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In this era of treat-to-target or remission targeted therapeutics, the options in managing nonresponders are many; often including off-label doses (i.e., dose escalations or reduction, increasing frequency; interrupted treatment). The use of above-label dosing, and its' effect on drug costs, has seldom been studied.
Schwartzman and colleagues have studied biologic utilization in psoriatic arthritis (PsA), and the economic impact of increased doses, specifically looking at costs associated with above-label dosing and noncompliance with biologics in PsA.
Using MarketScan claims data they analyzed the first biologic claim with a 1-year follow-up period. The duration of use was stratified into three groups: <30, 30–179, and ≥180 days and defined above-label dosing as >10% of the labeled dose. They analyzed 4245 PsA patients treated with common biolgics (etanercept; n = 2342 ; adalimumab 1788, golimumab 115) between 2011 - 2013.
Above-label dosing for <30 days was common and seen in 85% of adalimumab, 90.4% of etanercept, and 95.7% of golimumab patients. Longer term (≥180 days) was less common (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab).
The mean number of days of on-label use ranged from 267 (adalimumab) to 295 (golimumab).
The mean number of days of above-label use was lowest with golimumab (12 days) and highest with adalimumab (35 days). Etanercept days of above-label use was 17 days.
Noncompliance could be inferred by no-use or below-label use days. Below-label use was onlyreported for etanercept (4days) and adalimumab (1 day). No use was significantly higher for etanercept (71 days), compared to adalimumab (63 days), and golimumab (59 days).
All-cause total healthcare costs rose substantially with above-label use (p < 0.05).
These analyses suggest noncompliance with biologics is very common and that above-label use of anti-TNF biologics not only occurs, but is associated with significantly increased healthcare costs.
The clinical consequences or associations of these off-label dosing practices could not be studied in this claims dataset.
Dr. Schwartman collaborated with Novartis to perform these studies.