Organogenesis Inc. Release: Groundbreaking Research Presented At ISPOR Annual Meeting, Demonstrating The Health Economic Benefits For Medicare Patients Treated With Apligraf And Dermagraft

CANTON, Mass. and PHILADELPHIA, May 18, 2015 /PRNewswire/ -- Findings from a groundbreaking study on the health economic benefits for Medicare patients receiving Apligraf® and Dermagraft® for the treatment of diabetic foot ulcers (DFU) were presented today at the prestigious International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 20^th annual meeting, being held this week in Philadelphia.

"This type of analysis is the first of its kind in wound care technologies and paves the way for expanded research that could benefit patients living with DFUs," stated Brad Rice, PhD, an economist with Analysis Group.

In a presentation, entitled "Economic Outcomes Among Medicare Patients Receiving Bioengineered Cellular Technologies for Treatment of Diabetic Foot Ulcers," Dr. Rice revealed results from a study, generated in collaboration with a team of expert economists from Analysis Group, of over 20,000 DFU patients from 2006 to 2012, which was recently published in the peer-reviewed Journal of Medical Economics. 

Researchers compared the real-world medical resource utilization, rates of lower-limb amputation, and Medicare costs associated with the use of the bioengineered living cellular technologies Apligraf and Dermagraft, relative to conventional care in DFU patients.

"By carefully controlling for several factors including wound severity, comorbidities, and physician experience using the propensity score matching technique, the results account for differences across treatment groups," said Dr. Rice.

The results demonstrated that patients treated with Apligraf and Dermagraft had fewer costly healthcare services than DFU patients who underwent conventional care. Notable findings include:

• Apligraf patients had a 27.6% lower amputation rate, 33.3% fewer days hospitalized, and 32.3% fewer emergency department visits than their respective matched controls.
• Dermagraft patients had a 22.2% lower amputation rate, 42.4% fewer days hospitalized, and 25.7% fewer emergency department visits than their respective matched controls.
• The healthcare costs per patient for Apligraf and Dermagraft patients during the 18-month follow-up period were lower than their respective matched controls ($5,253 lower for Apligraf patients, $6,991 lower for Dermagraft patients).

Use of Apligraf or Dermagraft for treatment of DFUs was shown to improve patient outcomes with reduced incremental financial impact for payers.

"The results of this study demonstrate that the use of our FDA-approved, bioengineered living cellular technologies can improve patient outcomes through reduced utilization of costly healthcare services, which is a true win-win for the healthcare system and patients alike," said Gary S. Gillheeney Sr., President and Chief Executive Officer of Organogenesis Inc. "Our advanced wound healing products  Apligraf and Dermagraft are the only 'skin substitutes' that have FDA approval for the healing of wounds, and were demonstrated safe and effective through the rigorous FDA premarket review process. In this landmark new study, they've also shown real cost savings and real reduction of waste to the healthcare system."

Each year, nearly one million patients experience DFUs, requiring extensive healing and often leading to severe and costly outcomes such as infection and lower-limb amputations.^{1, 2} As a result, DFUs are estimated to cost the Medicare program and U.S. taxpayers up to $13 billion annually.³ According to the Centers for Disease Control and Prevention (CDC), there were over 73,000 lower-limb amputations in people with diabetes in 2010, equating approximately to one amputation every seven minutes.² Additionally, the three- and five-year mortality rates following amputation in patients with diabetes have been reported to be 50 percent and 60 percent respectively, which are higher than some common cancers.^{4, 5, 6}  

About Apligraf and Dermagraft
Apligraf is FDA-approved for the treatment of venous leg ulcers and diabetic foot 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 Apligraf.com.

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than 6 weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. Dermagraft should not be used on ulcers that have signs of clinical infection, sinus tracts (narrow passages extending from the wound), or exposed tendon, muscle, joint capsule, or bone. Dermagraft should not be used in patients with known allergy to bovine (cow) products, as it may contain small amounts of bovine proteins from the manufacturing and storage solutions. More information is available at Dermagraft.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 soft tissue 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 at http://www.ncbi.nlm.nih.gov/books/NBK65149/. Accessed March 3, 2015.

² Centers for Disease Control and Prevention. National diabetes statistics report, 2014. Available at http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf. Accessed March25, 2015. 

³ Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of Diabetic Foot Ulcers for Medicare and Private Insurer. Diabetes Care 2014; 37(3): 651-658. 

⁴ Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217-228.

⁵ Frykberg RG, Zgonis, T Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore C, Schuberth JM, Wukick OK, Andersen C, Vanore JV, American College at Foot and Ankle Surgeons. Diabetic foot disorders: a clinical practice guideline. J Foot Ankle Surg. 2006;45(5):52-66.

⁶ Armstrong DG, Wrobel J, Robbins JM. Int Wound J. Guest Editorial: are diabetes-related wounds and amputations worse than cancer? 2007 Dec;4(4):286-7.

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SOURCE Organogenesis Inc.