Cost-minimization analysis of the direct costs of TPE and IVIg in the treatment of Guillain-Barré syndrome.

BACKGROUND: Controlled trials have found therapeutic plasma exchange (TPE) and intravenous immunoglobulin (IVIg) infusion therapy to be equally efficacious in treating Guillain-Barré syndrome (GBS). Due to increases in the price of IVIg compared to human serum albumin (HSA), used as a replacement fluid in TPE, we examined direct hospital-level expenditures for TPE and IVIg for meaningful cost-differences between these treatments. METHODS: Using financial data from our two institutions, hospital cost profiles for IVIg and 5% albumin were established. Reimbursement amounts were obtained from publicly available Medicare data resources to determine payment rates for TPE, non-tunneled central catheter line placement, and drug infusion therapy. A model was developed which allows hospitals to input cost and reimbursement amounts for both IVIg and TPE with HSA that results in real-time valuations of these interventions. RESULTS: The direct cost of five IVIg infusion sessions totaling 2.0 grams per kilogram (g/kg) body weight was $10,329.85 compared to a series of five TPE procedures, which had direct costs of $4,638.16. CONCLUSIONS: In GBS patients, direct costs of IVIg therapy are more than twice that of TPE. Given equivalent efficacy and similar severity and frequencies of adverse events, TPE appears to be a less expensive first-line therapy option for treatment of patients with GBS.

Differences in annual medication costs and rates of dosage increase between tumor necrosis factor-antagonist therapies for rheumatoid arthritis in a managed care population.

BACKGROUND: Tumor necrosis factor (TNF) antagonists are commonly used to treat rheumatoid arthritis (RA). Differences in the dosage and mode of administration of these agents may result in differential rates of dosage adjustment and costs of care. OBJECTIVE: This study compared dosing patterns and annual costs associated with the use of the subcutaneous TNF antagonists adalimumab and etanercept, and the intravenous TNF antagonist infliximab. METHODS: A large managed care database (PharMetrics) was used to identify patients with RA who newly initiated TNF-antagonist therapy with adalimumab, etanercept, or infliximab on or after January 1, 2003, and had at least 6 months of continuous health plan enrollment before initiation of therapy and 12 months of continuous enrollment after initiation. The patients were followed over 12 months of enrollment. Annual pharmacy, inpatient, and outpatient costs were estimated based on plan reimbursements and were compared between cohorts. The average daily dosage (ADD) between prescription refills was used to compare the percentages of patients with greater-than-expected dosing (GTED), defined as 2 consecutive increases in ADD relative to the patient's established maintenance dosage. RESULTS: A total of 2382 patients (568 adalimumab, 1181 etanercept, 633 infliximab) were included in the analysis. Significantly more patients had GTED with infliximab compared with adalimumab and etanercept (32.1%, 8.5%, and 4.7%, respectively; both comparisons, P < 0.05). For patients with a dosage increase, the mean time to the first GTED was significantly shorter for infliximab compared with adalimu-mab and etanercept (154.5, 173.3, and 167.9 days; both, P < 0.05). The mean annual costs of anti-TNF therapy, adjusted for baseline differences, were significantly greater for infliximab compared with adalimumab and etanercept ($15,617, $12,200, and $12,146; both, P < 0.05). There were also significant differences between infliximab relative to adalimumab and etanercept in total RA-related medication costs ($16,280, $12,989, and $12,794; P < 0.05) and total pharmacy costs ($17,854, $14,805, and $14,398; P < 0.05). CONCLUSION: Patients initiating TNF-antagonist treatment for RA with infliximab incurred annual medication costs that were nearly 30% greater than costs in those initiating therapy with adalimumab or etanercept, in part because of the significantly greater rate of GTED in infliximab recipients.

Economic burden of transformed migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study.

OBJECTIVE: To evaluate the impact of incident transformed migraine on health care resource utilization, medication use, and productivity loss. In addition, the study estimates the total direct and indirect costs associated with transformed migraine. BACKGROUND: Emerging evidence indicates that migraine may be a chronic progressive disorder characterized by escalating frequency of headache attacks, often termed transformed migraine. Little is known about the economic impact of transformed migraine. METHODS: AMPP is a 5-year, national, longitudinal survey study of headache in the US. The study utilized data from the 2006 follow-up survey based on an initial sample of 14,544 adults identified as having migraine in either the 2004 screening or 2005 baseline survey. A diagnosis of migraine was assigned based on criteria proposed by the International Classification of Headache Disorders, 2nd Edition. Participants completed self-administered, validated questionnaires on headache features, frequency, impairment, resource use, medication use, and productivity loss. Direct and indirect headache-related costs were estimated using unit cost assumptions from the PharMetrics Patient-Centric database, wholesale acquisition costs (Red Book), and wage data from the US Bureau of Labor Statistics. Those who developed transformed migraine were compared with those who did not develop transformed migraine in the 1-2 year interval between screening/baseline and follow-up. RESULTS: A total of 7796 (54%) identified migraine cases completed the 2006 follow-up survey. Of those cases, 359 (4.6%) developed transformed migraine. Participants who developed transformed migraine reported significantly more primary care visits, neurologist or headache specialist visits, pain clinic visits, and emergency room visits compared with participants whose migraine remained episodic. Hospital nights and urgent care visits did not reach statistical significance. Transformed migraine participants reported significantly more time missed at work or school because of headaches and more time where work or school productivity was reduced by >50% in the previous 3 months because of headaches. Average per-person annual total costs, including direct and indirect costs, were 4.4-fold greater for those who developed transformed migraine ($7750) compared with those who remained episodic ($1757). CONCLUSION: Transformed migraine exacts a significantly higher economic toll on patients and health care systems compared with other forms of migraine. Our findings support the need to prevent migraine progression and to provide appropriate management and treatment of transformed migraine.

Management of hyperlipidemia in older adults.

Cardiovascular disease is the leading cause of death in men and women older than 65 years; therefore, its prevention is an important public health priority. Although cardiovascular risk is multifactorial, elevated low-density lipoprotein cholesterol levels contribute to risk even in old age. Despite the importance of lowering low-density lipoprotein cholesterol with statins to reduce cardiovascular events, specific evidence and recommendations for older populations are limited. Where evidence supports lipid lowering in older adults, provider and patient adherence to statins remains suboptimal. Paradoxically, risk is an inverse driver of statin use regardless of age, with those most likely to benefit being least likely to receive them. Reconsidering evidence around, use of statins as well as ways to optimize the prescription of statins and adherence in appropriately selected older adults is warranted.

The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis.

OBJECTIVES: Migraine is often perceived as a low-impact condition that imposes a limited burden to society and the health-care system. This study reviews the current understanding of the burden of migraine in the U.S., the history of economic understanding of migraine treatment and identifies emergent trends for future studies evaluating clinical and economic outcomes of migraine treatment. METHODS: This study traced the history of economic articles published on migraine by performing a literature search using PubMed MEDLINE database and ancestral searches of relevant articles. The intention was not to provide an exhaustive review of every article or adjudicate between studies with different findings. RESULTS: Migraine affects millions of individuals worldwide, generally during the most productive years of a person's life. Studies show that migraineurs are underdiagnosed, undertreated, and experience substantial decreases in functioning and productivity, which in turn translates into diminished quality of life for individuals, and financial burdens to both health-care systems and employers. Economic evaluations of migraine therapies have evolved with new clinical developments beginning with cognitive-behavioral therapy, introduction of triptans, concern over medication overuse, and emergence of migraine prophylaxis. Now recent clinical studies suggest that migraine may be a progressive disease with cardiovascular, cerebrovascular, and long-term neurologic effects. CONCLUSIONS: Migraine imposes a substantial burden on patients, families, employers and societies. The economic standards by which migraine and treatment are evaluated have evolved in response to clinical developments. Emerging evidence suggests that migraine is a chronic and progressive disease. If confirmed, approaches to acute and prophylactic treatments and economic evaluations of migraine treatment may require major reconsideration.

Clinical and economic outcomes of nonadherence to highly active antiretroviral therapy in patients with human immunodeficiency virus.

BACKGROUND: Nonadherence with highly active antiretroviral therapy (HAART) is common in typical human immunodeficiency virus (HIV) patient care settings, but the consequences have not been well described. This study aimed to quantify the clinical and economic effects of nonadherence and estimate the cost-effectiveness of improving adherence in treatment-naive HIV patients. METHODS: A Markov model was developed to project quality-adjusted life expectancy and direct medical costs for patients on an initial once-daily regimen of efavirenz, lamivudine, and stavudine XR. The model compared 2 adherence scenarios: "ideal" (based on clinical trials) and "typical" (based on observational studies in actual practice). Disease progression was a function of viral load, CD4 count, and adherence. Data on HIV natural history, treatment benefits, costs, and utilities were derived from the literature. RESULTS: With typical adherence, patients lose 1.2 quality-adjusted life years (QALYs) that could be gained with ideal adherence. Improving adherence to ideal levels is cost-effective at 29,400 US dollars/QALY gained. As much as 1,600 US dollars/y per patient could be spent on an intervention to improve adherence to ideal levels, and the incremental cost-effectiveness would remain less than 50,000 US dollars/QALY gained. A cost-effectiveness ratio of 50,000 US dollars/QALY is a commonly accepted minimum standard for cost-effective medical interventions in the United States, although many experts believe this standard has drifted upwards over time. CONCLUSIONS: Typical adherence with HAART reduces quality-adjusted life expectancy by 12% compared with ideal adherence. Interventions to improve adherence appear to be a highly cost-effective use of resources.

Clinical and economic burden of psoriasis.

In an effort to assess the burden associated with psoriasis, the MEDLINE database and bibliographies of articles published from 1975 through 2004 were searched, emphasizing patients with moderate-to-severe disease, to summarize the current understanding on various aspects of disease burden. The clinical burden of psoriasis is both well documented and significant. The disease is debilitating: Sufficient disease severity interferes with patients' work and day-to-day living. Perhaps even more damaging is the psychosocial toll psoriasis exacts on the afflicted. Numerous studies document the extent of mental and emotional anguish, features not often revealed through objective measures. Successful treatment must focus on improving a patient's quality of life as well as reducing the clinical features of psoriasis. The economic burden is also significant, though far fewer studies of the associated indirect costs have been published in the literature.