When evaluating the added therapeutic value of a drug, evidence of greater overall benefit or at least an add-on benefit is increasingly being required. Therefore, cost-effectiveness in addition to clinical efficacy is an important consideration. The efficacy of a drug must be examined on the basis of clinical trials by measuring specific parameters that are affected by the drug (for example blood pressure with antihypertensive treatment). Today not only efficacy but also patient-relevant changes (patient benefits) must be demonstrated for a drug, often by measuring quality of life. In order to evaluate the benefit of monotherapy with the N-methyl-D-aspartate antagonist memantine in the management of moderate to severe Alzheimer's disease, a systematic literature review was conducted. The results showed a benefit for memantine in comparison with placebo in terms of a decrease in nursing care, a delay in care dependency and a delay in admission to nursing homes. In addition, an increase in quality of life has been observed.
Terbinafine is very well tolerated in any topical pharmaceutical formulation and also has high efficacy as a cure for tinea pedis, irrespective of type of pharmaceutical formulation, treatment duration, and frequency of application, including the recently established one-shot regimen. In addition, terbinafine has an apparently unique advantage over other antifungal agents with respect to the required duration of treatment for tinea pedis.
Health-care systems all over the world tend to be under permanent review and policy decision making is increasingly driven only by political decisions concerning resource allocation. Drug utilization is a major concern within policy decision making, of relevance to and sometimes even bridging both the pharmaceutical industry and medical community. Outcomes and effectiveness research emphasizes the accountability of the health-care delivery system and focuses on the medium and long-term results of treatment and preventive interventions. With increasing health-care costs and growing concerns about the quality of care, appropriate health outcome measures are essential for assessing the quality, necessity, and effectiveness of health care. These outcome measures are reviewed addressing the influence of evidenced-based medicine and discussing the underlying methods which are applied throughout Europe and the US for reimbursement purposes and application procedures in drug utilization management.
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