Prozac, Paxil, Zoloft, Celexa and Lexapro, technically known as Selective Serotonin Receptor Inhibitors, are brand drugs currently on the market for depression. But, continued growth in the market for generic antidepressants provides great opportunity for managing costs associated with treatment of depression. Most notably, the brand drug Zoloft will have a generic available in 2006.

Generic Zoloft will have an affect on many employers’ pharmaceutical costs. Effective management of this drug will result in sustainable savings.

Other ways to control the cost associated with depression medications are formulary changes, step therapy programs, drug quantity management and generic co-pay changes. These strategies are effective because they encourage members to use the lower cost generic medications, ensure members are taking the right dose according to FDA regulations, prevent waste and stockpiling and prevent adverse events.

In addition to these cost-control mechanisms, some companies are getting creative in their approach to managing employees with depression.

Aetna has developed a new program to be launched in January to boost payments to primary care physicians that identify patients who suffer from depression. The new program, “Aetna Depression Management,” is the first national program to integrate medical and behavioral health care at the primary-care physician's office and provide incentives for screening and assessment for patients. This program was started, in part, because of employers that reported depression to be a frequent cause of employee absenteeism and low productivity.

Other national health insurers, such as Cigna HealthCare, also are looking at ways to help employers cut costs associated with depression. Cigna recently announced a new depression-management program to be offered as a workplace benefit starting in January as well. The Cigna Well Aware Depression Management program combines Cigna’s behavioral health with pharmacy and medical management programs to identify members with depression and provide them with the appropriate care.

As with most illnesses, early detection of depression is one of the most effective ways to manage prescription costs and promote positive patient outcomes.

Medicare Beneficiaries Sustain Their Confusion about the Program

Studies show that patients have very little knowledge of the Medicare Part D program. As a result, interest in participation is limited, particularly among affluent seniors who are satisfied with their current coverage and see little incentive for moving to a new program that they do not understand.

With Medicare Part D launching soon and Medicare Prescription Drug Improvement and Modernization Act (MMA) set to go into effect January 1, 2006, now is the time to clear up any confusion.

Low-income patients are expected to be most interested in the new program. This group is less likely to have adequate prescription coverage making Medicare Part D an attractive program.

As for seniors, the majority are participating in an employer sponsored prescription plan which is often superior to the Medicare Part D program. Seniors falling in this category will not be enrolling in Medicare Part D.

Patient and physician education will be the primary method to increase awareness of the program and encourage Medicare beneficiaries to enroll in Part D. Medicare Part D is a comprehensive program that offers plenty of benefits. It is crucial that seniors have all the facts to make an educated decision. In addition, it is important for beneficiaries to understand what their out-of-pocket costs will be under the federally subsidized program.

Another reason that education is vital as the program is launched is the incidence of scandals that have been reported. Individuals are falsely representing themselves to be representatives of an insurance company and obtaining pertinent financial information, Social Security number and credit card information from the elderly. Official Medicare representatives say that the better informed the general public is of the program and enrollment process the safer they will be from such schemes.

FDA Updates

New Drugs

New Drug Warnings, Label Updates and Withdrawals

• Cylert (pemoline): The FDA has issued an alert to all health care professionals indicating that the FDA had determined that the benefits of the drug do not outweigh the potential for the overall risk of liver failure. As a result, all manufacturers (both brand and generic) have stopped sales and marketing of the drug. The drug will remain available until all current existing supplies have been exhausted. (www.fda.gov, accessed 10-25-05)
• Strattera: The FDA has directed Lilly to include a boxed warning and additional warning statements that alert health care providers of the increased risk of suicidal thinking in children and adolescents being treated with Strattera. A Medication Guide will be developed advising patients of the risks associated with the drug. (www.fda.gov, accessed 10-31-05)
• Paxil: GSK has voluntarily added recent findings from a retrospective epidemiologic study to the pregnancy subsection of the Paxil package insert. Preliminary results of this study suggested an increased risk of congenital malformations, mostly cardiovascular, associated with the use the Paxil as compared with other antidepressants. However, these results differ from the results of other epidemiological studies making it difficult to conclude whether a causal relationship exists. Data from the Swedish Medical Birth Registry have not produced evidence for an increased risk of major malformations with SSRI medications, including Paxil. (www.fda.gov, accessed 10-31-05)
• Ligand and FDA issued a warning letter to healthcare providers, notifying them of revisions made to the prescribing information for the pain medication Avinza® (morphine sulfate extended-release capsules). The BOXED WARNING, WARNINGS, PRECAUTIONS, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION sections have been revised to include a strengthened warning against the consumption of alcohol when using this drug. In addition, the warning has been expanded to include the use of prescription or non-prescription medications containing alcohol while taking Avinza®.

Pipeline Updates

• Cephalon’s Sparlon (modafinil) was issued an approvable letter; if approved by FDA, launch is expected by early 2006. Treatment for ADHD.
• BMS’s Pargluva (muraglitazar) will require additional clinical trials to further study the potential for serious cardiovascular side effects; additional studies expected to take up to 5 years. Treatment for Rheumatoid Arthritis.