economic outcomes among individuals with schizophrenia.

Procurement and use of social determinants of health data among key health care stakeholders.

BACKGROUND: A growing body of evidence supports the need for health systems to shift towards addressing social determinants of health (SDoH) as part of routine care. However, little is known about the state of the industry in terms of procurement and use of SDoH data. OBJECTIVES: To assess stakeholders' perceptions and experiences in collecting and utilizing SDoH data. METHODS: A prospective, cross-sectional study was conducted using a 24-item electronic survey. The pilot-tested survey was distributed to a diverse convenience sample of 94 health care stakeholder organizations that are members of the Pharmacy Quality Alliance organization. Survey responses were collected from November to December 2020. Descriptive statistics were used to analyze responses. RESULTS: A total of 25 respondents completed the survey (response rate = 26.6%). More than half (n = 14, 56.0%) collected and tracked SDoH data, and of those, most (n = 6, 42.85%) reported using organization-specific tools instead of standardized SDoH tools. Economic stability and health and health care indicators were the most frequently identified types of SDoH data collected. Participants reported that both identifying (mean = 3.88 ± SD = 0.88; 1 = not important to 5 = extremely important) and addressing (3.88 ± 0.93) patients' SDoH were moderately important to their organization. Lack of standard data format (72.0%), lack of time (52.0%), and lack of technological capabilities (44.0%) were the most commonly reported barriers to collecting SDoH data. However, value-based payment programs that reward addressing SDoH needs (76.0%) and a coding structure or reimbursement mechanism for identification and management of SDoH (60.0%) were most commonly reported as mechanisms to overcome SDoH data collection barriers. CONCLUSIONS: Health care stakeholders consider patient SDoH indicators important but report significant challenges in collecting these data. Solutions that address data standardization, time burden, technological barriers, and the offering of incentives could facilitate its collection and effective use. DISCLOSURES: Pharmacy Quality Alliance received an unrestricted grant from Pfizer, Inc, to support this work.

An assessment of Parkinson's disease medication treatment patterns in the Medicaid population.

INTRODUCTION: Most Parkinson's disease (PD) medication adherence studies have focused on patients with commercial or Medicare health insurance coverage. However, less is known regarding medication treatment patterns within the Medicaid population. METHODS: This retrospective cohort study utilized 2011-2019 administrative healthcare claims from 7 state Medicaid programs. We compared newly diagnosed patients with PD started on either levodopa or a dopamine agonist (DA). Baseline comorbidities were compared. Outcomes were assessed during a 12-month post-index observation period, and included total medication days, proportion of days covered (PDC), adherence status, persistence to initiating PD medication, and time to non-persistence of initiating PD medication. RESULTS: Our study sample of 805 Medicaid patients had an average age of 54.1 years, with 52.0% being female. Levodopa was the predominant PD medication at initiation (75.4%). Roughly half of patients had a baseline depressive disorder and nearly 40% had an anxiety disorder. Levodopa patients had a significantly higher PDC compared to DA patients (0.621 vs. 0.546, p = 0.007). An adjusted logistic regression model showed no significant difference in the number of adherent patients between the two groups (p = 0.058). An adjusted Cox proportional hazards model controlling for demographic and baseline variables showed a 26% lower risk of non-persistence for levodopa patients versus DA patients (HR 0.740, CI 0.597-0.917, p = 0.006). CONCLUSIONS: Adherence and persistence rates were suboptimal following initiation of either levodopa or DA medication for patients with PD in Medicaid programs, though rates were better for those initiated on levodopa.

"It's Time to Represent": shifting the paradigm to improve the quality of inputs into value assessment frameworks.

"It's Time to Represent" integrates 2 strategies that challenge the status quo to increase the diversity of populations that participate in research and address drivers of health disparities to better inform value assessment. The first, a community-engaged campaign, proposes to develop authentic, long-term partnerships with community members, their health care providers, and researchers to tailor recruitment and retention methods for underrepresented groups and hold researchers accountable for equitable selection of study participants. The second proposes to create an expectation for researchers to routinely collect patient-reported, actionable social determinants of health data to generate enhanced real-world evidence and thereby improve the quality of inputs utilized in value assessment frameworks. DISCLOSURE: No specific funding was received for this manuscript. The authors report no potential conflicts of interest.

"It's Time to Represent": shifting the paradigm to improve the quality of inputs into value assessment frameworks.

"It's Time to Represent" integrates 2 strategies that challenge the status quo to increase the diversity of populations that participate in research and address drivers of health disparities to better inform value assessment. The first, a community-engaged campaign, proposes to develop authentic, long-term partnerships with community members, their health care providers, and researchers to tailor recruitment and retention methods for underrepresented groups and hold researchers accountable for equitable selection of study participants. The second proposes to create an expectation for researchers to routinely collect patient-reported, actionable social determinants of health data to generate enhanced real-world evidence and thereby improve the quality of inputs utilized in value assessment frameworks. DISCLOSURE: No specific funding was received for this manuscript. The authors report no potential conflicts of interest.

A ready-to-use liquid glucagon for treatment of severe hypoglycemia demonstrates reduced healthcare payer costs in a budget impact model.

Research aim: To model the annual value of a novel ready-to-use, room-temperature stable liquid glucagon rescue pen and prefilled syringe (GRP, G-PFS; Xeris Pharmaceuticals, Inc.) for treatment of severe hypoglycemia events (SHE) versus current lyophilized powder glucagon emergency kits (GEK). GRP is a prefilled auto-injector designed to promptly administer concentrated liquid glucagon in a simple two-step process. G-PFS is a stable liquid formulation of glucagon in a prefilled syringe. In simulated emergencies, GRP and G-PFS demonstrated high functional efficacy, where 99% of users successfully administered a full-dose of drug. Studies with currently available injectable GEK suggest very low success rates (6-31%). The high functional efficacy of GRP and G-PFS significantly reduces user errors and may reduce utilization across emergency medical services (EMS), emergency departments (ED), and inpatient and outpatient costs for SHE.Methods: To estimate the economic impact of GRP and G-PFS, we developed a one-year budget impact model from a US commercial health plan perspective. Cost offsets from successful glucagon administration incorporated EMS, ED, inpatient, and outpatient utilization. Diabetes prevalence and event probabilities were estimated from publicly-available sources and clinical expert opinion. Costs (US$) were obtained from the 2018 Medicare Fee Schedules and adjusted to represent commercial payer costs.Results: GRP and G-PFS led to fewer EMS, ED, inpatient, and outpatient costs compared to GEK and no kit, resulting in total per-patient SHE costs of $2,564, $3,606, and $3,849, respectively. Costs for 1 million covered lives were 8.2 million following the introduction of GRP and G-PFS compared to almost 9 million before GRP and G-PFS.Limitations: The model is limited by reliance on assumptions based on expert opinion for key variables, primarily the probability of: (1) ambulance calls, (2) ambulance transport to the ED, and (3) non-ambulance transport to the ED.Conclusions: A budget impact model suggests GRP and G-PFS can lead to significant annual cost savings for US commercial payers.

Impact of Pharmacist Immunization Authority on Seasonal Influenza Immunization Rates Across States.

PURPOSE: The goal of this study was to investigate the impact on immunization rates of policy changes that allowed pharmacists to administer influenza immunizations across the United States. METHODS: Influenza immunization rates across states were compared before and after policy changes permitting pharmacists to administer influenza immunizations. The study used Behavioral Risk Factor Surveillance System (BRFSS) survey data on influenza immunization rates between 2003 and 2013. Logistic regression models were constructed and incorporated adjustments for the complex sample design of the BRFSS to predict the likelihood of a person receiving an influenza immunization based on various patient health, demographic, and access to care factors. FINDINGS: Overall, as states moved to allow pharmacists to administer influenza immunizations, the odds that an adult resident received an influenza immunization rose, with the effect increasing over time. The average percentage of people receiving influenza immunizations in states was 35.1%, rising from 32.2% in 2003 to 40.3% in 2013. The policy changes were associated with a long-term increase of 2.2% to 7.6% in the number of adults aged 25 to 59 years receiving an influenza immunization (largest for those aged 35-39 years) and no significant change for those younger or older. IMPLICATIONS: These findings suggest that pharmacies and other nontraditional settings may offer accessible venues for patients when implementing other public health initiatives.

Infectious diseases specialty intervention is associated with decreased mortality and lower healthcare costs.

BACKGROUND: Previous studies, largely based on chart reviews with small sample sizes, have demonstrated that infectious diseases (ID) specialists positively impact patient outcomes. We investigated how ID specialists impact mortality, utilization, and costs using a large claims dataset. METHODS: We used administrative fee-for-service Medicare claims to identify beneficiaries hospitalized from 2008 to 2009 with at least 1 of 11 infections. There were 101 991 stays with and 170 336 stays without ID interventions. Cohorts were propensity score matched for patient demographics, comorbidities, and hospital characteristics. Regression models compared ID versus non-ID intervention and early versus late ID intervention. Risk-adjusted outcomes included hospital and intensive care unit (ICU) length of stay (LOS), mortality, readmissions, hospital charges, and Medicare payments. RESULTS: The ID intervention cohort demonstrated significantly lower mortality (odds ratio [OR], 0.87; 95% confidence interval [CI], .83 to .91) and readmissions (OR, 0.96; 95% CI, .93 to .99) than the non-ID intervention cohort. Medicare charges and payments were not significantly different; the ID intervention cohort ICU LOS was 3.7% shorter (95% CI, -5.5% to -1.9%). Patients receiving ID intervention within 2 days of admission had significantly lower 30-day mortality and readmission, hospital and ICU length of stay, and Medicare charges and payments compared with patients receiving later ID interventions. CONCLUSIONS: ID interventions are associated with improved patient outcomes. Early ID interventions are also associated with reduced costs for Medicare beneficiaries with select infections.

Utilization patterns of stimulants in ADHD in the Medicaid population: a retrospective analysis of data from the Texas Medicaid program.

BACKGROUND: Some previously published research on treatment utilization patterns in patients with attention deficit/hyperactivity disorder (ADHD) has been focused on data from commercial health plans, whereas research in the Medicaid population is lacking. Thus, little is known about these utilization patterns in Medicaid populations, which typically have demographic and clinical characteristics that differ from those of employer-based groups. OBJECTIVES: The objectives of the present retrospective data analysis were to evaluate the associations of medication groups (categorized by stimulant type [methylphenidate or amphetamine] and duration of action [short-acting (SA) or long-acting (LA)]) with measures of stimulant utilization patterns (adherence, persistence, and switching) in children, adolescents, and adults with ADHD enrolled in the fee-for-service delivery model within the Texas Medicaid Program. METHODS: Texas Medicaid fee-for-service claims data were analyzed retrospectively. Data from enrollees with ADHD (6-63 years) were included if patients were newly initiated on medication from January 2006 to September 2007, had ≥1 medical claim with a code for ADHD, and had continuous Medicaid eligibility 6 months before and after treatment initiation. Adherence, persistence, and switching were compared by initial stimulant medication group (SA methylphenidate [SA-M], LA-M, SA amphetamine [SA-A], and LA-A). Rates were compared overall and by age group (children, adolescents, and adults). Multivariate models were used to control for demographic, clinical, and utilization covariates. RESULTS: Of 15,055 eligible patients, mostly children, 71% were initiated on methylphenidate; 90% received LA formulations (LA-M, 65%; LA-A, 25%). Most children (66%) and adolescents (65%) were initiated on LA-M, followed by LA-A (23% and 29%, respectively). Among adults, 38% each were initiated on LA-M and LA-A. Overall adherence (measured using the days in possession ratio [DPR]) and persistence were significantly greater with the LA versus the SA formulations (mean DPR, 0.497-0.504 vs 0.407-0.418, respectively; mean persistence, 81 vs 66-67 days; both, P < 0.001), and the rates of switching were lower with the LA versus the SA formulations (12.3%-14% vs 27%-28%; P < 0.001). On multivariate analyses, the likelihoods of adherence and persistence were significantly greater with the LA formulations, and the likelihood of being switched was significantly greater with the SA formulations (P < 0.001). These analyses also showed that medication utilization was significantly related to demographic and clinical characteristics. CONCLUSION: Based on the findings from this retrospective analysis, ADHD treatment utilization patterns varied by formulation in this Texas Medicaid population. Persistence at 180 days was poor regardless of the stimulant used. Consideration of stimulant formulations and demographic characteristics in patients in whom long-term ADHD management is being initiated may assist in optimum utilization, perhaps leading to better symptom control and more efficient resource utilization.

Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions.

PURPOSE: To calculate the abandonment rate of oral oncolytic medications and identify factors that may affect likelihood of abandonment. STUDY DESIGN: Cross-sectional cohort study using administrative claims data. METHODS: We analyzed a nationally representative pharmacy claims database and identified 10,508 patients with Medicare and commercial insurance for whom oral oncolytic therapy was initiated between 2007 and 2009. We calculated the abandonment rate for the initial claim, in which abandonment was defined as reversal of an adjudicated pharmacy claim without a subsequent paid claim for any oncolytic (oral or intravenous) within the ensuing 90 days. We assessed likelihood of abandonment using bivariate and multivariate logistic regression analyses including patient demographics, plan type, drug type, cost sharing, and concurrent prescription activity. RESULTS: The abandonment rate of newly initiated oral oncolytics was 10.0%. Unadjusted bivariate analyses found that high cost sharing, increased prescription activity, lower income, and Medicare coverage were associated with a higher abandonment rate (P < .05). In the logistic regression model, claims with cost sharing greater than $500 were four times more likely to be abandoned than claims with cost sharing of $100 or less (odds ratio [OR], 4.46; P < .001). Patients with five or more prescription claims processed within in the previous month had 50% higher likelihood of abandonment than patients with no other prescription activity (OR, 1.50; P < .001). CONCLUSION: Abandonment of newly prescribed oral oncolytic therapy is not uncommon, and the likelihood increases for patients enrolled in plans with pharmacy benefit designs that require high cost sharing. Increased concurrent prescription activity was also associated with a higher abandonment rate. These factors should be taken into account when considering likely adherence to cancer therapy.

Impact of telephone medication therapy management on medication and health-related problems, medication adherence, and Medicare Part D drug costs: a 6-month follow up.

BACKGROUND: The Medicare Modernization Act of 2003 mandated the provision of medication therapy management (MTM) to eligible Part D beneficiaries to improve medication-related outcomes. As MTM programs evolve, evaluation is necessary to help inform MTM best practices. OBJECTIVE: The objective of this study was to determine the impact of pharmacist-provided telephone MTM on: (1) medication and health-related problems (MHRPs); (2) medication adherence; and (3) Part D drug costs. METHODS: This quasi-experimental study included Part D beneficiaries from a Texas health plan. Andersen's Behavioral Model of Health Services Use served as the study framework. MTM utilization was the health behavior. Age, gender, and race were predisposing factors, and number of medications, chronic diseases, and medication regimen complexity were need factors. Outcomes were pre-to-post changes in: (1) MHRPs; (2) medication adherence, using the medication possession ratio (MPR); and (3) total drug costs. Multiple regression was used to analyze group differences while controlling for predisposing and need factors. RESULTS: At baseline, the intervention (n = 60) and control (n = 60) groups were not statistically different regarding predisposing and need factors, with the exception of gender. The intervention group had significantly (P = 0.009) more men compared with the control group (51.7% vs 28.3%). There were 4.8 (2.7) and 9.2 (2.9) MHRPs identified at baseline and 2.5 (2.0) and 7.9 (3.0) MHRPs remained at the 6-month follow up in the intervention and control groups, respectively. The intervention group (vs control) had significantly more MHRPs resolved (P = 0.0003). There were no significant predictors of change in MPR or total drug costs from baseline to follow up, although total drug costs decreased by $158 in the intervention group compared with a $118 increase in the control group. CONCLUSIONS: A telephone MTM program resolved significantly more MHRPs compared with a control group, but there were no significant changes in adherence and total drug costs.

Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions.

OBJECTIVE: To calculate the abandonment rate of oral oncolytic medications and identify factors that may affect likelihood of abandonment. STUDY DESIGN: Cross-sectional cohort study using administrative claims data. METHODS: We analyzed a nationally representative pharmacy claims database and identified 10,508 patients with Medicare and commercial insurance for whom oral oncolytic therapy was initiated between 2007 and 2009. We calculated the abandonment rate for the initial claim, in which abandonment was defined as reversal of an adjudicated pharmacy claim without a subsequent paid claim for any oncolytic (oral or intravenous) within the ensuing 90 days. We assessed likelihood of abandonment using bivariate and multivariate logistic regression analyses including patient demographics, plan type, drug type, cost sharing, and concurrent prescription activity. RESULTS: The abandonment rate of newly initiated oral oncolytics was 10.0%. Unadjusted bivariate analyses found that high cost sharing, increased prescription activity, lower income, and Medicare coverage were associated with a higher abandonment rate (P <.05). In the logistic regression model, claims with cost sharing greater than $500 were 4 times more likely to be abandoned than claims with cost sharing of $100 or less (odds ratio [OR], 4.46; P <.001). Patients with 5 or more prescription claims processed within in the previous month had 50% higher likelihood of abandonment than patients with no other prescription activity (OR, 1.50; P <.001). CONCLUSION: Abandonment of newly prescribed oral oncolytic therapy is not uncommon, and the likelihood increases for patients enrolled in plans with pharmacy benefit designs that require high cost sharing. Increased concurrent prescription activity was also associated with a higher abandonment rate. These factors should be taken into account when considering likely adherence to cancer therapy.

Patient satisfaction with a pharmacist-provided telephone medication therapy management program.

BACKGROUND: Patient satisfaction with medication therapy management (MTM), a required component of the Medicare Part D benefit, is an important outcome to consider when evaluating MTM programs. OBJECTIVE: To measure patient satisfaction with a pharmacist-provided telephone MTM program. METHODS: The study design was nonexperimental and cross sectional. A survey was mailed to Scott & White Health Plan Medicare Part D beneficiaries (n=60) who received telephone MTM in 2007. The survey was composed of 15 Likert-scaled questions (1=strongly disagree to 5=strongly agree) that assessed satisfaction with MTM. Descriptive statistics were used for quantitative data analysis. A qualitative content analysis of patients' responses to 3 open-ended questions was also conducted. RESULTS: The response rate for the survey was 80% (47 of 59). Study participants were 70.8 (+/-7.9) years old, and most were white (84.1%) and female (54.3%). The alpha coefficient for the satisfaction scale was 0.88. Overall mean satisfaction score was 4.0 (+/-0.6), with items ranging from 3.6 to 4.3. The highest level of agreement (mean=4.3) was with the following statements: (1) I can easily contact my pharmacist when I have questions or concerns; (2) My pharmacist adequately answers my questions; and (3) I am content receiving MTM over the telephone. The patients agreed least (mean=3.6) with the following statements: (1) When necessary, my pharmacist has encouraged me to receive preventive health care services; and (2) When needed, my pharmacist refers me to other health care providers. CONCLUSIONS: Most of the beneficiaries were satisfied with their MTM care. The positive response to telephone MTM is important because Medicare Part D plans are using the telephone as a method of MTM delivery. Education regarding the pharmacist's role in preventive care and pharmacist follow-up with non-pharmacist health care providers may lead to greater satisfaction levels.

Effects of antiepileptic drug substitutions on epileptic events requiring acute care.

STUDY OBJECTIVES: To determine the odds of antiepileptic drug substitution among patients who had an epileptic event requiring acute care-ambulance service, emergency department visit, or hospitalization-relative to patients who did not have an event, and to compare these results with those from a recent study involving a similar method but different patients. DESIGN: Case-control analysis. DATA SOURCE: United States health care claims from the PharMetrics database. PATIENTS: A cohort of patients aged 12-64 years with a primary diagnosis of epilepsy between October 1, 2005, and December 31, 2006; 991 cases (patients who experienced an epileptic event requiring acute care) and 2973 controls (patients who did not have an event) were matched in a 1:3 ratio for sex, age, and type of epilepsy. MEASUREMENTS AND MAIN RESULTS: Using discordant pairs analysis, we calculated the odds ratio of an epileptic event that required acute care occurring in patients whose antiepileptic drug underwent substitution to an A-rated (therapeutically equivalent) alternative (switch from branded product to generic, generic to branded, or generic to generic) versus those whose drugs were not substituted. For matched data, 109 (11.0%) of 991 cases had an A-rated antiepileptic drug substitution in the 6 months before the event, whereas only 186 (6.3%) of 2973 controls had a substitution (odds ratio 1.84, 95% confidence interval 1.44-2.36). Our results were similar to those of a previous study involving a different patient database, which showed substitution rates of 11.3% for cases versus 6.5% for controls (odds ratio 1.81, 95% confidence interval 1.25-2.63). Our sensitivity analyses were robust, and we found a temporal relationship in that numerous substitutions occurred in the month before the acute event. CONCLUSION: Patients who had an epileptic event requiring acute care were about 80% more likely than matched controls without an acute event to have recently had an antiepileptic drug substitution. Our replication of a previously published case-control analysis revealed a similar association between substitution involving A-rated antiepileptic drugs and subsequent epileptic events requiring acute care, thereby lending credibility to the findings.

Patient adherence and reimbursement amount for antidiabetic fixed-dose combination products compared with dual therapy among Texas Medicaid recipients.

BACKGROUND: Little is known about the potential for improved adherence with and cost savings of fixed-dose combination therapy (FDCT) products compared with analogous dual therapy for type 2 diabetes mellitus. OBJECTIVES: The objectives of this study were as follows: (1) to describe patient adherence to various oral antidiabetic regimens (ie, dual therapy and FDCT); (2) to determine whether there is a difference in medication adherence between FDCT users and analogous dual-therapy users; and (3) to assess whether there is a difference in reimbursement amounts between an FDCT product and its individual components. METHODS: This study was a retrospective cohort analysis using the Texas Medicaid prescription claims database. The study subjects included those who used antidiabetic FDCT or dual therapy from August 1, 2000, to July 31, 2004. The identification period of study subjects was between August 1, 2000, and July 31, 2004, including 12 months before and after the index date, so that the overall time frame was from August 1, 1999, through July 31, 2005. Prescription claims were analyzed over a 12-month preindex and 12-month postindex period. Adherence was measured using medication possession ratio (MPR), and regimen costs per tablet were assessed utilizing the index prescription. RESULTS: Overall, 7570 FDCT users and 14,762 dual-therapy users were identified. Regarding the postindex period, FDCT users had 1.8% higher MPR compared with dual-therapy users (78.6% vs 77.2%). Patients who switched from monotherapy to FDCT had a 1.5% decrease in adherence (from 79.7% to 78.5%), whereas those who switched from monotherapy to dual therapy had a 10.0% decrease in adherence (from 83.0% to 74.7%). Those who switched from dual therapy to FDCT had a 12.4% increase in adherence (from 72.7% to 81.7%). Multivariate logistic regression analyses revealed that among preindex monotherapy users, FDCT users were significantly more likely to have higher adherence than dual-therapy users (odds ratio [OR] = 1.867; 95% CI, 1.716-2.032) after controlling for covariates, and the results were similar among preindex dual-therapy users (OR = 1.551; 95% CI, 1.204-1.999). From the perspective of the third-party payer, all FDCT products were significantly less expensive than their equivalent individual components (P < 0.001). CONCLUSIONS: Among these Texas Medicaid beneficiaries, antidiabetic FDCT users were more adherent to their regimen than dual-therapy users, and FDCT was less expensive than the analogous dual therapy. Because multiple agents are often required to achieve adequate glycemic control, it may be clinically and economically beneficial to treat eligible patients with FDCT products.

Extended-release, once-daily morphine (Avinza) for the treatment of chronic nonmalignant pain: effect on pain, depressive symptoms, and cognition.

OBJECTIVE: To evaluate the impact of an extended-release, once-daily morphine sulfate formulation on depressive symptoms and neurocognition in patients with chronic nonmalignant pain. DESIGN: Prospective, open-label, one-group trial with a pretest-posttest design. SETTING: Outpatient pain management clinic. PATIENTS AND INTERVENTION: Chronic nonmalignant pain patients inadequately controlled with short-acting opioid analgesics and eligible for treatment with once-daily morphine sulfate were initiated on a dose at or near the morphine-equivalent dose of the short-acting regimen. OUTCOMES: The following assessments were made at baseline and 4 weeks after initiating intervention: pain intensity, pain unpleasantness, pain suffering, pain behaviors, Beck Depression Inventory, and cognitive function. RESULTS: Eighty-four patients provided usable data. Pain intensity, unpleasantness, and suffering scores were significantly reduced at follow-up (P = 0.001). The mean Beck Depression Inventory scores were significantly lower at follow-up (P = 0.001). Significant improvements were seen in scores at follow-up on the three validated neurocognitive tests: the digit span test, the digit symbol substitution test, and the paced auditory serial addition test (P = 0.001). CONCLUSIONS: Achieving adequate pain control with once-daily morphine was associated with a reduction in pain and improvements in depressive symptoms and cognitive functioning in the short term.

Comparison of hospitalizations, emergency department visits, and costs in a historical cohort of Texas Medicaid patients with chronic obstructive pulmonary disease, by initial medication regimen.

BACKGROUND: Limited information is available on the relative outcomes and treatment costs of various pharmacotherapies for chronic obstructive pulmonary disease (COPD) in a Medicaid population. OBJECTIVE: This study compared the effects of initial medication regimens for COPD on COPD-related and all-cause events (hospitalizations and/or emergency department [ED] visits) and COPD-related and all-cause costs. METHODS: The study population was a historical cohort of Texas Medicaid beneficiaries aged 40 to 64 years with COPD-related medical costs (International Classification of Diseases, Ninth Revision, Clinical Modification codes 491.xx, 492.xx, 496.xx), 24 months of continuous Medicaid enrollment (12 months before and after the index prescription), and at least 1 prescription claim (index) for a combination product containing fluticasone propionate + salmeterol, an inhaled corticosteroid, salmeterol, or ipratropium between April 1, 2001, and March 31, 2003. The analyses of events employed Cox proportional hazards regression, controlling for baseline factors and preindex events. The analyses of costs used a 2-part model with logistic regression and generalized linear model to adjust for baseline characteristics and preindex utilization and costs. RESULTS: The study population included 6793 patients (1211 combination therapy, 968 inhaled corticosteroid, 401 salmeterol, and 4213 ipratropium). Only combination therapy was associated with a significantly lower risk for any COPD-related event (hazard ratio [HR] = 0.733; 95% CI, 0.650-0.826) and any all-cause event (HR = 0.906; 95% CI, 0.844-0.972) compared with ipratropium. COPD-related prescription costs were higher in all cohorts compared with the ipratropium cohort, but COPD-related medical costs were lower, offsetting the increase in prescription costs. For all-cause costs, prescription costs were higher in the combination-therapy cohort (+$415; P < 0.05) and the salmeterol cohort (+$247; P < 0.05) compared with the ipratropium cohort, but significant reductions in all-cause medical costs in the combination-therapy cohort (-$1735; P < 0.05) and salmeterol cohort (-$1547; P < 0.05) more than offset the increase in prescription costs. CONCLUSIONS: In this historical population of Texas Medicaid beneficiaries, the combination-therapy cohort was 27% less likely to have a COPD-related event than the ipratropium cohort, 10% less likely to have any all-cause event, had similar COPD-related costs, and had reduced all-cause costs. Thus, compared with the ipratropium cohort, the combination-therapy cohort had an improvement in outcomes (based on the decreased time to a hospitalization or ED visit), with similar or decreased direct medical costs. Future research is needed in other patient groups.

Topiramate prescribing patterns among medicaid patients: diagnosis, comorbidities, and dosing.

BACKGROUND: Routine clinical practice data are useful for payers and formulary decision makers to make sound decisions regarding coverage policy. Based on a literature search, there has been scant research into topiramate prescribing patterns among Medicaid patients. OBJECTIVE: The aim of this study was to describe diagnoses, demographic characteristics, additional co-existing diagnoses, and dosing among Medicaid patients prescribed topiramate. METHODS: This descriptive, retrospective database analysis used data from South Carolina (SC) and Texas (TX) ambulatory Medicaid claims dated October 1, 2003, to December 31, 2004. Patients whose data were eligible for inclusion in the study were enrolled in Medicaid during the study period, had >or=2 topiramate prescriptions, were aged <65 years, and had evidence of a topiramate treatment-related diagnosis (possible diagnoses were identified through literature search and drug compendiums). Four cohorts were defined: (1) epilepsy only; (2) migraine only; (3) epilepsy and migraine; and (4) nonepilepsy/nonmigraine. Demographic characteristics, diagnoses, comorbidities, and daily dose of topiramate were summarized using descriptive statistics. The initial study analysis (period 1) was a 180-day window comprising the 90 days before and after the first available topiramate prescription claim was filed. A second, 360-day analysis (period 2) was completed comprising the 180 days before and after the index topiramate prescription date. RESULTS: In the 180-day analysis, 2216 SC and 4766 TX Medicaid patients met the selection criteria. Cohort classification percentages were 32.3% and 39.6% (epilepsy only), 29.7% and 16.4% (migraine only), 10.7% and 9.2% (epilepsy and migraine), and 27.3% and 34.9% (nonepilepsy/nonmigraine) for SC and TX, respectively. Mean (SD) ages were 29.9 (15.9) (SC) and 27.1 (16.1) (TX) years. In the nonepilepsy/nonmigraine cohort, the most common diagnoses were bipolar disorder and depression. The median daily doses in the epilepsy-only cohort were 175 mg/d in the SC group and 200 mg/d in the TX group. In the migraine-only cohort, the median daily dose was 100 mg/d in SC and TX. Results for the 360-day analysis were similar. CONCLUSIONS: In this descriptive study using data from 2 Medicaid populations, the majority of patients using topiramate had a diagnosis of epilepsy and/or migraine. Median dosages ranged from 175 to 200 mg/d in patients with epilepsy and 100 mg/d in those with migraine. Depression was a common comorbidity in the migraine cohort and the nonepilepsy/nonmigraine cohort.