Analysis of real-world length of stay data and costs associated with use of autologous skin cell suspension for the treatment of small burns in U.S. centers.

BACKGROUND: Autologous skin cell suspension (ASCS) is a treatment for acute thermal burn injuries associated with significantly lower donor skin requirements than conventional split-thickness skin grafts (STSG). Projections using the BEACON model suggest that among patients with small burns (total body surface area [TBSA]<20 %), use of ASCS± STSG leads to a shorter length of stay (LOS) in hospital and cost savings compared with use of STSG alone. This study evaluated whether data from real-world clinical practice corroborate these findings. MATERIALS AND METHODS: Electronic medical record data were collected from January 2019 through August 2020 from 500 healthcare facilities in the United States. Adult patients receiving inpatient treatment with ASCS± STSG for small burns were identified and matched to patients receiving STSG using baseline characteristics. LOS was assumed to cost $7554/day and to account for 70 % of overall costs. Mean LOS and costs were calculated for the ASCS± STSG and STSG cohorts. RESULTS: A total of 151 ASCS± STSG and 2243 STSG cases were identified; 63.0 % of patients were male and the average age was 44.2 years. Sixty-three matches were made between cohorts. LOS was 18.5 days with ASCS± STSG and 20.6 days with STSG (difference: 2.1 days [10.2 %]). This difference led to bed cost savings of $15,587.62 per ASCS± STSG patient. Overall cost savings with ASCS± STSG were $22,268.03 per patient. CONCLUSIONS: Analysis of real-world data shows that treatment of small burn injuries with ASCS± STSG provides reduced LOS and substantial cost savings compared with STSG, supporting the validity of the BEACON model projections.

Length of Stay and Costs with Autologous Skin Cell Suspension Versus Split-Thickness Skin Grafts: Burn Care Data from US Centers.

INTRODUCTION: Autologous skin cell suspension (ASCS) significantly reduces donor skin requirements versus conventional split-thickness skin grafts (STSG) for thermal burn treatment. In analyses using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model, ASCS was associated with shorter hospital length of stay (LOS) and cost savings versus STSG. This study hypothesized that daily practice data from the USA would support these findings. METHODS: Electronic medical record data from 500 healthcare facilities (January 2019-August 2020) were used to match adult patients who received inpatient burn treatment with ASCS (± STSG) to patients treated with STSG alone on the basis of sex, age, percent total body surface area (TBSA), and comorbidities. Based on BEACON analyses, LOS was assumed to represent 70% of total costs and used as a proxy to assess the data. Mean LOS, costs, and the incremental revenue associated with inpatient capacity changes were calculated. RESULTS: A total of 151 ASCS and 2443 STSG patients were identified: 63.0% were male and average age was 44.5 years. Eight-one matches were made between cohorts. LOS was 21.7 days with ASCS and 25.0 days with STSG alone (difference 3.3 days [13.2%]). LOS was lower with ASCS than STSG in four of five TBSA intervals. The LOS difference led to hospital bed cost savings of $25,864 per ASCS patient; overall cost savings were $36,949 per patient. Similar cost savings were observed in TBSA groupings < 20% and ≥ 20%. The reduced LOS with ASCS translated into an increased capacity of 2.2 inpatients/bed annually, which increased hospital revenue by $92,283/burn unit bed annually. CONCLUSIONS: Real-world data show that ASCS (± STSG) is associated with reduced LOS and cost savings versus STSG alone across all burn sizes, supporting the validity of the BEACON analyses. ASCS use may also increase patient capacity and throughput, leading to increased hospital revenue.

Autologous skin cell suspension (ASCS) is a treatment for thermal skin burn injuries that can be used alone or in combination with split-thickness skin grafts (STSG), the conventional standard of care. Projections using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model indicate that ASCS leads to shorter hospital length of stay (LOS) and overall cost savings compared with STSG alone. These model findings are supported by benchmarking study data from a limited sample of US burn centers. The current study aimed to understand whether the BEACON projections are supported by daily clinical practice data from US healthcare facilities. Using electronic medical record data, we matched patients who received ASCS ± STSG from January 2019 to August 2020 to those receiving STSG alone on the basis of demographic and clinical factors. Data analysis showed that hospital LOS was shorter (3.3 days) with ASCS ± STSG than STSG alone, a difference associated with a hospital bed cost savings of $25,864 per ASCS patient. Overall cost savings, which included nursing time and other costs, were $36,949 per patient. Analysis of patients with burns comprising total body surface areas less than 20% or at least 20% showed cost savings in both groups. The reduced LOS with ASCS also translated into the ability to treat 2.2 more patients per hospital bed per year, which was projected to increase hospital earnings. These real-world findings support those of modeling analyses, indicating that use of ASCS ± STSG is associated with meaningful clinical and economic benefits compared with use of STSG alone.

The cost-effectiveness of therapeutic drug monitoring for the prescription drug-based treatment of chronic myeloid leukemia.

BACKGROUND: A recent study demonstrating the use of Therapeutic Drug Monitoring (TDM) in patients with chronic myeloid leukemia (CML) resulted in a higher response rate with imatinib (IM) than demonstrated in second-generation tyrosine kinase inhibitor studies. The cost-effectiveness of TDM combined with IM (IM TDM) in first-line CML treatment has not yet been studied. OBJECTIVES: To determine the cost-effectiveness of IM TDM for the first-line treatment of CML compared to tyrosine kinase inhibitor only treatment. METHODS: A recently published cost-effectiveness model of tyrosine kinase inhibitor-treatment in CML was modified to include IM TDM as a first-line tyrosine kinase inhibitor-based CML treatment option. Efficacy inputs for major molecular response (MMR) rates were taken from previously published studies: IM TDM 65%, dasatinib 52%, nilotinib 53%. Annual tyrosine kinase inhibitor drug prices were derived from the Federal Supply Schedule (FSS) and the average and lowest wholesale acquisition costs (WAC) reported in the Red Book; the annual cost of TDM was $228. Other input costs modeled in the original CML CEA model were updated to 2016 US dollars using the medical service component of the Consumer Price Index. A US payer perspective was used with a 5-year time horizon and a 3.0% discount rate. The model compared first-line IM TDM versus IM alone, nilotinib (NIL) or dasatinib (DAS) in terms of the following outcomes: costs, quality-adjusted life-years (QALYs), and cost-effectiveness (total cost/QALY). Deterministic and probabilistic sensitivity analyses were performed using all key clinical and economic parameters. RESULTS: This study found that IM TDM dominates IM alone with $15,452 to $36,940 in savings and 0.25 higher QALYs. Using FSS, per patient total costs for IM and IM TDM were $270,905 and $233,965, respectively.; Using average WAC, these costs were $461,657 and $446,205, and using lowest WAC, these costs were $366,966 and $350,090. The results comparing first line using of IM TDM to NIL/DAS found that TDM IM had higher QALYs and lower costs (0.08 QALYs lower, and $117,006 to $172,420 savings per patient [varying by price basis]). Thus, in terms of cost-effectiveness, IM TDM dominates NIL/DAS with both lower costs and higher QALYs. CONCLUSIONS: IM TDM is a clinically and economically viable first-line treatment option for CML. DISCLOSURES: This study was funded by Saladax Biomedical. Salamone is an employee of Saladax Biomedical. This study was presented at the IATDMCT Congress, September 2018, Brisbane, Australia.

Impact of adherence to antidepressants on healthcare outcomes and costs among patients with type 2 diabetes and comorbid major depressive disorder.

OBJECTIVE: To evaluate the association between adherence to antidepressants and an effect on clinical outcomes and healthcare costs in patients with major depressive disorder (MDD) and comorbid type 2 diabetes (T2D). METHODS: This retrospective study used MarketScan claims data from January 2012 to March 2014. Study entry was the first claim for an antidepressant and a diagnosis code for MDD and T2D in the prior 6 months. Adherence and persistence with antidepressant therapy in the first 180 days were defined as medication possession ratio (MPR) ≥ 80% and length of therapy (LOT), with no treatment gap of >15 days, respectively. T2D control (HbA1c <7%), oral diabetes medication adherence, and healthcare costs were measured in the 12 month post-index period. The impact of antidepressant adherence and persistence on outcomes was assessed using multivariable analyses. RESULTS: Among the 1361 patients included, the mean age was 59 years and 55% were women. About one-third of the patients were adherent (35.9%, mean MPR = 40%), persistent (32.0%, average LOT = 100 days), and adherent/persistent (31.2%) on antidepressants. Being adherent, persistent, or adherent/persistent to antidepressants was associated with a two-fold improvement in adherence to oral diabetes medications. Of those with HbA1c data (n = 121), adherence or adherence/persistence to antidepressants was associated with patients being five times more likely to have T2D control (odds ratio [OR]: 4.95; 95% confidence interval [CI]: 1.39, 17.59, p = .0134). Comparison between antidepressant-persistent and non-persistent patients was not significant. Mean difference in adjusted all-cause annual costs showed lower costs among antidepressant-adherent and adherent/persistent patients (adherent: -$350, 95% CI: -$462, -$247; adherent/persistent: -$1165; 95% CI: -$1280, -$1060). CONCLUSIONS: Patients with better antidepressant adherence and adherence/persistence demonstrated better HbA1c control, with lower all-cause total and medical costs. Adherence, persistence, or adherence/persistence to antidepressants was associated with improved adherence to oral diabetes medications.

Effects of cohort selection on the results of cost-effectiveness analysis of disease-modifying drugs for relapsing-remitting multiple sclerosis.

BACKGROUND: Decision-analytic cost-effectiveness models are used to determine the most cost-effective treatment option on the basis of the best available data. Guidelines for pharmacoeconomic model development indicate that models should be updated as new evidence becomes available. OBJECTIVE: To evaluate the appropriateness of the clinical data that were selected for Goldberg et al.'s 2009 model of cost-effectiveness in multiple sclerosis and calculate results based on a revised cohort selection method for intramuscular (IM) interferon (IFN) beta-1a. METHODS: The original model compared cost per relapse avoided for IM IFN beta-1a, subcutaneous (SC) IFN beta-1a, IFN beta-1b, and glatiramer acetate (GA) based on intent-to-treat (ITT) results from clinical trials. However, due to lower-than-expected subject dropout rates, the IM IFN beta-1a trial had sufficient statistical power to be terminated early and was subsequently found to have met its primary endpoint, time to sustained 1.0-point Expanded Disability Status Scale progression. Within the "all-patient"(ITT) cohort (n=301), approximately 43% of patients were followed for less than 2 years; 172 patients were followed for 2 years or more. In contrast, the proportions of patients followed for at least 2 years in the clinical trials of IFN beta-1b, SC IFN beta-1a, and GA were 92%, 90%, and 86%, respectively. To test the impact of data selection on the cost-effectiveness model results, we recreated the original model using both the all-patient and 2-year cohorts from the IM IFN beta-1a pivotal trial. We then compared our results with those of the original model. RESULTS: In the original model, costs per relapse avoided were $141,721 for IM IFN beta-1a, $80,589 for SC IFN beta-1a, $87,061 for SC IFN beta-1b, and $88,310 for GA. In the reanalysis using the 2-year completer data for IM IFN beta-1a, costs per relapse avoided were $77,980 for IM IFN beta-1a, $80,121 for SC IFN beta-1a, $86,572 for IFN beta-1b, and $87,767 for GA. The cost per relapse avoided for IM IFN beta-1a was approximately 45% lower than in the original analysis, whereas the recreated results for the other 3 therapies differed from the original results by less than 1%. Sensitivity analyses showed that the recreated model was robust and that the rank order of cost-effectiveness results was unaffected by changes to any univariate parameter. CONCLUSIONS: The current study highlights the importance of data selection in cost-effectiveness analyses. After limiting the pivotal trial data for IM IFN beta-1a to patients followed for at least 2 years, we found that IM IFN beta-1a was more cost-effective than in the original analysis, while results for the other first-line disease-modifying drugs remained stable.

A model analysis of costs of blood pressure destabilization and edema associated with rofecoxib and celecoxib among older patients with osteoarthritis and hypertension in a Medicare Choice population.

BACKGROUND: Economic analyses consider all costs relevant to the use of a particular treatment or treatments. Recently, head-to-head, randomized, controlled trials have shown a significantly higher incidence of blood pressure (BP) destabilization and clinically significant edema with rofecoxib than with celecoxib among older, hypertensive patients with osteoarthritis (OA). OBJECTIVE: The objective of this analysis was to estimate the COX-2 specific inhibitor medication costs, in addition to the costs of drugs and physicians' fees, for BP destabilization and clinically significant edema associated with the use of rofecoxib 25 mg QD and celecoxib 200 mg QD in patients with OA and hypertension in a Medicare Choice population (aged > or = 65 years). METHODS: A decision analysis model was constructed to determine the costs (from the payer's perspective) of treating patients in this population with either of the 2 regimens for 6 weeks. The analysis used pooled data from 2 recent, independently conducted, multicenter, double-blind, randomized, controlled trials of OA patients aged > or = 65 years with treated hypertension who received either celecoxib 200 mg QD or rofecoxib 25 mg QD for 6 weeks. In the individual trials, rofecoxib was associated with significantly higher rates of destabilized BP (P < 0.032 and P < 0.001) and edema (P < 0.01 and P = 0.045) than celecoxib. RESULTS: For a 100,000-member Medicare Choice population, an estimated 25,630 persons would have OA and hypertension (stages I-III), and an estimated 5126 of these patients would use celecoxib or rofecoxib. The estimated costs were 33,938 dollars (6.2%) higher if all hypertensive patients with OA were treated with rofecoxib rather than celecoxib for 6 weeks. The cost per day of use was 0.16 dollars less with celecoxib, and per-patient, per-month costs were 4.79 dollars lower. CONCLUSION: Celecoxib was a less costly treatment option than rofecoxib among OA patients with hypertension aged > or = 65 years, based on our model of the direct costs of COX-2 specific inhibitor therapy combined with those associated with physician monitoring and treatment of edema and BP destabilization.