Organogenesis Presents Findings from Groundbreaking Research Highlighting the Healthcare Resource and Economic Burden of Venous Leg Ulcers and Diabetic Foot Ulcers

CANTON, Mass. and NEW ORLEANS, May 22, 2013 /PRNewswire/ -- Organogenesis Inc., a commercial leader in the field of regenerative medicine, presented new data generated in collaboration with a team of expert economists from Analysis Group (a leading health economics consultancy) demonstrating the significant healthcare resource and economic burden that diabetic foot ulcers (DFU) and venous leg ulcers (VLU) place upon the US healthcare system.

The results of this research, which reveal annual costs of up to $15 billion and $18 billion for DFU and VLU respectively, were presented at the prestigious International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18^th Annual Meeting held May 18-22, 2013 in New Orleans, LA. These large, real-world analyses of privately-insured and Medicare beneficiaries evaluated data from control matched pairs of 81,516 VLU and 32,414 DFU patients, and are the first to rigorously assess patient characteristics, medical resource usage and costs for both DFU and VLU populations.

The findings underscore the urgent need for improved identification, prevention and aggressive treatment of these debilitating chronic wounds.

"Despite the high prevalence in the US, little is known about the burden of conditions like DFU and VLU," said Brad Rice, PhD, an economist with Analysis Group. "When conducting research that employs these robust matching methods, we don't typically see incremental costs as high as those we have uncovered here."

In a podium presentation, "Medical, Drug and Work-loss Costs of Diabetic Foot Ulcers," Dr. Rice unveiled the results from an analysis of per-patient costs of DFUs, which are estimated to affect 900,000 patients in the US annually.^[1],[2] Compared to matched non-DFU diabetic patients, DFU patients had higher rates of comorbidities and utilized more medical resources during the 12-month follow-up period, including increases in days hospitalized (+138.2% Medicare, +173.5% private), days requiring home health care (+85.4% Medicare, +230.0% private), emergency department visits (+40.6% Medicare, +109.0% private), and outpatient/physician office visits (+35.1% Medicare, +42.5% private).  This resulted in costs among DFU patients of approximately twice that of matched non-DFU diabetic patients, with annual incremental per-patient healthcare costs of $11,296 for Medicare and $15,329 for privately-insured patients. These findings suggest an annual payer burden associated with DFUs of up-to $15 billion.

A poster presentation, titled "Medical, Drug and Work-loss Costs of Venous Leg Ulcers," unveiled findings from the first study to analyze  the US resource and economic burden imposed by VLUs, which are the most frequently occurring type of chronic leg wound, estimated to affect approximately 2.5 million patients in the US per year.^[3],[4]

Results showed that compared to non-VLU matched patients, VLU patients were found to be nearly twice as costly as the general population for private payers and 50% more costly for Medicare. VLU patients utilized more medical resources, including more days hospitalized (+80.6% Medicare, +83.5% private), days requiring home health care (+74.4% Medicare, +202.8% private), emergency department visits (+36.5% Medicare, +46.9% private), and outpatient/physician office visits (+27.3% Medicare, +39.7% private).  These findings suggest an annual payer burden of up to $18 billion.

"These startling results highlight the urgent crisis posed on our health care system by DFUs and VLUs, and should serve as a call to action for improving both the prevention and aggressive treatment of these wounds," said Geoff MacKay, president and CEO of Organogenesis Inc.  "With approaches currently available, including living cell-based products like Apligraf that have been proven to shorten healing times, there is no reason that a patient affected by a VLU or DFU should receive sub-optimal care. We will continue to work to ensure that these important data are well understood in an era of health care reform, and to ensure the millions of patients with chronic wounds receive the advanced care they deserve."

About Apligraf®

Apligraf contains two layers of human living cells: a layer of differentiated keratinocytes and a layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins and has been demonstrated to promote healing. In controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments alone.

Important Safety Information:

Apligraf is FDA-approved for the treatment of diabetic foot ulcers lasting longer than three weeks, and venous leg ulcers lasting longer than one month, that have not adequately responded to conventional therapy. It contains living cells, proteins produced by the cells, and collagen. Complications may include suspected wound or non-wound infection, skin inflammation, wound drainage, swelling, a skin tear or cut, pain, a new ulcer, red, flaky skin, bone infection, rash, low or high blood sugar, bruising, swelling, worsening ulcer, and dry skin. Apligraf should not be used if your wound is infected or if you are allergic to cow collagen or the agarose shipping medium. For more information, please read the complete prescribing information available at www.Apligraf.com.

About Organogenesis Inc.

Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit www.organogenesis.com.

[1] Margolis D, Malay DS, Hoffstad OJ, Leonard, CE, MaCurdy T, Lopez de Nava K, Tan Y, Molina T, Siegel KL. Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008. AHRQ Publication No. 10(11)-EHC009-1-EF [article online] January 2011. Available from: http://www.effectivehealthcare.ahrq.gov/ehc/products/287/627/Datapoints_2_Diabetic-Foot-Ulcer_Report_02-2011.pdf., Accessed 18 January 2013.

[2] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, [article online] 2011. Available from: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed 18 January 2013.

[3] Gillespie DL, et al. "Venous ulcer diagnosis, treatment, and prevention of recurrences," Journal of Vascular Surgery 2010; 52(5 suppl): 8S–14S.

[4] Phillips T, B Stanton, A Provan, and R Lew. "A study of the impact of leg ulcers on quality of life: Financial, social, and psychologic implications," Journal of the American Academy of Dermatology 1994; 31(1): 49–53.

CONTACT:
Angelyn Lowe
(781) 830-2353
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SOURCE Organogenesis Inc.