Commentary: Unnecessary Burden of Step Therapy

In their original research article, Boytsov et al¹ show evidence that insurance mandated prior authorizations or step therapy protocols negatively impact patient care and therapy adherence of patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).

Commercial insurance claims for PsA or RA diagnoses were retrospectively reviewed from January 2014 through December 2015. The authors selected multiple criteria (such as medication adherence, no changes in dose or frequency of medication, need for additional medications to control disease, etc) that needed to be fulfilled for a patient’s care to be considered a treatment success. Healthcare resource utilization such as emergency room visits and inpatient admissions were included as well. The criteria the authors used for treatment success has been validated previously.¹

Patients with PsA with medication access restriction in their insurance plans were more likely to fill a prescription for additional medications like non-steroidal anti-inflammatory drugs (NSAID) and oral steroids, had more frequent inpatient admissions, and a 25% less chance for treatment success than patients with no access restrictions. Patients with PsA who did not have step therapy or prior authorization restrictions were also 27% more likely to adhere to their medications (defined as >80% refill rate on time).¹

These results make a great case for lessening step therapy and prior authorizations. However, the study authors work for a pharmaceutical company—Eli Lilly and Company—that makes a biologic approved for psoriasis and PsA.

There is no doubt lessening the step therapy and prior authorizations process our patients face benefit the pharmaceutical industry. That said, there is also no doubt that lessening the step therapy and prior authorization burden would greatly benefit dermatologists (and the time we have to spend doing them) and most importantly our patients, whom we serve.

In my private practice, patients often have to wait a few months for an insurance company step therapy override for the prescribed medication and suffer with their disease while waiting. Also, patients routinely have to suffer through interruption of therapy for months when a biologic they have been using, sometimes for years, is suddenly subject to step therapy override.

We should definitely share the information presented by Boytsov et al¹ with state dermatology and medical societies whom are trying to foment legislation that lessens and/or eliminates prior authorizations and step therapy.

As far as step therapy and the burdens it places on patients, physicians, and pharma, the antagonist here is the insurance companies who are ostensibly trying to save dollars. In reality, it seems the extra roadblocks the insurers are placing impede patients’ ability to become healthy and may even lead to insurers spending more money in the long run on patients than they would have if there was no step therapy process in place.

My suggestion would be to replicate this study with physician authors who are not employed by big pharma, and, if possible, do a cost analysis that would show how step therapy could cost insurers more.

Dr Green is section editor of the Psoriasis Centers of Excellence, clinical professor of dermatology at George Washington University School of Medicine in Washington, DC, and on the National Psoriasis Foundation Medical Board.

Disclosure: Dr Green is currently chair of the American Academy of Dermatology Association State Policy Committee, and a speaker, investigator, or consultant for Amgen, AbbVie, Celgene, Eli Lilly and Company, Novartis, Ortho-Dermatologic, Sun Pharmaceutical Industries Ltd, and Sienna Biopharmaceuticals.

Reference

1. 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 June 8, 2019]. Pharmacoecon Open. doi:10.1007/s41669-019-0152-1