Getting to specialty treatment in dermatologic inflammatory conditions: Treatment requirements and patient journey.

Abstract

Many payers and pharmacy benefit managers (PBMs) use step therapy requirements and formulary alternatives to reduce prescription spending. The clinical utility and ultimate therapy outcomes for patients participating in these programs is an area of needed research. To evaluate medication outcomes and time requirements to access therapy in patients required to use a step therapy or formulary alternative after being prescribed a specialty medication for psoriasis (PsO) or atopic dermatitis (AD). A single-center, retrospective review of data collected from electronic health records and the specialty pharmacy patient management system was conducted. Patients were included if they had a referral for a specialty medication by a dermatology provider for PsO or AD that was discontinued because of the payer/PBM requiring step therapy or formulary alternative use from January 2021 to June 2022. The primary outcome was the number of days from the time of patient referral for specialty medication until the second specialty medication referral. Secondary outcomes included the number of patients that failed step therapy or formulary alternative and were referred back to the specialty pharmacy as well as the number of patients not started on a specialty medication and the reason. The included patients (N = 83) were predominantly White (75%) and female (61%) with a median age of 50 years (interquartile range [IQR] = 37-61 years). 51% of patients had an indication of AD. 62 patients were required to use step therapy, and 21 were required to use a formulary alternative. Of the patients required to use step therapy, 37 (60%) had a second referral for a specialty medication because of failing step therapy requirements, with a median time to a second referral of 75 days (IQR = 27-135). The remaining 25 patients were not started on a specialty medication: 5 patients (8%) benefited from and remained on step therapy, 15 (24%) were lost to follow-up, 3 (5%) decided not to start step therapy, and 2 (3%) were referred for psoriatic arthritis evaluation. All patients required to use a formulary alternative initiated specialty medication with a median time from the initial referral to second referral of 3 days (IQR = 1-9 days). Most patients required to complete nonspecialty step therapy ultimately initiated specialty medications after a lengthy delay, demonstrating the potential impact of step therapy requirements on initiating clinically appropriate treatment for AD and PsO. Further research assessing the financial burden and clinical impact of requiring step therapy before specialty medications is warranted.