The burden of productivity loss of U.S. commercially insured patients diagnosed with Dupuytren's disease undergoing collagenase versus fasciectomy treatment.

Background: We conducted a comparative assessment of the productivity loss associated with the two different treatment options for Dupuytren's disease: collagenase and fasciectomy. Methods: The retrospective claims analysis was performed using the data from IBM MarketScan® Commercial (CD) and Health and Productivity Management (HPM) Databases over five years (2012-2016). We identified two cohorts of patients who underwent either collagenase or fasciectomy in the CD. Propensity-score matched patients were linked to their productivity loss claims in the HPM database. Productivity loss measures were assessed over a 12-month follow-up period. Results: Out of 702 collagenase and 999 fasciectomy propensity score-matched patients in the CD, there were 147 collagenase and 273 fasciectomy patients in the HPM database. Over the follow-up period, collagenase-treated patients were significantly less likely to use short-term disability (STD) leave (9.7% vs. 20.2%; P = 0.009), reflecting in the lower average number of absent STD days (mean, 2.8 vs. 8.1; P = 0.002) in comparison to fasciectomy-treated. The mean indirect STD cost was considerably lower in the collagenase vs. fasciectomy group ($375 vs. $1,108; P = 0.002). Conclusion: This study indicates that collagenase vs. fasciectomy treatment may be related to a lower rate of workplace absence and lower indirect cost in a year following the treatment.

Cost effectiveness of adding clostridial collagenase ointment to selective debridement in individuals with stage IV pressure ulcers.

OBJECTIVE: The purpose of this study was to determine the cost effectiveness (from a payer's perspective) of adding clostridial collagenase ointment (CCO) to selective debridement compared with selective debridement alone (non-CCO) in the treatment of stage IV pressure ulcers among patients identified from the US Wound Registry. METHODS: A 3-state Markov model was developed to determine costs and outcomes between the CCO and non-CCO groups over a 2-year time horizon. Outcome data were derived from a retrospective clinical study and included the proportion of pressure ulcers that were closed (epithelialized) over 2 years and the time to wound closure. Transition probabilities for the Markov states were estimated from the clinical study. In the Markov model, the clinical outcome is presented as ulcer-free weeks, which represents the time the wound is in the epithelialized state. Costs for each 4-week cycle were based on frequencies of clinic visits, debridement, and CCO application rates from the clinical study. The final model outputs were cumulative costs (in US dollars), clinical outcome (ulcer-free weeks), and incremental cost-effectiveness ratio (ICER) at 2 years. RESULTS: Compared with the non-CCO group, the CCO group incurred lower costs ($11,151 vs $17,596) and greater benefits (33.9 vs 16.8 ulcer-free weeks), resulting in an economically dominant ICER of -$375 per ulcer. Thus, for each additional ulcer-free week that can be gained, there is a concurrent cost savings of $375 if CCO treatment is selected. Over a 2-year period, an additional 17.2 ulcer-free weeks can be gained with concurrent cost savings of $6,445 for each patient. CONCLUSIONS: In this Markov model based on real-world data from the US Wound Registry, the addition of CCO to selective debridement in the treatment of pressure ulcers was economically dominant over selective debridement alone, resulting in greater benefit to the patient at lower cost.

A single-centre cost comparison analysis of collagenase injection versus surgical fasciectomy for Dupuytren's contracture of the hand.

BACKGROUND AND AIM: The options for treating patients with Dupuytren's contracture have broadened with the introduction of collagenase. Although the literature would suggest that collagenase treatment is effective, has few complications and is popular with patients, it has not been widely commissioned by the National Health Services of the United Kingdom and other European countries due to concerns about cost. The aim of this study was to compare the cost of surgical fasciectomy to collagenase injections for the treatment of Dupuytren's contracture in a single centre. METHOD: Prospective data on 40 patients undergoing fasciectomy or collagenase injection (20 patients in each group) were collected between January and March 2013. Financial data on the costs of the procedures, equipment, theatre time and follow-up appointments were calculated. RESULTS: The average cost of an open partial fasciectomy pathway was £ 7115.34 and that of a collagenase pathway was £ 2110.62. Eight collagenase patients had physician-led follow-up appointments and only three had hand physiotherapy appointments. By contrast, every fasciectomy patient had at least one physician and one physiotherapist follow-up appointment routinely. CONCLUSION: The results of this study demonstrate that collagenase treatment for Dupuytren's contracture of a single digit in selected patients is just over £ 5000 less than treatment for the same condition using surgical fasciectomy. Collagenase-treated patients require much less physician- and physiotherapist-led postoperative follow-up.

Costs for collagenase injections compared with fasciectomy in the treatment of Dupuytren's contracture: a retrospective cohort study.

OBJECTIVES: To compare collagenase injections and surgery (fasciectomy) for Dupuytren's contracture (DC) regarding actual total direct treatment costs and short-term outcomes. DESIGN: Retrospective cohort study. SETTING: Orthopaedic department of a regional hospital in Sweden. PARTICIPANTS: Patients aged 65 years or older with previously untreated DC of 30° or greater in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints of the small, ring or middle finger. The collagenase group comprised 16 consecutive patients treated during the first 6 months following the introduction of collagenase as treatment for DC at the study centre. The controls were 16 patients randomly selected among those operated on with fasciectomy at the same centre during the preceding 3 years. INTERVENTIONS: Treatment with collagenase was given during two standard outpatient clinic visits (injection of 0.9 mg, distributed at multiple sites in a palpable cord, and next-day finger extension under local anaesthesia) followed by night-time splinting. Fasciectomy was carried out in the operating room (day surgery) under general or regional anaesthesia using standard technique, followed by therapy and splinting. PRIMARY AND SECONDARY OUTCOME MEASURES: Actual total direct costs (salaries of all medical personnel involved in care, medications, materials and other relevant costs), and total MCP and PIP extension deficit (degrees) measured by hand therapists at 6-12 weeks after the treatment. RESULTS: Collagenase injection required fewer hospital outpatient visits to a therapist and nurse than fasciectomy. Total treatment cost for collagenase injection was US$1418.04 and for fasciectomy US$2102.56. The post-treatment median (IQR) total extension deficit was 10 (0-30) for the collagenase group and 10 (0-34) for the fasciectomy group. CONCLUSIONS: Treatment of DC with one collagenase injection costs 33% less than fasciectomy with equivalent efficacy at 6 weeks regarding reduction in contracture.

Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study.

BACKGROUND: Despite significant advances, the treatment of diabetic foot ulcers (DFUs) remains a major therapeutic challenge for clinicians, surgeons, and other health care professionals. There is an urgent need for new strategies with clinically effective interventions to treat DFUs to reduce the burden of care in an efficient and cost-effective way. OBJECTIVE: This randomized trial evaluated and compared the clinical effectiveness, tolerability, and costs of clostridial collagenase ointment (CCO) debridement to that of debridement using saline moistened gauze (SMG) and selective sharp debridement for the treatment of DFUs. METHODS: Randomized, controlled, parallel group, multicenter, open-label, 12-week study of 48 patients with neuropathic DFUs randomized to 4 weeks of treatment with either CCO or SMG after baseline surgical debridement. The primary end point was the condition of the ulcer bed at the end of treatment as measured using a standardized wound assessment tool. Secondary end points were the percentage of reduction in wound area and therapeutic response rates. Adverse events were monitored for the tolerability analysis. In addition, a comparative cost-effectiveness analysis was performed from the perspective of the Centers for Medicare and Medicaid Services as a payer. RESULTS: Both the CCO and SMG groups had significantly improved wound assessment scores after 4 weeks of treatment (CCO, -2.5, P = 0.007; SMG, -3.4, P = 0.006). Only CCO treatment resulted in a statistically significant decrease from baseline in the mean wound area at the end of treatment (P = 0.0164) and at the end of follow-up (P = 0.012). In addition, the CCO group exhibited a significantly better response rate at the end of follow-up compared with the SMG group (0.92 vs 0.75, P < 0.05). Reported adverse events were similar between the 2 treatment groups. None of the reported adverse events were considered to be related to treatment. The economic analysis indicated that the direct mean costs per responder in the physician office setting of care were $832 versus $1042 for the CCO group versus the SMG group, whereas the direct mean costs per responder in the hospital outpatient department setting were $1607 versus $1980. CONCLUSIONS: CCO treatment provides equivalent debridement of DFUs similar to SMG while fostering better progress toward healing as measured by decreasing wound area over time and improved response rates at the end of follow-up. In addition, CCO yields a more favorable cost-effectiveness ratio in both the physician office and hospital outpatient department settings of care. ClinicalTrials.gov identifier: NCT01056198.

Cost-effectiveness in the management of Dupuytren's contracture. A Canadian cost-utility analysis of current and future management strategies.

In Canada, Dupuytren's contracture is managed with partial fasciectomy or percutaneous needle aponeurotomy (PNA). Injectable collagenase will soon be available. The optimal management of Dupuytren's contracture is controversial and trade-offs exist between the different methods. Using a cost-utility analysis approach, our aim was to identify the most cost-effective form of treatment for managing Dupuytren's contracture it and the threshold at which collagenase is cost-effective. We developed an expected-value decision analysis model for Dupuytren's contracture affecting a single finger, comparing the cost-effectiveness of fasciectomy, aponeurotomy and collagenase from a societal perspective. Cost-effectiveness, one-way sensitivity and variability analyses were performed using standard thresholds for cost effective treatment ($50 000 to $100 000/QALY gained). Percutaneous needle aponeurotomy was the preferred strategy for managing contractures affecting a single finger. The cost-effectiveness of primary aponeurotomy improved when repeated to treat recurrence. Fasciectomy was not cost-effective. Collagenase was cost-effective relative to and preferred over aponeurotomy at $875 and $470 per course of treatment, respectively. In summary, our model supports the trend towards non-surgical interventions for managing Dupuytren's contracture affecting a single finger. Injectable collagenase will only be feasible in our publicly funded healthcare system if it costs significantly less than current United States pricing.

Clinical and economic benefit of enzymatic debridement of pressure ulcers compared to autolytic debridement with a hydrogel dressing.

OBJECTIVE: The purpose of this study was to determine the cost-effectiveness of enzymatic debridement using collagenase relative to autolytic debridement with a hydrogel dressing for the treatment of pressure ulcers. METHODS: A 3-stage Markov model was used to determine the expected costs and outcomes of wound care for collagenase and hydrogel dressings. Outcome data used in the analysis were taken from a randomized clinical trial that directly compared collagenase and hydrogel dressings. The primary outcome in the clinical trial was the proportion of patients achieving a closed epithelialized wound. Transition probabilities for the Markov states were estimated from the clinical trial. A 1-year time horizon was used to determine the expected number of closed wound days and the expected costs for the two alternative debridement therapies. Resource utilization was based on the wound care treatment regimen used in the clinical trial. Resource costs were derived from standard cost references and medical supply wholesalers. The economic perspective taken was that of the long-term care facility. No cost discounting was performed due to the short time horizon of the analysis. A deterministic sensitivity analysis was conducted to analyze economic uncertainty. RESULTS: The number of expected wound days for the collagenase and hydrogel cohorts are estimated at 48 and 147, respectively. The expected direct cost per patient for pressure ulcer care was $2003 for collagenase and $5480 for hydrogel debridement. The number of closed wound days was 1.5-times higher for collagenase (317 vs 218 days) than with the hydrogel. The estimated cost/closed wound day was 4-times higher for the hydrogel ($25) vs collagenase ($6). CONCLUSIONS: In this Markov model based on a randomized trial of pressure ulcer care in a long-term care setting collagenase debridement was economically dominant over autolytic debridement, yielding better outcomes at a lower total cost. Since it was a single institution study with a small sample size, the results should be interpreted with caution. Specifically, the findings may not necessarily be generalized to other hydrogel dressings, healthcare settings, age groups, or to wounds of other etiologies.

Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

BACKGROUND: The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. METHODS: After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. RESULTS: From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P < .001). However, total hospital charges did not differ. CONCLUSION: There are no differences in outcomes between topical SSD or CO in the management of childhood burns results.

Cost-effectiveness of open partial fasciectomy, needle aponeurotomy, and collagenase injection for dupuytren contracture.

PURPOSE: We undertook a cost-utility analysis to compare traditional fasciectomy for Dupuytren with 2 new treatments, needle aponeurotomy and collagenase injection. METHODS: We constructed an expected-value decision analysis model with an arm representing each treatment. A survey was administered to a cohort of 50 consecutive subjects to determine utilities of different interventions. We conducted multiple sensitivity analyses to assess the impact of varying the rate of disease recurrence in each arm of the analysis as well as the cost of the collagenase injection. The threshold for a cost-effective treatment is based on the traditional willingness-to-pay of $50,000 per quality-adjusted life years (QALY) gained. RESULTS: The cost of open partial fasciectomy was $820,114 per QALY gained over no treatment. The cost of needle aponeurotomy was $96,474 per QALY gained versus no treatment. When we performed a sensitivity analysis and set the success rate at 100%, the cost of needle aponeurotomy was $49,631. When needle aponeurotomy was performed without surgical center or anesthesia costs and with reduced hand therapy, the cost was $36,570. When a complete collagenase injection series was priced at $250, the cost was $31,856 per QALY gained. When the injection series was priced at $945, the cost was $49,995 per QALY gained. At the market price of $5,400 per injection, the cost was $166,268 per QALY gained. CONCLUSIONS: In the current model, open partial fasciectomy is not cost-effective. Needle aponeurotomy is cost-effective if the success rate is high. Collagenase injection is cost-effective when priced under $945. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic and Decision Analysis II.

Economic evaluation of collagenase-containing ointment and hydrocolloid dressing in the treatment of pressure ulcers.

OBJECTIVE: To evaluate the efficacy and cost effectiveness of two treatments of pressure sores on the heel: a collagenase-containing ointment and a hydrocolloid dressing. DESIGN: Study and cost data were collected prospectively in a randomised clinical trial in The Netherlands by counting the resource use for each patient until wound healing occurred. STUDY PARTICIPANTS: All 24 female study participants were inpatients from the same hospital with grade IV pressure sores on the heel following orthopaedic surgery. INTERVENTIONS: Two different treatment strategies were analysed: a collagenase-containing ointment (Novuxol) and a hydrocolloid dressing (Duoderm). PERSPECTIVE: Hospital perspective. MAIN OUTCOME MEASURES AND RESULTS: The average costs per patient for treatment with the hydrocolloid dressing were about 5% higher than those with the collagenase-containing ointment. The treatment costs were similarly distributed within both groups, with 34% for materials and 66% for personnel. The cost-effectiveness analysis revealed that cost savings of 899 Dutch guilders (1998 values) per successfully treated patient could be expected using the collagenase-containing ointment instead of the hydrocolloid dressing. In addition, wound healing was achieved, on average, within a shorter time period with the collagenase treatment (10 weeks) compared with the hydrocolloid treatment (14 weeks). The robustness of the results were also tested using sensitivity analyses. These analyses served to confirm that collagenase treatment provides a better cost-effectiveness ratio than hydrocolloid treatment. CONCLUSIONS: With regard to overall costs and costs per successfully treated patient, this study showed collagenase treatment to be more cost effective than the hydrocolloid treatment in patients with grade IV pressure sores on the heel and that the amount of time needed for wound healing was shorter.

Outcomes of 4 methods of debridement using a decision analysis methodology.

OBJECTIVE: To compare the clinical efficacy of 4 debridement alternatives in pressure ulcer management. DESIGN: Nonexperimental design combining computer modeling and a decision analysis methodology. Data input into the model were derived from a literature review of the MEDLINE database for the years 1985 to 1995 (indexing terms: pressure ulcer, decubitus, economics, cost-effectiveness, and outcome) and a Delphi consensus process with an independent panel of 9 specialists in geriatric care. SETTING: Long-term care. PATIENTS: Hypothetical elderly female resident with a new full-thickness pressure ulcer (mild odor, minimal draining, no undermining, intact periulcer skin). INTERVENTIONS: The study patient underwent 1 month of therapy with each of 4 debridement methods: autolysis, wet-to-dry dressings, collagenase (Santyl) or fibrinolysin (Elase). MAIN OUTCOME: Specific clinical outcomes (time to clean wound bed, risk of infection) and relative cost-effectiveness of each debridement method were calculated. RESULTS: The likelihood of achieving a clean wound bed at 2 weeks was 70% for collagenase, 57% for fibrinolysin, 50% for autolysis, and 30% for wet-to-dry dressings. The total cost for 1 month of treatment was $610.96 for collagenase, $920.73 for autolysis, $986.38 for fibrinolysin, and $1,008.72 for wet-to-dry dressings. CONCLUSIONS: The study patient was most likely to have a clean wound bed after 2 and 4 weeks of treatment, less likely to need to switch debridement methods, and of equal or less likelihood of experiencing and infection and subsequent hospitalization when her wound was debrided with collagenase. Treatment with collagenase also resulted in the lowest total cost of treatment. Longer term, prospective studies using actual utilization data are needed to refine these estimates of the clinical and cost-effectiveness of each product.