Off-label versus on-label prescribing of oral oncology agents on time to receipt of medication in patients with soft tissue sarcoma

Abstract

Purpose

Off-label prescribing of oral oncology agents has been explored in the treatment of soft tissue sarcoma. The time for a prior authorization approval or rejection for an off-label use can be lengthy. The purpose of this study is to capture this burden by comparing the time it takes for patients to receive off-label versus on-label treatment for their soft tissue sarcoma.

Patients and methods

In this retrospective chart review study, patients aged 18 and older who received a new prescription for an oral oncology agent for soft tissue sarcoma from one of three sarcoma providers at Oregon Health & Science University oncology clinics between March 2014 and February 2016 were included. Objectives included comparing the effect of off-label to on-label prescribing of oral oncology agents on time to receipt of medication and patient copays for a 30-day supply of oral chemotherapy agent(s).

Results

The time to receipt of medication (median (IQR)) for the off-label group (N = 26) was 12.5 (3.3 to 30.8) days compared to the on-label group (N = 29), which was 8.0 (4.0 to 15.0) days (p = 0.327). The patient cost was $0.00 ($0.00 to $20.00) for the off-label group (N = 18) compared to $3.00 ($0.00 to $68.80) for the on-label group (N = 18) (p = 0.467).

Conclusions

There were no differences in the time to receipt of medication or patient cost between off-label and on-label prescriptions in soft tissue sarcoma patients. Despite lack of statistical significance, these results are meaningful to patient care and require further study to investigate these findings.

Keywords

Gastrointestinal stromal tumor off-label oral chemotherapy soft tissue sarcoma

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