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The Case Against Step Therapy

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Step therapy has become a frustrating consequence of the ever-evolving health system’s efforts to control costs.

(Related: Final Medicare Drug Plan Regs May Frustrate Some Patients)

It requires your individual health insurance clients, and your group health plan clients’ employees, to try and fail a health plan’s preferred treatments before gaining access to the medicine their doctor prescribed. New research underscores the consequences of these practices, and the importance of access on patients’ treatment goals.

My co-authors and I, representing Eli Lilly and Company and IBM Watson Health, worked together to conduct a new study to evaluate the impact step therapy has on people with rheumatoid arthritis (RA )and psoriatic arthritis (PsA).

Recently published in PharmacoEconomics, the research included 3,993 people with RA and 1,713 people with PsA.

The group of individuals included into the study represent 25 different insurance plans.

The study found that access restrictions were common: one-third of those studied had access restrictions to at least one biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD ) treatment through step therapy or prior authorization or both.

And of those with restrictions, nearly 70% of people with RA and 79% of people with PsA were enrolled in plans that required step therapy with or without prior authorization. Our study also found that step therapy requirement has an impact on adherence to and effectiveness of medications.

Among individuals with RA whose plans require step therapy to their RA treatment, medication adherence was 18% lower and odds of treatment effectiveness were 17% less compared to people with RA who did not have access restrictions.

The impact of step therapy among people with PsA was even higher: medication adherence was 27% lower, and the likelihood of treatment effectiveness was 25% lower compared to people with PsA in plans without access restrictions.

While using step therapy to contain costs may seem like a valid approach to cost containment, more and more research is showing the negative consequences it can have on patients.

Step therapy assumes a one-size-fits-all approach, which isn’t always the best for patients — especially those with heterogeneous autoimmune diseases.

Delaying access to treatments that could optimize patients’ treatment goals may have an irreversible impact on disease progression and consequently on treatment outcomes and patients’ daily lives.

Study results show that people in plans with step therapy have additional health care resource use throughout the course of an individual’s coverage period.

For example, individuals with RA whose plans required step therapy were three times more likely to be admitted to the hospital due to an infection, and nearly twice as likely to visit the emergency room during the study compared to people with RA in plans without step therapy restrictions.

In addition, those with access restrictions filled prescriptions for glucocorticoids (a class of corticosteroids) and nonsteroidal anti-inflammatory drugs (NSAIDs) more often, which could be an indication of a poorly managed disease. Our aim in supporting this research is to help educate key stakeholders within the healthcare system about the consequences of step therapy— especially providers and health insurance agents who are on the frontlines helping patients navigate prior authorizations and drug access approvals.

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Pen (Image: iStock)

Natalie Boytsov, Ph.D., is a health economist and research advisor at Eli Lilly and Company.