Cost Effectiveness of Becaplermin Gel on Wound Closure for the Treatment of Pressure Injuries.

OBJECTIVE: This study aims to determine the cost effectiveness of becaplermin gel on wound healing for the treatment of stage 3 and stage 4 pressure injuries (PIs). MATERIALS AND METHODS: A 2-stage Markov model was used to predict expected costs and outcomes of wound healing for becaplermin gel once daily plus good wound care (BGWC) compared with a placebo gel plus good wound care (control) over 1 year; good wound care consisted of debridement, infection management, and moisture balance. Patients in both arms received dressing changes and gel applications twice daily. Outcome data used in the analysis were derived from a 16-week randomized clinical trial. The primary outcome of interest was PI-free weeks. Transition probabilities for the Markov states were estimated from the clinical trial. Pressure injury recurrence rates were derived from PI literature. Utilization for becaplermin was calculated using the manufacturer's recommended dosing algorithm. Costs were derived from standard cost references and medical supply wholesalers; economic perspective taken was that of the long-term care facility. RESULTS: A total of 62 patients completed the study: 31 for BGWC and 31 for control. Over 1 year, patients treated with BGWC had substantially higher PI-free weeks compared with control patients (11.6 vs. 3.1, respectively). Patients treated with BGWC incurred higher total costs than those receiving the control treatment. Expected annual direct costs for PI were $3827 for BGWC and $1279 for the control. The incremental cost-effectiveness ratio was $298 (about $43/day), indicating that patients would have to pay an extra $298 to gain 1 additional PI-free week. CONCLUSIONS: Becaplermin gel plus good wound care was cost effective over standard of care, yielding better outcomes at a slightly higher cost and should be considered for management of PIs.

Cost-minimization Analysis of Negative Pressure Wound Therapy in Long-term Care Facilities.

OBJECTIVE: This study aims to conduct a cost-minimization analysis comparing wound treatment costs between single-use negative pressure wound therapy (sNPWT) and traditional negative pressure wound therapy (tNPWT). MATERIALS AND METHODS: Assuming comparable outcomes, cost data obtained from the ECRI Institute were compared between the 2 NPWT options using data extracted from an electronic wound management program between August 2010 and March 2016. RESULTS: Use of sNPWT versus tNPWT resulted in daily and total treatment duration cost savings of $55 and $1586, respectively. CONCLUSIONS: Long-term care facilities can potentially accrue significant cost savings by using sNPWT instead of tNPWT on a majority of eligible wounds.

Clostridial collagenase ointment and medicinal honey utilization for pressure ulcers in US hospitals.

AIMS: To describe the utilization of clostridial collagenase ointment (CCO) and medicinal honey debridement methods in real-world inpatient and outpatient hospital settings among pressure ulcer (PU) patients and compare the frequency of healthcare re-encounters between CCO- and medicinal honey-treated patients. MATERIALS AND METHODS: De-identified hospital discharge records for patients receiving CCO or medicinal honey methods of debridement and having an ICD-9 code for PU were extracted from the US Premier Healthcare Database. Multivariable analysis was used to compare the frequency of inpatient and outpatient revisits up to 6 months after an index encounter for CCO- vs medicinal honey-treated PUs. RESULTS: The study identified 48,267 inpatients and 2,599 outpatients with PUs treated with CCO or medicinal honeys. Among study inpatients, n = 44,725 (93%) were treated with CCO, and n = 3,542 (7%) with medicinal honeys. CCO and medicinal honeys accounted for 1,826 (70%) and 773 (30%), respectively, of study outpatients. In adjusted models, those treated with CCO had lower odds for inpatient readmissions (OR = 0.86, 95% CI = 0.80-0.94) after inpatient index visits, and outpatient re-encounters both after inpatient (OR = 0.73, 95% CI = 0.67-0.79) and outpatient (OR = 0.78, 95% CI = 0.64-0.95) index visits in 6 months of follow-up. LIMITATIONS: The study was observational in nature, and did not adjust for reasons why patients were hospitalized initially, or why they returned to the facility. Although the study adjusted for differences in a variety of demographic, clinical, and hospital characteristics between the treatments, we are not able to rule out selection bias. CONCLUSION: Patients with CCO-treated PUs returned to inpatient and outpatient hospital settings less often compared with medicinal honey-treated PUs. These results from real-world administrative data help to gain a better understanding of the clinical characteristics of patients with PUs treated with these two debridement methods and the economic implications of debridement choice in the acute care setting.

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers.

Chronic dermal ulcers affect approximately 2.4-4.5 million people in the USA and are associated with loss of function, decreased quality of life and significant economic burden. Debridement is a critical component of wound care involving removal of nonviable tissue from chronic wounds to stimulate the granulation and epithelialization process. Clostridial collagenase ointment has been used as a method of wound debridement for more than 50 years and is currently the only enzymatic debriding ointment with US FDA approval. This review discusses the results of recent real-world studies that build upon the evidence demonstrating the clinical effectiveness, cost-effectiveness and safety of clostridial collagenase ointment across wound types and care settings.

Economic analysis and budget impact of clostridial collagenase ointment compared with medicinal honey for treatment of pressure ulcers in the US.

OBJECTIVES: Pressure ulcer (PU) treatment poses significant clinical and economic challenges to health-care systems. The aim of this study was to assess the cost-effectiveness and budget impact of enzymatic debridement with clostridial collagenase ointment (CCO) compared with autolytic debridement with medicinal honey (MH) for PU treatment from a US payer/Medicare perspective in the hospital outpatient department setting. METHODS: A cost-effectiveness analysis using a Markov model was developed using a 1-week cycle length across a 1-year time horizon. The three health states were inflammation/senescence, granulation/proliferation (ie, patients achieving 100% granulation), and epithelialization. Data sources included the US Wound Registry, Medicare fee schedules, and other published clinical and cost studies about PU treatment. RESULTS: In the base case analysis over a 1-year time horizon, CCO was the economically dominant strategy (ie, simultaneously conferring greater benefit at less cost). Patients treated with CCO experienced 22.7 quality-adjusted life weeks (QALWs) at a cost of $6,161 over 1 year, whereas MH patients experienced 21.9 QALWs at a cost of $7,149. Patients treated with CCO achieved 11.5 granulation weeks and 6.0 epithelization weeks compared with 10.6 and 4.4 weeks for MH, respectively. The number of clinic visits was 40.1 for CCO vs 43.4 for MH, and the number of debridements was 12.3 for CCO compared with 17.6 for MH. Probabilistic sensitivity analyses determined CCO dominant in 72% of 10,000 iterations and cost-effective in 91%, assuming a benchmark willingness-to-pay threshold of $50,000/quality-adjusted life year ($962/QALW). The budget impact analysis showed that for every 1% of patients shifted from MH to CCO, a cost savings of $9,883 over 1 year for a cohort of 1,000 patients was observed by the payer. CONCLUSION: The results of these economic analyses suggest that CCO is a cost-effective, economically dominant alternative to MH in the treatment of patients with PUs in the hospital outpatient department setting.

Comparative Effectiveness of Clostridial Collagenase Ointment to Medicinal Honey for Treatment of Pressure Ulcers.

Objective: Compare enzymatic debridement using clostridial collagenase ointment (CCO) with autolytic debridement using medicinal honey in the hospital outpatient setting for treating pressure ulcers (PUs). Approach: Retrospective deidentified electronic health records from 2007-2013 were extracted from the U.S. Wound Registry. Propensity score matching followed by multivariable analyses was used to adjust for selection bias and assess treatment effects comparing CCO-treated versus honey-treated PUs. Key outcomes included 100% granulation and epithelialization at 1 year. Results: Five hundred seventeen CCO-treated PUs (446 patients) were matched to corresponding honey-treated PUs (341 patients). The majority of PUs were stage III (CCO 56%, honey 55%). CCO users had significantly fewer total visits (9.1 vs. 12.6; p < 0.001), fewer total selective sharp debridements (2.7 vs. 4.4; p < 0.001), and fewer PUs receiving negative pressure wound therapy (29% vs. 38%; p = 0.002) compared with honey. Innovation: CCO-treated PUs were 38% more likely to achieve 100% granulation compared to honey-treated PUs at 1 year, p = 0.018. Mean days to 100% granulation were significantly lower for CCO-treated PUs (255 vs. 282 days, p < 0.001). CCO-treated PUs were 47% (p = 0.024) more likely to epithelialize at 1 year compared to PUs treated with honey. Mean days to epithelialization were significantly lower for PUs treated with CCO at 1 year (288 vs. 308 days; p = 0.011). Conclusion: All stages of PUs treated with CCO achieved faster rates of granulation and subsequent epithelialization compared to PUs treated with medicinal honey as measured by real-world data collected in the hospital outpatient department care setting.

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.

Erratum to: Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial.

[This corrects the article DOI: 10.1186/s13047-015-0065-x.].

Treating pressure ulcers with clostridial collagenase ointment: Results from the US Wound Registry.

We assessed the clinical effectiveness of clostridial collagenase ointment (CCO) as an adjunct to selective debridement compared with selective debridement alone for the management of stage IV pressure ulcers (PU) in the hospital outpatient department setting. Outcome data were derived from retrospective de-identified electronic medical records from 2007 to 2013 using the US Wound Registry. A propensity score method was used to adjust for selection bias and to test for treatment effect between PU treated with CCO plus selective debridement vs. selective debridement alone. A total of 337 CCO and 336 non-CCO stage IV PU were identified. The proportion of wounds closed at any time (e.g., at 1 or 2 years) was two times greater for stage IV PU treated with CCO compared with those not treated with CCO. Kaplan-Meier analysis showed that time to wound closure at 1 year was significantly faster for PU treated with CCO vs. PU not treated with CCO. Among those with five or more CCO applications or selective debridement treatments, significantly more CCO-treated PU were closed at 1 or 2 years than non-CCO-treated PU. CCO as an adjunct to selective debridement improved clinical outcomes and provided faster rates of closure of stage IV PU relative to selective debridement alone.

Difficult-to-heal wounds of mixed arterial/venous and venous etiology: a cost-effectiveness analysis of extracellular matrix.

IMPORTANCE: Difficult-to-heal wounds pose clinical and economic challenges, and cost-effective treatment options are needed. OBJECTIVE: The aim of this study is to determine the cost-effectiveness of extracellular matrix (ECM) relative to standard of care (SC) on wound closure for the treatment of mixed arterial/venous (A/V) or venous leg ulcers (VLUs). DESIGN SETTING AND PARTICIPANTS: A two-stage Markov model was used to predict the expected costs and outcomes of wound closure for ECM and SC. Outcome data used in the analysis were taken from an 8-week randomized clinical trial that directly compared ECM and SC. Patients were followed up for an additional 6 months to assess wound closure. Forty-eight patients completed the study; 25 for ECM and 23 for SC. SC was defined as a standard moist wound dressing. Transition probabilities for the Markov states were estimated from the clinical trial. MAIN OUTCOMES AND MEASURES: The economic outcome of interest was direct cost per closed-wound week. Resource utilization was based on the treatment regimen used in the clinical trial. Costs were derived from standard cost references. The payer's perspective was taken. RESULTS: ECM-treated wounds closed, on average, after 5.4 weeks of treatment, compared with 8.3 weeks for SC wounds (P=0.02). Furthermore, complete wound closure was significantly higher in patients treated with ECM (P<0.05), with 20 wounds closed in the ECM group (80%) and 15 wounds closed in the SC group (65%). After 8 months, patients treated with ECM had substantially higher closed-wound weeks compared with SC (26.0 weeks versus 22.0 weeks, respectively). Expected direct costs per patient were $2,527 for ECM and $2,540 for SC (a cost savings of $13). CONCLUSION AND RELEVANCE: ECM yielded better clinical outcomes at a slightly lower cost in patients with mixed A/V and VLUs. ECM is an effective treatment for wound healing and should be considered for use in the management of mixed A/V and VLUs.

Cost-Effectiveness of Becaplermin Gel on Diabetic Foot Ulcer HealingChanges in Wound Surface Area.

BACKGROUND: A comparison of the cost-effectiveness of becaplermin plus good wound care (BGWC) versus good wound care (GWC) alone in treating patients with diabetic foot ulcers (DFUs) may enable physicians and health-care decision makers in the United States to make better-informed choices about treating DFUs, which currently contribute to a substantial portion of the economic burden of diabetes. METHODS: Data from three phase III trials were used to predict expected 1-year costs and outcomes, including the average percentage reduction from baseline in wound surface area (WSA), the direct costs of DFU therapy, and the cost per cm(2) of WSA reduction. RESULTS: At 20 weeks, the BGWC group had a statistically greater probability of complete wound closure than the GWC group (50% versus 35%; P = .015). Based on reported WSA reduction rates, DFUs in the BGWC group were predicted to close by 100% at 27 weeks, and those in the GWC group were predicted to close by 88% at 52 weeks. The GWC group had higher total estimated 1-year direct cost of DFU care ($6,809 versus $4,414) and higher cost per cm(2) of wound closure ($3,501 versus $2,006). CONCLUSIONS: Becaplermin plus good wound care demonstrated economic dominance compared with GWC by providing better clinical outcomes via faster reduction in WSA and higher rates of closure at a lower direct cost.

Cost-effectiveness of becaplermin gel on wound healing of diabetic foot ulcers.

We sought to determine the long-term cost effectiveness (payer's perspective) of becaplermin gel plus good wound care (BGWC) vs. good wound care (GWC) alone in terms of wound healing and risk of amputation in patients with diabetic foot ulcers (DFUs). Outcomes data were derived from a propensity score-matched cohort from the Curative Health Services database between 1998 and 2004, which was followed for 20 weeks. A four-state Markov model was used to predict costs and outcomes of wound healing and risk of amputation for BGWC vs. GWC alone over 1 year in patients with DFU. The primary outcome was closed-wound weeks. Transition probabilities for healing and amputation were derived from the aforementioned propensity score-matched cohorts. Ulcer recurrence was estimated from the medical literature. Utilization for becaplermin was calculated using the dosing algorithm in the product labeling. Of 24,898 eligible patients, 9.6% received BGWC. Based on the model, patients treated with BGWC had substantially more closed-wound weeks compared with GWC (16.1 vs. 12.5 weeks, respectively). More patients receiving BGWC had healed wounds at 1 year compared with those receiving GWC (48.1% vs. 38.3%). Risk of amputation was lower in the BGWC cohort (6.8% vs. 9.8%). Expected annual direct costs for DFU were $21,920 for BGWC and $24,640 for GWC. BGWC was economically dominant over GWC, providing better outcomes at a lower cost in patients with DFU. Compared with GWC alone, BGWC is more effective in healing wounds and lowering amputation risk, thereby decreasing long-term costs for DFU.

Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial.

BACKGROUND: Approximately 10%-15% of people with diabetes develop at least one foot ulcer during their lifetime. Treatment of diabetic foot ulcers (DFUs) represents a significant economic burden. Enzymatic debridement with clostridial collagenase ointment (CCO) can be used to remove necrotic tissue from wounds. This study examined the impact of CCO as an effective adjunct therapy to serial sharp debridement (SSD) and assessed the cost-effectiveness of CCO compared with standard DFU treatments over 1 year. METHODS: Adults 18 years or older with a diagnosis of type 1 or type 2 diabetes who had a neuropathic DFU were enrolled in a 12-week, randomized, open-label trial. Patients were randomly assigned to either treatment with CCO + SSD or to investigator-selected supportive care + SSD (Control). A 3-state Markov model with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of healed-wound weeks and the expected DFU cost per patient. The 3 states included unhealed, healed, and death. Results were extrapolated to 1 year to estimate the number of healed-wound weeks per treatment and the average cost to achieve epithelialization. The perspective of the analysis was that of the payer, specifically, the third party payer. RESULTS: The study sample included 55 patients (28 in CCO group; 27 Control). The majority were men (74.5%) with a mean age of 57.9 years. Projected healing rates were greater for the CCO + SSD group compared to Control (89% vs. 80%, respectively). The expected number of epithelialized weeks accumulated over 1 year was 25% greater in the CCO + SSD group than for Control (35 vs. 28 weeks, respectively). Over a 1-year time horizon, the expected cost per DFU was greater in the Control group than the CCO group ($2,376 vs. $2,099, respectively). The estimated cost per ulcer-free week was 40% higher for Control ($85/closed-wound week) than for CCO + SSD ($61/closed-wound week). CONCLUSIONS: CCO + SSD therapy is a cost-effective method of debridement in the management of patients with DFUs, providing better outcomes at a lower cost. Further high quality trials are needed to confirm this finding. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov as NCT01408277.

Cost-effectiveness of three adjunct cellular/tissue-derived products used in the management of chronic venous leg ulcers.

OBJECTIVES: Determine the cost-effectiveness of three topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to standard care in the management of venous leg ulcers (VLUs). METHODS: A three-state Markov model derived from the medical literature was developed to estimate the comparative cost-effectiveness of three CTPs in relation to VLU standard care. CTPs evaluated in the study included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE). The three Markov states included unhealed, healed, and death. A 1-year time horizon was used to determine the number of ulcer-free weeks and the expected costs of therapies. The payer perspective was taken in the analysis and only the direct costs of care were considered. Sensitivity analyses were performed to gauge model parameter uncertainty. RESULTS: The expected costs for standard care, ECM, HSE, and LSE VLU therapy were $6,132, $6,732, $10,638, and $11,237, while the expected outcomes were 24, 31, 29, and 27 ulcer-free weeks, respectively. ECM was economically dominant among the three CTPs. In the base case of ECM versus standard care, the incremental cost-effectiveness ratio for ECM therapy was $86 per ulcer-free week. Sensitivity analysis did not alter ECM dominance. Clinic visits and home health utilization exhibited the greatest influence on cost. CONCLUSIONS: ECM is the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. These findings suggest that VLU standard care therapy with ECM can yield potential cost savings and produce better outcomes than do other CTPs.

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.

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.

Economic and clinical benefit of collagenase ointment compared to a hydrogel dressing for pressure ulcer debridement in a long-term care setting.

INTRODUCTION: The purpose of this study is to determine the cost-effectiveness of collagenase ointment relative to autolysis with a hydrogel dressing when debriding necrotic pressure ulcers in a long-term care setting. METHODS: A Markov decision process model with 2 states (necrotic nonviable wound bed transitioning to a granulated viable wound bed) was developed using data derived from a prospective, randomized, 6-week, single-center trial of 27 institutionalized subjects with pressure ulcers that were ≥ 85% necrotic nonviable tissue. Direct medical costs from the payer perspective included study treatments, wound treatment supplies, and nursing time. Clinical benefit was measured as "granulation days" and was derived from the time-dependent debridement rates of the alternative products. RESULTS: The average cost per patient for 42 days of pressure ulcer care was $1,817 in 2012 for the collagenase group and $1,611 for the hydrogel group. Days spent with a granulated wound were 3.6 times higher for collagenase (23.4 vs 6.5) than with the hydrogel. The estimated cost per granulation day was > 3.2 times higher for hydrogel ($249) vs collagenase ($78). CONCLUSIONS: In this economic analysis based on a randomized, controlled clinical trial, collagenase ointment resulted in a faster time to complete debridement and was more cost-effective than hydrogel autolysis for pressure ulcers in a long-term care setting. Even though collagenase ointment has a higher acquisition cost than hydrogel, the clinical benefit offsets the initial cost difference, resulting in lower cost per granulation day to the nursing home over the course of the 42-day analysis.

Correction of high myopia with a phakic intraocular lens: interim analysis of clinical and patient-reported outcomes.

PURPOSE: To assess uncorrected distance visual acuity (UDVA) and patient-reported outcome changes after bilateral anterior chamber angle-fixated phakic intraocular lens (pIOL) implantation for high myopia. SETTING: Multiple North American surgical centers. DESIGN: Nonrandomized multicenter clinical trials. METHODS: This was a pooled interim analysis of 2 open-label single-arm studies of high myopia patients with bilateral anterior chamber angle-fixated pIOLs. Assessments compared baseline with 6-month, 1-year, and 2-year measurements. Outcomes included binocular UDVA, binocular corrected distance visual acuity (CDVA), satisfaction with vision, spectacle independence, and Refractive Status and Vision Profile (RSVP) questionnaire results. RESULTS: One hundred thirty-eight patients (mean age 37 years, 67% women) completed all 4 assessments. The UDVA at 6 months, 1 year, and 2 years postoperatively was statistically better than the baseline CDVA (0.12 logMAR, 0.11 logMAR, 0.12 logMAR, respectively, versus 0.06 logMAR) (P<.005). The increase in preoperative to postoperative satisfaction with uncorrected vision was significant (P<.0001). Distance vision spectacle independence improved from 0% preoperatively to 94% postoperatively (P<.0001). Patients reported significant improvements in the RSVP overall score (P<.0001) and the following 7 subscales: concern with vision (P<.0001), driving (P<.001), problems with glare (P<.05), optical problems (P ≤.001), physical/social functioning (P<.0001), problems with corrective lenses (P<.005), and ocular symptoms (P<.0001). CONCLUSIONS: After pIOL implantation, the UDVA was better than the preoperative CDVA and most patients required no distance vision correction, had improved satisfaction with uncorrected vision, and had improved vision-related quality of life.

Improvements in patient-reported outcomes and visual acuity after bilateral implantation of multifocal intraocular lenses with +3.0 diopter addition: multicenter clinical trial.

PURPOSE: To assess changes in patient-reported outcomes, satisfaction, vision quality, and visual acuity after bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D addition (add) in cataract patients. SETTING: Twelve study centers, United States. DESIGN: Randomized multicenter clinical trial. METHODS: In this 6-month trial, cataract patients had bilateral implantation of the AcrySof IQ ReSTOR +3.0 IOL (model SN6AD1). Patient-reported outcomes were collected using the Cataract TyPE questionnaire. Clinical outcomes included uncorrected near (UNVA), uncorrected intermediate (UIVA), and uncorrected distance (UDVA) visual acuities. RESULTS: The study comprised 147 patients. From preoperatively to 6 months postoperatively, the mean UDVA improved from 0.45 logMAR (approximate Snellen, 20/56) to 0.04 logMAR (20/22 Snellen), the mean UIVA from 0.56 logMAR (20/73) to 0.17 logMAR (20/30), and the mean UNVA from 0.62 logMAR (20/83) to 0.10 logMAR (20/25); all improvements were clinically and statistically significant (P<.0001). There was also a statistically significant improvement in patient satisfaction with uncorrected vision (P<.0001). Clinically and statistical significant reductions occurred in trouble with vision (daytime and nighttime), trouble with glare, limitations with UDVA, limitations with UNVA, and limitations in social activities (P<.0001). CONCLUSIONS: Bilateral implantation of multifocal intraocular lenses (IOLs) with a 3.00 D add produced statistically significant and clinically relevant postoperative improvements in UNVA, UIVA, and UDVA. Commensurate significant postoperative improvements were observed in the patient-reported uncorrected functional vision, satisfaction with uncorrected vision, and social activities.

Economic evaluation of toric intraocular lens: a short- and long-term decision analytic model.

OBJECTIVE: To assess the economic value of improved uncorrected visual acuity among patients with cataract and preexisting astigmatism treated with toric intraocular lenses (IOLs) compared with conventional monofocal IOLs. METHODS: We developed a decision analytic model of hypothetical patients with preexisting astigmatism. We examined costs and outcomes among patients 65 years and older with cataract and preexisting astigmatism (1.5-3.0 diopters) who were receiving either toric or conventional IOLs with and without intraoperative refractive correction (IRC). Data were obtained from the literature and from a survey of 60 US ophthalmologists. Total medical costs of bilateral treatment were calculated for the first posttreatment year and remaining lifetime. Cost-effectiveness and cost-utility outcomes were computed. Future costs and utilities were discounted by 3%. RESULTS: A larger proportion of patients receiving toric IOLs achieved distance vision spectacle independence (67%) and uncorrected visual acuity of 20/25 or better OU (53%) compared with conventional IOLs with (63% and 48%, respectively) or without IRC (53% and 44%, respectively), resulting in fewer future vision corrections. Toric IOLs provided an additional 10.20 quality-adjusted life years (QALYs) compared with conventional IOLs with (10.14 QALYs) and without IRC (10.10 QALYs). Higher first-year costs of the toric IOL ($5739) compared with the conventional IOL with ($5635) or without ($4687) IRC were offset by lifetime cost savings of $34 per patient, $393 per patient achieving uncorrected visual acuity of 20/25 or better, and $349 per QALY compared with the conventional IOL without IRC. CONCLUSIONS: Toric IOLs reduce lifetime economic costs by reducing the need for glasses or contact lenses following cataract removal. These results can inform physicians and patients regarding the value of toric IOLs in the treatment of cataract and preexisting astigmatism.