OBJECTIVE To estimate the annual, per-patient incremental burden of diabetic foot ulcers (DFUs). RESEARCH DESIGN AND METHODS DFU patients and non-DFU patients with diabetes (controls) were selected using two deidentified databases: ages 65+ years from a 5% random sample of Medicare beneficiaries (Standard Analytical Files, January 2007–December 2010) and ages 18–64 years from a privately insured population (OptumInsight, January 2007–September 2011). Demographics, comorbidities, resource use, and costs from the payer perspective incurred during the 12 months prior to a DFU episode were identified. DFU patients were matched to controls with similar pre-DFU characteristics using a propensity score methodology. Per-patient incremental clinical outcomes (e.g., amputation and medical resource utilization) and health care costs (2012 U.S. dollars) during the 12-month follow-up period were measured among the matched cohorts. RESULTS Data for 27,878 matched pairs of Medicare and 4,536 matched pairs of privately insured patients were analyzed. During the 12-month follow-up period, DFU patients had more days hospitalized (+138.2% Medicare, +173.5% private), days requiring home health care (+85.4% Medicare, +230.0% private), emergency department visits (+40.6% Medicare, +109.0% private), and outpatient/physician office visits (+35.1% Medicare, +42.5% private) than matched controls. Among matched patients, 3.8% of Medicare and 5.0% of privately insured DFU patients received lower limb amputations. Increased utilization resulted in DFU patients having $11,710 in incremental annual health care costs for Medicare, and $16,883 for private insurance, compared with matched controls. Privately insured matched DFU patients incurred excess work-loss costs of $3,259. CONCLUSIONS These findings document that DFU imposes substantial burden on public and private payers, ranging from $9–13 billion in addition to the costs associated with diabetes itself.

These findings suggest an annual US payer burden of $14.9 billion.

We evaluated the comparative effectiveness of a bioengineered living cellular construct (BLCC) and a dehydrated human amnion/chorion membrane allograft (dHACM) for the treatment of diabetic foot ulcers (DFUs). Using a wound carespecific electronic medical record database, we assessed real-world outcomes in 218 patients with 226 DFUs receiving treatment in 2014 at 99 wound care centers. The analysis included DFUs 1 and <25 cm 2 with duration <=1 year and area reduction 20% in 14 days prior to treatment (N=163, BLCC; N=63, dHACM). The average baseline areas and durations were 6.0 cm 2 and 4.4 months for BLCC and 5.2 cm 2 and 4.6 months for dHACM, respectively. Patients treated with dHACM had more applications compared to those treated with BLCC (median 3.0 vs. 2.0) (p=0.003). A Cox model adjusted for key covariates including area and duration found the median time to closure for BLCC was 13.3 weeks compared to 26 weeks for dHACM, and the proportion of wounds healed were significantly higher for BLCC by 12 weeks (48% vs. 28%) and 24 weeks (72% vs. 47%) (p=0.01). Treatment with a bioengineered living cellular technology increased the probability of healing by 97% compared with a dehydrated amniotic membrane (hazard ratio 5 1.97 [95% confidence interval 1.17, 3.33], p=0.01).

Objective: To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC). Methods:DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an 'intent-to-treat' design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., !1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006-2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples. Results:Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (À27.6% BLCC, À22.2% HFDS), fewer days hospitalized (À33.3% BLCC, À42.4% HFDS), and fewer emergency department visits (À32.3% BLCC, À25.7% HFDS) among BLCC/ HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (À$5253 BLCC, À$6991 HFDS). Limitations:Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation. Conclusion:These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.

Most cost-effectiveness modeling studies of global endometrial ablation (GEA) for treatment of heavy menstrual bleeding (menorrhagia) are from a UK perspective. Costs and cost-effectiveness information about GEA from a US perspective are lacking. Study objectives were: 1) identify/review all costeffectiveness modeling studies of GEA; 2) assimilate GEA costs across these studies at current levels (2012 US dollars) to proxy a US market perspective; and 3) perform statistical summarizations of the data. METHODS: All published literature and health technology assessments of menorrhagia treatment costeffectiveness published 2004-2012 were reviewed; studies with GEA as a comparator were selected for inclusion. GEA cost data were abstracted and converted to US dollars using purchasing power parity indices (PPPI) and adjusted to 2012 levels using the US consumer price index (CPI). Statistical summarizations (minimum, maximum, mean, median) were performed for studies in their respective 1-, 2-, 5-, and 10-year analysis scenarios. RESULTS: From a total of eight cost-effectiveness modeling studies, 14 GEA cost data values were abstracted. All values pertained to either microwave endometrial ablation (MEA) or thermal balloon endometrial ablation (TBEA), or a composite weighted average of the two techniques. No studies reported costs associated with cryoablation, bipolar radiofrequency ablation, or hydrothermal ablation (HTA).