References

Olsson M, Järbrink K, Divakar U The humanistic and economic burden of chronic wounds: a systematic review. Wound Repair Regen. 2019; 27:(1)114-125 https://doi.org/10.1111/wrr.12683

Medicare Annual Report. 2022. http://tinyurl.com/29meuvj9 (accessed 13 February 2024)

Atkin L, Bućko Z, Conde Montero E Implementing TIMERS: the race against hard-to-heal wounds. J Wound Care. 2019; 23:S1-S50 https://doi.org/10.12968/jowc.2019.28.Sup3a.S1

Carter MJ, DaVanzo J, Haught R Chronic wound prevalence and the associated cost of treatment in Medicare beneficiaries: changes between 2014 and 2019. J Med Econ. 2023; 26:(1)894-901 https://doi.org/10.1080/13696998.2023.2232256

Sen CK, Gordillo GM, Roy S Human skin wounds: a major and snowballing threat to public health and the economy: perspective article. Wound Repair Regen. 2009; 17:(6)763-771 https://doi.org/10.1111/j.1524-475X.2009.00543.x

Gravereaux EC, Donaldson MC Chapter 56. Venous insufficiency. In: Patterson D, Belch JF (eds). : Saunders; 2006 https://doi.org/10.1016/B978-0-7216-0284-4.50062-2

Rice JB, Desai U, Cummings AKG Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care. 2014; 37:(3)651-658 https://doi.org/10.2337/dc13-2176

Tettelbach WH, Cazzell SM, Hubbs B The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers. J Wound Care. 2022; 31:(9)16-26 https://doi.org/10.12968/jowc.2022.31.Sup9.S16

Armstrong DG, Tettelbach WH, Chang TJ Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare database (2015–2018). J Wound Care. 2021; 30:S5-S16 https://doi.org/10.12968/jowc.2021.30.Sup7.S5

Some skin substitute manufacturers did not comply with new ASP reporting requirements. 2023. http://tinyurl.com/3nnx636p (accessed 13 February 2024)

Tettelbach W, Driver V, Oropallo A Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers. J Wound Care. 2023; 32:(11)704-718 https://doi.org/10.12968/jowc.2023.32.11.704

O'Meara S, Cullum N, Nelson EA, Dumville JC Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012; 11:(11) https://doi.org/10.1002/14651858.CD000265.PUB3

Adam DJ, Naik J, Hartshorne T The diagnosis and management of 689 chronic leg ulcers in a single-visit assessment clinic. Eur J Vasc Endovasc Surg. 2003; 25:(5)462-468 https://doi.org/10.1053/EJVS.2002.1906

Rasmussen L, Lawaetz M, Serup J Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up. J Vasc Surg Venous Lymphat Disord. 2013; 1:(4)349-356 https://doi.org/10.1016/J.JVSV.2013.04.008

Brittenden J, Cotton SC, Elders A A randomized trial comparing treatments for varicose veins. N Engl J Med. 2014; 371:(13)60-61 https://doi.org/10.1056/NEJMOA1400781

Barwell JR, Davies CE, Deacon J Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. The Lancet. 2004; 363:(9424)1854-1859 https://doi.org/10.1016/S0140-6736(04)16353-8

Gohel MS, Barwell JR, Taylor M Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial. BMJ. 2007; 335:(7610)83-87 https://doi.org/10.1136/bmj.39216.542442.BE

Gohel MS, Mora J, Szigeti M Long-term clinical and cost-effectiveness of early endovenous ablation in venous ulceration: a randomized clinical trial. JAMA Surg. 2020; 155:(12)1113-1121 https://doi.org/10.1001/jamasurg.2020.3845

Gohel MS, Heatley F, Liu X A randomized trial of early endovenous ablation in venous ulceration. N Engl J Med. 2018; 378:(22)2105-2114 https://doi.org/10.1056/nejmoa1801214

Zheng H, Magee GA, Tan TW Cost-effectiveness of compression therapy with early endovenous ablation in venous ulceration for a medicare population. JAMA Netw Open. 2022; 5:(12) https://doi.org/10.1001/JAMANETWORKOPEN.2022.48152

Žulec M, Pavlič DR, Žulec A The effect of an educational intervention on self-care in patients with venous leg ulcers—a randomized controlled trial. Int J Environ Res Public Health. 2022; 19:(8) https://doi.org/10.3390/IJERPH19084657

Pinhasov T, Isaacs S, Donis-Garcia M Reducing lower extremity hospital-acquired pressure injuries: a multidisciplinary clinical team approach. 2023; 32:S31-S36 https://doi.org/10.12968/jowc.2023.32.Sup7.S31

Tettelbach WH, Armstrong DG, Chang TJ Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. J Wound Care. 2022; 31:S10-S31 https://doi.org/10.12968/JOWC.2022.31.SUP2.S10

Atkin L, Bućko Z, Montero EC Implementing TIMERS: The race against hard-to-heal wounds. J Wound Care. 2019; 23:S1-S52 https://doi.org/10.12968/jowc.2019.28.Sup3a.S1

Schultz GS, Barillo DJ, Mozingo DW Wound bed preparation and a brief history of TIME. Int Wound J. 2004; 1:(1)19-32 https://doi.org/10.1111/j.1742-481x.2004.00008.x

Wu S, Carter M, Cole W Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs). J Wound Care. 2023; 32:S1-S31 https://doi.org/10.12968/JOWC.2023.32.SUP4B.S1

Center for Medicare and Medicaid Studies. CMS Manual System Pub 100-04 Medicare Claims Processing. 2021. http://tinyurl.com/3wmkuutz (accessed 13 February 2024)

Koob TJ, Lim JJ, Zabek N, Massee M Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015; 103:(5)1133-1140 https://doi.org/10.1002/JBM.B.33265

Lei J, Priddy LB, Lim JJ Identification of extracellular matrix components and biological factors in micronized dehydrated human amnion/chorion membrane. Adv Wound Care. 2017; 6:(2)43-53 https://doi.org/10.1089/WOUND.2016.0699

Koob TJ, Lim JJ, Massee M Angiogenic properties of dehydrated human amnion/chorion allografts: Therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014; 6:(1) https://doi.org/10.1186/2045-824X-6-10

Koob TJ, Rennert R, Zabek N Biological properties of dehydrated human amnion/chorion composite graft: Implications for chronic wound healing. Int Wound J. 2013; 10:(5)493-500 https://doi.org/10.1111/IWJ.12140

Maan ZN, Rennert RC, Koob TJ Cell recruitment by amnion chorion grafts promotes neovascularization. J Surg Res. 2015; 193:(2) https://doi.org/10.1016/J.JSS.2014.08.045

Massee M, Chinn K, Lei J Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. J Biomed Mater Res B Appl Biomater. 2016; 104:(7)1495-1503 https://doi.org/10.1002/JBM.B.33478

Bianchi C, Cazzell S, Vayser D A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft for the treatment of venous leg ulcers. Int Wound J. 2018; 15:(1) https://doi.org/10.1111/IWJ.12843

Bianchi C, Tettelbach W, Istwan N Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft. Int Wound J. 2019; 16:(3)761-767 https://doi.org/10.1111/IWJ.13094

Serena TE, Carter MJ, Le LT A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014; 22:(6)688-693 https://doi.org/10.1111/WRR.12227

Skin substitutes for adults With diabetic foot ulcers and venous leg ulcers: a health technology assessment. Ont Health Technol Assess Ser. 2021; 21:(7)1-165

Department of Health and Human Services. CMS. Update of the ambulatory surgical center payment system. http://tinyurl.com/bdza6fp4 (accessed 13 February 2024)

Sanders GD, Neumann PJ, Basu A Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine. JAMA. 2016; 316:(10)1093-1103 https://doi.org/10.1001/JAMA.2016.12195

Finlayson KJ, Parker CN, Miller C Predicting the likelihood of venous leg ulcer recurrence: The diagnostic accuracy of a newly developed risk assessment tool. Int Wound J. 2018; 15:(5)686-694 https://doi.org/10.1111/iwj.12911

Xu J, Murphy SL, Kochanek KD, Arias E Mortality in the United States, 2021. NCHS Data Brief. 2022; (456)1-8

Iglesias CP, Birks Y, Nelson EA Quality of life of people with venous leg ulcers: a comparison of the discriminative and responsive characteristics of two generic and a disease specific instruments. Qual Life Res. 2005; 14:(7)1705-1718 https://doi.org/10.1007/s11136-005-2751-9

Sullivan PW, Ghushchyan V Preference-based EQ-5D index scores for chronic conditions in the United States. Medical Decision Making. 2006; 26:(4)410-420 https://doi.org/10.1177/0272989X06290495

Iversen MM, Tell GS, Riise T History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trøndelag Health Study, Norway. Diabetes Care. 2009; 32:(12)2193-2199 https://doi.org/10.2337/DC09-0651

US Department of Veterans Affairs. Pharmaceutical Prices. Office of Procurement, Acquisition and Logistics. http://tinyurl.com/57t4cpyf (accessed 13 February 2024)

Charlson ME, Pompei P, Ales KL, MacKenzie CR A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chron Dis. 1987; 40:(5)373-383 https://doi.org/10.1016/0021-9681(87)90171-8

Walzer S, Dröschel D, Vollmer L A cost-effectiveness analysis of a hydration response technology dressing in the treatment of venous leg ulcers in the UK. J Wound Care. 2018; 27:(3)166-172 https://doi.org/10.12968/jowc.2018.27.3.166

Gueltzow M, Khalilpour P, Kolbe K, Zoellner Y Budget impact of antimicrobial wound dressings in the treatment of venous leg ulcers in the German outpatient care sector: a budget impact analysis. J Mark Access Health Policy. 2018; 6:(1) https://doi.org/10.1080/20016689.2018.1527654

Cheng Q, Gibb M, Graves N Cost-effectiveness analysis of guideline-based optimal care for venous leg ulcers in Australia. BMC Health Serv Res. 2018; 18:(1)) https://doi.org/10.1186/s12913-018-3234-3

Carter MJ, Waycaster C, Schaum K, Gilligan AM Cost-effectiveness of three adjunct cellular/tissue-derived products used in the management of chronic venous leg ulcers. Value in Health. 2014; 17:(8)801-813 https://doi.org/10.1016/j.jval.2014.08.001

Kirsner RS, Delhougne G, Searle RJ A cost-effectiveness analysis comparing single-use and traditional negative pressure wound therapy to treat chronic venous and diabetic foot ulcers. Wound Manag Prev. 2020; 66:(3)30-38

Mostow EN, Haraway GD, Dalsing M Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005; 41:(5)837-843 https://doi.org/10.1016/J.JVS.2005.01.042

Krishnamoorthy L, Harding K, Griffiths D The clinical and histological effects of Dermagraft in the healing of chronic venous leg ulcers. Phlebology. 2003; 18:(1)12-22 https://doi.org/10.1258/026835503321236858

Falanga V, Margolis D, Alvarez O Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol. 1998; 134:(3)293-300 https://doi.org/10.1001/archderm.134.3.293

Omar AA, Mavor AID, Jones AM, Homer-Vanniasinkam S Treatment of venous leg ulcers with Dermagraft. Eur J Vasc Endovasc Surg. 2004; 27:(6)666-672 https://doi.org/10.1016/j.ejvs.2004.03.001

Chan DYS, Surendra NK, Ng YZ Prospective study on the clinical and economic burden of venous leg ulcers in the tropics. J Vasc Surg Venous Lymphat Disord. 2023; 11:(5)954-963 https://doi.org/10.1016/J.JVSV.2023.05.009

Nussbaum SR, Carter MJ, Fife CE An economic evaluation of the impact, cost, and medicare policy implications of chronic nonhealing wounds. Value in Health. 2018; 21:(1)27-32 https://doi.org/10.1016/j.jval.2017.07.007

Reassessing your outpatient wound clinic in 2014. 2014. http://tinyurl.com/58rt63wn (accessed 13 February 2024)

Reimbursement pearls from wound clinic business 2019. 2019. http://tinyurl.com/fvbfhcf3 (accessed 13 February 2024)

The Medicare value-based care strategy: alignment, growth, and equity. http://tinyurl.com/yr2nzhpf (accessed 13 February 2024)

Dietz DW, Padula WV, Zheng H, Pronovost PJ Costs of defects in surgical care: a call to eliminate defects in value.: NEJM Catalyst; 2021 https://doi.org/10.1056/CAT.21.0305

Wennberg JE, O'Connor AM, Collins ED, Weinstein JN Extending the P4P agenda, part 1: How Medicare can improve patient decision making and reduce unnecessary care: an agenda for Medicare to help drive improvements through pay-for-performance and shared decision making. Health Aff. 2007; 26:(6)1564-1574 https://doi.org/10.1377/hlthaff.26.6.1564

Spivack SB, Bernheim SM, Forman HP Hospital cardiovascular outcome measures in federal pay-for-reporting and pay-for-performance programs: a brief overview of current efforts. Circ Cardiovasc Qual Outcomes. 2014; 7:(5)627-633 https://doi.org/10.1161/CIRCOUTCOMES.114.001364

Specialty payment model opportunities and assessment: oncology simulation report. 2015. http://tinyurl.com/57afkvjs (accessed 13 February 2024)

Keating NL, Jhatakia S, Brooks GA Association of participation in the oncology care model with Medicare payments, utilization, care delivery, and quality outcomes. JAMA. 2021; 326:(18)1829-1839 https://doi.org/10.1001/JAMA.2021.17642

Tettelbach W, Forsyth A Specialty specific quality measures needed to improve outcomes in wound care. Int Wound J. 2023; 20:(5)1662-1666

Sen CK, Roy S Sociogenomic approach to wound care: a new patient-centered paradigm. Adv Wound Care. 2019; 8:(11)523-526 https://doi.org/10.1089/WOUND.2019.1101NEJM197012032832305

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis

02 September 2024
Volume 8 · Issue 2

Abstract

Objective:

To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU).

Method:

This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30–45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015–2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results.

Results:

DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold.

Conclusion:

In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds.

Approximately 1–3% of total healthcare expenditures are devoted to hard-to-heal wounds in high-income countries, and these rates are likely to increase as the population ages.1 In 2021, the US Medicare programme covered over 63.8 million lives, at a cost of $839 billion USD or 3.9% of the US gross domestic product (GDP), and is projected to increase to 6.5% of GDP by 2096.2 Hard-to-heal or chronic wounds, defined as wounds which have failed to close by 40–50% after four weeks of good standard care,3 affected about 10.5 million US Medicare beneficiaries in 2019 and cost projections for all wounds ranged from $22.5–67.0 billion USD.4 In the US, it has been estimated that 500,000–600,000 people experience a venous leg ulcer (VLU) annually,5 accounting for approximately 2% of total US healthcare costs.6 A retrospective analysis highlighted Medicare spending for wound care per beneficiary with the principal diagnosis of VLU increased from a mean value of $1206 USD in 2014 to $1803 USD in 2019.4 If medical resources and work absenteeism are taken into account, the annual US payor burden was estimated at $14.9 billion USD in 2014 for Medicare and private insurers, excluding generic payors.7

Register now to continue reading

Thank you for visiting Wound Central and reading some of our peer-reviewed resources for wound care professionals. To read more, please register today. You’ll enjoy the following great benefits:

What's included

  • Access to clinical or professional articles

  • New content and clinical updates each month