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.

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.

Comparison of clinical and patient-reported outcomes with bilateral AcrySof toric or spherical control intraocular lenses.

PURPOSE: To compare clinical and patient-reported outcomes with bilateral implantation of AcrySof toric or spherical control (Alcon Laboratories Inc) intraocular lenses (IOLs). METHODS: Patients with cataract and corneal astigmatism who previously received either an AcrySof toric IOL or an AcrySof spherical control IOL were offered implantation of the same IOL in the fellow eye. Six-month assessments included visual acuity, refractive cylinder, spectacle use, and patient satisfaction. RESULTS: The study included 62 patients (toric, n=40; control, n=22). All corneal incisions were temporal, with final mean incision sizes of 3.0 mm for the toric IOL and 3.1 mm for the spherical control IOL. A significantly greater proportion of patients with toric IOLs achieved spectacle independence for distance vision and did not require prescription glasses for near or distance vision (P=.0190). Patients with toric IOLs had significantly less residual refractive cylinder (P<.0001) and better binocular distance uncorrected visual acuity (UCVA) (P=.0014) than those with spherical control IOLs. CONCLUSIONS: Patients with bilateral AcrySof toric IOLs achieved superior spectacle freedom, residual refractive cylinder, and distance UCVA compared to patients with bilateral spherical control IOLs.

A United States cost-benefit comparison of an apodized, diffractive, presbyopia-correcting, multifocal intraocular lens and a conventional monofocal lens.

PURPOSE: To demonstrate the value, from the patient's perspective, of an apodized, diffractive, presbyopia-correcting multifocal intraocular lens (MF-IOL) compared to a conventional monofocal intraocular lens (CM-IOL). SETTING: Open-label, multi-site U.S. clinical trial. METHODS: A cost-benefit analysis was conducted using cataract patients' willingness-to-pay (WTP) for spectacle independence as the measure of economic benefit. WTP was elicited from participants in a clinical trial comparing a MF-IOL and a CM-IOL. Costs borne by patients were obtained from standard reference sources. A 14-year analytical timeframe was used, and a 3% annual discount rate was applied to both costs and benefits. The outcome of interest was net benefit (difference between benefits and costs). A probabilistic sensitivity analysis was used to confirm the robustness of the economic results. RESULTS: Four hundred ninety-five patients provided WTP estimates for spectacle independence (MF-IOL, n = 339; CM-IOL, n = 156). Eighty percent of all patients were willing to pay at least $5 per day to be spectacle independent. The incremental acquisition cost associated with bilateral implantation of 2 MF-IOLs was estimated at $4,000. Eighty percent in the MF-IOL group and 8% in the CM-IOL group reported post-operative spectacle independence. The net benefit was $11,670 in the MF-IOL group and $155 in the CM-IOL group. The probabilistic sensitivity analysis confirmed the robustness of the economic outcomes. CONCLUSION: The net benefit of the MF-IOL exceeded its acquisition cost and the net benefit of the CM-IOL, demonstrating its value to select cataract patients willing to pay a premium for spectacle independence.

An economic evaluation of two ototopical treatments for acute otitis media in tympanostomy tube patients.

OBJECTIVE: The goal of this research was to determine the cost-effectiveness of ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension versus ofloxacin 0.3% otic solution (OFX) for treatment of acute otitis media in tympanostomy tube patients. METHODS: A decision-analytic model was used to emulate the ototopical treatment of acute otitis media in patients with tympanostomy tubes. The economic outcome was the cost per otorrhea-free day (OFD) achieved per episode of care. Three tiers of antimicrobial therapy were modeled, with each successive tier representing the retreatment of clinical failures from the preceding tier. First-tier therapy compared CD and OFX using outcome measures obtained from a randomized clinical trial (n = 599). Second-tier therapy modeled the use of amoxicillin/clavulanate (ACA) using outcome measures obtained from a physician survey and medical literature. Third-tier therapy was modeled as pathogen-specific and curative. It could follow one of three pathways: 1) intramuscular ceftriaxone; 2) oral fluconazole; or 3) hospitalization for intravenous antibiotics. Third-tier outcomes were based on a physician survey. Cost data were obtained from standard references and presented from a payer perspective. RESULTS: The expected therapeutic costs were 249.40 dollars for the CD pathway and 265.44 dollars for the OFX pathway. The estimated number of OFDs per episode of care was 25.88 for the CD pathway and 23.86 for the OFX pathway. The cost-effectiveness ratios for CD and OFX therapies were 9.64 dollars and 11.13 dollars per OFD, respectively. CONCLUSION: CD is both more effective and less costly than OFX for the treatment of acute otitis media in patients with tympanostomy tubes.

A cost threshold analysis of ciprofloxacin-dexamethasone versus ofloxacin for acute otitis media in pediatric patients with tympanostomy tubes.

OBJECTIVE: The aim of this study was to determine the cost-effectiveness hreshold of a ciprofloxacin 0.3% and dexamethasone 0.1% (CD) otic suspension relative to olfloxacin otic solution (OFX) for the treatment of acute otitis media in pediatric patients with tympanostomy tubes (AOMT). METHODS: This study used a decision-analytic model to simulate the costs and consequences of the ototopical treatment of AOMT. The AOMT model consisted of 3 tiers of antimicrobial therapy. Each successive tier represented the repeat treatment of clinical failures from the preceding tier. Patients were modeled for treatment until cured or until third-tier therapy was complete, at which time patients were considered cured. First-tier therapy modeled a comparison of CD and OFX using efficacy rates taken from a randomized clinical trial with a population of 599 patients. Second-tier therapy modeled the use of amoxicillin and clavulanic acid using an efficacy rate taken from the medical literature. Third-tier therapy was modeled as being pathogen specific and could follow 1 of 3 possible clinical pathways: (1) PO fluconazole, (2) IM ceftriaxone, or (3) IV antibiotics administered in a hospital setting. Third-tier therapeutic pathway probabilities were based on the microbiologic spectrum of the treatment failures from the clinical trial. Cost information (in year-2003 US dollars) was taken from accepted cost reference sources and presented from the perspective of a third-party payer. The economic outcome of interest was the cost-effectiveness threshold of CD relative to OFX. RESULTS: Given the model parameters, CD had a cost-effectiveness threshold value of 4.5 times the wholesale acquisition cost of OFX. Based on actual cost, first-tier CD therapy was more cost-effective than OFX up to a threshold price of US 152.64 dollars. CONCLUSION: In this decision-analytic model, CD was more cost-effective than OFX for AOMT therapy in pediatric patients up to a threshold price of 4.5 times the price of OFX.