APA is working with other medical and mental health organizations to formulate a response strongly protesting a recently proposed rule from the Centers for Medicare and Medicaid Services (CMS) to eliminate antidepressants—and potentially antipsychotics—after 2015 from the Medicare Part D prescription drug program’s six protected classes of clinical concern.
Since the inception of the Medicare Part D program, APA has strongly supported its formulary’s inclusion of the six protected classes: antiretrovirals, immunosuppressants used for organ rejection, antidepressants, antipsychotics, anticonvulsant agents, and antineoplastics. When a medication is in the protected class, “all or substantially all” of those medications must be offered under Part D.
Removing protected-class status would allow plans to limit the number of covered antidepressants or antipsychotics as determined by CMS formulary review requirements. Part D plans could also impose additional utilization management protocols, such as step therapy on drugs in these classes. Overall, access to medications deemed necessary by the attending physician could be truncated, resulting in new administrative burdens, especially when physicians choose to navigate the coverage appeals process.
But in a proposed rule issued January 6, CMS is seeking to eliminate antidepressants and potentially antipsychotics, stating that the drugs are costly and overutilized. APA is working to develop a broad-based response that includes support from other mental health and medical organizations. Among the key points that will be included in APA’s response are the following:
The removal of antidepressants and antipsychotics can result in unintended consequences, for example, delays in initiation of therapy, hospitalizations, and exacerbation of the mental illness, especially in those with severe and persistent illnesses.
There is a strong clinical rationale for classifying antidepressants and antipsychotics as protected classes, similar to the rationale for the other protected classes. For example, the drugs in the antidepressant and antipsychotic classes are not interchangeable. Evidence from population-based studies shows that risk of suicide attempts and completed suicide is increased for patients with any psychiatric disorder, and risk is increased multifold for patients with disorders for which antidepressants or antipsychotics are commonly used, including mood disorders, schizophrenia, and anxiety disorders. Patients with mental illness are most vulnerable before an effective medication is provided.
The potential savings to Part D plans and to patients of removing the protected status of these drug classes would be dwarfed by the clinical harms and social costs of delayed, limited, or denied access to treatment for vulnerable patients. These harms and costs include increased disease disability, increased hospitalization and use of emergency health care services, and death from suicide.
With respect to patient welfare, CMS cites overutilization as a specific concern for eliminating the protected status of antipsychotics; the high rates of use of antipsychotics, particularly off-label, suggest inappropriate use, such as for treatment of insomnia, and use as a first-line treatment of behavioral symptoms of dementia. However, there are clinical circumstances when off-label use of antipsychotics is appropriate, such as when patients with dementia are at risk of harming themselves or others or when the use of an antipsychotic to manage aggression and agitation can allow patients to receive needed care or avoid transition to a higher level of care, such as from the community to a nursing home or from a nursing home to an inpatient hospital setting.
CMS has cited APA practice guidelines as supporting evidence to eliminate these medications from the protected classes. APA is arguing that CMS is misrepresenting APA practice guidelines by selectively quoting from them and ignoring strong recommendations that evidence for efficacy is only one factor that must be considered when choosing an antidepressant or an antipsychotic.
All APA guidelines that address the use of antidepressants and antipsychotics, including those on major depressive disorder, anxiety disorders, schizophrenia, and obsessive-compulsive disorders, recommend that choice of medication must be made on the basis of how a drug’s unique effects may interact with patient factors including age, gender, ethnicity, pregnancy, co-occurring psychiatric conditions, and comorbid medical conditions. These drug effects include different mechanisms of action, pharmacological properties (drug-drug interactions), side effects, and safety concerns. ■