ICER’s Message of Hopelessness

The Institute for Clinical and Economic Review is dashing patients’ hopes yet again.  The latest target: people whose depression doesn’t respond to existing treatment.

A new drug, esketamine, recently became the first new FDA-approved therapy for depression in 30 years.  Acknowledging treatment-resistant depression as “serious and life threatening,” the FDA fast tracked the drug’s approval.  It also gave esketamine breakthrough therapy status.  

The drug is a nasal spray approved for patients who have tried at least two antidepressants without success.  It’s administered in a doctor’s office and used in combination with an antidepressant. In addition to its novel administration, esketamine is fast acting.  The drug can take effect in a matter of hours – a far cry from oral antidepressants alone, which can take several weeks to alleviate depression, if they work at all.  

And while esketamine is chemically similar to a common off-label treatment, ketamine, the new drug is FDA approved specifically for treatment-resistant depression – making health insurers more apt to cover it.

Unless, that is, they take their cues from a new ICER report.

In its cost-effectiveness analysis ICER emphasizes that “there is such need for treatment” for patients with persistent depression.  But that doesn’t stop its economists from deeming the drug too expensive.

As with past reports on treatments for uncontrolled asthma, or cystic fibrosis, or endometriosis, ICER dismisses its lack of data and inability to meaningfully incorporate quality-of-life factors that matter to patients.  And it uses its economic framework to effectively squash the hopes of people with few or no other treatment options.  If ICER says a therapy is not cost effective, health plans may feel justified in limiting coverage for the drug. Never mind the fact that few other FDA-approved therapies for treatment-resistant depression exist.  Or that alleviating depression can have a life-saving and life-altering effect on patients.

So ICER proclaims that esketamine is “overpriced.”  The drug’s manufacturer counters that ICER’s report is “inaccurate” and “reckless.”  But the real losers here are patients – the one in three Americans with depression who don’t respond to traditional treatment.  

Saddled with persistent sadness and inertia, these people struggle with everyday tasks like sleeping, eating and interacting socially.  The burden of trying antidepressant after antidepressant, weathering new side effects with each new medication, can intensify their hopelessness.

Having a therapy, finally, to break the cycle of treatment resistance represents an important step forward for these patients.  ICER shouldn’t stand in the way.