An economic assessment of Apligraf® (Graftskin) for the treatment of hard‐to‐heal venous leg ulcers

Abstract

Several recent advances in wound care may offer promise for the treatment of hard-to-heal venous leg ulcers. One such treatment is Apligraf (Graftskin), a bilayered, living human skin construct. To assess the economic impact of Graftskin, a model was constructed to compare the annual medical costs and cost-effectiveness of treating hard-to-heal venous leg ulcers with Graftskin vs. compression therapy using Unna's boot. A semi-Markov model was used to describe the pattern of ulcer treatment, healing, and recurrence among patients with venous leg ulcers. Patients received 1 of 2 treatment regimens, Graftskin or Unna's boot, and were followed in the model for a 12-month period. The analysis was done from the perspective of a commercial health plan; therefore, only direct medical costs were included. Health care resource use included the primary therapeutic intervention, additional compression dressings, physician office visits, home health visits, laboratory tests and procedures, management of adverse events, and hospitalizations. The model estimated the annual medical cost of managing patients with hard-to-heal venous leg ulcers to be $20,041 for those treated with Graftskin and $27,493 for those treated with Unna's boot. In addition, treatment with Graftskin led to approximately 3 more months in the healed state per person per year than did treatment with Unna's boot. Because patients treated with Graftskin experienced improved healing compared with those treated with compression therapy using Unna's boot, they required fewer months of treatment for unhealed ulcers. As a result, the use of Graftskin for treating hard-to-heal venous leg ulcers resulted in lower overall treatment costs.

Cost-Effectiveness of Three Adjunct Cellular/Tissue-Derived Products Used in the Management of Chronic Venous Leg Ulcers

“…Previous cost-effectiveness analyses have found similar results when assessing the relative costs and benefits of CTPs in the management of VLUs. Schonfeld et al [31] evaluated the cost-benefit of HSE in comparison to Unna's boot as the standard care using a semi-Markov model over a horizon time of 1 year and found that rates of healing in the HSE group were approximately 48.1% compared with 25.2% in standard care patients. Annual costs for HSE patients were slightly more expensive than the annual cost for Unna's boot patients ($12,807 vs. $10,482, respectively; 1996 US dollars), with a calculated ICER of $800 per additional month of healing.…”

“…The longer it takes to heal an ulcer, the greater the financial burden to the health care system [29]. Controlled clinical studies have shown that HSE is more economical and effective at healing chronic VLUs than is standard care alone [30,31]. Schonfeld et al [31] reported that the estimated average direct cost (US dollars) of care for VLUs treated with HSE was $12,807 compared with $10,482 with Unna boot therapy; moreover, patients treated with HSE had almost 3 additional healed months (4.60 vs. 1.75, respectively).…”

“…Controlled clinical studies have shown that HSE is more economical and effective at healing chronic VLUs than is standard care alone [30,31]. Schonfeld et al [31] reported that the estimated average direct cost (US dollars) of care for VLUs treated with HSE was $12,807 compared with $10,482 with Unna boot therapy; moreover, patients treated with HSE had almost 3 additional healed months (4.60 vs. 1.75, respectively). Kerstein et al [30] reported in a systematic literature review that the cost of 12-week wound care for a healing VLU ranged from $1,873 to $ 15,053, which included some VLUs treated with HSE.…”

Retrospective Cohort Study Evaluating Clinical Outcomes in Lower Extremity Ulcers Treated with a Bi-layered Bioengineered Skin Substitute (BBSS) as Compared to Standard Therapy

“…Zaulyanov et al, reviewed several clinical studies on both DFU and VLU with BBSS treatment. BBSS has been determined as more effective and economical at healing chronic VLU [16][17][18] and DFU [19] than standard wound care therapy alone [19]. BBSS has been shown to reduce the risk of development of osteomyelitis and amputation in diabetic patients (Table 5).…”

Venous ulcer care: which dressings are cost effective?

“…Among ulcers present for a year or longer, a theoretical semi-Markov model suggested that both annual costs ($20, 041 versus $24, 493) and healed months per year (4.60 versus 1.75) favored the use of Apligraf over paste bandages. 38 However, another cost analysis suggested that the incremental cost to achieve an additional successfully treated patient was $1600 ($1600 -$6400), $3150 ($1890 -$24, 570) and $29, 952 ($14,976 -$119,808) for Talymed, Oasis, and Apligraf respectively.…”