Joseph R. Calabrese, M.D.
Director, Mood Disorders Program, University Hospitals Case Medical Center
Bipolar Disorder Research Chair & Professor of Psychiatry, CWRU School of Medicine
Dir., Bipolar Disorders Research Center
This week we are pleased to post the expert opinion of Joseph Calabrese, M.D. on the serious consequences of the proposed regulation to limit access to antidepressant, immunosuppressant and antipsychotic medications for recipients of Medicare Part D. Read the post and take action by participating in the conversation. This enables all of us to share these collective stories with our elected officials through e-mails, letters and in-person visits.
Why I’m Speaking Out Against the Proposed Medicare Part D Change —
And Why You Should, Too
Last month the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would initiate major changes to prescription drug plans under Medicare Part D. These changes would severely limit access to medications that are commonly used to treat serious mental illness and create serious challenges for people who have these mental health disorders.
Protected Class Status
Currently under Medicare Part D, there are six drug categories—immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretroviral and antineoplastics — considered “protected,” meaning that Part D plans must provide beneficiaries access to “all or substantially all” of the available products in those categories. Of the six classes of medications, three are commonly used to treat psychiatric illness antidepressants (depression), antipsychotics (bipolar disorder and schizophrenia), and anticonvulsants (bipolar disorder). This protects enrollees from fail-first experiences and ensures patients have access to the medication their doctors consider most clinically appropriate. Often there are none or only very few medications available to treat a particular illness, such as the depressed phase of bipolar disorder.
The proposed rule would remove many of the antidepressants used to treat serious mental illness, as well as some of the immunosupressants from protected-class status in 2015, with antipsychotics removed in 2016. If a drug is not in a protected category, a plan need only offer two product selections, severely restricting both physicians’ prescribing ability and patients’ treatment options.
When it comes to the treatment of mental illness, the clinical management of real world patients often involves “trial and error.” For the treatment of the depressed phase of bipolar disorder, there are only two approved medications within the US. Not allowing patients to be treated with FDA-approved treatments for their illness, and requiring that they first fail a less expensive generic medication simply because of cost is cruel.
This proposed change is both surprising, given the progress the nation has recently made in federal mental health parity laws and coverage; and alarming, considering the devastating consequences the change could have on patients. I recently lent my support to a DBSA statement protesting the change. I want to explain why this issue is so important to me and why any concerned mental health advocate, patient or provider should feel a similar call to action.
1. One size does not fit all
Treating serious mental illness is not like treating pneumonia, where an oral antibiotic medicine is started and (in almost all instances) the illness goes away and the medication is stopped several weeks later. In contrast, the treatment of serious mental illness is almost always “trial and error,” and in many instances requires long-term treatment. In fact, the available published evidence suggests that only 25 percent to 33 percent of people who have a mental disorder experience a complete clinical response to the first two to three medications, even when prescribed in the presence of ongoing psychotherapy.
2. Age is a factor
The age of a patient is particularly important when prescribing psychiatric medications to treat serious mental illnesses such as depression, bipolar disorder and schizophrenia. Older patients tend to be considerably more difficult to treat and tend to have more side effects. Older adults can experience troublesome side effects to psychiatric medications because of their age and because these medications have not been adequately studied in older adults. Restricting seniors’ access to the full category of drugs could lead to significant decreases in quality of life and an increase in side effects .
3. The burden of co-payments
In the practice of psychiatry, co-pays or out-of-pocket costs for medications are a serious concern. It is particularly problematic in psychiatry because many mental disorders have few FDA-approved treatment options. As a result, many medications are used “off-label.” This means that they weren’t approved by the FDA for this particular use, but have been shown by investigators, such as myself, to nevertheless work in the treatment of the mental disorders. We call this “drug development by serendipity.” Lithium, the treatment of choice for bipolar disorder, for example, was discovered by accident.
Limiting the number of approved medications for the treatment of mental disorders places an unfair burden on consumers who have these disorders, as well as society. Restrictions are likely to result in higher morbidity, mortality and cost to the U.S. economy. The economic toll is manifested in diminished work productivity. The human toll results in a substantial shortening of life span through suicide, which now exceeds homicides within the US.
4. Restricting access to care
The proposed regulation poses a significant impact to the physician / patient relationship. Physicians will be required to obtain pre-authorization for medication through a strict approval process. The processes are intended to manage cost by limiting medication use. In effect they become barriers to care by discouraging physicians to follow the correct course of treatment for their patient.
5. Inappropriate use of formularies
Highly restrictive formularies in the practice of psychiatry are only appropriate when the approved available treatments are numerous and safely tolerated. Unfortunately, this is not the case, and particularly so for bipolar disorder, schizophrenia, severe major depressive disorders, and the alcohol and drug use disorders.
Finally, perhaps most important, the widespread and potentially devastating impact this change would have cannot be underscored enough. About 35 percent to 40 percent of people in the United States will experience a mental illness during their lifetime. I have been practicing psychiatry for 30 years and I can predict with a very high certainty that imposing additional limitations and challenges upon this population will result in a dramatic increase in suicide attempts, and deaths due to suicide.
I am opposing this proposed rule change. I urge my fellow physicians and psychiatrists and people affected by mental illness to speak up, share their stories and fight this significant step backwards in mental health care.
Begin the discussion with your elected officials. Educate yourself on the facts. Engage in the dialogue with family and friends. By working together, the voices of physicians, patients and family members can be heard. Tell Washington not to adopt this misguided proposed CMS regulation.
- As a clinician, share your clinical experience in treating patients through medication. What effect will this proposed regulation have on your ability to provide effective treatment?
- As a patient, what has been your experience with medication? How many medications did you need to try before you were able to lead a thriving life of recovery?