Authors: S. Schwartzman^*1, Y. Li², H. Zhou³, V. Herrera², J. Palmer² Affiliations: ¹Hospital for Special Surgery, New York, NY, US; ²Novartis Pharmaceuticals Corporation, East Hanover, NJ, US; ³KMK Consulting Inc., Morristown, NJ, US

Background/Purpose: Disease control among patients with moderate-to-severe psoriatic arthritis (PsA) may involve above-label dosing of biologic drugs; limited information is available about the economic impact of above-label dosing. We examined the costs associated with above-label dosing among patients with moderate-to-severe PsA receiving etanercept (ETA), adalimumab (ADA), certolizumab (CER), golimumab (GOL), and ustekinumab (UST).

Methods: Adult PsA patients in the MarketScan® Commercial Claims databases were identified between 01/01/2011‒03/31/2013 (identification period) and followed-up for 1 year, with a 3-month look-forward period (post-index period) ending in 3/31/2015. Patients had ≥1 PsA diagnosis using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code 696.0, ≥1 pharmacy claim for ETA, ADA, CER, GOL, or UST during the identification period. Intravenous therapy was not evaluated due to lack of available data in MarketScan databases. Patients who switched to a different biologic following the use of their initial biologic or had any autoimmune disease for which one of the studied biologics of interest could potentially be used were excluded. Above-label use was defined as a daily maintenance dose ≥10% higher than indicated in the label. Each cohort and its total healthcare costs associated with above-label use were divided into 3 categorizes: <30, 30-179 and ≥180 days, respectively.

Results: This study identified 4245 PsA patients on ETA (n=2342), ADA (n=1788), and GOL (n=115). Patients on CER (n=0) or UST (n=14) were not included due to small sample size and because both agents were approved for PsA in late 2013. Ninety percent of the ETA, 85% of the ADA, and 96% of the GOL patient cohorts had at least 30 days of above-label use. Five and a half percent (5.5%) of the ETA, 5.4% of the ADA, and 1.7% of the GOL patient cohorts had at least 30-179 days of above-label use whereas 4% of the ETA, 9.6% of the ADA, and 2.6% of the GOL patient cohorts had ≥180 days above-label use. In the post-index period, the mean total all-cause healthcare costs (medical and pharmacy) were increased in the biologic patient cohorts with more above-label use (ETA cohort: $30,625 <30 days vs. $55,359 ≥180 days; ADA cohort: $31,620 <30 days vs. $54,176 ≥180 days; GOL cohort: $37,224 <30 days vs. $47,993 ≥180 days, respectively). Within the above-label use categories, ETA and ADA showed increased costs associated with increased duration of above-label dosing in annual mean total all-cause healthcare costs per patient (ETA: $10,561 <30 days; $16,213 30-179 days; $25,167 ≥180 days; ADA: $13,446 <30 days; $17,623 30-179 days; $16,251 ≥180 days); The observations for patients treated with GOL are limited by the small sample size.

Conclusion: Even a short duration of above-label dosing was associated with increased total healthcare costs among PsA patients treated with ETA and ADA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/economic-impact-of-above-label-dosing-with-biologics-in-patients-with-moderate-to-severe-psoriatic-arthritis/