A Retrospective Claims-Based Study Evaluating Clinical and Economic Burden Among Patients With Moderate to Severe Osteoarthritis Pain in the United States.

Background: There has been limited evaluation of medication adherence, healthcare resource utilization (HCRU), and healthcare costs over time in patients with osteoarthritis (OA), and stratification by pain severity level has not been reported. Assessing such longitudinal changes may be useful to patients and healthcare providers for tracking disease progression, informing treatment options, and employing strategies to optimize patient outcomes. Objectives: To characterize treatment patterns, HCRU, and costs over time in patients with moderate to severe (MTS) OA pain in the United States. Methods: We conducted a retrospective claims analysis, using IBM® MarketScan® databases, from 2013-2018. Eligible patients were aged ≥45 years with ≥12 months pre-index (baseline) and ≥24 months (follow-up) of continuous enrollment; index date was defined as a physician diagnosis of hip or knee OA. An algorithm was employed to identify MTS OA pain patients, who were propensity score matched with patients having non-MTS OA pain. Data were summarized using descriptive statistics and univariate analyses. Results: After propensity score matching, the overall OA pain cohorts consisted of 186 374 patients each: 61% were female, mean age was 63 years, and two-thirds (65.6%) were of working age (45-65 years). Sleep-related conditions, anxiety, and depression were significantly higher in the MTS OA pain cohort vs non-MTS (P<0.001). At baseline and 12- and 24-month follow-ups, receipt of prescription pain medications, HCRU, and direct medical costs were significantly higher in the MTS OA pain cohort (all P<0.01). Medication adherence was significantly higher in the MTS OA pain cohort for all medication classes except analgesics/antipyretics, which were significantly lower vs the non-MTS OA pain cohort (all P<0.0001). Conclusions: The burden of MTS OA pain is substantial, with patterns that show increasing medication use, HCRU, and costs vs non-MTS OA pain patients over time. Understanding the heterogeneity within the OA population may allow us to further appreciate the true burden of illness for patients in pain.

Healthcare Costs and Resource Utilization in Patients with Infantile Spasms Treated with H.P. Acthar Gel(®).

INTRODUCTION: The purpose of this study was to describe healthcare resource utilization and costs resulting from early (within 30 days of diagnosis) versus late (>30 days after diagnosis) treatment with prescriptions for H.P. Acthar(®) Gel (repository corticotropin injection; Acthar; Mallinckrodt) to manage infantile spasms (IS). METHODS: We included all patients in the Truven Health MarketScan(®) Commercial Claims and Encounters Database and the Truven Health MarketScan Multi-State Medicaid Database who were diagnosed with IS from 2007 to 2012. We performed unadjusted and adjusted regressions examining the relationship between healthcare resource utilization variables and their associated costs to compare outcomes in the early and late Acthar users. RESULTS: A total of 252 patients with IS who received Acthar fit our study criteria; 191 (76%) were early Acthar users. In adjusted analyses, we found that early Acthar use was associated with, on average, 3.8 fewer outpatient services (99% CI 0.7-6.7 fewer services). We did not find significant associations between early prescriptions for Acthar and number of hospitalizations, emergency room visits, prescription medications filled, or total costs of health services. CONCLUSION: Patients prescribed Acthar within 30 days of their IS diagnoses tended to have fewer outpatient services performed compared to patients prescribed Acthar later in the disease process. Although additional research is needed to confirm these exploratory findings, physicians may consider early treatment with Acthar to manage IS. FUNDING: This study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals.

Healthcare Costs and Resource Utilization in Patients with Multiple Sclerosis Relapses Treated with H.P. Acthar Gel(®).

INTRODUCTION: Multiple sclerosis (MS) is an autoimmune disorder with large annual costs. This study evaluated utilization and costs for the management of MS relapses with H.P. Acthar(®) Gel (repository corticotropin injection; Acthar; Mallinckrodt) compared to receipt of plasmapheresis (PMP) or intravenous immunoglobulin (IVIG) among patients with MS who experienced multiple relapses. METHODS: We identified patients with MS diagnoses who had relapses treated with intravenous methylprednisolone (IVMP), the first-line treatment for MS relapse. Patients who were treated for the subsequent relapses were eligible for the study. We analyzed 12- and 24-month healthcare utilization and costs among patients who received Acthar prescriptions compared to patients who were treated with PMP/IVIG using generalized linear and logistic regression models to calculate unadjusted and adjusted means and 95% confidence intervals. RESULTS: For the 12-month analysis, a total of 213 patients received Acthar prescriptions and 226 were treated with PMP or IVIG. Patients who received Acthar prescriptions were similar to those who received other treatments in terms of most demographic variables. Acthar recipients had fewer hospitalizations (0.2 vs. 0.4; P = 0.01) and received fewer outpatient services (29 vs. 43; P < 0.0001) but received more prescription medications (36 vs. 30; P < 0.0001) compared to recipients of PMP/IVIG. Patients who received Acthar prescriptions had lower inpatient and outpatient costs ($15,000 lower; P = 0.001; and $54,000 lower; P < 0.0001, respectively) but similar total costs. Similar results were seen in the cohort with 24 months of outcome data. CONCLUSION: Acthar may be a useful treatment option compared to PMP/IVIG for patients with MS experiencing multiple relapses. FUNDING: This study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals.