The Migration of Atypical Antipsychotics Into the WCMSA Arena

Medicare Set-Aside Blog on July 22, 2011
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The drug class of atypical antipsychotics includes Seroquel® (quetiapine), Seroquel XR® (quetiapine extended-release), Zyprexa® (olanzapine), Geodon® (ziprasidone), Risperdal® (risperidone), Abilify® (aripiprazole) and Clozaril® (clozapine). For the most part, these drugs were originally marketed for the treatment of schizophrenia.  As compared to older antipsychotics, these drugs were praised for offering equivalent or superior effectiveness without a lot of the untoward side effects of traditional antipsychotics. Since their inception, they have also shown utility in the area of mood stabilization and bipolar disorder. More recently, they have begun to emerge as viable treatment options for depression.  In 2007, Abilify® secured FDA approval for the adjunctive treatment of major depressive disorder. In 2009, the manufacturer of Seroquel XR® followed suit by obtaining FDA approval for the adjunctive treatment of major depressive disorder with antidepressants. Since then, both Zyprexa® and Risperdal® have captured medical acceptance for the treatment of depression in an off-label capacity. Zyprexa® has obtained a favorable evidence rating from Micromedex®, a repository of medical information published by Thomson Reuters, as adjunctive therapy for treatment-resistant depression.  Similarly, Micromedex® has assigned a favorable evidence rating to Risperdal® for the adjunctive treatment of refractory depression. CMS has previously clarified that medically accepted, off-label indications for prescription drugs are Medicare-covered and properly included within a WCMSA. This trend has significant implications for WCMSAs, as workers’ compensation claimants frequently experience depression as a result of chronic pain syndrome and/or a debilitating injury. Combination pharmacologic therapy for depression is gaining momentum among clinicians, and often times an atypical antipsychotic is added to a regimen that already includes a more traditional agent such as a SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin-norepinephrine reuptake inhibitor). Perhaps more significant than the potential inclusion of these drugs within a WCMSA is the resulting cost. By way of example, the current AWP for a Zyprexa® 20mg tablet is just over $40.00 per tablet. Due to the obvious trend in favor of the utilization of these drugs for the treatment of depression, previous guidance from CMS regarding the proper inclusion of medications within a WCMSA and the cost of these agents, this is most certainly an area to watch in the coming months and years.