Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis.

INTRODUCTION: In evaluating therapies for migraine prevention, emphasis is placed on frequency and less attention is paid to duration or severity. Total pain burden (TPB) combines frequency, duration, and severity of migraine headache, and has the potential to further characterize the benefit of preventive treatment using a single composite measure. TPB was previously used to characterize response to galcanezumab (GMB) in patients with migraine. In this post hoc analysis we assessed the impact of GMB in lowering TPB in patients who had previously not benefited from two to four categories of migraine preventive medication. METHODS: CONQUER trial patients (N = 462), 18-75 years old who had previously not benefited from two to four categories of migraine preventive medication, were randomized (1:1) to monthly placebo or GMB 120 mg with 240 mg loading dose. For each patient, monthly TPB in severity-weighted hours was calculated by multiplying migraine headache duration (hours) by maximum severity for each migraine headache day, then summing these daily scores over the month for the monthly score. Changes from baseline in monthly TPB across months 1-3 were analyzed. Spearman correlations between TPB and scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) total and Migraine Disability Assessment Scale (MIDAS) were assessed at baseline. RESULTS: Mean (SD) baseline monthly TPB was 192.1 (158.3) and 188.2 (197.4) severity-weighted hours for GMB-treated and placebo-treated patients, respectively. Across the 3-month double-blind period, GMB-treated patients experienced significantly greater mean reductions from baseline in monthly TPB compared with placebo-treated patients, both for mean change (GMB - 82.7, placebo - 15.8, p < 0.001) and percentage change (GMB - 38.6%, placebo 9.4%, p < 0.001). Furthermore, baseline TPB correlated with MSQ score (r = - 0.39) and MIDAS score (r = 0.40), suggesting good association of TPB with functional and disability outcomes. CONCLUSION: GMB reduced mean TPB in patients who had previously not benefited from two to four categories of migraine preventive medication. TRIAL REGISTRATION: NCT03559257.

Costs of Early Stage Alzheimer's Disease in the United States: Cross-Sectional Analysis of a Prospective Cohort Study (GERAS-US)1.

BACKGROUND: Costs associated with early stages of Alzheimer's disease (AD; mild cognitive impairment [MCI] and mild dementia [MILD]) are understudied. OBJECTIVE: To compare costs associated with MCI and MILD due to AD in the United States. METHODS: Data included baseline patient/study partner medical history, healthcare resource utilization, and outcome assessments as part of a prospective cohort study. Direct, indirect, and total societal costs were derived by applying standardized unit costs to resources for the 1-month pre-baseline period (USD2017). Costs/month for MCI and MILD cohorts were compared using analysis of variance models. To strengthen the confidence of diagnosis, amyloid-ß (Aß) tests were included and analyses were replicated stratifying within each cohort by amyloid status [+ /-]. RESULTS: Patients (N = 1327) with MILD versus MCI had higher total societal costs/month ($4243 versus $2816; p < 0.001). These costs were not significantly different within each severity cohort by amyloid status. The largest fraction of overall costs were informal caregiver costs (45.1%) for the MILD cohort, whereas direct medical patient costs were the largest for the MCI cohort (39.0%). Correspondingly, caregiver time spent on basic activities of daily living (ADLs), instrumental ADLs, and supervision time was twice as high for MILD versus MCI (all p < 0.001). CONCLUSION: Early AD poses a financial burden, and despite higher functioning among those with MCI, caregivers were significantly impacted. The major cost driver was the patient's clinical cognitive-functional status and not amyloid status. Differences were primarily due to rising need for caregiver support.

Identifying factors of activities of daily living important for cost and caregiver outcomes in Alzheimer's disease.

BACKGROUND: We aimed to obtain a better understanding of how different aspects of patient functioning affect key cost and caregiver outcomes in Alzheimer's disease (AD). METHODS: Baseline data from a prospective observational study of community-living AD patients (GERAS) were used. Functioning was assessed using the Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale. Generalized linear models were conducted to analyze the relationship between scores for total activities of daily living (ADL), basic ADL (BADL), instrumental ADL (IADL), ADL subdomains (confirmed through factor analysis) and individual ADL questions, and total societal costs, patient healthcare and social care costs, total and supervision caregiver time, and caregiver burden. RESULTS: Four distinct ADL subdomains were confirmed: basic activities, domestic/household activities, communication, and outside activities. Higher total societal costs were associated with impairments in all aspects of ADL, including all subdomains; patient costs were associated with total ADL and BADL, and basic activities subdomain scores. Both total and supervision caregiver hours were associated with total ADL and IADL scores, and domestic/household and outside activities subdomain scores (greater hours associated with greater functional impairments). There was no association between caregiver burden and BADL or basic activities subdomain scores. The relationship between total ADL, IADL, and the outside activities subdomain and outcomes differed between patients with mild and moderate-to-severe AD. CONCLUSIONS: Identification of ADL subdomains may lead to a better understanding of the association between patient function and costs and caregiver outcomes at different stages of AD, in particular the outside activities subdomain within mild AD.

Comparison of vials and prefilled pens of a rapid-acting insulin analog on pharmacy budgets in a long-term care setting.

OBJECTIVE: Estimate budgetary impact for skilled nursing facility converting from individual patient supply (IPS) delivery of rapid-acting insulin analog (RAIA) 10-mL vials or 3-mL prefilled pens to 3-mL vials. DESIGN: A budget-impact model used insulin volume purchased and assumptions of length of stay (LOS), daily RAIA dose, and delivery protocol to estimate the cost impact of using 3-mL vials. SETTING: Skilled nursing facility. PARTICIPANTS: Medicare Part A patients. INTERVENTIONS: Simulations conducted using 12-month current and future scenarios. Comparisons of RAIA use for 13- and 28-day LOS. MAIN OUTCOME MEASURES: RAIA costs and savings, waste reduction. RESULTS: For patients with 13-day LOS using 20 units/day of IPS insulin, the model estimated a 70% reduction in RAIA costs and units purchased and a 95% waste reduction for the 3-mL vial compared with the 10-mL vial. The estimated costs for prefilled pen use were 58% lower than for use of 10-mL vials. The incremental savings associated with 3-mL vial use instead of prefilled pens was 28%, attributable to differences in per-unit cost of insulin in vials versus prefilled pens. Using a more conservative scenario of 28-day LOS at 20 units/day, the model estimated a 40% reduction in RAIA costs and units purchased, resulting in a 91% reduction in RAIA waste for the 3-mL vial, compared with 10-mL vial. CONCLUSION: Budget-impact analysis of conversion from RAIA 10-mL vials or 3-mL prefilled pens to 3-mL vials estimated reductions in both insulin costs and waste across multiple scenarios of varying LOS and patient daily doses for skilled nursing facility stays.

Utilization of duloxetine and celecoxib in osteoarthritis patients.

OBJECTIVES: To describe utilization patterns of duloxetine and celecoxib and subsequent opioid use among patients with osteoarthritis. RESEARCH DESIGN AND METHODS: Pharmacy and medical claims from SDI Health were analyzed for adult osteoarthritis patients (ICD-9-CM: 715.xx) who initiated duloxetine or celecoxib between 11/30/2010 and 4/30/2011. Initiation was defined as no pill coverage in the prior 90 days. Included patients had continuous enrollment for 6 months before and after the initiation and did not use opioid for 90 days before initiation. Propensity score matching was used to select patients with similar demographic and clinical characteristics for duloxetine and celecoxib cohorts. Compliance to index medication was assessed via medication possession ratio (MPR), proportion of days covered (PDC), and proportion discontinued (no access for 60 days). Initiating dose and opioid use after the index date was assessed. A Cox proportional hazard model was estimated to compare time to first opioid use. RESULTS: A total of 1360 patients initiated duloxetine and 1408 patients initiated celecoxib. After matching, 784 patients were selected for the duloxetine (mean age: 66, female: 78%) and celecoxib (mean age: 66; female: 76%) cohorts, respectively. Of the duloxetine cohort 92.5% started on ≤60 mg/day, the recommended dose, and 72.8% of the celecoxib cohort started on ≤200 mg/day. The duloxetine cohort had higher MPR and PDC and a lower proportion of discontinuation than the celecoxib cohort (MPR: 0.81 vs. 0.70; PDC: 0.51 vs. 0.35; discontinuation: 57% vs. 78%; all p < 0.001). A lower proportion of the duloxetine cohort used opioids after the index date (48.6% vs. 68.5%, p < 0.001), and they started on opioids later than the celecoxib cohort (25th percentile: 69.5 vs. 32 days; median: >183 days vs. 117 days, p < 0.001). After controlling for baseline characteristics, the duloxetine cohort initiated opioids later than the celecoxib cohort (hazard ratio: 0.66, 95% confidence interval: 0.58-0.76). CONCLUSION: Osteoarthritis patients initiating duloxetine had better compliance and a lower likelihood of opioid utilization than those initiating celecoxib. Study limitations included lack of information on reasons for medication initiation and discontinuation, severity of disease symptoms, and use of over-the-counter medications.

Real-world treatment patterns and opioid use in chronic low back pain patients initiating duloxetine versus standard of care.

To describe the use of pain medications in patients with chronic low back pain (CLBP) after initiating duloxetine or standard of care (SOC [muscle relaxants, gabapentin, pregabalin, venlafaxine, and tricyclic antidepressants]) for pain management, pharmacy and medical claims from Surveillance Data, Inc (SDI) Health were analyzed. Adult patients with CLBP who initiated duloxetine or SOC between November 2010 and April 2011 were identified. Treatment initiation was defined as no pill coverage for duloxetine or SOC in the previous 90 days. Included patients had no opioid use in the 90 days before initiation. Propensity score matching was used to select patients with similar baseline demographic and clinical characteristics for duloxetine and SOC cohorts. Compliance with index medication was assessed via medication possession ratio (MPR) and proportion of days covered (PDC) for 6 months after initiation. The proportion of patients receiving opioids and days on opioids after index date were assessed, and regression models were estimated to compare opioid use between cohorts. A total of 766 patients initiated duloxetine and 6,206 patients initiated SOC. After matching, 743 patients were selected for the duloxetine (mean age 57 years; female 74%) and SOC (mean age 57 years; female 75%) cohorts, respectively. Of the duloxetine cohort, 92% started on or below recommended daily dose (≤60 mg). The duloxetine cohort had significantly higher MPR (0.78 versus [vs] 0.60) and PDC (0.50 vs 0.31), were less likely to use opioids (45% vs 61%), and had fewer days on opioids (median 0 vs 7 days) than the SOC cohort (all P < 0.001). After adjusting for demographic and clinical characteristics, the duloxetine cohort initiated opioids later than the SOC cohort (hazard ratio 0.77, 95% confidence interval 0.66-0.89). CLBP patients initiating duloxetine had better compliance with initiated medication and were less likely to use opioids than those initiating SOC.