With 'step therapy,' insurers won't cover new, more expensive treatments until older therapies fail

Pressure to control costs and reduce unnecessary utilization of expensive drugs has led insurers to increasing rely on "step therapy," whereby patients are forced to try cheaper therapies before more expensive ones are covered, even when physicians are convinced the lower cost drugs won't be effective, according to STAT.

A variety of factors have contributed to the growing prevalence of step therapy protocols. In addition to rising drug costs, employer-sponsored health plans are becoming more restrictive with coverage. Also, the increasing number of insurers leaving the Affordable Care Act exchanges has created fewer options for patients, with many remaining carriers enforcing step therapy models.

"Step therapy is addressing the problem of making sure patients get the right treatment at the right time, and if there's an affordable alternative, they have access to it first," Clare Krusing, a spokeswoman for trade group America's Health Insurance Plans, told STAT.

While healthcare providers generally agree that trying less expensive treatments before moving to pricier ones is reasonable if both drugs offer equal benefits, "the important nuance comes when there might be specific reasons where a patient or doctor feels like the more expensive drug would work better," said Steven D. Pearson, MD, founder of the Institute for Clinical and Economic Review, according to the report. "So it all depends on what the harm would be if they tried the less expensive one first."

There are several main issues with step therapy, according to Dr. Pearson, including a lack of a clear definition of failure, potential for long-term harm, lack of evidence for developing step therapy guidelines and no quick and easy way for physicians to appeal insurers' decisions.

"Step therapy can have a place in a reasonable plan design," said Alan Balch, PhD, CEO of the National Patient Advocate Foundation. However, such plans should be transparent to patients, and physicians should have greater opportunities to appeal, he added. "There is no humane reason to deny a patient access to a therapy that has the best chance of curing them."

At least five states, including California and Indiana, have recently passed legislation to limit step therapy approaches, and more than a dozen others are working on similar laws.

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