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

Abstract

IntroductionThe 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).MethodsWe 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.ResultsA 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.ConclusionPatients 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.FundingThis study was funded by a grant to the University of Washington from Mallinckrodt Pharmaceuticals.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0361-2) contains supplementary material, which is available to authorized users.

Validating an Algorithm to Identify Patients With Infantile Spasms Using Medical Claims

“…The methods were developed through consensus from the authors and review of the existing literature. 9 Each method used a different combination of 4 clinical concepts. They were (a) "IS Claim" if a patient had an inpatient claim with an infantile spasms-specific diagnosis code (ICD-9 codes: 345.60 and 345.61 or ICD-10 codes: G40.821, G40.822, G40.823 and G40.824); (b) "EEG" if a patient had an EEG billing code in the CPT system (95816, 95817, 95818, 95819, 95820, 95821, 95822, 95823, 95824, 95825, 95826, 95827, 95828, 95829, 95830, 95831, 95832, 95833, 95834, 95835, 95836, 95837, 95838, 95839, and 95840); (c) "Rx" if a patient had filled a prescription for a medicine typically used for infantile spasms (solution/suspension drugs with name containing "H.P.…”

“…One study comparing early versus late prescription of adrenocorticotropic hormone (ACTH) used a combination of an ICD-9 code (345.6) and pharmacy claims for ACTH in a database of commercial claims. 9 However, this algorithm had not been validated. Here, the authors propose, validate, and compare several different algorithms to identify patients with infantile spasms in a claims database.…”

Clinical and Economic Evaluation of Repository Corticotropin Injection: A Narrative Literature Review of Treatment Efficacy and Healthcare Resource Utilization for Seven Key Indications

“…Of 21 patients treated for ≥6 months, 11 had improvements in ≥1 organ and 10 had stable disease; 2 had a relapse. Of 19 patients receiving prednisone at baseline, 17 were able to reduce prednisone reduce by >50% Healthcare resource utilization studies Infantile spasms Gold et al [ 53 ] Objective: To describe healthcare resource utilization and costs resulting from early (within 30 days of diagnosis) versus late (30 days after diagnosis) treatment with RCI to manage IS Study design: Retrospective observational study of healthcare claims data Treatment: RCI Sample size: 252 Outcomes: Adjusted 12-month mean number of outpatient and inpatient services, medications, and costs Inclusion criteria: Age <2 years at time of IS diagnosis Exclusion criteria: Not continuously enrolled in health plan for ≥3 months before and ≥12 months after index date; subsequent diagnosis of tuberous sclerosis complex Of 252 patients, 191 (76%) had early RCI treatment and 61 (24%) had late treatment. Early RCI treatment was associated with 3.8 fewer outpatient services (99% CI, −6.7 to −0.7) Multiple sclerosis relapse Gold et al [ 54 ] Objective: To describe healthcare resource utilization and costs in patients with MS relapse treated with RCI vs. PMP or IVIG Study design: Retrospective observational study of healthcare claims data Treatment: RCI vs. PMP or IVIG Sample size: 439 (12-month analysis); 228 (24-month analysis) Outcomes: 12-month and 24-month mean number and cost of hospitalizations, outpatient services, and prescription medications Inclusion criteria: Diagnosis of MS; ≥2 relapses with first relapse treated with IVMP and second relapse treated with RCI, PMP, or IVIG within 30 days of exacerbation Exclusion criteria: Not continuously enrolled in health plan for ≥6 months before and ≥12 months (for 12-month analysis) or ≥24 months (for 24-month analysis) after index date In the 12-month adjusted analysis, compared with the PMP/IVIG group ( n = 226), the RCI group ( n = 213) had fewer hospitalizations (0.2 vs. 0.4; p = 0.01) and outpatient services (29 vs. 43; p = 0.0001), more prescription medications (36 vs. 30; p = 0.0001), lower inpatient costs (US$15,000 lower; p = 0.001) and lower outpatient costs (US$54,000 lower; p = 0.0001), and similar total costs.…”

“…A claims-based analysis of infants with IS who were treated with RCI demonstrated a resource use benefit associated with early treatment (within 30 days of diagnosis) compared with later treatment (≥30 days after diagnosis) [ 53 ]. In particular, early use of RCI led to 3.8 fewer outpatient visits (99% confidence interval [CI] −6.7 to −0.7; p = 0.002) and 4.2 fewer visits for all health services combined (99% CI −7.9 to −0.4; p = 0.005).…”

Letter to the Editor Regarding “Neuroinflammation in Children With Infantile Spasms: A Prospective Study Before and After Treatment with Acthar Gel (Repository Corticotropin Injection)”

“…Interestingly, a previous research determined that earlier prescribing (within 30 days of diagnosis) of Acthar Gel to treat infantile spasms was associated with fewer outpatient procedures compared to later prescribing of this drug. 4 Hence, it is of potential significance to elucidate the response of children with infantile spasms of different duration and severity to Acthar Gel treatment. Since only 8 children with infantile spasms were included in the present study, and the authors did not record the duration and frequency of their seizures, this concern could not be addressed temporarily.…”