Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN).

Aims: To analyze secondary objectives of the REGAIN study related to acute headache medication use and healthcare resource utilization (HCRU) in patients with chronic migraine treated with galcanezumab, a monoclonal antibody to calcitonin gene-related peptide.

Methods: Adults with chronic migraine ( = 1,113) were randomized (2:1:1) and treated with double-blind monthly injections of placebo, galcanezumab-120 mg, or galcanenzumab-240 mg for 3 months, followed by a 9-month open-label extension with 120 or 240 mg/month galcanezumab. Headache and medication information was collected by daily eDiary.

Direct cost and healthcare resource utilization of patients with migraine before treatment initiation with calcitonin gene-related peptide monoclonal antibodies by the number of prior preventive migraine medication classes.

Objective: This study compared all-cause direct cost and healthcare resource utilization (HCRU) among preventive migraine medication (PMM)-naïve patients and patients with up to 3 PMM category switches before initiating calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs).

Methods: This was a retrospective analysis of the IBM Marketscan database. Patients who initiated injectable CGRP mAbs between May 2018 and December 2019 (index period) were included in 4 groups based on the number of prior non-CGRP PMM classes used during the 24-month pre-index period: P0 = none; P1 = one; P2 = two; P3 ≥ three.

Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm.

Introduction: Subcutaneous galcanezumab was an effective, well-tolerated preventive treatment for adults with episodic (EM) or chronic migraine (CM) in 4 phase 3 randomized controlled trials: EVOLVE-1, EVOLVE-2, REGAIN, and CONQUER. Number needed to treat (NNT) and to harm (NNH) are metrics of effect size used to evaluate benefit-risk profiles. This study evaluated NNT, NNH, and benefit-risk profiles (measured as likelihood to be helped or harmed, LHH) of galcanezumab 120 mg versus placebo in patients with EM or CM.

Economic burden and risk factors of migraine disease progression in the US: a retrospective analysis of a commercial payer database.

Aims: To evaluate the prevalence and risk factors of migraine progression and to assess the incremental burden of migraine progression on healthcare systems.

Materials And Methods: Adult patients were required to have a migraine diagnosis in IQVIA's US adjudicated claims database between 1 January 2012 and 30 June 2016, continuous enrollment ≥12 months before and after the index date (i.e.

A real-world analysis of patient-reported outcomes in patients with migraine by preventive treatment eligibility status in the US and Europe.

Background: Migraine has a severe impact on health-related quality of life (HRQoL) affecting physical, emotional, and social aspects of daily living of an individual. Preventive treatment has been demonstrated to improve HRQoL by reducing the frequency of migraine headache days.

Methods: The study used data from 2017 Adelphi Migraine Disease Specific Program, which is a cross-sectional survey of physicians and their consulting patients with migraine in the United States (US) and five European countries (EU [Germany, France, UK, Italy and Spain]).

Predicting initiation of preventive migraine medications: exploratory study in a large U.S. medical claims database.

Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication.

Treatment patterns and predictors of costs among patients with migraine: evidence from the United States medical expenditure panel survey.

Within a treated migraine population, to evaluate if the sub-group meeting criteria for high disease-specific total costs is significantly different to the sub-group with medium and/or low-costs, and to identify the associated risk factors. Data from the Household Component of Medical Expenditure Panel Survey (MEPS-HC, 2008-2012), a nationally representative survey of non-institutionalized civilians in the US, were analyzed. Key inclusion criteria were migraine diagnosis (ICD-9 code: 346.

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine.

Background: Effects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine.

Methods: Patients with episodic (78.9%) or chronic migraine (21.

Direct and Indirect Costs Among United States Commercially Insured Employees With Migraine.

Objective: The aim of this study was to compare direct, indirect, and societal (direct plus indirect) costs between patients with and without migraine (controls).

Methods: Patients with migraine were identified from MarketScan claims and Health and Productivity Management databases from January 1, 2010, to December 31, 2013, and were propensity score matched (1:1) to controls.

Results: Patients with migraine (N = 26,647) were matched to controls, of whom 4323 were matched for work absence and 26,212 for short-term disability eligibility.

Cycling Through Migraine Preventive Treatments: Implications for All-Cause Total Direct Costs and Disease-Specific Costs.

Background: Migraine is a common and disabling neurological disease associated with substantial economic burden. Among patients with migraine, it is unknown if cost differences exist when preventive migraine medication (PMM) switches occur.

Objective: To understand the cost burden and health care resource utilization of patients who discontinue or cycle through 1 (PMM1), 2 (PMM2), or ≥ 3 (PMM3) unique PMM drug classes over a 12-month period versus patients who adhere persistently to their initial PMM class.

Real-world health outcomes in adults with moderate-to-severe psoriasis in the United States: a population study using electronic health records to examine patient-perceived treatment effectiveness, medication use, and healthcare resource utilization.

Background: Little is known regarding real-world health outcomes data among US psoriasis patients, but electronic health records (EHR) that collect structured data at point-of-care may provide opportunities to investigate real-world health outcomes among psoriasis patients. Our objective was to investigate patient-perceived treatment effectiveness, patterns of medication use (duration, switching, and/or discontinuation), healthcare resource utilization, and medication costs using real-world data from psoriasis patients.

Methods: Data for adults (≥18-years) with a dermatology provider-given diagnosis of psoriasis from 9/2014-9/2015 were obtained from dermatology practices using a widely used US dermatology-specific EHR containing over 500,000 psoriasis patients.

Cost Per Additional Responder Associated With Ixekizumab and Etanercept in the Treatment of Moderate-to-Severe Psoriasis.

BACKGROUND: Newer psoriasis treatments can achieve greater levels of efficacy than older systemic therapies; however, current psoriasis costs are substantial. We sought to estimate costs per additional responder associated with ixekizumab and etanercept, versus placebo, using efficacy data from phase 3 clinical trials (UNCOVER-2 and UNCOVER-3). METHODS: In UNCOVER-2/UNCOVER-3, patients received subcutaneous placebo, etanercept 50 mg twice weekly (BIW), or ixekizumab one 80 mg injection every 2 weeks (Q2W) after a 160-mg starting dose.

Cost per additional responder for ixekizumab and other FDA-approved biologics in moderate-to-severe plaque psoriasis.

Background: Evidence of the cost-efficacy of ixekizumab for the treatment of moderate-to-severe plaque psoriasis (PsO) in the US is limited.

Objective: To estimate the number needed to treat (NNT) and monthly cost of achieving one additional Psoriasis Area and Severity Index (PASI) 75, 90, and 100 responder for ixekizumab and other Food and Drug Administration (FDA)-approved biologics in PsO.

Methods: A network meta-analysis estimated the probability of achieving PASI 75, 90, or 100 response during induction for each biologic.

Healthcare costs in psoriasis and psoriasis sub-groups over time following psoriasis diagnosis.

Aims: To quantify healthcare costs in patients with psoriasis overall and in psoriasis patient sub-groups, by level of disease severity, presence or absence of psoriatic arthritis, or use of biologics.

Methods: Administrative data from Truven Health Analytics MarketScan Research Database were used to select adult patients with psoriasis from January 2009 to January 2014. The first psoriasis diagnosis was set as the index date.

Patient Characteristics, Health Care Resource Utilization, and Costs Associated with Treatment-Regimen Failure with Biologics in the Treatment of Psoriasis.

Background: Psoriasis is a chronic, incurable, and immune-mediated skin disorder that is characterized by erythematous scaly papules and plaques. Understanding of psoriasis at the molecular level has led to the development of biologic agents that target disease-specific inflammatory mediators in psoriatic lesions. Biologic agents have become important components of the psoriasis armamentarium, but some patients become refractory to these agents over time or fail to respond to subsequent biologics.

Effect of corticosteroid use by dose on the risk of developing organ damage over time in systemic lupus erythematosus-the Hopkins Lupus Cohort.

Objectives: The impact of corticosteroids on the risk of organ damage in the context of clinical end points endorsed in some systemic lupus erythematosus (SLE) clinical trials is underexplored.

Methods: We analysed data from the Hopkins Lupus Cohort using Cox proportional hazards models to understand the impact of exposure to different corticosteroid doses on the risk of developing any new organ damage or any new organ damage at the individual organ systems over time.

Results: Mean prior prednisone dose, recent disease activity and immunosuppressant use during follow-up, as well as organ damage score at cohort entry, were significant independent predictors of the risk of developing any new organ damage.

Predictors of self-reported benign prostatic hyperplasia in European men: analysis of the European National Health and Wellness Survey.

Purpose: This study aimed to identify predictors of European men who self-reported being diagnosed with benign prostatic hyperplasia (DxBPH) compared to men with moderate-to-severe lower urinary tract symptoms [American Urological Association Symptom Index (AUA-SI) score ≥8] who did not self-report a BPH diagnosis (non-DxBPH).

Methods: Data were taken from the 2010 European National Health and Wellness Survey; a cross-sectional, self-administered, Internet-based questionnaire. This analysis included males ≥40 years with DxBPH or without DxBPH, but with AUA-SI ≥8.

Erectile dysfunction with or without coexisting benign prostatic hyperplasia in the general US population: analysis of US National Health and Wellness Survey.

Objective: Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) commonly affect older men. There is limited epidemiology information on coexisting ED and BPH. This study assessed self-reported prevalence of ED with or without a diagnosis of BPH (ED/DxBPH versus ED only) in US men.

Osteoporosis and treatments in Japan: management for preventing subsequent fractures.

Prevalent fractures are major contributors to an increased risk of subsequent fractures, particularly in people with osteoporosis. While many studies have been conducted to assess the incidence of fracture in Japanese people with osteoporosis, far fewer have been conducted to assess the risk of subsequent fractures. This article reviews the morbidity, mortality, and risk of fracture in patients who are at high risk of subsequent fracture in Japan and the current treatment options available for these patients.

Fractures in women treated with raloxifene or alendronate: a retrospective database analysis.

Background: Raloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published.

Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study.

Background: Improper medication adherence is associated with increased morbidity, healthcare costs, and fracture risk among patients with osteoporosis. The objective of this study was to evaluate the healthcare utilization patterns of Medicare Part D beneficiaries newly initiating teriparatide, and to assess the association of medication adherence and persistence with bone fracture.

Methods: This retrospective cohort study assessed medical and pharmacy claims of 761 Medicare members initiating teriparatide in 2008 and 2009.

The direct and indirect costs among U.S. privately insured employees with hypogonadism.

Introduction: While previous studies have noted that hypogonadism (HG) may pose a significant economic and quality-of-life burden, no studies have evaluated the impact of HG on healthcare utilization and costs in the United States.

Aim: Compare direct (health care) and indirect (disability leave or medical absence) costs between privately insured U.S.

Budget impact analysis of insulin therapies and associated delivery systems.

Purpose: A budget impact analysis of insulin therapies and associated delivery systems is presented.

Methods: Based on inputted procurement totals, per-item costs (based on 2011 average wholesale price), insulin distribution system (floor stock or individual patient supply), waste, and treatment protocols for a specified time frame, the budget impact model approximated the number of patients treated with subcutaneous insulin, costs, utilization, waste, and injection mechanism (pen safety needle or syringe) costs. To calculate net changes, results of one-year 3-mL vial use were subtracted from one-year 10-mL vial or 3-mL pen use.

Preadmission glycemic control and changes to diabetes mellitus treatment regimen after hospitalization.

Objective: To evaluate treatment patterns associated with diabetes medication regimen changes after hospitalization on the basis on preadmission hemoglobin A1c levels.

Methods: In this retrospective database analysis, patients with a diabetes diagnosis, hospitalization, and documented hemoglobin A1c level within the 90 days leading up to hospital admission were identified in an administrative claims database. Treatment regimens were assessed before and after hospitalization.