Press & Announcements
Journal of Medical Economics Publishes Findings from Groundbreaking Research Demonstrating the Health Economic Benefits of Apligraf® and Dermagraft®
Robust Analysis in Wound Care Uses Real-World Patient Data from Medicare Records
CANTON, MASS. (March 26, 2015) – Organogenesis Inc., a world leading regenerative medicine company, announced publication of groundbreaking new data demonstrating significantly improved outcomes and economic benefits of both Apligraf® and Dermagraft® in the treatment of diabetic foot ulcers (DFUs) in the peer-reviewed Journal of Medical Economics.
The study, titled "Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers," assessed the real-world medical resource utilization and Medicare costs associated with the use of Apligraf and Dermagraft relative to conventional care in DFU patients.
The findings of this study have important implications regarding policies surrounding optimal DFU treatment, and suggest that more widespread use of bioengineered living cellular technologies can improve patient outcomes through reduced utilization of costly healthcare services.
The study, which analyzed over 20,000 DFU patients from 2006-2012, was generated in collaboration with a team of expert economists from Analysis Group, a leading health economics consultancy.
DFUs are estimated to affect over one million patients in the US annually and are associated with severe and costly outcomes such as infection and lower-limb amputations.1,2 The economic burden imposed by DFUs on the US healthcare system is estimated to be up to $13 billion annually.3
"The objective of this study was to expand and improve on previous research to compare the real-world medical services utilization, rates of lower-limb amputations, and costs for Medicare DFU patients treated with bioengineered cellular technologies," said Brad Rice, PhD, an economist with Analysis Group. "Propensity score matching technique was used to account for differences across treatment groups. In the field of wound care technologies, this type of robust analysis has never before been conducted."
The study, which evaluated data from 502 matched pairs of Apligraf and control patients and 222 matched pairs of Dermagraft and control patients receiving conventional care, demonstrated that patients treated with Apligraf or Dermagraft used fewer costly healthcare services. Specifically:
- Apligraf patients had statistically significantly lower amputation rates (27.6%), fewer days hospitalized (33.3%), and fewer emergency department visits (32.3%) than their respective matched controls.
- Dermagraft patients had lower amputation rates (22.2%), statistically significantly fewer days hospitalized (42.4%), and fewer emergency department visits (25.7%) than their respective matched controls.
Consequently, Apligraf and Dermagraft patients had per-patient average healthcare costs during the 18-month follow-up period that 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.
"In this era of healthcare reform, it becomes even more critical to demonstrate that advanced wound healing products are not only safe and effective via the FDA approval process, but also that they are cost-effective to the healthcare system and to patients," said Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis Inc. "Sometimes when a product demonstrates a clinical benefit, payers will incur a higher cost. However in this analysis the improved outcomes observed in Apligraf- and Dermagraft-treated patients came at a reduced cost, which is a win-win for the healthcare system and patients."
Mr. Gillheeney continued, "Apligraf and Dermagraft are the only 'skin substitutes' to have undergone rigorous FDA review and approval demonstrating safety and efficacy for treatment of chronic DFUs. And now we also have data – the first of its kind, utilizing Medicare’s own patient records - demonstrating that our products can reduce the burden that chronic DFUs place on the healthcare system."
Research has shown that the majority of DFUs fail to heal with conventional therapy alone, and can lead to amputation. These low success rates contribute to both the costs and risks associated with chronic wounds. More than 80% of leg amputations in patients with diabetes are preceded by a DFU.4,5 In the US in 2010, there were over 73,000 lower-limb amputations in people with diabetes, which equates to approximately 1 every 7 minutes.2 And in fact, the three- and five-year mortality rates following amputation in patients with diabetes have been reported to be 50% and 60% respectively, which are higher than some common cancers.6,7
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.
- Margolis D, Malay DS, Hoffstad OJ, Leonard, CE, MaCurdy T, López 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.
- 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 March 25, 2015.
- 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.
- Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005;293:217-228.
- Driver VR, Fabbi M, Lavery LA, Gibbons G. The costs of diabetic foot: the economic case for the limb salvage team. J Am Podiatr Med Assoc. 2010;100:335-341.
- 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.
- 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.