patient looking at medicine bottle being shown to her by doctor

What Patients Think About Step Therapy

Eli Lilly and Company  | December 5, 2019

Tags |  Policy

This guest article comes from Patrik Jonsson, Senior Vice President and President of Lilly Bio-Medicines. 

Every day in Lilly Bio-Medicines, we know there are people missing out in life – the grandma who is too afraid to hold her grandson due to her arthritis, or the young professional who is too ashamed to go out in public and dance with her friends because of her psoriasis. These are the kinds of stories that motivate us to deliver innovative medicines that change people’s lives. 

However, we know that discovering innovative medicines does not always mean that patients can access them. Every day in the U.S., payers and pharmacy benefits managers (PBMs) play a critical part of the clinical decision-making process by requiring that patients first try and fail one or more treatments with preferred access through a utilization policy called “step therapy.” 

Recent research, supported by Lilly and conducted by Xcenda, found that step therapy has a significant and harmful impact on patients. 

In fact, 35% of patients surveyed reported that step therapy has had a very/extremely negative impact on what they considered the main thing that gives them the most satisfaction in life. Additionally, 52% of patients and 44% of friends and family members reported that the restriction very/extremely negatively affected their emotional health. 

Step therapy practices can also negatively affect the physical health of people, particularly on those living with immunological conditions. The fail-first approach of step therapy means that patients can cycle through multiple medications for a series of months. Often those medications do not effectively treat individual patient conditions or ease the symptoms of the chronic illness because individual biological makeups respond differently to each medicine. 

Patients who are subject to step therapy are more likely to be nonadherent to their treatment and/or pay higher out-of-pocket costs for medication compared to individuals whose treatment did not require step therapy. A Lilly study, published in Pharmacoeconomics in 2019, found that patients with step therapy restrictions were less adherent to their medications, and after 12 months, experienced treatment efficacy that was 19% lower for rheumatoid arthritis patients and 27% lower for psoriatic arthritis patients. 

This finding was supported by the Xcenda research, which showed that 40% of patients who encounter step therapy stopped taking medications that did not work for them. This is not only a painful process for patients, both mentally and physically, but it delays their access to a medication that could have helped more immediately if the preferred prescription was approved. 

Eliminating step therapy practices would result in patients getting the medication they need to effectively treat their chronic, painful medical conditions. Patients deserve access to the best quality of life possible, and we at Lilly are committed to partnering with multiple stakeholders to support this reality.