Economic impact of biologic utilization patterns in patients with psoriatic arthritis

Clin Rheumatol DOI 10.1007/s10067-017-3636-3 ORIGINAL ARTICLE Economic impact of biologic utilization patterns in patients with psoriatic arthritis Sergio Schwartzman 1 & Yunfeng Li 2 & Huanxue Zhou 3 & Jacqueline B. Palmer 2 Received: 17 January 2017 / Revised: 10 April 2017 / Accepted: 13 April 2017 # The Author(s) 2017. This article is an open access publication Abstract The aim of the study is to examine the frequency and costs associated with above-label dosing of biologics in patients with psoriatic arthritis (PsA). MarketScan identified adults with ≥1 International Classification of Diseases, Clinical Modification diagnosis for PsA and ≥1 pharmacy claim for biologics of interest between January 1, 2011 and December 31, 2013. The first biologic claim was the index date with a 1-year follow-up period and three additional months to confirm continuous biologic use. Exclusion criteria included switching to a different biologic or diagnosis with another autoimmune disease. During the follow-up period, duration was stratified into three groups: <30, 30–179, and ≥180 days of above-label dosing (>10% of the labeled dose). One-tailed t test was conducted to examine the impact of above-label duration on healthcare costs. We identified 4245 PsA patients receiving etanercept (n = 2342), adalimumab (n = 1788), and golimumab (n = 115). Above-label dosing of <30 days (85% adalimumab, 90.4% etanercept, and 95.7% golimumab) and ≥180 days (9.6% adalimumab, 4.1% etanercept, and 2.6% golimumab) was observed. All-cause total healthcare costs for <30 days of above-label use (etanercept $30,625, adalimumab $31,620, and golimumab $37,224), 30–179 days (etanercept $35,602, adalimumab $38,915, and golimumab $64,349), and ≥180 days (etanercept $55,349, adalimumab $54,176, and golimumab $47,993) were reported. Longer above-label duration (30–179 versus * Sergio Schwartzman 1 The Hospital for Special Surgery, 535 E 70th St, New York, NY 10021, USA 2 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA 3 KMK Consulting Inc., Morristown, NJ, USA <30 days, ≥180 versus 30–179 and ≥180 days) with etanercept or adalimumab was significantly associated with higher mean increased total all-cause healthcare, PsAspecific healthcare, and biologic costs (p < 0.05). Abovelabel use of anti-TNF biologics does occur and is associated with significantly increased healthcare costs. Keywords Above-label dosing . Disease-modifying antirheumatic drug . Dose escalation . Drug costs . Psoriatic arthritis Introduction Psoriatic arthritis (PsA) is a chronic disease which requires aggressive and continuous treatment to manage symptoms and prevent disability [1]. Biologic disease-modifying antirheumatic drugs (bDMARDs, also referred to as biologics) are currently recommended for patients with PsA [2, 3]. A lack of PsA symptom control with initial bDMARD use has been reported to influence decisions to change medications or request additional treatment options [1, 3–7]. Traditionally in a non-responder, a physician may switch the patient from one bDMARD to another bDMARD or change the dose of the therapy being utilized [3–8]. Treat-to-target strategies are also being recommended as a patient-centric approach for managing PsA. Minimal disease activity criteria have been developed to provide targets for tailoring treatments according to patient needs [9, 10]. A recent clinical trial examined a treatto-target approach and reported statistically significant improvements in both disease activity as well as patientreported outcomes without any unexpected safety concerns [11]. Recent studies have shown that optimizing bDMARD therapy via off-label dosage for patients with rheumatic diseases is Clin Rheumatol becoming more routine [12–14]. Limited research has been conducted to support long-term health outcomes associated with patterns of bDMARD utilization in the symptom management of PsA [3, 4, 12, 15, 16]. Off-label dosages (i.e., dose escalation or reduction, interrupted treatment) have been shown to occur in clinical practice for the treatment of other inflammatory conditions, such as psoriasis (PsO) and rheumatoid arthritis (RA) [8, 13, 17–20]. Studies have demonstrated that dose escalation with bDMARDs commonly occurs for patients with RA and results in increased cost [13, 18–22]. Off-label dosage has also been examined in patients with PsO, where dose escalation in non-responders generally resulted in increased efficacy with certain bDMARDs (etanercept, adalimumab, infliximab, ustekinumab, and alefacept) [17, 23]. An understanding of the economic implications of realworld medication utilization patterns to manage and control the symptoms of PsA is needed. bDMARDs are reported to be cost-effective for the treatment of moderate-to-severe PsA, mainly due to substantial improvement in decreasing disease activity, preventing radiographic progression, and improving functional status and quality of life [2, 24, 25]. A recent US commercial claims study reported that the annual costs associated with bDMARD treatment for PsA were $$26,916, $27,987, $28,749, and $31,974 (2015 US dollars) for etanercept, golimumab, adalimumab, and infliximab, respectively [26]. Annual direct medical costs for patients with PsA have been reported as $5108 ($22,258) (2012 US dollars, mean [SD]) [27]; however, to date, economic studies for PsA do not provide information on the cost of off-label treatment with patients on biologics and cost-effectiveness of offlabel dosing [2, 24, 25]. Due to the long-term nature of treating PsA, the costs of real-world medication utilization of bDMARDs can define treatment options for clinicians and formulary decision makers [28]. This study describes the patient demographics, medication utilization patterns, and associated total healthcare costs among patients with PsA receiving subcutaneous bDMARDs in a real-world setting in the USA. Materials and methods Database constructs include information on patient demographics (age, gender, employment status, and geographic location), healthcare utilization, costs (payment), and comprehensive prescription drug data [29, 30]. All study data were accessed using techniques compliant with the Health Insurance Portability and Accountability Act of 1996. No identifiable or protected health information was extracted during the course of the study; hence, the study did not require informed consent or institutional review board approval. Sample selection and patient population Adult PsA patients enrolled in the Truven Health MarketScan Commercial and Medicare Supplemental Claims Databases were identified between January 1, 2011 and December 31, 2013 (identification period) [29]. Patients’ first bDMARD claim was the index date, followed by a 1-year follow-up period and an additional 3-month look-forward period to confirm continuous enrollment and biologic use. The study period ended March 31, 2015. Patients included in the study had ≥1 International Classificat (...truncated)