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| |  Prozac Shown to be Cost Efficient, While Producing Fewer Side Effects INDIANAPOLIS, June 25, 1996 -- A study to be published June 26 in the Journal of the American Medical Association challenges the long-standing assumption that newer, more expensive antidepressant medications increase the overall cost of treating clinical depression, an illness that costs the United States $44 billion annually. Researchers at one of the nation's leading health maintenance organizations found that, when the total direct cost of treating depression in the primary-care setting is evaluated, treatment with Eli Lilly and Company's Prozac(R) (fluoxetine hydrochloride) is no more expensive than treatment with two widely prescribed, low-cost generic antidepressants. The findings could change the way physicians manage clinically depressed patients and lead managed-care organizations, hospitals and other health systems to modify their drug formularies. In the first major "real-world" study of its kind in depression, researchers at the Center for Health Studies, Group Health Cooperative in Seattle, Washington, set out to determine if fluoxetine (the generic name for Prozac) or the older generic drugs desipramine or imipramine should be recommended as the initial antidepressant for primary-care patients. Prozac, which is approaching the 10th anniversary of its first market introduction, was the first of a new class of medicines known as selective serotonin reuptake inhibitors (SSRIs) to be introduced in the United States. It was launched in the U.S. in early 1988. Desipramine and imipramine are among a class of antidepressants called the tricyclics, which have been on the market since the 1950s. The report, "Initial Antidepressant Choice in Primary Care: Effectiveness and Cost of Fluoxetine vs. Tricyclic Antidepressants," appears in the June 26 issue of the Journal of the American Medical Association. Seventy percent of patients treated for depression receive care in the primary-care setting. The question of which class of drugs should be regarded as "first-line" therapy for depression has increasingly confronted health care practitioners and administrators as pressures to control treatment costs have intensified in recent years. In their study, a team of researchers led by Gregory Simon, M.D., M.P.H., found that initial therapy with low-cost tricyclics did not save money over a six-month course of treatment. Furthermore, the researchers found that nearly half of the patients initially treated with tricyclics were switched to Prozac due to intolerable side effects. Patients initially treated with Prozac, on the other hand, reported significantly fewer side effects, resulting in fewer medication changes. "The Group Health study addresses a critical health policy question," said co-author John H. Heiligenstein, M.D., a senior research physician at Eli Lilly and Company. "These findings confirm what patients and prescribers have been telling us since Prozac was introduced--that is, that Prozac is a patient- and prescriber-friendly medication that is safe and effective in the treatment of depression. Economic and clinical data from this study should challenge formulary review boards and physicians to critically question the use of older tricyclics in the first-line treatment of this illness." Clinical outcomes for the three drugs examined in the Group Health study proved to be equal, but this finding was not surprising. It has long been recognized that all antidepressants are effective in approximately 70 percent of patients. The clear advantage that Prozac offered to patients and physicians upon its introduction was its favorable safety profile. A major factor in calculating the actual cost of any drug is the cost associated with adjusting doses and switching medications when initial therapy is unsuccessful. The researchers found that nearly half of the patients initially prescribed tricyclics did require changes in medication. Forty-eight percent of those taking desipramine and 43 percent of those taking imipramine were ultimately switched to Prozac at the discretion of their primary-care physicians. More than two-thirds of the patients who were switched to Prozac continued treatment with the drug through the end of the six-month assessment period. "It is important to recognize that drugs alone represent only one component of the total treatment cost for clinical depression," Heiligenstein said. "When you consider total direct health care costs, which include a variety of items, such as overall pharmacy costs, outpatient services and inpatient treatment, Prozac may well provide an administratively relevant savings when compared with the older tricyclic medications." In addition to the higher costs associated with more physician visits and hospitalizations, patients taking tricyclic drugs reported more often that the side effects they encountered interfered with their daily activities. "Since desipramine and imipramine show no cost advantage over Prozac, we can conclude that the choice of initial treatment for depression should be guided strictly by the preferences of patients and their doctors," Heiligenstein said. Numerous commentators have cited the need for a study of this type. As recently as this past April in the British Journal of Psychiatry, Matthew Hotopf, M.D., called attention to the lack of definitive research in this area. Simon and his colleagues conducted their research between 1992 and 1994 at the Group Health Cooperative of Puget Sound, a staff-model health maintenance organization serving approximately 500,000 members. Five hundred thirty-six patients were randomly assigned an initial prescription of desipramine, imipramine or Prozac. Subsequent changes in dosage or medication or specialty referrals were managed by the primary-care physician as is consistent with standard medical practice. Clinical outcomes for participants were measured after one, three and six months of treatment, and costs were assessed using the Group Health Cooperative's computerized data. Clinical depression affects 16 million Americans annually, and the costs associated with depression every year exceed $43.7 billion. It has been estimated, however, that the indirect savings attainable through the appropriate treatment of depression could outweigh the direct treatment costs by about $4 billion annually. Prozac is the world's most widely prescribed branded antidepressant. The medicine has been used by more than 21 million people worldwide (more than 14 million people in the United States). Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering superior health care solutions--by combining pharmaceutical innovation, existing pharmaceutical technology, disease prevention and management, and information technologies--in order to provide customers worldwide with optimal clinical and economic outcomes. Central-nervous-system research is one of five therapeutic areas in which the company is focusing its efforts. Complete prescribing information for Prozac(R) (fluoxetine hydrochloride) is available from Eli Lilly and Company. Prozac(R) (fluoxetine hydrochloride, Dista)
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