Fail First is Failing Neurological Patients

June 11, 2020

By Robert Fekete, MD

In my effort to provide patient-centered care for people with neurological conditions, I encounter a variety of obstacles. One irks me more than any other: step therapy.

This is the process where insurance companies withhold coverage for prescribed medications until patients first try and fail the insurer-preferred drug.  I take issue with step therapy for several reasons.

First, it can cause my patients unnecessary suffering.  Despite my best efforts at personalized, evidence-based care, step therapy can hold FDA-approved medications hostage.  My patients must often try an off-label drug before their insurer approves what I prescribed.  

In my experience, insurers typically require the patient to try a drug for at least six weeks to prove that it doesn’t work for them – unless there’s a severe event.  For me, it’s like being in the car across the intersection when you see someone run a stop sign. This requirement forces physicians to sit and wait – and cringe.  

It happens often for people with tardive dyskinesia.  The movement disorder is commonly known for its involuntary, overt signs, such as grimacing, sticking out of the tongue, jerky movements and vocal outbursts.  The condition can cause inner agitation, called tardive akathisia.  Severe cases can lead to psychosis, depressive episodes and even suicide.  Yet insurers often tell me that patients must use an off-label drug, with a black-box warning no less, before getting the tardive dyskinesia medication approved by the FDA.  

In some cases, patients must try and fail on multiple medications. So for weeks or months, I watch my patients’ symptoms worsen.

Second, in addition to the harm step therapy can cause, it puts prescribers like me in a precarious position.  Step therapy takes away my decision-making power as a physician.  Yet I can be held accountable if a patient is hospitalized or harmed, even though the insurer-preferred medication was not my choice.

Once, an insurer required me to submit a prior authorization request for a medication it required my patient to step through.  It’s as though the insurance company wanted me to look like the one who thought using the medication was a good idea.

Equally frustrating, there seem to be no repercussions for the harm and heartache caused by insurance companies’ step therapy policies.

Finally, insurers claim that step therapy saves money, which helps keep premiums low for patients.  I question this claim.  Too often I’ve seen patients’ symptoms spiral out of control, landing them in the emergency room.  This negates any potential savings.  Besides, I suspect my patients would rather keep their symptoms at bay and their quality of life high than potentially save a couple dollars each month.  

“Step therapy” is just a nice way to say “fail first,” which is what insurers’ policies force upon patients.  And the tradeoffs are just not worth it. 

Robert Fekete, MD, is a neurologist in New York state and a member of the Alliance for Patient Access’ Neurological Disease Working Group.

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