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Biomedical subjects

Robert J Lipsy

Publications and source records attributed to Robert J Lipsy.

7 recordsLinked to original sources

Anticipating the future: how the emergence of innovative biologic agents impacts benefit design, utilization, and provider relations.

OBJECTIVE: To review the impact of biologic therapies on commercial and government payers. SUMMARY: Biologic agents, a mainstay in the treatment of cancer and immunopathologic conditions, are being used for an expanding number of indications, and new agents are being developed for use in many other diseases. These biologic agents have the potential to improve patient quality of life and the overall quality of care with minimal risk of adverse events. Many of these agents require administration via nontraditional methods and are priced at a premium, compared with existing therapies. Consequently, both commercial and government payers must devise strategies that simultaneously ensure access to these agents while minimizing their overall cost impact. Several tools are available to payers to achieve these goals, including aggressive formulary management, drug-use evaluation, and the use of specialty pharmacy services. CONCLUSION: With appropriate planning and oversight, the value of biologic therapy can be optimized in the managed care setting.

Biological Therapy↗

Advances in migraine management: implications for managed care organizations.

Migraine headache is a disabling disease that poses a significant societal burden. Stratified care and early intervention are current strategies for migraine management. It has been shown that early treatment with triptans in select patients can improve treatment outcomes. Triptans are selective 5-HT receptor agonists that are specific and effective treatments in the management of migraine, and they meet the acute treatment goal of rapid relief with minimal side effects. Triptans are associated with improved quality of life. Factors such as speed of onset, need for a second triptan dose, and patient satisfaction should be considered in the selection of a specific triptan treatment. Appropriate treatment can decrease costs. The patient's migraine history and response to prior therapy should be considered when selecting acute treatment. Cost-effectiveness models can be used to understand the effect of treatment choices on health care budgets. The direct cost per migraine episode, driven primarily by the need for rescue medications, is important to include in economic models. All aspects of effectiveness (efficacy, tolerability, and cost) should be considered to reduce overall managed care expenditures for migraine treatment. The improved clinical profiles of the triptans provide substantial value to managed care organizations.

Cost-Benefit Analysis↗

Injectable biologic case studies.

OBJECTIVE: To identify strategies used by a commercial managed care organization (MCO) to affect appropriate cost-effective use and prioritize payment for biologic agents. SUMMARY: With the rapid increase in the number of biologic agents and the lack of head-to-head comparative trials, determining clinical superiority of one agent may be challenging. Four case studies are presented that highlight strategies used by a commercial MCO to manage the costs and utilization of these agents and identify a preferred biologic therapy to recommend for its internally developed prior-authorization (PA) criteria for rheumatoid arthritis, asthma, psoriasis, and multiple sclerosis. The first case illustrates how the route of drug administration, differences in distribution channels, and the need for cotherapy can impact the overall cost of therapy. The second case demonstrates the need for tight control of drug utilization when a biologic agent offers only marginal incremental clinical benefit over existing options but at a substantial increase in cost. The third case provides an example of the relationship between increased efficacy and the cost of therapy, and the fourth case demonstrates that PA criteria can be flexible with respect to drug coverage when clear therapeutic differences have not been demonstrated among drugs. CONCLUSION: As more biologic agents become available, it is critical that pharmacy decision makers critically evaluate these innovative new therapies by using the best available evidence to determine the products that provide the greatest clinical and economic value.

Asthma↗

Effective management of patients with dyslipidemia.

Coronary heart disease (CHD) is the leading cause of morbidity and mortality in the United States. A direct relationship has been demonstrated between dyslipidemia and the risk for developing CHD. Improving lipid status has been clearly demonstrated to reduce the morbidity and mortality associated with lipid disorders. The recently published National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines and revised Health Plan Employer Data and Information Set (HEDIS) performance measures have placed added emphasis on screening and treatment of lipid disorders and global risk for CHD. Current ATP III and HEDIS cholesterol screening and goal measures are targeting more Americans for cholesterol-lowering therapy. This review summarizes the implications of the HEDIS performance measures and the ATP III guidelines, reviews the economic benefits of lowering cholesterol, and identifies optimal cholesterol levels. In addition, the challenges associated with patients who have suboptimal control and patients with poor compliance are discussed, as these factors significantly increase CHD morbidity, mortality, and cost of disease. In addition, lipid-lowering drug therapies are reviewed, and a lipid-lowering agent currently in phase 3 development, rosuvastatin, is introduced.

Adult↗

Etanercept and its implications for managed care.

Etanercept, a new drug for psoriatic arthritis (PsA), offers a safe and effective, but somewhat costly treatment for a condition for which therapeutic options have been scarce. Its debut poses a challenge to managed care organizations in terms of its potentially adverse impact on the pharmacy budget. Managed care organizations must take the initiative in developing appropriate criteria for authorizing the use of etanercept and in overseeing the management and reimbursement of various treatments for PsA. Care is warranted in evaluating the options to take into account the clinical, human, and financial ramifications of their use.

Adult↗

The National Cholesterol Education Program Adult Treatment Panel III guidelines.

Coronary heart disease (CHD) persists as a major cause of morbidity and mortality in the United States, with more than 40% of all deaths each year directly attributed to the disease. Dyslipidemia is recognized as a major risk factor for the development and progression of CHD, with clinical trials clearly demonstrating the public health and economic benefits of favorable cholesterol modification. As a result of this evidence, the National Cholesterol Education Program (NCEP) has developed guidelines for the detection, evaluation, and treatment of high blood cholesterol in adults. The most recent of the NCEP recommendations, the Adult Treatment Panel III (ATP III) guidelines, were released in May 2001 and build on the earlier editions and reiterate the importance of low-density lipoprotein cholesterol (LDL-C) reduction to modify CHD risk. New features of the guidelines include the identification of CHD risk equivalents; lower treatment target goals; an emphasis on conditions conferring a higher risk for CHD, such as the metabolic syndrome; and a scoring system for calculating CHD risk. The ATP III emphasis on risk assessment will result in a substantial increase in the number of patients considered at risk for CHD and will expand the number eligible for lifestyle and drug intervention.

Adult↗

Overview of pharmacologic therapy for the treatment of dyslipidemia.

Although the National Cholesterol Education Program Adult Treatment Panel III (ATP III) guidelines stress the importance of nonpharmacologic lipid modification interventions such as diet and exercise, the guidelines also recognize that many patients will require drug therapy to achieve low-density lipoprotein cholesterol (LDL-C) target goals. Currently available lipid-modifying drugs include bile acid sequestrants (or resins), fibrates, nicotinic acid, and statins, with each class exerting different effects on the lipid profile. In addition, nonprescription agents such as plant stanols and sterols have been shown to be effective in modifying plasma lipids. Of these agents, the statins are the most effective, most widely prescribed, and best-tolerated form of lipid-lowering drug therapy. New formulations of other drugs, such as niacin and bile acid sequestrants, can also improve treatment regimes and reduce side effects, thereby improving patient compliance with these therapies. In patients who have high levels of LDL-C and triglycerides together with low concentrations of high-density lipoprotein cholesterol (HDL-C), combination therapy may be required. Ezetimibe, a selective cholesterol absorption inhibitor, is the first of a new class of lipid-lowering agents and provides a new agent for the management of patients with dyslipidemia. Data from the ezetimibe clinical development program suggests that this agent can be used alone or in combination with statins to reduce LDL-C, improve compliance, and bring more patients to ATP III target goal.

Allylamine↗