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.

Comparative Effectiveness of First-Line Selpercatinib versus Standard Therapies in Patients with RET-Activated Cancers: An Exploratory Interpatient Analysis of LIBRETTO-001.

Selpercatinib is indicated for locally advanced/metastatic RET-activated solid tumors after progression or following prior systemic therapies. Until the recently published data from LIBRETTO-431 and LIBRETTO-531, there were limited effectiveness data comparing selpercatinib with other first-line treatments in RET-activated non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and thyroid cancer (TC). This study analyzed patient data from LIBRETTO-001 and compared the outcomes (time to treatment discontinuation {TTD}, time to next treatment or death {TTNT-D}, time to progression {TTP}, and the objective response rate {ORR}) of first-line selpercatinib (selpercatinib arm) use with the outcomes of first-line standard therapies in patients who then received selpercatinib in later lines of treatment (comparator arm). Overall, the first-line selpercatinib arm had a longer TTD, TTNT-D, and TTP versus the first-line comparator arm. The hazard ratios (HRs) for TTD were 0.29 (NSCLC), 0.15 (MTC), 0.08 (TC); for TTNT-D, the HRs were 0.48 (NSCLC), 0.11 (MTC), 0.09 (TC); and for TTP, the HRs were 0.54 (NSCLC), 0.15 (MTC), and 0.12 (TC). The ORR was higher for first-line selpercatinib versus the first-line comparator (NSCLC: 85.3% vs. 39.7%; MTC: 82.6% vs. 15.2%; and TC: 81.8% vs. 31.8%). First-line selpercatinib use is associated with improved outcomes compared to first-line comparator therapies for patients with advanced/metastatic RET-activated cancers.

Network Meta-Analysis of Once Weekly Selinexor-Bortezomib-Dexamethasone in Previously Treated Multiple Myeloma.

Background: Despite the availability of new treatments, multiple myeloma (MM) is an incurable cancer with nearly all patients relapsing and undergoing multiple lines of treatment. Performing head-to-head comparisons of all treatment options is not feasible. Thus, network meta-analyses play an important role in allowing health-care decision makers to compare the effectiveness of treatment options. Objectives: A Bayesian network meta-analysis (NMA) was developed from studies identified from a systematic literature review (SLR) to evaluate the efficacy of once weekly oral selinexor with once weekly bortezomib and low-dose dexamethasone (XVd) relative to other therapies in previously treated MM. Methods: Ovid was systematically searched for phase 2-3 randomized clinical trials (RCTs) in MM that assessed progression-free survival (PFS), overall survival (OS) and overall response rates (ORR). Two population subsets were assessed: second-line patients (2L) and third-line or greater patients (3L+). Base case results compared all regimens against twice weekly bortezomib and dexamethasone (Vd) as the anchored comparator regimen. Results: Forty-seven RCTs met inclusion. For 2L PFS, OS and ORR, XVd had, on average, out of all iterations, the 6th (out of 21), 4th (out of 15), and 5th (out of 20) best result, respectively, versus Vd. For 3L+ PFS, OS and ORR, XVd had the 12th (out of 24), 11th (out of 22), and 8th (out of 25) best result, respectively, versus Vd. There was no statistically significant difference between XVd and other top-ranking therapies for PFS, OS, and ORR in either 2L and 3L+ except for daratumumab/bortezomib/dexamethasone [DVd], which was favorable versus XVd (2L PFS only). Discussion: Results for XVd were more favorable in 2L, having a higher probability of being a top 5 regimen, compared with 3L+ therapies based on the reported clinical trial results. However, in typical clinical practice, most triplet regimens have been modified using weekly bortezomib dosing, raising questions about the actual efficacy of these regimens versus the reported results using twice weekly bortezomib dosing. Conclusions: The addition of XVd, which was designed with once weekly bortezomib dosing, to the treatment landscape for previously treated MM provides a regimen that may potentially be noninferior to the other top 5 regimens in both 2L and 3L+ settings and is associated with less peripheral neuropathy.

Health-related quality of life and pain with selinexor in patients with advanced dedifferentiated liposarcoma.

Objective: Compare health-related quality of life (HRQoL) of selinexor versus placebo in patients with dedifferentiated liposarcoma. Materials & methods: HRQoL was assessed at baseline and day 1 of each cycle using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Results were reported from baseline to day 169 (where exposure to treatment was maximized while maintaining adequate sample size). Results: Pain scores worsened for placebo versus selinexor across all postbaseline visits, although differences in HRQoL at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms deteriorated over time. Conclusion: Patients treated with selinexor reported lower rates and slower worsening of pain compared with patients who received placebo.

Lay abstract The goal of this study was to compare the health-related quality of life (HRQoL) of patients with advanced unresectable dedifferentiated liposarcoma treated with selinexor compared with those treated with placebo. HRQoL was measured prior to treatment initiation and at the first day of each cycle of their treatment using the European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire. Pain scores worsened for placebo compared with selinexor across all visits after treatment, but differences at some visits were not significant. Other domains did not exhibit significant differences between arms; however, scores in both arms worsened over time reflecting the progressive disease burden in this patient population. As pain is one of the most devastating symptoms associated with advanced and progressing cancers, the significant reduction in pain in the selinexor arm, according to patient perception, represent a relevant added value of this drug in dedifferentiated liposarcoma.

Development of a Prognostic Factor Index Among Women With HR+/HER2- Metastatic Breast Cancer in a Community Oncology Setting.

BACKGROUND: This study explored the impact of multiple prognostic factors on patient overall survival (OS) and real-world progression-free survival (rwPFS) for patients with hormone receptor-positive (HR+)/human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (MBC). MATERIALS AND METHODS: This retrospective study used electronic health record data of patients in the United States from community oncology practices from January 1, 2008 to April 30, 2017. Eligibility included HR+/HER2- MBC diagnosis in 2008 or later and prior systemic therapy for MBC. An index variable was created to assess the effect of multiple clinical prognostic factors collectively, including liver metastases (LM), primary endocrine resistance (PER), negative progesterone receptor (PR-) status, and high tumor grade (TG). Patients were grouped based on the number of prognostic factors present at MBC diagnosis: 0, 1, and 2+. Differences in rwPFS and OS from start of first-line therapy were evaluated by the Kaplan-Meier method and multivariable Cox proportional hazards regression. RESULTS: Approximately 29.1% of the 378 eligible patient sample had 0, 36.0% had 1, and 34.9% had 2+ prognostic factors. For the patients with 1 of the prognostic factors, 24.3% had high TG, 14.7% were LM+, 39.7% had PER, and 21.3% were PR-. Univariate and multivariate results showed that rwPFS and OS were significantly (P < .05) shorter in patients with 1 and 2+ prognostic factors compared with patients with 0. CONCLUSIONS: The individual prognostic factors and the prognostic factor index may enable early identification of patients with a less favorable prognosis across the HR+/HER2- MBC population and help inform treatment decisions in difficult-to-treat populations.

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.

Treatment patterns and medication adherence among patients diagnosed with multiple myeloma and treated with panobinostat.

AIM: To examine real-world treatment patterns in multiple myeloma (MM) patients treated with panobinostat. MATERIALS & METHODS: Using a US claims database, MM patients treated with panobinostat during 02/01/2015-01/31/2017 were evaluated. Lines of therapy, combination regimens, dosing and duration were measured. RESULTS: Ninety-five patients were included (mean age: 61.4 years). Patients were heavily pretreated, with 88.4% exposed to both a proteasome inhibitor and an immunomodulatory agent. A panobinostat containing regimen was started in the fourth or more (86%) lines of therapy within a median of 3.77 years from initial treatment. The most common treatment combination was bortezomib/dexamethasone/panobinostat (31.6%) with 69.5% receiving the recommended dose (20 mg). Mean duration was 98.8 days. CONCLUSION: Patients received the recommended dose, most commonly with bortezomib and dexamethasone. Panobinostat was used in heavily pretreated patients within 4 years post-diagnosis, reflecting an advanced MM population.

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.

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.

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.

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.

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.].