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The Impact of Step Therapy on Patients Taking Biologics


Does step therapy harm patient outcomes?

Drug Vials

Step therapy can negatively affect treatment outcomes and in some cases may even damage a person’s health, according to a new study.

The study published in PharmacoEconomics, conducted by Lilly in partnership with IBM Watson Health, found that among insurance plans with access restrictions, step therapy is common. Further, the study confirms that step therapy negatively impacts treatment effectiveness and medication adherence for people with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

For example, people with PsA whose insurance plans required this fail-first approach had 25% lower odds of treatment effectiveness compared to people with this same disease who did not have access restrictions. This data is especially important as public and private payers continue to adopt the practice of step therapy, even while many healthcare professionals’ associations and patient advocacy organizations speak out against it, including most recently the American College of Rheumatology

Patient population data for this study were drawn from the IBM MarketScan Commercial Claims and Encounters Database, and cross-referenced with pharmacy benefit plan formulary data provided by Managed Markets Insights and Technology, Inc. The study included people who:

  • Had at least one claim for a biologic or traditional synthetic disease-modifying antirheumatic drug (bDMARD or tsDMARD) during the study period, which ran from January 1, 2014, to December 31, 2015;

  • Were at least 18 years old on the date of the first observed prescription for the study drugs during the study period;

  • Had at least 6 months of continuous enrollment in an insurance plan with medical and pharmacy benefits prior to the initiation of their treatment (the baseline period);

  • At least one non-diagnostic medical claim with a diagnosis code for RA or PsA during the baseline period, and

  • Had been continuously enrolled in the same insurance carrier from the initiation of their treatment through the 12-month follow-up period.

Overall, the study included two mutually exclusive cohorts of 3,993 people with RA, some of whom had PsA, and 1,713 people who had PsA only. Twenty-five different insurance plans covered the 5,706 people studied. Patient cohorts were stratified according to their treatment access restrictions, from no access restrictions, through prior authorization (PA) only, to step therapy with or without PA.

“We were primarily interested in treatment effectiveness during the follow-up period, which we assessed using the claims-based algorithm that was defined and validated by Curtis et al,” says lead study author Natalie Boytsov, PhD, health economist and research advisor at Eli Lilly and Company. “According to this algorithm, if a patient’s dose is increased, their treatment is changed, or their treatment is supplemented with the addition of a steroid, their treatment is considered ‘ineffective.’”

Related: Drug Price Reform Takes Off In 2019

The researchers also assessed medication adherence as a secondary outcome, and assessed both total healthcare costs and the use of healthcare resources in relation to each of our cohorts. For their assessment of healthcare costs and resources, they considered inpatient admissions, emergency room visits, RA-related office visits, outpatient prescription costs, medical costs, and total healthcare costs (medical plus outpatient prescription costs).

Overall, one third of the people with RA or PsA had plans that restricted their access to at least one bDMARD or tsDMARD. Among those, 71% of people with RA and 79% of people with PsA were in plans that required step therapy.

The results showed: 

  • People with RA in plans with step therapy requirement had 17% lower odds of treatment effectiveness compared to people who did not have access restrictions.

  • Medication adherence was 18% lower for people with RA whose plans included step therapy requirement, compared to people who did not have access restrictions.

  • Patterns were similar among people with PsA: the odds of medication adherence were 27% lower among people with PsA, and the likelihood of treatment effectiveness was 25% lower among people whose insurance plans had step therapy versus people who did not have access restrictions.

The findings also suggest that step therapy may actually lead to additional healthcare use, according to Boytsov. “For example, people with RA in insurance plans with treatment access restrictions were almost twice as likely to visit the emergency room during the study period, for any reason, and they were three times as likely to be admitted to the hospital because of an infection,” she says. “Additionally, more people with access restrictions filled prescriptions for glucocorticoid steroids and non-steroidal anti-inflammatory drugs than patients without access restrictions, which could be an indication of poorly managed disease. These patterns were similar among people with PsA.”

Related article: How Payers Are Keeping Specialty Drug Costs Down

While some people in the healthcare industry suggest that step therapy helps contain costs, this study provides conclusive evidence that step therapy can negatively impact medication effectiveness, and adherence, and, as a result, people’s health outcomes, according to Boytsov.

“People with inflammatory arthritis in plans with step therapy had a higher likelihood of hospitalization due to infection, and higher consumption of glucocorticoid steroids and pain medications, which were most likely due to the poor management of their disease,” she says. “These are the consequences of step therapy. These outcomes have implications for people with inflammatory disease, and implications for payers, because poor patient outcomes lead to increased healthcare expenses.

“This research expands our understanding of step therapy, including its consequences. These data also provide compelling reasons for ensuring people have access to the treatments they need, when they need them.”

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