A rule proposed in 2014 that would have likely reduced the number of prescription antidepressant drugs available to Medicare patients would have had little impact on clinical care had the policy gone into effect, a new study from Weill Cornell Medical College suggests.
As a cost-saving measure, the Centers for Medicare and Medicaid Services (CMS) proposed removing special protections for antidepressants, which require insurers to cover nearly all drugs in that class. Comparative effectiveness research found no significant differences on average between antidepressant drugs within the same subclass. The CMS proposal sought support from this evidence and would have allowed Medicare Part D prescription drug plans to cover as few as two of some 30 related antidepressants within each subclass. Patient groups, the pharmaceutical industry, insurers and policymakers opposed the rule — which CMS eventually abandoned — arguing that the changes would harm millions of older and disabled Americans by restricting their drug choices.
Funded by the National Institute of Mental Health and the National Institutes of Health Clinical and Translational Science Awards program, investigators from Weill Cornell and the University of Pittsburgh sought to quantify the effects the proposed policy would have on patient care. The findings, published Jan. 21 in JAMA Psychiatry, found that few patients would have been affected by the policy change had it been implemented.
For the study, the investigators examined patient records of more than 47,000 Medicare beneficiaries who were treated for depression in 2009 and 2010 and found that only 4 percent of them tried more than two antidepressants over the course of treatment.
"More importantly, we found that 76 percent of patients used only one drug throughout treatment," said lead author Dr. Yuhua Bao, an associate professor of healthcare policy and research at Weill Cornell. "This suggests a disconnect between actual clinical practice and compelling scientific evidence of the benefits of at least two antidepressant drug trials for a vast majority of patients."
Implemented in 2006, Medicare Part D give special protections to six drug classes, including the five subclasses of antidepressants. The U.S. Affordable Care Act in 2010 authorized CMS to propose changes to the prescription drug program's "protected status" requirement, based on certain care quality and cost-savings criteria.
Dr. Bao believes the current debate detracts from a probably more important discussion about gaps in depression treatment.
"Comprehensive drug coverage alone is not enough to improve the quality of depression management," Dr. Bao said. "Ultimately, better outcomes are achieved when doctors and patients work together throughout the course of treatment, which may include regular monitoring of a patient's symptoms and response to medication and adjustment of their antidepressant regimens to maximize the benefits of treatment."