Parkinson's disease and Parkinson's disease psychosis: a perspective on the challenges, treatments, and economic burden.

Parkinson's disease (PD) is a progressive neurodegenerative disease associated with a decrease in the neurotransmitter dopamine and characterized by the cardinal motor hallmarks of resting tremor, rigidity, bradykinesia/akinesia, and postural instability. Lesser-known features of PD revolve around nonmotor concerns including psychosis, dementia, sleep disturbances, autonomic dysfunction, and sensory abnormalities. Parkinson's disease psychosis (PDP) contributes significantly to morbidity, mortality, nursing home placement, and quality of life (QOL). PDP management suffers from a lack of safe, effective pharmacological agents and the opposing nature of atypical antipsychotics and dopaminergic therapies. Pimavanserin, the only atypical antipsychotic currently approved by the FDA for treating PDP-related hallucinations and delusions, has no appreciable affinity for dopaminergic receptors, and a controlled clinical study demonstrated its efficacy in treating PDP-associated hallucinations and delusions without affecting motor function. A recent analysis of all health resource utilization (HRU) and total costs attributable to PD and PDP found that mean 12-month HRU services per patient were 2.3 times higher and costs were 2.1 times higher in the PDP cases, while falls were 3.4 times higher and fractures 2.3 times higher, respectively. Products or services that prevent, delay, or lessen the severity of PDP may contribute to reduced healthcare system costs and improve the QOL of patients with PDP and of their caregivers.

Quantifying Differences in Health Care Consumption for the Management of Multiple Sclerosis Within Privately and Publicly Insured Health Care Programs.

BACKGROUND: Multiple sclerosis (MS) is a chronic and debilitating disease of the central nervous system that affects more than 570,000 persons in the United States and 2.3 million worldwide. Since most individuals experience initial symptoms between the ages of 20 and 40 years, MS can have a significant effect on health care consumption, quality of life, productivity, and employment over the long-term disease course. Opportunities exist to better understand how benefit design and other nonclinical factors can affect health care delivery and associated costs. OBJECTIVE: To observe and report variances in health care consumed for the treatment of MS in patients enrolled in privately (commercial) and publicly (Medicaid) funded health insurance programs. METHODS: In a retrospective analysis using Havas Gemini's proprietary MS Benchmarks Disease-Modeling Process and IMS LifeLink Health Plan Claims and Longitudinal Prescriptions databases, integrated medical and pharmacy claims data were analyzed to select patients with a diagnosis of MS during the 2012 calendar year. Comorbidities were determined using ICD-9-CM codes present on medical claims. Prescription drug use was evaluated by pharmacy claims and drug-specific billing codes. RESULTS: 19,984 patients with MS were identified-18,269 from commercial payers and 1,715 from Medicaid. Although total annual costs related to the care of MS for the groups reflected a relatively small difference ($31,107 commercial; $33,344 Medicaid), costs associated with specific service categories varied greatly. Pharmacy costs were considerably less in the Medicaid group; however, inpatient and emergency room costs were as much as 5 times higher. Overall use of disease-modifying treatments (DMTs) in the Medicaid group was seen in 32.5% of patients and 52.1% in the commercial patient group. Thus, lower pharmacy costs in the Medicaid group were possibly related to lesser use of DMTs among that group of patients. CONCLUSIONS: This analysis illustrates that notable variances exist in consumption of health care resources between patients enrolled in privately and publicly funded health care programs. These variances may have additional implications relating to outcomes specific to MS. DISCLOSURES: Funding for this study was contributed by Biogen. The preparation, writing, revision, and approval of this manuscript were conducted in collaboration with Pill, who is employed by Havas Gemini. Livingston, Fay, and Wells are employed by and own stock in Biogen. Iyer was employed with Biogen at the time of the study. Study concept and design were contributed by Livingston, Fay, and Iyer, along with Pill and Wells. Livingston, Fay, and Pill collected the data, along with Iyer and Wells. Data interpretation was performed by Livingston, Fay, and Iyer, along with Pill and Wells. The manuscript was written by Livingston, Fay, and Wells, along with Pill and Iyer, and revised by Fay, Wells, and Pill, along with Livingston and Iyer.

National and regional dose escalation and cost of tumor necrosis factor blocker therapy in biologic-naïve rheumatoid arthritis patients in US health plans.

OBJECTIVE: This study examined the proportion and magnitude of dose escalation nationally and regionally among rheumatoid arthritis (RA) patients treated with TNF-blockers and estimated the costs of TNF-blocker therapy. METHODS: This retrospective cohort study used claims data from US commercially-insured adult RA patients who initiated adalimumab, etanercept, or infliximab therapy between 2005-2009. Biologic-naïve patients enrolled in the health plan for ≥6 months before and ≥12 months after therapy initiation were followed for 12 months. Dose escalation was assessed using three methods: (1) average weekly dose > recommended label dose, (2) average ending dispensed dose > maintenance dose, and (3) average dose after maintenance dose > maintenance dose. Annual cost of therapy included costs for mean dose and drug administration fees. RESULTS: Overall, 1420 etanercept, 874 adalimumab, and 454 infliximab patients were included. A significantly lower proportion of etanercept-treated patients had dose escalation using the average weekly dose (3.9% vs 21.4% adalimumab and 69.6% infliximab; p < 0.0001), average ending dispensed dose (1.1% vs 10.6% adalimumab and 63.0% infliximab; p < 0.0001), and average dose after maintenance dose methods (2.8% vs 15.7% adalimumab and 69.6% infliximab; p < 0.0001). Regional dose escalation rates and magnitudes of escalation were directionally consistent with national rates. Etanercept had the lowest cost per treated RA patient ($19,690) compared to adalimumab ($23,020) and infliximab ($24,030). LIMITATIONS: Exclusion of patients not on continuous TNF-blocker therapy limits the generalizability; however, ∼50% of patients were persistent on therapy for 12 months. The study population comprised RA patients in commercial health plans, thus the results may not be generalizable to Medicare or uninsured populations. CONCLUSIONS: In this retrospective study, etanercept patients had the lowest proportions and magnitudes of dose escalation across all methods compared to adalimumab and infliximab patients nationally and regionally. Mean annual cost was lowest for etanercept-treated patients.

Narrative review of the literature on adherence to disease-modifying therapies among patients with multiple sclerosis.

While no curative treatment exists for multiple sclerosis (MS), several disease-modifying therapies (DMTs) have been developed to reduce relapse rates, slow disability progression, and modify the overall disease course. However, because of the chronic nature of the disease, long-term therapy adherence can be challenging for some patients with MS. Low adherence to DMTs has been shown to be associated with higher rates of disease relapses and progression as well as with an increase in medical resource utilization. As new MS treatments are developed, a comprehensive understanding of current adherence rates and the impact of adherence on clinical and economic outcomes is of particular interest. Our objective was to conduct a review of the published literature to evaluate rates of adherence to DMTs in MS and the impact of adherence on both clinical and economic outcomes from the patient and payer perspectives. Systematic literature searches were conducted using MEDLINE, EMBASE, and the Cochrane Central Register for Controlled Trials. Studies were limited to those completed on human subjects, written in the English language, and published between May 1, 2001, and May 1, 2011. Additional inclusion criteria required that studies involve a population of patients with MS, utilize the administration of DMTs, and report a measurement of adherence. Studies reporting persistence measures (e.g., treatment discontinuation rates) or rates of switching between DMTs (with no other measure of adherence reported) were excluded if they did not also assess adherence. Among the 24 studies meeting inclusion criteria, adherence to DMTs ranged from 41% to 88%. Weighted mean adherence rates were higher for intramuscular (IM) interferon beta-1a (IFNß-1a) administered once a week (69.4%), and subcutaneous (SC) IFNß-1b administered every other day (63.8%) than for SC IFNß-1a administered 3 times a week (58.4%) and glatiramer acetate administered daily (56.8%). There was a numerically greater risk of MS relapse or disease progression among patients nonadherent to therapy versus adherent patients, with findings statistically significant in 2 of 4 studies. Additionally, 2 studies showed statistically significant reductions in inpatient or emergency room utilization and total MS-related medical costs among patients adherent to therapy compared with nonadherent patients. Higher patient out-of-pocket copayments and coinsurance were significantly associated with lower adherence to DMTs, while the use of interventional or disease therapy management programs were associated with improved adherence. Lack of medication adherence remains a problem among patients with MS. Improvements in adherence have the potential to improve patient and payer burden in terms of improved clinical outcomes and lower nonpharmacy medical resource utilization.  

Perspectives for managed care organizations on the burden of multiple sclerosis and the cost-benefits of disease-modifying therapies.

Disease-modifying therapies (DMTs) are a core component of multiple sclerosis (MS) management. Given current constraints on health care expenditures, the relative cost-effectiveness of these therapies needs to be considered when making treatment decisions. The objective of this article is to review the burden of illness of MS, discuss the cost-effectiveness data for DMTs, and summarize the implications for payers. For the burden of illness in MS, a retrospective analysis of managed care administrative data from the IMS LifeLink Health Plan Claims Database was performed. Data from claims submitted for patients with confirmed MS (ICD-9-CM code 340) over a period of 1 year (2009) were analyzed. A literature review was conducted to put these data into perspective. The retrospective analysis determined that the mean annual cost of treating MS in the United States in 2009 was $23,434, which varied according to the presence of comorbidities/complications. Overall, DMTs accounted for 69% of the total costs of managing the disease. According to the literature review, the typical first-line DMTs (interferon beta [IFNß] formulations and glatiramer acetate [GA]) are generally associated with incremental cost-utility or cost-effectiveness ratios in excess of $100,000 per quality of life year gained. Natalizumab may have cost benefits over other agents in patients with more aggressive disease. According to the available data, studies indicate that DMT cost-effectiveness (specifically cost per quality-adjusted life years) appears to improve with treatment initiation during the early stages of the disease. In relapsing-remitting MS, there is currently little evidence to differentiate between the DMTs that are typically used first-line (IFNs and GA) based on cost-effectiveness or cost-utility studies. Presently, optimal therapy decisions for DMT-naïve patients are likely to be made individually based on patient and provider preference, adherence, and medication risk-benefit profiles. For patients with more advanced disease, natalizumab appears to have greater efficacy and to be more cost-effective than other agents.

Quantifying the role of natalizumab in health and economic outcomes in multiple sclerosis.

Multiple sclerosis (MS) is an autoimmune disease of the central nervous system defined by inflammation, demyelination, and axonal degeneration. MS progresses slowly and usually strikes at a fairly young age, causing both the direct and indirect costs of treating the disease to be very high. The direct costs to treat MS can average up to $30,000 per year; including indirect costs raises this to as high as $47,000. Natalizumab has proven to be able to reduce the signs of MS and has been associated with improvements in health-related quality-of-life measures; these effects have the potential to also reduce some of the economic burden of this debilitating disease. The significant clinical burden of MS can be quantified by cost and societal impact, important information to both payers and employers.

A claims-based view of health care charges and utilization for commercially insured patients with osteoarthritis.

PURPOSE: To evaluate managed care medical and pharmacy claims data from commercially insured patients with osteoarthritis and to examine cost and resource utilization patterns across inpatient care, outpatient care, emergency department, and pharmaceuticals. DESIGN: Retrospective claims-based analysis. METHODOLOGY: Data were obtained from the PharMetrics/IMS Integrated Patient-Centric Database which contains medical and pharmacy claims for over 60 million Americans. Patients were selected by the presence of one or more Episode Treatment Groups (721* and 722*) associated with joint degeneration and then further segmented by ICD-9 codes (715*) to create a homogeneous group of patients with diagnosed osteoarthritis. Patients were then further stratified into groups for evaluation based on demographics and clinical variables and their effect on cost and utilization patterns. Patients were eligible for inclusion if they fulfilled the ETG and ICD-9 code criteria from Jan. 1, 2007 through Dec. 31, 2007 and possessed 12 months of plan eligibility. PRINCIPAL FINDINGS: Over 1.1 million patients were included in the analysis. The average age was 54 years, and over 68% of the patients were between ages 36 and 64. Average annual charges associated with osteoarthritis treatment were $5,938, with about 40% from the inpatient environment, 53% from outpatient care, and only 6.3% from pharmaceuticals. The most commonly utilized pharmacotherapies were narcotic analgesics, NSAIDs, and corticosteroids. There was also significant utilization of prescription proton-pump inhibitors and H2 antagonists. CONCLUSION: These osteoarthritis-specific, population-based measurements are an exercise in developing data that are easily reproducible in a managed care environment. These data offer a starting point and comparator to further investigate and contrast the charges associated with osteoarthritis and the utilization of ancillary pharmacotherapeutic agents.

Applications of disease benchmarks and case presentations.

A large dataset of integrated pharmacy and medical claims, extracted from independent third-party databases, is being combined with disease benchmarking technology to facilitate analysis of inpatient, outpatient, ancillary services, and pharmaceutical utilization and costs. The Disease Benchmarks Program was developed to create opportunities for health care decision makers to evaluate the entire health care continuum in a disease-specific fashion. The Benchmarks program is valuable because of its flexibility and because it depicts what is occurring in clinical practice. It can be customized and also show regional variations in treatment. The possible applications of benchmarking applications are discussed in the case presentations of otitis externa, acute otitis media with tympanostomy tubes, and Sjorgren's syndrome.

Allergic rhinitis, asthma, and rhinosinusitis: diseases of the integrated airway.

OBJECTIVE: To review data supporting the integrated airway hypothesis. Allergic rhinitis, rhinosinusitis, and asthma are common conditions associated with significant morbidity and health care costs. A theory has been developed suggesting that these conditions may be manifestations of an inflammatory process within a continuous airway rather than fully separate diseases. Based on this theory, the presence of upper airway symptoms may negatively influence the natural course of lower airway disease. Controlling upper airway inflammation and symptoms among asthma patients may help improve health and economic outcomes. SUMMARY: Further clarifying and understanding the relationship between diseases of the upper and lower respiratory tracts is important because of the prevalence of allergic rhinitis, rhinosinusitis, and asthma and the resulting burden on patients and the health care system. Recent progress in understanding the biology of airway disease has identified inflammation as playing a critical and integrating role in these diseases; however, other important questions remain, including factors that determine the clinical phenotype in allergic airway disorders and optimal treatment approaches. CONCLUSIONS: Several recent studies have suggested that allergic rhinitis, rhinosinusitis, and asthma may be manifestations of a common underlying pathology, but there are many unanswered questions. More studies are needed to better define all the underlying pathologic mechanisms as well as treatments to optimize outcomes for patients with allergic rhinitis, rhinosinusitis, and asthma.