Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET-altered solid tumors in the US.

OBJECTIVE: To estimate the potential budget impact on US third party payers (commercial or Medicare) associated with addition of selpercatinib as a tumor-agnostic treatment for patients with Rearranged during Transfection (RET)-altered solid tumors. METHODS: An integrated budget impact model (iBIM) with 3-year (Y) time horizon was developed for 19 RET-altered tumors. It is referred to as an integrated model because it is a single model that integrated results across multiple tumor types (as opposed to tumor-specific models developed traditionally). The model estimated eligible patient populations and included tumor-specific comparator treatments for each tumor type. Estimated annual total costs (2022USD, $) included costs of drug, administration, supportive care, and toxicity. For a one-million-member plan, the number of patients with RET-altered tumors eligible for treatment, incremental total costs, and incremental per-member per-month (PMPM) costs associated with introduction of selpercatinib treatment were estimated. Uncertainty associated with model parameters was assessed using various sensitivity analyses. RESULTS: Commercial perspective estimated 11.68 patients/million with RET-altered tumors as treatment-eligible annually, of which 7.59 (Y1), 8.17 (Y2), and 8.76 (Y3) patients would be selpercatinib-treated (based on forecasted market share). The associated incremental total and PMPM costs (commercial) were estimated to be: $873,099 and $0.073 (Y1), $2,160,525 and $0.180 (Y2), and $2,561,281 and $0.213 (Y3), respectively. The Medicare perspective estimated 55.82 patients/million with RET-altered tumors as treatment-eligible annually, of which 36.29 (Y1), 39.08 (Y2), and 41.87 (Y3) patients would be selpercatinib-treated. The associated incremental total and PMPM costs (Medicare) were estimated to be: $4,447,832 and $0.371 (Y1), $11,076,422 and $0.923 (Y2), and $12,637,458 and $1.053 (Y3), respectively. One-way sensitivity analyses across both perspectives identified drug costs, selpercatinib market share, incidence of RET, and treatment duration as significant drivers of incremental costs. CONCLUSIONS: Three-year incremental PMPM cost estimates suggest a modest impact on payer-budgets associated with introduction of tumor-agnostic selpercatinib treatment.

Ixekizumab treatment patterns and healthcare utilization and costs for patients with psoriasis.

Objectives: To describe ixekizumab treatment patterns, all-cause healthcare utilization, and costs among psoriasis patients.Methods: Adults diagnosed with psoriasis having ≥1 ixekizumab claim were selected from MarketScan® databases between March 01, 2016 and July 31, 2017. Patients were continuously enrolled for ≥6 months prior and ≥3 months after the index date (first ixekizumab claim) and followed until inpatient death, end of enrollment, or end of data. Treatment patterns included persistence, switching, and re-initiation. All-cause utilization and costs were reported per-patient-per-month (PPPM).Results: 801 patients (mean age 49 years; 55.8% male; median follow-up 201 days) were included. Among all patients, 87.4% were persistent (mean (median) duration 86 (75) days) Of the 12.6% of patients who discontinued ixekizumab, 11.9% re-initiated and 6.9% switched treatments. Mean (median) time to switching was 208 (206) days. Mean number of all-cause inpatient admissions and physician office visits PPPM were 0.01 and 0.72, respectively. Mean total cost PPPM was $8,371, of which pharmacy comprised $7,792. Ixekizumab costs, $7,079, occurred primarily during induction and were paid predominantly by health plans ($6,810 [96.2%]).Conclusion: Most (87.4%) ixekizumab users remained persistent during follow-up. Pharmacy was the primary driver of total healthcare costs, with the majority covered by health plans and <4% as patient out-of-pocket expense.

Comparison of all-cause, stroke, and bleed-specific healthcare resource utilization among patients with non-valvular atrial fibrillation (NVAF) and newly treated with dabigatran or warfarin.

BACKGROUND: We compared healthcare utilization outcomes and persistence among non-valvular atrial fibrillation (NVAF) patients newly treated with dabigatran or warfarin. METHODS: Using a nationwide, US administrative claims database, a retrospective matched-cohort of newly diagnosed NVAF patients (age≥18 years) treated with dabigatran or warfarin (propensity score matched 1:1) in 01/01/2011-12/31/2013 was evaluated. All-cause, stroke-, and bleed-specific per patient per month (PPPM) healthcare resource utilization (HCRU), incidence rate of hospitalization for stroke or bleed, 30-day readmission, and persistence were reported. RESULTS: In total, 18,890 dabigatran patients were matched to corresponding warfarin patients. Compared to warfarin users, dabigatran users PPPM had significantly fewer all-cause hospitalizations (0.04 vs 0.05), total outpatient visits (3.98 vs 5.87), and lower 30-day readmissions (14.5% vs 17.4%, all p < 0.001). Dabigatran users had lower incidence rate for stroke (0.65 vs 1.06) and bleed (1.69 vs 2.20), stroke (0.0006 vs 0.0011, p < 0.001) and bleed-specific hospitalizations (0.002 vs 0.003, p = 0.008), and stroke (0.03 vs 0.04, p < 0.001) and bleed-specific outpatient visits (0.07 vs 0.08, p = 0.018), and significantly lower non-persistence (62.1% vs 66.3%, p < 0.001). CONCLUSION: Among newly diagnosed newly treated NVAF patients, dabigatran users had significantly lower all-cause, stroke- and bleed-specific HCRU, lower risk of hospitalization for stroke or bleed events, lower 30-day readmissions, and higher persistence than warfarin users.

Comparison of stroke- and bleed-related healthcare resource utilization and costs among patients with newly diagnosed non-valvular atrial fibrillation and newly treated with dabigatran, rivaroxaban, or warfarin.

BACKGROUND: This is one of the first head-to-head real-world evidence studies comparing stroke-related and bleed-related healthcare and resource utilization (HCRU) and costs among non-valvular atrial fibrillation (NVAF) patients initiating oral anticoagulants. METHODS: Adult NVAF patients newly diagnosed and treated with dabigatran, rivaroxaban, or warfarin between 10/01/2010 and 12/31/2014 were identified using MarketScan Commercial and Medicare Supplemental databases. Per-patient-per-month stroke and bleed-related HCRU and costs were reported. RESULTS: Dabigatran patients were matched 1:1 to 26,592 rivaroxaban and 33,024 warfarin patients (mean age=68 years). Compared to rivaroxaban, dabigatran patients had lower bleed-related inpatient and outpatient HCRU (0.004 vs. 0.005; 0.099 vs. 0.145) and significantly lower adjusted bleed-related costs ($116 vs. $172), all p <0.05. Compared to warfarin, dabigatran patients had significantly lower stroke-related outpatient visits (0.034 vs. 0.048, p<0.001) and higher bleed-related outpatient visits (0.101 vs. 0.091, p=0.045). Multivariate adjusted bleed-related costs were significantly lower for dabigatran patients than warfarin patients ($94 vs. $138, p<0.001). CONCLUSIONS: The results suggest that dabigatran patients had lower bleed-related HCRU and costs than rivaroxaban patients, and lower outpatient stroke-related HCRU, higher bleed-related outpatient HCRU, and lower bleed-related costs than warfarin patients. It provides valuable stroke-related and bleed-related HCRU and costs information among commercially insured and Medicare patients.

Health Economics and Outcomes Research of Wound Care: Overview of Methodology.

Objective: To provide an overview of comparative effectiveness research (CER) methodology and discuss the challenges of health economics and outcomes research (HEOR) in wound care. Approach: Narrative description of HEOR methodology with supporting references. Results: With the increasing costs of clinical trials, the use of observational studies in a real-world setting will be essential. Wound care clinicians should understand the importance of proper methods for conducting CER studies. Propensity score methods and marginal structural modeling can create a "quasi-randomized" environment for measuring wound closure and can help drive informed decision-making. In wound care, a paucity of HEOR information is available with great reluctance to use this information by payers, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and other agencies. Furthermore, a limited amount of high-quality retrospective data to measure wound care outcomes exist. The U.S. Wound Registry is one of few data sources that accurately reports on outcomes for all wound types and is a Qualified Clinical Data Registry. Innovation and Conclusions: Several CER approaches in observational studies provide sufficiently detailed information to help decision-makers make informed choices about wound care products regarding efficacy in the real-world setting. Using CER and cost-effectiveness studies succinctly needs to be incorporated if progress is to be made in improving wound care outcomes and reducing cost.

Direct and Indirect Costs Among United States Commercially Insured Employees With Migraine.

OBJECTIVE: The aim of this study was to compare direct, indirect, and societal (direct plus indirect) costs between patients with and without migraine (controls). METHODS: Patients with migraine were identified from MarketScan claims and Health and Productivity Management databases from January 1, 2010, to December 31, 2013, and were propensity score matched (1:1) to controls. RESULTS: Patients with migraine (N = 26,647) were matched to controls, of whom 4323 were matched for work absence and 26,212 for short-term disability eligibility. Mean annualized direct costs ($13,032 vs $3234), indirect costs due to absence ($4104 vs $3531) and short-term disability ($1131 vs $52), and societal costs due to absence ($16,043 vs $6938) and short-term disability ($14,278 vs $3182) were all significantly higher (P < 0.001) for those patients with migraine versus controls, respectively. CONCLUSION: Migraine imposes high direct and indirect economic burden on payers and society due to significantly higher work productivity loss than controls.

Death or Debt? National Estimates of Financial Toxicity in Persons with Newly-Diagnosed Cancer.

PURPOSE: The purpose of this study was to evaluate the impact of cancer upon a patient's net worth and debt in the US. METHODS: This longitudinal study used the Health and Retirement Study from 1998-2014. Persons ≥50years with newly-diagnosed malignancies were included, excluding minor skin cancers. Multivariable generalized linear models assessed changes in net worth and debt (consumer, mortgage, home equity) at 2 and 4 years after diagnosis (year+2, year+4), controlling for demographic and clinically-related variables, cancer-specific attributes, economic factors, and mortality. A 2-year period before cancer diagnosis served as a historical control. RESULTS: Across 9.5 million estimated new diagnoses of cancer from 2000-2012, individuals averaged 68.6±9.4 years with slight majorities being married (54.7%), not retired (51.1%), and Medicare beneficiaries (56.6%). At year+2, 42.4% depleted their entire life's assets, with higher adjusted odds associated with worsening cancer, requirement of continued treatment, demographic and socioeconomic factors (ie, female, Medicaid, uninsured, retired, increasing age, income, and household size), and clinical characteristics (ie, current smoker, worse self-reported health, hypertension, diabetes, lung disease) (P<.05); average losses were $92,098. At year+4, financial insolvency extended to 38.2%, with several consistent socioeconomic, cancer-related, and clinical characteristics remaining significant predictors of complete asset depletion. CONCLUSIONS: This nationally-representative investigation of an initially-estimated 9.5 million newly-diagnosed persons with cancer who were ≥50 years of age found a substantial proportion incurring financial toxicity. As large financial burdens have been found to adversely affect access to care and outcomes among cancer patients, the active development of approaches to mitigate these effects among already vulnerable groups remains of key importance.

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.

Comparison of all-cause costs and healthcare resource use among patients with newly-diagnosed non-valvular atrial fibrillation newly treated with oral anticoagulants.

OBJECTIVES: Compare costs and healthcare resource utilization (HCRU) among newly-diagnosed non-valvular atrial fibrillation (NVAF) patients newly treated with dabigatran vs apixaban, rivaroxaban, or warfarin. METHODS: Newly-diagnosed adult NVAF patients initiating dabigatran, apixaban, rivaroxaban, or warfarin (index event) between October 1, 2010-December 31, 2014 were identified using MarketScan claims data, and followed until medication discontinuation, switch, inpatient death, enrollment end, or study end (December 31, 2015). Dabigatran patients were propensity-score matched 1:1 separately with apixaban, rivaroxaban, and warfarin patients. Per-patient-per-month (PPPM) all-cause cost, HCRU, and 30-day re-admissions were reported. Costs were analyzed using generalized linear models. RESULTS: Final cohorts, each matched with dabigatran patients, included 8,857 apixaban patients, 26,592 rivaroxaban patients, and 33,046 warfarin patients. Dabigatran patients had lower adjusted PPPM total healthcare, inpatient, and outpatient costs compared to rivaroxaban ($4,093 vs $4,636, $1,476 vs $1,862, and $2,016 vs $2,121, respectively, all p ≤ .001) and warfarin ($4,199 vs $4,872, $1,505 vs $1,851, and $2,049 vs $2,514, respectively, all p < .001). Adjusted costs were similar for dabigatran and apixaban. Dabigatran patients had significantly fewer hospitalizations, outpatient visits, and pharmacy claims than rivaroxaban patients (0.06 vs 0.07, 4.84 vs 4.96 and 4.80 vs 4.93, respectively, all p < .020) and warfarin patients (0.06 vs 0.07, 4.77 vs 6.88, and 4.76 vs 5.89, respectively, all p < .001). Dabigatran patients had similar hospitalizations to apixaban, but higher outpatient visits (4.70 vs 4.31) and pharmacy claims (4.86 vs 4.61), both p < .001. CONCLUSIONS: This real-world study found adjusted all-cause costs were lower for dabigatran compared to rivaroxaban and warfarin patients and similar to apixaban patients.

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.

All-Cause, Stroke-, and Bleed-Specific Healthcare Costs: Comparison among Patients with Non-Valvular Atrial Fibrillation (NVAF) Newly Treated with Dabigatran or Warfarin.

OBJECTIVE: Our objective was to compare all-cause and stroke- and bleed-specific healthcare costs among patients with non-valvular atrial fibrillation (NVAF) treated with dabigatran or warfarin. METHODS: Administrative claims data from the MarketScan® Databases for 2009-2014 were used. Patients with NVAF newly treated with dabigatran were matched 1:1 to those treated with warfarin. All-cause and stroke- and bleed-specific costs per patient per month (PPPM) ($US, year 2015 values) up to a 12-month follow-up period were analyzed. Stroke- or bleed-specific costs were defined as hospitalizations with stroke or bleed as the primary discharge diagnosis and outpatient claims with stroke or bleed diagnosis in any position. Differences in costs between dabigatran and warfarin users were assessed using descriptive and multivariate analyses. RESULTS: A total of 18,980 dabigatran-treated patients were matched to corresponding warfarin-treated patients. Adjusted all-cause total healthcare, inpatient, and outpatient costs were significantly lower for the dabigatran cohort ($US3053 vs. 3433; $US904 vs. 1194; $US1594 vs. 1894, respectively; all p < 0.001), but mean pharmacy costs were significantly higher ($US556 vs. 345, p < 0.001). Stroke-specific total healthcare and outpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US30.37 vs. 40.99 and $US7.36 vs. 12.20, respectively; p < 0.05 for both values). Similarly, bleed-specific total healthcare and inpatient costs were significantly lower for the dabigatran than for the warfarin cohort ($US50.00 vs. 73.49 and $US27.75 vs. 48.66, respectively; p < 0.01 for both values). CONCLUSION: Patients receiving dabigatran had significantly lower total all-cause, inpatient, and outpatient costs but higher pharmacy costs than those receiving warfarin. In addition, stroke-specific total and outpatient costs and bleed-specific total and inpatient costs were significantly lower in dabigatran users compared with warfarin users.

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.].

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.

Determinants of life expectancy in the Eastern Mediterranean Region.

BACKGROUND: Although the Eastern Mediterranean Region (EMR) healthcare sector has been expanding rapidly, many differences exist across socioeconomic status, clinical practice standards and healthcare systems. OBJECTIVE: Predict production functions of health by measuring socioeconomic and expenditure factors that impact life expectancy in the EMR. METHODS: Data from the World Health Organization (WHO) Global Health Observatory and the World Bank were used for this cross-sectional, time-series study spanning 21 nations in the EMR from 1995 to 2010. The primary outcome was life expectancy at birth. Covariates of interest included sociodemographic and health indicators. To both establish and validate appropriate categorization of countries, a cluster analysis was undertaken to group cases by taking selected characteristics into account. A variance-component, multilevel mixed-effects linear model was employed that incorporated a finite, Almon, distributed lag of 5 years and bootstrapping with 5000 simulations to model the production function of life expectancy. RESULTS: Results of the cluster analysis found four groupings. Clusters 1 and 2, composed of six total countries, generally represented non-industrialized/least developed countries. Clusters 3 and 4, totalling 15 nations, captured more industrialized nations. Overall, gross domestic product (GDP) (P = 0.011), vaccination averages (P = 0.026) and urbanization (P = 0.026), were significant positive predictors of life expectancy. No significant predictors existed for Cluster 1 countries. Among Cluster 2 nations, physician density (P = 0.014) and vaccination averages (P = 0.044) were significant positive predictors. GDP (P = 0.037) and literacy (P = 0.014) were positive significant predictors among Cluster 3 nations. GDP (P = 0.002), health expenditures (P = 0.002) and vaccination averages (P = 0.014) were positive significant predictors in Cluster 4 countries. CONCLUSION: Predictors of life expectancy differed between non-industrialized and industrialized nations, with the exception of vaccination averages. Non-industrialized/least developed nations were associated with adjusted life expectancies of >14% lower than their industrialized peers. Continued work to address differences in the quality of and access to care in the EMR is required.

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.