Step Therapy Protocols Vary By Health Plan, 55% Too Strict

November 08, 2021 - For certain diseases, some payers implement step therapy protocols that are stricter than clinical and regulatory entities have recommended, researchers found in a Health Affairs study.

“Step therapy protocols can improve the quality of care by guiding patients to drugs with better safety, efficacy, and cost-effectiveness profiles,” the study began. 

“There is a risk, however, that if health plans primarily use step therapy protocols as cost-control measures—that is, to drive patients toward cheaper treatments—patients may experience delays in receiving effective treatment and thus encounter avoidable disease progression, prolonged pain, and potentially negative long-term effects.”

To prevent the latter outcome, more than half of the states in the US (29 states) have established step therapy protocols, as of January 1, 2021.

The researchers used Tufts Medical Center’s Specialty Drug Evidence and Coverage (SPEC) Database to assess how many commercial payers employ step therapy and to evaluate step therapy usage for ten diseases across commercial payers. Tufts’ data covers 17 of the 20 largest payers in the US, representing around 60 percent of the commercial market’s covered lives.

“We considered an insurance plan to have imposed a step therapy protocol if it required patients to try one or more alternative treatments and experience treatment failure before receiving a particular drug,” the study explained.

In step therapy, a payer may have a three-step step therapy process. In such a scenario, a patient must use a drug in step one before being able to receive coverage for step two therapies. Step one treatments might be generic medications, step two treatments might encompass preferred brands, and step three treatments might be non-preferred brands.

Nearly four out of ten coverage policies employed step therapy protocols. However not all health plans employed each step of the step therapy process.

The researchers found that plans used an average of 1.5 steps out of the step therapy process.  Two-thirds of health plan step therapy protocols included one step of step therapy. Meanwhile, 3.1 percent—or 90 protocols—included as many as four or more steps. The plan with the most steps had eight steps in its step therapy process.

Over three-quarters of payers’ coverage policies regarding the ten diseases that the researchers studied involved step therapy. The diseases included chronic migraines, rheumatoid arthritis, multiple sclerosis, and hepatitis C. 

Three out of ten policies aligned with clinical guidelines. However, more than half (55.6 percent) required more steps than clinical guidelines for these particular diseases recommended. Crohn’s disease protocols more often aligned with clinical guidelines, compared to diseases such as multiple sclerosis, psoriasis, psoriatic arthritis, or chronic migraines.

However, while some diseases experienced a higher rate of strict step-therapy protocols than others, there was a significant presence of strict protocols among all of the diseases that the researchers studied.

When compared to FDA’s guidelines for these treatments, 17.5 percent of the plans studied aligned with FDA’s expectations while 82.4 percent of plans’ protocols were more strict.

“Onerous step therapy protocols can add to the complexity and burden of health care,” the researchers emphasized.

“There is a risk that if plans use these protocols primarily to reduce costs, they may compromise sound clinical decision making. The frequency with which health plans’ step therapy protocols deviated from recommended treatment guidelines is cause for concern.”

The researchers recommended more consumer protections established via regulation in order to ensure that health plans did not amplify negative outcomes through step therapy.

Some states have already seen the need for this strategy. In July 2020, the Massachusetts State Senate passed a law to reform step therapy in the state, reining in ineffective payer practices.

During the coronavirus pandemic, Centene waived step therapy protocols around coronavirus testing and screening in addition to prior authorizations, certifications, and notifications.

Still, payers must find ways to reduce treatment costs for consumers, even in the face of escalating prescription drug pricing.