My mom said to never use the word hate but, honestly, I hate step therapy. I dislike prior authorization but step therapy, well I hate it. Both fall under the concept of utilization management which are barriers to access put up by payers (really pharmacy benefit managers (PBMs)) for cost or safety concerns. The idea is to use less expensive (to PBMs) but equally effective (in theory) treatments.

The use of prior authorization and step therapy has skyrocketed over the past decade, particularly in the Medicare prescription drug benefit (Medicare Part D). A study in Health Affairs found that 23.7% of branded drugs (without a generic) were subject to prior authorization or step therapy restrictions in 2020.

I liken prior authorization to a “Mother may I?” Providers need to fill out a form and get permission from PBM before a patient can get the prescription from the pharmacy. The PBM is usually trying to push another drug as preferred or wants to make sure that this drug is appropriate for the beneficiary. It is frustrating for patients and pharmacists and providers as they sort out what medicine the patient ultimately can get paid for by the payer. Because dealing with pharmacy counters is fun when things go well.

Step therapy is even worse. It requires that a patient try and fail a drug preferred by the PBM. Sometimes a drug that they have tried and failed in the past with devastating consequences. And sometimes even if they are stabilized on a treatment that works for them. These patients must go back and again try the drug they know that won’t work to get back on the drug that does work for them. If you’re scratching your head at the inefficiency of this process, you’re not alone.

A few years ago, I had the privilege of speaking on a panel with a patient who had gone through this journey and to call it a hero’s journey is an understatement. She was stable and thriving on a medicine, but, with a new plan year came new coverage, and her medicine was not covered. Her insurance required step therapy and moved her off the drug she was stabilized on to try a drug that previous did not work for her. Her condition deteriorated so badly and her story so awful that she had Hill staff openly weeping while she told it.

Patients who are stabilized on a drug that works for them shouldn’t have to switch and especially if they have already tried the alternate drug and it didn’t work for them.

You’d think this would be against the law. It isn’t in most places. I spent a lot of May reading state legislation on prior authorization and step therapy for a project I was working on and saw huge variation between states. In my analysis, 35 states have legislation requiring approval of  step therapy if the patient has already tried the drug. Two more states have caveats on that (12 months prior, 6 months prior). But the strength of the patient protection varies from state to state with some states having wiggle room on the timing and if they don’t respond, what happens. Also this only applies to plans regulated by the state.

And yet, it is something. And, in some cases, better than that. Last month, Illinois passed legislation that banned step therapy. A moment of victory for patients. Now, with utilization management expected to dramatically increase with Part D redesign and negotiation, I’m hoping that Medicare will take another look at this. Or, dare I say, Congress?