PHARMACOEPIDEMIOLOGY OF CELLULAR/TISSUE DERIVED PRODUCTS FOR THE TREATMENT OF VENOUS LEG ULCERS IN OUTPATIENT CARE SETTINGS

Author(s)

Gilligan AM, Waycaster C
Smith & Nephew Biotherapeutics, Fort Worth, TX, USA

OBJECTIVES: Venous leg ulcers (VLUs) are a debilitating condition for patients with venous insufficiency. Compression therapy is the standard care for treatment of VLU; however the success rate is approximately 50% at 6 months. Clinical trials with cellular/tissue derived products (CTPs) have shown promising efficacy for the treatment of VLU. The objective was to identify patient and clinical characteristics in the VLU population and examine patterns of CTP utilization.  METHODS: Retrospective, de-identified electronic medical records from 2007-2013 were extracted from the Intellicure Limited Data Set (I-LDS). The I-LDS extracts records from 96 hospital-based outpatient wound centers. Patient, wound and encounter level characteristics were examined. CTPs of interest included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE).     RESULTS: A total of 9,091 patients, 25,734 wounds, and 222,666 encounters for VLU were identified. The majority of patients was male (50.5%), Caucasian (74.1%), and reported Medicare as their primary insurance (53.4%). The average age was 68.9 (SD=14.6) and the average number of physician visits was 17.7 (SD=22.5). The mean wound surface area was 20.1cm (SD=83.4). The overall average wound duration was 5.8 months (SD=26.7). Of the 25,734 wounds, approximately 7.1% received ECM (3.4%), HSE (3.5%), or LSE (0.2%). The average number of applications for ECM was 2.7 (SD=2.8), 0.6 (SD=1.3) for HSE, and 3.1 (SD=3.3) for LSE. Wounds treated with CTPs were, on average, several months older: 12.5, 13.7, and 11.1 months for ECM, HSE, and LSE, respectively. Overall average wound treatment time was 2.9 months (SD=4.8). However, treatment time was substantially longer with CTP utilization with an average time of 9.6, 9.7, and 7.5 months for ECM, HSE, and LSE, respectively. CONCLUSIONS: CTP utilization was relatively low within outpatient wound centers. Results from this analysis indicate that health care providers are using CTPs on older, more difficult-to-heal VLUs.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PSS8

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Sensory System Disorders

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