Jennifer Pocoski

Fatigue heralding multiple sclerosis.

Background: Fatigue is a common symptom in multiple sclerosis (MS) and is an important determinant of overall well-being and disability. Objective: To assess the frequency with which fatigue precedes the diagnosis of MS using a retrospective database analysis. Methods: Between January 1, 2003 and September 30, 2008, patients diagnosed with fatigue with and without fatigue-related medications within a 3-year period prior to newly diagnosed MS were identified from the MarketScan Databases. All statistical analysis was performed using SAS. Results: Of the 16,976 patients with MS in the overall population, 5305 (31.3%) were newly diagnosed with MS and had three years of continuous healthcare coverage prior to MS diagnosis. Of these patients, 1534 (28.9%) were labeled with chronic fatigue syndrome (ICD9-780.71) or malaise or fatigue (ICD9-780.79) prior to the diagnosis of MS. One-third of these patients were labeled with fatigue one to two years before the diagnosis; 30.8% were diagnosed only with fatigue and had no other MS symptoms prior to their MS diagnosis. Among the patients diagnosed with fatigue, 10.4% were also prescribed medication for fatigue. Conclusion: This study demonstrates that fatigue may herald MS, often by years. A careful history for transient neurological symptoms and a physical examination is warranted in any patient presenting with fatigue.

Cost Burden and Treatment Patterns Associated with Management of Heavy Menstrual Bleeding

OBJECTIVES This study evaluated the healthcare resource use, work productivity loss, costs, and treatment patterns associated with newly diagnosed idiopathic heavy menstrual bleeding (HMB) using a large employer database. METHODS Medical and pharmacy claims (1998-2009) from 55 self-insured U.S. companies were analyzed. Women aged 18-52 years with ≥2 HMB claims (ICD-9 626.2, 627.0) and continuously enrolled for ≥6 months before the first claim were matched 1:1 with controls. Exclusion criteria were cancer, pregnancy, and infertility; HMB-related uterine conditions; endometrial ablation; hysterectomy; anticoagulant medications; and other known HMB causes. All-cause healthcare resource use and costs were compared between the HMB and control cohorts using statistical methods accounting for matched study design. Treatment patterns were examined for HMB subjects. RESULTS HMB and control cohorts (n=29,842 in both) were matched and balanced in baseline characteristics and costs. During follow-up, HMB subjects had significantly higher all-cause resource use than did control subjects: hospitalization incidence rate ratio (IRR)=2.70 (95% confidence interval [CI] 2.62-2.79); emergency room visits IRR=1.35 (95% CI 1.31-1.38); outpatient visits IRR=1.29 (95% CI 1.29-1.30). Average annualized all-cause costs were also higher for HMB subjects than controls (mean difference

Cardiovascular comorbidities are increased in US patients with haemophilia A: a retrospective database analysis

2,607, p<0.001). Costs associated with HMB claims represented 50% (

Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 13.5 mg in contraception.

1,313) of the all-cause cost difference. Of HMB subjects, 63.2% underwent surgical treatment as initial therapy. CONCLUSIONS In this large matched-cohort study, an idiopathic diagnosis of HMB was associated with high rates of surgical intervention and increased healthcare resource use and costs.

The Cost-Effectiveness of the Levonorgestrel-Releasing Intrauterine System for the Treatment of Idiopathic Heavy Menstrual Bleeding in the United States

There is conflicting evidence in the literature on whether individuals with haemophilia in the USA have greater, reduced, or similar risks for cardiovascular disease as the general population. This study evaluated the prevalence of cardiovascular comorbidities among USA males with haemophilia A, relative to an unaffected general male population with similar characteristics. Males with haemophilia A and continuous insurance coverage were identified by ICD‐9‐CM code 286.0 (1 January 2007–31 December 2009) using the MarketScan® Commercial and Medicare Research Databases. Individuals with haemophilia A were exact matched 1:3 with males without a diagnosis of haemophilia A. The prevalence of cardiovascular comorbidities identified by ICD‐9‐CM code was determined for matched cohorts. Of the study population, 2506 were grouped in the haemophilia A cohort and 7518 in the general cohort. Proportions of individuals with haemorrhagic stroke (2.0% vs. 0.5%, P < 0.001), ischemic stroke (4.7% vs. 2.7%, P < 0.001), coronary artery disease (10.7% vs. 5.8%, P < 0.001), myocardial infarction (0.8% vs. 0.3%, P = 0.003), hypertension (22.6% vs. 15.5%, P < 0.001), hyperlipidaemia (15.9% vs. 11.9%, P < 0.001), arterial thrombosis (12.1% vs. 5.9%, P < 0.001), and venous thrombosis (4.4% vs. 1.1%, P < 0.001) were significantly greater for the haemophilia A cohort. Results were consistent across most age groups, and comorbidities appeared at an earlier age in those with haemophilia A than in the general population. Among the USA haemophilia A population cardiovascular comorbidities are more prevalent and they appear earlier in life in comparison to the general male population, suggesting the need for earlier, enhanced screening for age‐related comorbidities in the haemophilia community.

Health economic models in hemophilia A and utility assumptions from a clinician's perspective

BACKGROUND Levonorgestrel-releasing intrauterine system (LNG-IUS) 13.5 mg (total content) is a low-dose levonorgestrel intrauterine system for up to 3 years of use. This analysis evaluated the cost-effectiveness of LNG-IUS 13.5 mg in comparison with short-acting reversible contraceptive (SARC) methods in a cohort of young women in the United States from a third-party payers perspective. STUDY DESIGN A state transition model consisting of three mutually exclusive health states -- initial method, unintended pregnancy (UP) and subsequent method -- was developed. Cost-effectiveness of LNG-IUS 13.5 mg was assessed vs. SARC methods in a cohort of 1000 women aged 20-29 years. SARC methods comprise oral contraceptives (OC), ring, patch and injections, which are the methods commonly used by this cohort. Failure and discontinuation probabilities were based on published literature, contraceptive uptake was determined by the most recent data from the National Survey of Family Growth, and costs were taken from standard US databases. One-way sensitivity analysis was conducted around key inputs, while scenario analysis assessed a comparison between LNG-IUS 13.5 mg and the existing IUS, LNG-IUS 20 mcg/24 h. The key model output was cost per UP avoided. RESULTS Compared to SARC methods, initiating contraception with LNG-IUS 13.5 mg resulted in fewer UP (64 UP vs. 276 UP) and lower total costs (

Retrospective analysis of variation in heavy menstrual bleeding treatments by age and underlying cause

1,283,479 USD vs.

A second retrospective database analysis confirms prior findings of apparent increased cardiovascular comorbidities in hemophilia A in the United States

1,862,633 USD, a 31% saving) over the 3-year time horizon. Results were most sensitive to the probability of failure on OC, the probability of LNG-IUS 13.5 mg discontinuation and the cost of live births. Scenario analysis suggests that further cost savings may be generated with the initiation of LNG-IUS 20 mcg/24 h in place of SARC methods. CONCLUSIONS From a third-party payer perspective, LNG-IUS 13.5 mg is a more cost-effective contraceptive option than SARC. Therefore, women switching from current SARC use to LNG-IUS 13.5 mg are likely to generate cost savings to third-party health care payers, driven principally by decreased UP-related expenditures and long-term savings in contraceptive costs.

Matching-adjusted indirect comparisons of efficacy of BAY 81-8973 vs two recombinant factor VIII for the prophylactic treatment of severe hemophilia A

OBJECTIVES Heavy menstrual bleeding negatively impacts the health and quality of life of about 18 million women in the United States. Although some studies have established the clinical effectiveness of heavy menstrual bleeding treatments, few have evaluated their cost-effectiveness. Our objective was to evaluate the cost-effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) compared with other therapies for idiopathic heavy menstrual bleeding. METHODS We developed a model comparing the clinical and economic outcomes (from a US payer perspective) of three broad initial treatment strategies over 5 years: LNG-IUS, oral agents, or surgery. Up to three nonsurgical treatment lines, followed by up to two surgical lines, were allowed; unintended pregnancy was possible, and women could discontinue any time during nonsurgical treatments. Menstrual blood loss of 80 ml or more per cycle determined treatment failure. RESULTS Initiating treatment with LNG-IUS resulted in the fewest hysterectomies (6 per 1000 women), the most quality-adjusted life-years (3.78), and the lowest costs (

Analysis of Diagnoses Associated with Multiple Sclerosis–Related In-Hospital Mortality Using the Premier Hospital Database

1137) among all the nonsurgical strategies. Initiating treatment with LNG-IUS was also less costly than surgery, resulted in fewer hysterectomies (vs. 9 per 1000 for ablation) but was associated with fewer quality-adjusted life-years gained per patient (vs. 3.80 and 3.88 for ablation and hysterectomy, respectively). Sensitivity analyses confirmed these results. CONCLUSIONS LNG-IUS resulted in the lowest treatment costs and the fewest number of hysterectomies performed over 5 years compared with all other initial strategies and resulted in the most quality-adjusted life-years gained among nonsurgical options. Initial treatment with LNG-IUS is the least costly and most effective option for women desiring to preserve their fertility.