Pharmacoeconomic review of medical management of persistent asthma.

Asthma affects 20 million Americans and causes a substantial loss of productivity. Medications help to increase symptom-free days and improve quality of life. Examining the cost-effectiveness of different treatments, in addition to their clinical efficacy, allows us to choose the optimal strategy in managing patients. This study reviews published pharmacoeconomic analyses of different medications used for asthma management, with a focus on medications available in the United States. English language, peer-reviewed articles, or abstracts were identified from MEDLINE and Current Contents databases (both 1966 to March 1, 2006) using the search terms asthma, pharmacoeconomics, cost-effectiveness, steroids, beta(2)-agonists, cromolyn, methylxanthines, leukotriene receptor antagonists, and omalizumab. Citations from available articles were reviewed also for additional references. Pharmacoeconomic analysis from a payer's perspective has shown that salmeterol/fluticasone is a cost-effective treatment option for moderate persistent asthma management, when compared with fluticasone with or without the addition of leukotriene modifiers. Leukotriene modifiers are less cost-effective than inhaled corticosteroids or combined inhaled steroids and long-acting beta(2)-agonists for mild or moderate persistent asthma. Anti-IgE antibody has been shown inconsistently, to be cost-effective in patients with moderate to severe allergic asthma. Although the acquisition cost of levalbuterol is higher, one study showed that it may be more cost-effective than albuterol after taking into account reduction in hospitalizations. Cost-effectiveness analyses and clinical efficacy of medications, together with other patient-specific factors, are important information to be considered when selecting treatment regimens for asthma. Future economic analysis should focus on finding better ways to evaluate productivity lost due to asthma, in addition to hospitalization.

Cost-effectiveness analysis: should it be required for drug registration and beyond?

Cost-effectiveness analysis (CEA) is applied in situations where trade-offs exist, typically, greater benefit for an increased cost over an alternative therapy or strategic option versus usual care. CEA is useful where a new strategy is more costly but expected to be more effective or where a new strategy is less costly but less effective. A good example for the relevance of CEA is the unanimous recommendation of a US federal vaccine advisory panel to vaccinate 11-year-old girls against cervical cancer. This recommendation was at least partly because of data showing the relative cost-effectiveness of HPV vaccine. In this era of finite budgets, CEA may facilitate drug development, drug approval, patient segmentation and pricing model development throughout the drug lifecycle continuum.

Assessment of outcomes and parental effect on Quality-of-Life endpoints in the management of atopic dermatitis.

The objective of this study was to assess the consequences of atopic dermatitis/ eczema on two areas: (1) the quality of life of parents/caregivers and (2) resource utilization from two large group practices. Data from 414 patients with atopic dermatitis, aged two to 12 years, were collected between January 2001 and December 2003. Parents/caregivers completed the Parent's Index of Quality of Life-Atopic Dermatitis (PIQoL-AD). One-way analysis of variance and analysis of covariance models determined statistical significance. Pairwise significance testing was performed to determine statistical differences (P < .05). Mean patient age was 6.7 years and 55% of patients were males; mild and moderate atopic dermatitis was present in 82% and 13% of patients, respectively. Mean PIQoL-AD scores worsened (5.9 +/- 5.4 vs. 3.0 +/- 3.6, P < .001) for caregivers whose child had disease flares versus those without disease flares. Patients with atopic dermatitis incurred an additional 1.8 unscheduled visits annually at a cost of $93.54 per patient. It was determined that atopic dermatitis may have considerable quality-of-life and financial consequences to both family and community.

The cost-effectiveness of argatroban treatment in heparin-induced thrombocytopenia: the effect of early versus delayed treatment.

A decision-tree analysis was used to estimate the average cost per patient using the direct thrombin inhibitor argatroban for early treatment (<48 hours after thrombocytopenia onset) compared with delayed treatment (> or =48 hours after thrombocytopenia onset) of immune-mediated heparin-induced thrombocytopenia (HIT) with or without thrombosis. Clinical probability data used to populate the model were obtained from argatroban clinical trials and from published clinical literature. Resource utilization data and cost data were also obtained from available literature, the 2003 Physician's Fee Reference, the Healthcare Cost and Utilization Project 2000, the 2003 Drug Topics RedBook, and a modified Delphi panel. The total per-patient cost included hospital days, diagnostic tests, heparin, argatroban, major hemorrhagic events, and patient outcomes (ie, amputation, new thrombosis, stroke, or death), multiplied by the probability of each event. The incremental cost-effectiveness ratio was calculated by dividing the incremental cost between patients with and without argatroban treatment by the incremental effectiveness, or the cost per new thrombosis event avoided. The mean cost per HIT patient without thrombosis who did not receive argatroban was $38,046. The mean cost decreased by 6.85% for patients who were treated earlier with argatroban therapy (average cost, $35,441), representing a $2605 saving per patient compared with those not treated with argatroban. For those receiving delayed argatroban therapy, the mean cost increased by $9024 per patient compared with those receiving early treatment with argatroban. The mean cost for HIT patients with thrombosis who did not receive argatroban was $48,101, which was 9.0% higher than for those receiving early argatroban therapy, representing a $3957 savings per patient. For HIT with thrombosis, mean costs increased by 18.2% in patients whose argatroban was delayed, representing a cost increase of $8020 per patient compared with early treatment (mean cost $44,144 for early treatment and $52,164 for delayed treatment). The results of this analysis support the recommendation to initiate early argatroban treatment upon suspicion of HIT to reduce the thrombotic consequences of HIT and associated healthcare costs. Argatroban therapy should not be delayed pending the results of HIT diagnostic tests.

Clinical implications of chemotherapy-induced diarrhea in patients with cancer.

Diarrhea is a common, often dose-limiting toxicity associated with cancer chemotherapy treatment. However, the problem is not well recognized and frequently is not managed appropriately. The primary objectives of the current study were to describe the sociodemographic and clinical characteristics of cancer patients with chemotherapy-induced diarrhea (CID) and describe the clinical consequences of CID on treatment changes. This was a retrospective review of medical records from 378 cancer patients who experienced diarrhea while receiving chemotherapy at 25 geographically dispersed US cancer clinics. Severe diarrhea (National Cancer Institute-Common Toxicity Criteria grades 3 or 4) was experienced by about one third of patients during their chemotherapy. Patients who experienced CID underwent changes in their chemotherapy treatment, including dose reductions (45%), delays in therapy (71%), reduction in dose intensity (64%), and discontinuation of therapy (3%). Dose reductions were statistically significant. Although the majority of diarrhea was grade 1, almost one half of all patients required dosing reductions, and more than one half of these patients experienced dosing delays. Changes to chemotherapy treatment resulting from CID may ultimately impact patient clinical outcomes.

The effect of atopic dermatitis on total burden of illness and quality of life on adults and children in a large managed care organization.

OBJECTIVE: To assess the impact of atopic dermatitis (AD) on total burden of illness and quality of life in a managed care population. METHODS: This study included retrospective evaluation of electronic claims, patient surveys of financial burden and quality of life (QOL), and medical chart review. A total of 962 AD patients had 12 months of claims data available. Of these, the Dermatology Life Quality Index (DLQI), SF-36, and Children's Dermatology Life Quality Index (CDLQI) were mailed to 400 participants (42%) who consented to take part in the prospective evaluation, 298 of whom returned evaluable questionnaires (75% response rate to survey and 31% of eligible patients). Survey responders comprised the cohort used for determination of economic and humanistic burden of illness. Additionally, socioeconomic demographics, out-of-pocket expenses, and clinical history (including disease severity) were collected via survey. Provider assessments of disease severity were collected via chart review. RESULTS: The patient mean age was 17.22+/-0.94 years, which was not unexpected considering AD is the eighth most common disease in people younger than 25 years. Mean 167 dollars per person, or only 27.4% of the total burden. A vast majority of the direct medical expenditures occurred in the outpatient setting and were composed primarily of clinic visits and medications. Approximately 50% of the total burden of illness associated with AD resulted from days lost from work. The remainder of the burden was out-of-pocket costs to the patients and their families. More than 75% of the out-of-pocket costs resulted from household items and medications. The mean DLQI score for the 107 adults was 6.6+/-5.4, and the mean CDLQI score among the 132 children aged 4 to 16 years was 5.8+/-5.9, compared with adults without skin disease (0.5+/-1.1) and children without skin disease (0.38+/-0.71) in the validation populations. Patient-assessed severity demonstrated a stronger correlation with CDLQI and DLQI than did provider-assessed severity. CONCLUSION: Atopic dermatitis, while not a life-threatening illness, imposes a financial burden on the health care system, but even more so on the individual. Indirect costs, such as the purchase of special household items and days lost from work, comprise a great proportion of this burden and should not be overlooked when evaluating this disease.