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Step Therapy in RA or PsA Leads to Worse Treatment Outcomes, Study Says


A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

Disease-modifying antirheumatic drugs (DMARDs), whether conventional synthetic ones or biologics, can slow disease progression among patients with RA and PsA; however, some health plans require prior authorization (PA) or step therapy for access to treatments. In step therapy, less expensive drugs must be tried and failed, before other therapies, such as biologics, are covered.

This retrospective study compared treatment effectiveness among patients with RA and PsA both with and without plan-level access restrictions to biologics and conventional DMARDs; the study considered access restrictions to include the use of PA and step therapy.

Researchers included 3993 people with rheumatoid arthritis (RA) and 1713 people with PsA, identified through a claims database.

Patients aged 18 to 64 years with 1 or more claims for subcutaneous biologics in 2014 and 2015 were identified; the primary outcome was treatment effectiveness assessed during the 12 months following the first qualifying DMARD claim.

Medication adherence was examined as a secondary outcome during the 12-month follow-up period, and was compared between patients with and without access restrictions. Researchers used multivariate modeling to examine the correlation between access restrictions and treatment effectiveness.

Results show that 34.2% of the patients with RA and 35.1% of those with PsA patients had access restrictions; 70.5% and 78.9%, respectively, had plans with step therapy.

Odds of treatment effectiveness were 19% lower (odds ratio [OR], 0.8; 95% CI, 0.67-0.98; P = .033) among patients with RA who were subject to step therapy when compared with patients whose plans did not require step therapy; they were 27% lower (OR, 0.73; 95% CI, 0.55-0.98; P = .037) among patients with PsA in plans with step therapy versus those without step therapy.

Differences in medication adherence drove the effectiveness differences, as the odds of adherence were 19% lower (OR, 0.81; 95% CI, 0.68-0.96; P = .014) in RA and 29% lower (OR, 0.71; 95% CI, 0.54-0.94; P = .017) in PsA in plans with versus without step therapy.

“In this study, we collected compelling data that supports our hypothesis that step therapy, which delays people’s access to the full range of available therapies, is associated with worse treatment outcomes,” said lead study author Natalie Boytsov, PhD, health economist and research advisor at Eli Lilly and Company, in an email to The Center for Biosimilars.® “We hope this data demonstrates the need for people to have access to the treatments they need when they need them.”

Boytsov noted that medical associations and patient advocacy organizations have long voiced concerns about step therapy. “It is important to emphasize that individuals’ experiences with arthritis therapies varies, and that a one-size-fits-all approach does not allow a healthcare provider to tailor a treatment plan to their patient’s individual needs,” she said.

“Delaying a person’s access to treatments with different mechanisms of action may prevent them from getting their disease under better control. We now have data to support this, and to describe the additional burden of care that step therapy places on healthcare providers, and payers, as well.”

Looking at treatment patterns for patients with RA, those who were younger, female, living in the south, and having a baseline diagnosis of anxiety and depression were associated with lower odds of treatment effectiveness and adherence. Boytsov said the study was not powered to understand why that is, but said the, “difference could be explained by the disease duration and progression. People of younger age might not have higher severity of RA, and hence may have lower perception of the medication benefit.”

In a possible sign of poorly managed disease, more people whose plans included access restrictions filled prescriptions for glucocorticoids and nonsteroidal anti-inflammatories than people without access restrictions.

Boytsov also said that step therapy could lead to more healthcare use; for those whose plans had access restrictions, almost twice as many people with RA visited an emergency department at least once during follow-up, compared with people without access restrictions. People with access restrictions also were admitted to the hospital for infections 3 times as often as those without access restrictions.

However, total healthcare costs were significantly higher among RA patients without access restrictions mainly due to higher medication adherence, which led to higher prescription costs.


Boytsov N, Zhang X, Evans KA, Johnson BH. Impact of plan‑level access restrictions on effectiveness of biologics among patients with rheumatoid or psoriatic arthritis [published online June 8, 2019]. Pharmacoecon Open. doi: 10.1007/s41669-019-0152-1.

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