Analysis of Medicare Patients Treated with Pimavanserin versus Other Atypical Antipsychotics: A Cost-Offset Model Evaluating Skilled Nursing Facility Stays and Long-Term Care Admissions in Parkinson's Disease Psychosis.

Background: Patients with Parkinson's disease psychosis (PDP) treated with pimavanserin (PIM) versus other atypical antipsychotics (AAPs) including quetiapine (QUE) may have health-care cost savings due to fewer skilled nursing facility-stays (SNF-stays) and long-term care admissions (LTCA). Methods: A decision analytic model was developed using the 2019 Medicare Patient Driven Payment Model (PDPM) to estimate SNF-stays and LTCA associated per-patient- per-year (PPPY) facility and rehabilitation costs among patients that initiated PIM vs QUE or vs other-AAPs (i.e, quetiapine, risperidone, olanzapine, aripiprazole). Model inputs were derived for: (i) annual SNF-stay and LTCA rates from an analysis of Medicare beneficiaries with PDP, and (ii) annual mean rehabilitation and resident care-stay costs from PDPM case-mix adjusted value-based payment rates for 5 rehabilitation components (ie, physical-therapy, occupational-therapy, nursing, speech-language pathology, non-therapy ancillary), and an additional variable-per-diem for room/board services. PPPY costs were estimated from (i) SNF-stay and (ii) LTCA rates multiplied by annual mean costs of stay in 2022 USD. Probabilistic sensitivity analysis (PSA) was performed using 1000 Monte Carlo simulations. Results: Overall SNF-stay rates of 20.2%, 31.4%, and 31.7%, and LTCA rates of 23.2%, 33.8%, 34.6% were observed for PIM, QUE, and other-AAPs, respectively. Based on annual mean costs, PPPY SNF-stay rehabilitation and resident related costs for PIM ($41,808) vs QUE ($65,172) or vs other-AAPs ($65,664), resulted in $23,364 and $23,856 PPPY cost savings, respectively. Similarly, PPPY LTCA rehabilitation and resident related costs for PIM ($47,957) vs QUE ($70,091) or vs other-AAPs ($71,566) resulted in $22,134 and $23,609 PPPY cost-savings for PIM, respectively. PSA suggested PIM would provide cost-savings vs QUE or other-AAPs in >99% of iterations. Conclusion: In this analysis, PIM demonstrated nearly 36% and 32% lower PPPY SNF-stays and LTCA costs, respectively, vs QUE or other-AAPs. Research examining additional cost-offsets (i.e., fewer falls/fractures) associated with SNF-stay or LTCA may be needed.

Risk of long-term care admissions among Medicare beneficiaries treated with pimavanserin or quetiapine for Parkinson's disease psychosis in USA: a retrospective administrative claims database analysis.

Aim: Risk of long-term care (LTC) admission (LTCA) associated with atypical antipsychotic (AAP) use among patients with Parkinson's disease psychosis (PDP) is a major concern. However, no comparative studies have examined the differences in risk of LTC admissions between pimavanserin (PIM), the only FDA-approved AAP for PDP, and other off-label AAPs including quetiapine (QUE). Objective: To examine all-cause LTCA rates and risk among PDP patients treated with AAPs such as QUE or PIM. Methods: Analysis of Parts A, B and D claims (100% Medicare sample; 2013-2019) of Medicare beneficiaries with PDP that initiate ≥12-month continuous PIM or QUE monotherapy from 1 January 2014 to 31 December 2018 (i.e., index date) without any AAP use in the 12-month pre-index period was conducted. Outcome assessments among 1:1 propensity score-matched (31 variables - age, sex, race, region and 27 Elixhauser comorbidities) beneficiaries on PIM versus QUE included risk of all-cause skilled nursing facility stays (SNF-stays), LTC-stays, and overall LTCA (i.e., SNF-stays or LTC-stays). All-cause LTCA rates and LTCA risk were compared using logistic regression and cox proportional hazards models, respectively, controlling for demographics, comorbidities and co-existing-dementia or insomnia. Results: Of the matched sample (n = 842 for each group) from total sample (n = 9652), overall all-cause LTCA and SNF-stay rates were 23.2 and 20.2% for PIM versus 33.8 and 31.4% for QUE, respectively (p < 0.05, for each). Hazard ratio (95% CI) for risk of SNF-stay and overall LTCA was 0.78 (0.61, 0.98) and 0.80 (0.66, 0.97), respectively, for PIM versus QUE beneficiaries (p < 0.05, for each). Conclusion: The 20% lower risk of LTCA (i.e., greater delay) with PIM versus QUE in this analysis may suggest that PIM should be started early for the treatment of PDP.

Incremental health care resource utilization and costs associated among patients with Parkinson's disease psychosis and incident dementia: An analysis of medicare beneficiaries.

BACKGROUND: Real-world evidence examining the incremental health care resource use (HCRU) and cost burden of incident dementia among patients with Parkinson's disease psychosis (PDP) are needed within the United States (US). OBJECTIVES: To compare HCRU and cost burden between PDP patients with incident dementia (PDP + D) versus without incident dementia (PDP). METHODS: A retrospective analysis of inpatient (Part A), outpatient (Part B), and prescription drug (Part D) claims from the 100% Medicare sample was conducted to compare PDP + D patients versus PDP patients between 01/01/14-12/31/18. Patients with a diagnosis of dementia, psychosis, secondary parkinsonism, or other psychotic disorders, during 12-month pre-index were excluded. Patients in both groups were matched using 1:1 propensity score matching (PSM) methodology using 31 variables (age, sex, race, region and 27 Elixhauser comorbidity characteristics). Differences in 12-month post-index HCRU rates and mean per patient per year (PPPY) costs for all-cause inpatient (IP) hospitalizations, and by type of IP stay (i.e., short-term [ST-stay], skilled nursing facility [SNF-stay] and long-term [LT-stay]) were analyzed via logistic and gamma log-link regression models. RESULTS: Of the 12,484 patients who met our study criteria, 1855 PSM-matched cohorts were identified. Mean age, gender, and comorbidities were similar in PSM groups. Approximately, 50.3% with PDP + D reported ≥1 all-cause IP hospitalizations versus 36.0% with PDP (p < 0.05) during 12-month follow-up. Specifically, all-cause ST-stay, SNF-stay, and LT-stay among PDP + D versus PDP patients were: 45.2% versus 35.7%, 28.3% versus 15.7%, and 8.5% versus 6.0% (p < 0.05), respectively. Psychiatric-related ST-stay, SNF-stay, and LT-stay among PDP + D versus PDP patients were: 12.3% versus 9.0%, 7.5% versus 3.4%, and 2.4% versus 1.2% (p < 0.05), respectively. Mean PPPY all-cause IP hospitalization costs for PDP + D patients versus PDP patients was $17,891 (±29,882) versus $11,599 (±$25,247) (p < 0.05). CONCLUSIONS: Patients with PDP + D experience significantly higher all-cause and psychiatric-related IP hospitalizations, including ST-stays, LT stays, and SNF stays. They also had 54% greater mean PPPY IP hospitalization costs versus PDP patients.

Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries.

BACKGROUND: Pimavanserin (PIM) is the only FDA approved atypical antipsychotic (AAP) for the treatment of Parkinson's Disease Psychosis (PDP) while other off-label AAPs like quetiapine (QUE) are also used. Real-world comparative effects of PIM and QUE on health resource utilization (HCRU) may provide insights about their relative benefits. OBJECTIVES: To examine annual HCRU among newly initiated PIM or QUE monotherapy among patients with PDP. METHODS: Retrospective analysis of 100% Medicare (Parts A, B, and D) claims of patients with PDP during 1 January 2013 to 31 December 2019 was conducted. Treatment-naive patients with first prescription for PIM or QUE from 1 January 2014 to 31 December 2018 were selected if they had ≥12-months continuous monotherapy and had no prior AAP use for ≥12-month pre-index. Post-index 12-month HCRU was compared between 1:1 propensity score matched (PSM) PIM or QUE cohorts. HCRU outcomes included: rates of all-cause and psychiatric-related inpatient hospitalizations by stay-type [i.e., long-term stays (LT-stays), short-term stays (ST-stays), skilled nursing facility stays (SNF-stays)], outpatient hospitalizations, emergency room (ER) visits, and office visits. Relative risk and 95% confidence intervals are reported [RR (95% CI)]. RESULTS: A total of 842 and 7,116 were treated with PIM and QUE, respectively. Mean age and gender distribution were similar among both groups. After PSM, those on PIM (n=842) had significantly lower RR for all-cause: inpatient hospitalizations [RR=0.78 (0.70-0.87)], ST-stays [RR=0.75 (0.66-0.84)], SNF-stays [RR=0.64 (0.54-0.76)], and ER visits [RR=0.91 (0.84-0.97)] vs. QUE (n=842). PIM patients had slightly higher RR for all-cause office visits [RR=1.03 (1.01-1.05)] vs. QUE. Psychiatric-related inpatient hospitalizations were also lower for PIM vs. QUE: [RR=0.63 (0.48-0.82)] ST-stays [RR=0.61 (0.43-0.86)], SNF-stay [RR=0.69 (0.47-1.02)], and ER visits [RR=0.53 (0.37-0.76)]. CONCLUSIONS: In this analysis of PDP patients, PIM monotherapy resulted in nearly 22% and 37% lower all-cause hospitalizations and psychiatric-related inpatient hospitalizations compared to QUE.

Health care resource utilization patterns among patients with Parkinson's disease psychosis: analysis of Medicare beneficiaries treated with pimavanserin or other-atypical antipsychotics.

BACKGROUND: Pimavanserin (PIM) is the only FDA-approved atypical antipsychotic (AAP) for hallucinations and delusions associated with Parkinson's disease psychosis (PDP). Comparative real-world analyses demonstrating its benefits are needed. OBJECTIVES: To evaluate health care resource utilization (HCRU) outcomes among PDP patients treated with PIM vs. other-AAPs. METHODS: Retrospective cohort analysis of Parts A, B, and D claims from 100% Medicare sample from 01 January 2013-31 December 2019 was conducted. PDP Patients initiating (i.e. index date) continuous monotherapy (PIM vs. other-AAPs) for ≥12-months during 01 January 2014-31 December 2018 without 12-months pre-index AAP use were selected after 1:1 propensity score matching (PSM) on 31 variables (sex, race, region, age, and 27 Elixhauser comorbidities). HCRU outcomes included: annual all-cause and psychiatric hospitalization (short-term stay, long-term stay, and SNF-stay [skilled nursing facility]) rates, annual all-cause and psychiatric-ER visit rates, mean per-patient-per-year (PPPY) hospitalizations, and average length of stay (ALOS). PIM and other-AAPs were compared using generalized linear models (GLM) controlled for demographic characteristics, comorbidities, coexisting-dementia, and coexisting insomnia. RESULTS: Of 12,164 PDP patients, 48.41% (n = 5,889) were female, and mean age was 77 (±8.14) years. Among 1:1 matched patients (n = 842 in each), 37.8% (n = 319) on PIM vs. 49.8% (n = 420) on other-AAPs (p < .05) reported ≥1 all-cause hospitalizations, respectively. Specifically, short-term and SNF-stay among PIM patients vs. other-AAPs were: 34% (n = 286) vs. 46.2% (n = 389) and 20.2% (n = 170) vs. 31.8% (n = 267) (p < .05), respectively. Similarly, 9.6% (n = 81) of PIM vs. 14.6% (n = 123) of other-AAPs patients had ≥1 psychiatric hospitalization (p < .05). Furthermore, ≥1 all-cause and psychiatric ER visit among PIM vs. other-AAPs were 61.6% (n = 519) vs. 69.4% (n = 584) and 5.2% (n = 43) vs. 10.2% (n = 86) (p < .05), respectively. PIM also had significantly lower ALOS, and mean PPPY short-term hospitalization and SNF-stays. CONCLUSIONS: In this analysis of PDP patients, PIM monotherapy resulted in nearly 12% and 7% lower all-cause hospitalizations and ER visits vs. other-AAPs.

Role of Pimavanserin Treatment-Continuity on Discharge From Long-term Care: Assessing the Quality of Antipsychotic Medication Review.

Objective: To investigate the role of (1) antipsychotic medication review (AP-MR) documentation quality of Minimum Data Set 3.0 (MDS) surveys, and (2) treatment-continuity on discharge-to-community and clinical outcomes among long-term care (LTC) residents treated with pimavanserin. Design, Setting, and Participants: A retrospective cohort analysis of Parts A, B, and D claims from Medicare 100% sample merged with MDS data from June 2016 through December 2018 was conducted. Residents with more than 100-day LTC stay and 1 pimavanserin prescription or more with completed antipsychotic-use MDS question were selected. AP-MR documentation quality (ie, gradual dose reduction [GDR] attempts, clinical contraindication to GDR), discharge-to-community, and clinical outcomes (eg, falls, fractures) were obtained from MDS. Treatment-continuity was assessed from Part D claims. Data Analysis: Descriptive statistics (frequencies, proportions, Chi-square tests, and means) and adjusted logistic regressions (ORs with 95% CIs reported association between pimavanserin treatment-continuity and discharge-to-community. Results: Of 4,021 eligible residents, 29% (n = 1,182) attempted a GDR per AP-MR MDS documentation. Approximately 41% (n = 1,665) had documentation showing GDR was clinically contraindicated, yet 39% (n = 645) still attempted GDR. While overall discharge-to-community rates were low, it was significantly higher (P < 0.05) among LTC residents continuing (14.94%; n = 380/2,546) versus discontinuing (11.84%; n = 171/1,444) pimavanserin. OR for treatment-continuity was 1.96, 95% CI 1.50-2.55. Residents continuing pimavanserin had lower incidents of falls (2.8% vs 9.4%), hip fractures (0.29% vs 0.69%), and pelvic/femur fractures (0% vs 0.92%) versus those residents who discontinued it. Conclusions: Among LTC-stay residents, high discordance between GDR rates and AP-MR MDS documentation quality was observed. Pimvanserin treatment-continuity showed greater likelihood of discharge-to-community; continued documentation training can ensure appropriate antipsychotic use with a balanced benefit:risk profile.

Patient-Reported Experiences in Discussing Prescribed Medications with a Health Care Provider: Evidence for Racial/Ethnic Disparities in a Large Health Care Delivery System.

The objective was to understand patient-reported experiences in communicating with a health care provider about prescribed medications in a health care setting serving diverse racial/ethnic groups. Adult patients who completed a patient-experience survey and received a prescription for a hypertension, hyperlipidemia, or diabetes medication at the surveyed encounter were studied (N = 19,006). Data were collected in a large mixed-payer outpatient health care system in northern California between 2011 and 2014. Surveys were linked to the electronic health records of the office visit to which the survey refers, with detailed information on visit content, provider, and patient characteristics. The focus was on 2 survey questions asking about providers' efforts to include patients in treatment decisions and the information received about medications. Logistic regression was used to assess factors associated with survey responses, which were dichotomized as very good or not (ie, good, fair, poor, very poor). Chinese (OR: 0.59; 95% CI: 0.50-0.70), Asian Indians (0.68; 0.54-0.84), Japanese (0.74; 0.57-0.98), Koreans (0.46; 0.25-0.83), Vietnamese (0.51; 0.27-0.98), and African Americans (0.74; 0.55-0.99) vs. non-Hispanic whites (NHWs) reported poorer experiences of involvement in treatment decisions. Similarly, Chinese (0.59; 0.49-0.70), Asian Indians (0.67; 0.54-0.83), Koreans (0.38; 0.21-0.70), Vietnamese (0.46; 0.25-0.87), African Americans (0.65; 0.49-0.87), and Mexicans (0.77; 0.61-0.98) vs. NHWs reported poorer experiences for information received about medications. Almost all racial/ethnic groups report poorer experiences with involvement in treatment decisions and information received about medications than NHWs in the same clinical setting, which may contribute to poorer adherence and outcomes among racial/ethnic minority groups.

Impact of Behavioral Health Screening on Proactive Identification of Patients at Risk for Hospital Readmission.

Improving the ability to predict which patients are at increased risk for readmission can lead to more effective interventions and greater compliance with CMS Hospital Readmissions Reduction Program (HRRP) requirements. This study evaluated the performance of a risk model that used data from a health system's electronic medical record (EMR) to predict all-cause readmission among adult inpatients with acute medical conditions, with a specific focus on the impact of including behavioral health screening data. The study included 39,155 unique adult patients admitted during 2015 to 4 acute care inpatient facilities within a nonprofit community-based health care system. The risk model integrated a comprehensive set of data elements including demographics, psychosocial characteristics, medical history, assessment results, and clinical events. Predictive models were constructed using a multivariable logistic regression with a stepwise selection approach. Among study participants, the mean age was 62.9 years, 48.0% were male, 31.2% had comorbid psychiatric conditions, and 6986 had medical conditions/procedures subject to HRRP penalties. Results from exploratory predictive analyses demonstrated that any patients with a Serious Mental Illness (SMI) diagnosis were 28% more likely to be readmitted within 30 days, and the likelihood of readmission associated with SMI increased to 56% for patients with medical conditions subject to HRRP penalties. As health care systems face increasing pressures to reduce readmissions and avoid CMS HRRP financial penalties, study results indicate the importance of including behavioral health data from EMRs and screening assessments for all inpatients to improve discharge planning and patient outcomes.

Patients' Medication-Related Experience of Care Is Associated with Adherence to Cardiometabolic Disease Therapy in Real-World Clinical Practice.

Adherence to cardiometabolic disease (CMD) medications is typically suboptimal. This study sought to evaluate the relationship between patients' medication-related experiences of care and adherence to CMD therapy. This study was conducted using electronic health records and administrative data from an ambulatory care setting. It included adult managed care beneficiaries with a prescription for CMD medications (antihyperlipidemic, antihypertensive, or antihyperglycemic agents) between 2010 and 2014, written ±14 days of an office encounter linked to a completed patient experience survey. Outcomes were primary and overall adherence. Primary adherence was defined as ever filling a CMD medication and overall adherence as ≥80% days covered over 365 days among those with an initial fill. Survey items ("inclusion in treatment decisions" and "information about medications") are measured on a scale from 1 (very poor) to 5 (very good). Logistic regression was used to assess associations between ratings on each item (5 vs. <5) and primary or overall adherence. Eligibility criteria were met by 7368 patients; 5865 had ≥1 fill. After adjusting for confounders, better patient experiences with "inclusion in treatment decisions" (adjusted odds ratio [OR]:1.16; P = 0.049) and "information about medications" (OR:1.22; P = 0.009) were associated with greater odds of overall adherence to therapy. No significant associations were found between patient experience and primary adherence. Better patient medication-related experience of care is associated with improved adherence to CMD therapy. Efforts to include patients in treatment decision making and to provide better education on medications are simple, modifiable solutions to improve adherence and resultant outcomes of CMD treatment.

Health care resource utilization and costs of California Medicaid patients with schizophrenia treated with paliperidone palmitate once monthly or atypical oral antipsychotic treatment.

OBJECTIVE: To compare all-cause health care utilization and costs between patients with schizophrenia treated with once monthly paliperidone palmitate (PP1M; Invega Sustenna 1 ) and atypical oral antipsychotic therapy (OAT). METHODS: This was a retrospective claims-based analysis among adult California Medicaid (Medi-Cal) patients with schizophrenia having ≥2 claims for PP1M or OAT from 1 July 2009 to 31 December 2013 and continuous health plan enrollment for ≥1 year pre- and post-index date (PP1M or OAT initiation date). Baseline characteristics were reported descriptively. Propensity score matching with a 1:1 greedy match method was used to create two matched cohorts. Treatment patterns, all-cause health care utilization, and costs for the 12 month follow-up period were compared between the two matched cohorts. RESULTS: Two well matched cohorts of 722 patients were produced with similar baseline characteristics. During the 12 month follow-up period, PP1M patients were significantly less likely to discontinue treatment (30.6% vs. 39.5%, p < .001) or switch to a new therapy (21.6% vs. 27.7%, p = .007). PP1M patients had fewer inpatient visits (5.0 vs. 7.9, p < .001), lower mean hospitalization days (15.0 vs. 27.7 days, p < .001) and inpatient costs ($5060 vs. $10,880, p < .001). While pharmacy costs were significantly higher in the PP1M cohort ($16,347 vs. $9115, p < .001), total costs were not significantly different between the matched cohorts ($25,546 vs. $25,307, p = 0.853). CONCLUSIONS: Patients with schizophrenia treated with PP1M had significantly fewer inpatient hospitalizations and associated costs with no significant difference in the total costs between the two cohorts. This study is subject to limitations associated with claims data such as miscoding, inability to examine clinical severity, etc.

Medicaid managed care penetration and drug utilization for patients with serious mental illness.

OBJECTIVES: State Medicaid programs are under increasing pressure to contain pharmaceutical spending. Many states have attempted to limit spending through greater Medicaid managed care penetration, which rose nationally from 54.5% in 1999 to 74.9% in 2011. It is not clear how this expansion has affected beneficiaries with serious mental illness (SMI)-a vulnerable population that often has their drug spending "carved out" from their managed care benefit. We sought to assess the association between managed care penetration and pharmaceutical spending on drugs for SMIs in these states. STUDY DESIGN: Retrospective cohort study. METHODS: State-year observations were constructed to study the relationship between managed care penetration and pharmaceutical spending on drugs for SMIs over the period 1999 to 2011. We analyzed the relationship using both cross-sectional and panel-data methods. RESULTS: Our cross-sectional analyses suggested that carve-out states with greater managed care penetration spend significantly less per enrollee on pharmaceuticals for the treatment of mental disorders: our panel data analyses did not generate statistically meaningful results. CONCLUSIONS: Future studies should address whether any effects of managed care on mental health prescription utilization and spending reflect improved care coordination or worsening access to valuable care for the population with SMI.

Comparative effectiveness of injectable paliperidone palmitate versus oral atypical antipsychotics: early postmarketing evidence.

AIM: To provide comparative effectiveness evidence for long-acting injectable paliperidone palmitate versus oral atypical antipsychotics. PATIENTS & METHODS: We performed a retrospective, observational cohort study using patient claims data from Missouri Medicaid to compare the likelihood of emergency department (ED) visits and hospitalizations in the year following drug initiation using multivariable logistic regression. RESULTS: Adjusted odds ratios (AOR) for ED visits (AOR: 0.63; 95% CI: 0.47-0.85) and hospitalizations (AOR: 0.85; 95% CI: 0.64-1.13) were lower in paliperidone palmitate patients, although hospitalizations did not achieve statistical significance. Sensitivity analyses examining mental health-related outcomes and using different analytic strategies for patient selection bias showed directionally similar beneficial effects but were not statistically significant. CONCLUSION: Early evidence for paliperidone palmitate under real-world conditions is encouraging. However, caution should be taken until additional research substantiates the findings with greater certainty.

Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics.

OBJECTIVE: To identify relapse in schizophrenia and the main cost drivers of relapse using a cost-based algorithm. METHODS: Multi-state Medicaid data (1997-2010) were used to identify adults with schizophrenia receiving atypical antipsychotics (AP). The first schizophrenia diagnosis following AP initiation was defined as the index date. Relapse episodes were identified based on (1) weeks during the ≥2 years post-index associated with high cost increase from baseline (12 months before the index date) and (2) high absolute weekly cost. A compound score was then calculated based on these two metrics, where the 54% of patients associated with higher cost increase from baseline and higher absolute weekly cost were considered relapsers. Resource use and costs of relapsers during baseline and relapse episodes were compared using incidence rate ratios (IRRs) and bootstrap methods. RESULTS: In total, 9793 relapsers were identified with a mean of nine relapse episodes per patient. Duration of relapse episodes decreased over time (mean [median]; first episode: 34 [4] weeks; remaining episodes: 8 [1] weeks). Compared with baseline, resource utilization during relapse episodes was significantly greater in pharmacy, outpatient, and institutional visits (hospitalizations, emergency department visits), with IRRs ranging from 1.9-2.4 (all p < 0.0001). Correspondingly, relapse was associated with a mean (95% CI) incremental cost increase of $2459 ($2384-$2539) per week, with institutional visits representing 53% of the increase. LIMITATIONS: Relapsers and relapse episodes were identified using a cost-based algorithm, as opposed to a more clinical definition of relapse. In addition, their identification was based on the assumption from literature that ~54% of schizophrenia patients will experience at least one relapse episode over a 2-year period. CONCLUSIONS: Significant cost increases were observed with relapse in schizophrenia, driven mainly by institutional visits.

The threshold rate of oral atypical anti-psychotic adherence at which paliperidone palmitate is cost saving.

OBJECTIVE: To identify, estimate, and compare 'real world' costs and outcomes associated with paliperidone palmitate compared with branded oral atypical anti-psychotics, and to estimate the threshold rate of oral atypical adherence at which paliperidone palmitate is cost saving. METHODS: Decision analytic modeling techniques developed by Glazer and Ereshefsky have previously been used to estimate the cost-effectiveness of depot haloperidol, LAI risperidone, and, more recently, LAI olanzapine. This study used those same techniques, along with updated comparative published clinical data, to evaluate paliperidone palmitate. Adherence rates were based on strict Medication Event Monitoring System (MEMS) criteria. The evaluation was conducted from the perspective of US healthcare payers. RESULTS: Paliperidone palmitate patients had fewer mean annual days of relapse (8.7 days; 6.0 requiring hospitalization, 2.7 not requiring hospitalization vs 17.8 days; 12.4 requiring hospitalization, 5.4 not requiring hospitalization), and lower annual total cost ($20,995) compared to oral atypicals (mean $22,481). Because paliperidone palmitate was both more effective and less costly, it is considered economically dominant. Paliperidone palmitate saved costs when the rate of adherence of oral atypical anti-psychotics was below 44.9% using strict MEMS criteria. Sensitivity analyses showed results were robust to changes in parameter values. For patients receiving 156 mg paliperidone palmitate, the annual incremental cost was $1216 per patient (ICER = $191 per day of relapse averted). Inclusion of generic risperidone (market share 18.6%) also resulted in net incremental cost for paliperidone palmitate ($120; ICER = $13). Limitations of this evaluation include use of simplifying assumptions, data from multiple sources, and generalizability of results. CONCLUSIONS: Although uptake of LAIs in the US has not been as rapid as elsewhere, many thought leaders emphasize their importance in optimizing outcomes in patients with adherence problems. The findings of this analysis support the cost-effectiveness of paliperidone palmitate in these patients.

Evaluation of resource utilization and cost burden before and after an employer-based migraine education program.

OBJECTIVES: Study objectives were to determine the impact of migraine and severe headache on employer burden, resource utilization, and workplace productivity before and after a migraine education program; estimate the associated costs in an employed sample; and evaluate whether a migraine management program can help manage costs. METHODS: Employees of three US companies were informed of a company-specific web site with information regarding the study as well as a validated migraine screening questionnaire. Employees who screened positive for migraine completed a baseline survey examining migraine frequency and severity, Migraine Disability Assessment (MIDAS) grade, medical resource utilization, and impact on workplace productivity. After the baseline survey, employees received three print packets and six e-mailed newsletters of migraine management educational materials. Six months after the last mailing, participants completed a follow-up survey. Participants were stratified by MIDAS grade and prevention needs status. Direct and indirect migraine-related costs were estimated and differences between baseline and follow-up survey results were analyzed. RESULTS: Indirect costs and measures of migraine impact improved after the educational program. Three-month indirect costs of migraine decreased 34.5% and total costs decreased 14.7% after the educational program. CONCLUSION: Migraine management programs, including screening questionnaires and educational initiatives, may potentially help reduce the employer cost burden due to improvements in their employees' disability associated with migraine headache.

Potential drug-drug interactions with antiepileptic drugs in Medicaid recipients.

PURPOSE: The frequency of potential drug-drug interactions (DDIs) between antiepileptic drugs (AEDs) and other (non-AED) medications in Medicaid patients taking newer AED monotherapy, older AED monotherapy, and combinations of AED treatment was studied. METHODS: A retrospective, observational study was conducted using administrative claims obtained from South Carolina Medicaid. Patients were included in the analysis if they (1) had at least one prescription for an AED between January 1, 2004, and December 31, 2004, (2) were taking a specific AED for at least 60 days, (3) had at least one epilepsy diagnosis during the 6 months before or during the enrollment period, and (4) were enrolled in Medicaid for at least 11 of the 12 months of the follow-up period. Possible DDI exposure was defined as 10 days of overlap between an AED and a non-AED known to have the potential to cause a clinically relevant interaction. RESULTS: A total of 4955 patients met the inclusion criteria. Approximately 45% of patients receiving monotherapy with an older AED had a potential DDI, compared with 3.9% receiving a newer AED. An average of 0.08 potential DDI per year of exposure occurred in the newer AED monotherapy cohort compared with 1.18 in the older AED monotherapy cohort. The most common potential interaction category was a decreased concentration of the non-AED. CONCLUSION: Older AEDs were associated with a greater likelihood of a potential DDI than were newer AEDs. Further research is needed to elucidate the relationship between the occurrence of potential DDIs and actual clinically relevant consequences.

A comparison of levofloxacin and moxifloxacin use in hospitalized community-acquired pneumonia (CAP) patients in the US: focus on length of stay.

OBJECTIVE: Length of stay (LOS) and hospitalization costs were compared among patients admitted for community-acquired pneumonia (CAP) and initially treated with either levofloxacin 750 mg intravenous (IV) or with moxifloxacin 400 mg IV. Hospital-related complications and relationship of LOS and comorbidities were descriptively examined. METHODS: A retrospective database study was conducted of adult patients admitted for CAP and given levofloxacin 750 mg IV or moxifloxacin 400 mg IV through the first 3 days of hospitalization, using the Premier Perspective comparative database. Cohorts were matched 1:1 by hospital geographic location, by coarse caliper propensity scores using all baseline covariates, and by Mahalanobis metric matching based on age and severity (All Patient Refined-Diagnosis-related Groups Severity of Illness (APR-DRG SOI) index). Comparisons between groups were further adjusted for characteristics that remained imbalanced after matching using generalized estimating equation methodology. RESULTS: The initial sample of 3868 patients (levofloxacin = 827; moxifloxacin = 3041) was reduced to 1594 (797 patients per treatment group) after matching. Analyses of matched cohorts showed that the mean hospital LOS was significantly shorter for patients treated with levofloxacin 750 mg IV than for those patients treated with moxifloxacin 400 mg IV (5.8 vs. 6.4 days, respectively; least squares mean difference = 0.54 days; p = 0.020). Hospitalization costs were also lower for the levofloxacin 750 mg IV-treated patients (least squares mean difference = US$129; p = 0.753). There were no significant differences in the percentage of patients experiencing complications. LIMITATIONS: Although claims databases provide large sample sizes and reflect routine care, they do have several inherent limitations. Since randomization of subjects is not possible, adequate statistical techniques must be used to ensure treatment groups are balanced with respect to patient and clinical characteristics. In addition, data may be missing or miscoded. CONCLUSIONS: This retrospective study suggests that among patients hospitalized with CAP, initial treatment with levofloxacin 750 mg IV is associated with a significantly shorter mean hospital LOS compared with treatment with moxifloxacin 400 mg IV. The clinical implications of a shorter hospital LOS include improved patient and economic outcomes.

Treatment failure rates and health care utilization and costs among patients with community-acquired pneumonia treated with levofloxacin or macrolides in an outpatient setting: a retrospective claims database analysis.

BACKGROUND: Macrolide antibiotics and fluoroquinolones are extensively used in the treatment of community-acquired pneumonia (CAP). OBJECTIVE: This analysis was conducted to compare treatment failure rates and health care utilization and cost outcomes among patients with CAP treated with levo-floxacin (500 or 750 mg) or macrolides (azithromycin, clarithromycin, or erythromycin) in an outpatient setting. METHODS: This was a retrospective analysis of claims data from a large US health plan. Patients were aged > or =18 years and had a primary diagnosis of CAP that was treated with oral levofloxacin or a macrolide in an outpatient setting (including physicians' offices, outpatient clinics, urgent care centers, and large ambulatory health centers). Patients were followed for 30 days after the index drug date to measure study outcomes. Multivariate regression analysis and a propensity score technique were used to compare rates of treatment failure and CAP-related health care utilization and costs. Two post hoc subgroup analyses were conducted in patients aged > or =50 and > or =65 years. RESULTS: Of the 7526 patients meeting the inclusion criteria, 2968 (39.4%) were treated with levofloxacin and 4558 (60.6%) with a macrolide. Unadjusted rates of treatment failure were 21.1% and 22.7% in the levofloxacin and macrolide cohorts, respectively. After adjustment for demographic characteristics, baseline comorbidities, and severity of illness, levofloxacin recipients were significantly less likely to experience treatment failure than macrolide recipients (odds ratio [OR] = 0.84; 95% CI, 0.75-0.94, P = 0.003). The likelihood of treatment failure was significantly lower in levofloxacin recipients aged > or =50 years (OR = 0.79; 95% CI, 0.66-0.94; P = 0.007) and > or =65 years (OR = 0.65; 95% CI, 0.43-1.00; P = 0.049) compared with the corresponding subgroups of macrolide recipients. The magnitude of this difference was greatest in the subgroup aged > or =65 years, which had a 35% reduced risk of treatment failure compared with the corresponding group of macrolide-treated patients. The rate of CAP-related emergency department visits was significantly lower among patients receiving levofloxa-cin (OR = 0.68; 95% CI, 0.51-0.91; P = 0.009); there were no differences in CAP-related hospitalizations or total CAP-related health care costs between levofloxa-cin and macrolide recipients. CONCLUSIONS: Multivariate-adjusted rates of treatment failure in outpatients with CAP were significantly lower in those treated with levofloxacin relative to those treated with a macrolide. The lower rates of treatment failure with levofloxacin were consistently observed across all patients and in the subgroups aged > or =50 and > or =65 years. Rates of emergency department visits were also significantly lower among levofloxacin-treated patients, whereas overall CAP-related hospitali-zations and costs did not differ significantly between the 2 treatment groups.