What’s Wrong with Step Therapy Reform: Safe Step Act

RE Sachs, MA Kyle. NEJM 2022; 386: 901-904. Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices

Step therapy is a utilization-management strategy whereby insurers implement tiered treatment pathways for various conditions. Patients (and their physicians) who seek approval for restricted therapies must document unsuccessful attempts at treatment with less expensive therapies in earlier ‘steps.’ Most employer-sponsored insurance plans incorporate requirements for step therapy into their drug formularies.”

The fundamental flaw with step therapy: “Payers have turned to step-therapy protocols because we have failed to address high drug prices at a societal level, instead transferring the problem to the point of care and imposing administrative burdens on physicians and patients.”

While step therapy makes sense with high-cost, low-value medications, it is problematic with high-cost, high efficacy medications. To mitigate some of the harmful effects of step therapy, lawmakers have drafted the Safe Step Act.

“The Safe Step Act also lists five specific circumstances under which insurers would be required to grant an exception to step-therapy protocols. It would require exceptions in cases in which the required treatments have previously been ineffective for the patient, delay of effective treatment would lead to “severe or irreversible consequences,” required treatments are contraindicated, required treatments would prevent the patient from performing activities of daily living, or the patient’s condition is stable on the existing medication and the patient has previously received coverage approval for it. The act would also empower the executive branch to identify other circumstances that might require exemptions. Most of these exceptions, however, could create additional administrative burdens for patients and clinicians that might pose challenges for maintaining continuity of care.”

My take (from authors): “the Safe Step Act focuses on legal action at the individual-prescription level, failing to bring down drug prices while increasing administrative costs.”

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