Step Therapy
Terri D’Arrigo
Step therapy, also known as “fail first,” is a utilization management technique employed by health insurers that only allows patients access to a particular medication after they have tried other, less expensive medications that did not work. Although step therapy is touted by payers as a cost-saving measure, a 2019 report by Xcenda found that patients who experienced step therapy were more likely to pay out of pocket or not take their medications as prescribed than patients who did not experience step therapy restrictions.
Many step therapy protocols do not align with the principles of evidence-based care. A 2021 study in Health Affairs looked at step therapy protocols for 10 different diseases among 17 health plans and found that only 34% of the protocols were consistent with corresponding clinical guidelines. Furthermore, 55.6% were more stringent than corresponding clinical guidelines and 4.2% required patients to try alternatives not included in clinical guidelines.
“Step therapy interrupts patient care by being a barrier to the medications the patient’s care team has decided are best for the patient,” said Garth Reynolds, BSPharm, RPh, MBA, executive director of the Illinois Pharmacists Association. “It’s a nontherapeutic disruption where they tell patients ‘No, we want you to use this other medication because of cost.’ It’s not in the best interest of the patient. It’s in the best interest of the insurance company. That’s the wrong mindset.”
States step up
Although 37 states currently have patient protection laws that limit insurers’ use of step therapy or provide guidance on ways prescribers can request exceptions to step therapy requirements, enforcement is inconsistent from state to state. Thirteen states and the District of Columbia do not have patient protection laws regarding step therapy at all.
However, some states have passed laws designed to increase patient protection and close loopholes exploited by payers. For example, in Kentucky, a 2022 law requires that step therapy protocols be based on widely accepted guidelines.
“The protocols can’t be arbitrary or based on cost alone. They have to be in line with medical guidelines that are expected to change as treatments, the pharmaceutical market, and research change,” said Taylor Williams, PharmD, MPA, director of government affairs at the Kentucky Pharmacists Association. The law builds upon a 2012 law that requires a clear and convenient process for requesting overrides and mandates, Williams explained.
Legislation recently signed into law in Illinois will do away with step therapy protocols entirely. The law goes into effect on January 1, 2025, although it will not be applicable for another year after that for certain contract provisions.
“This is going to be important for patients, prescribers, and pharmacists in making sure there’s enforcement,” Reynolds said. “Enforcement was not as strong as we wanted for other [previous utilization management] laws, but people may not have complained about violations to the Department of Insurance. It’s up to the entire health care team to make sure we’re filing the necessary complaints.”
Pharmacists as educators
Pharmacists often have an up-close view of step therapy restrictions: The Xcenda report found that most pharmacists spend at least 20% of their time managing medications that were denied because of step therapy, with some pharmacists reporting that this task takes up as much as 80% of their time.
Williams said that the community pharmacist is usually the first person to know when a patient’s prescription is restricted by step therapy, namely when a plan denies payment.
“Plans vary and prescribers don’t always know what their patients’ plans say, so it’s often up to the pharmacist to bear the news to the patient and explain what step therapy means,” Williams said.
She added that pharmacists can document the discussions they have with patients and prescribers and use their knowledge as medication experts in support of the patient. For example, the pharmacist may discover a potential interaction between a patient’s current medications and a medication that step therapy requires that a patient try first for a newly diagnosed condition.
“The complexities of individualized care—coexisting conditions, allergies, drug interactions, costs, access, even the number of pills you put on someone per day—these all have to be considered by both prescribers and pharmacists,” Williams said. “Step therapy guidelines and protocols don’t always fit those elements.” ■