Is Reconstruction of Unstable Midfoot Charcot Neuroarthropathy Cost Effective from a US Payer's Perspective?

BACKGROUND: Charcot neuroarthropathy is a morbid and expensive complication of diabetes that can lead to lower extremity amputation. Current treatment of unstable midfoot deformity includes lifetime limb bracing, primary transtibial amputation, or surgical reconstruction of the deformity. In the absence of a widely adopted treatment algorithm, the decision to pursue more costly attempts at reconstruction in the United States continues to be driven by surgeon preference. QUESTIONS/PURPOSES: To examine the cost effectiveness (defined by lifetime costs, quality-adjusted life-years [QALYs] and incremental cost-effectiveness ratio [ICER]) of surgical reconstruction and its alternatives (primary transtibial amputation and lifetime bracing) for adults with diabetes and unstable midfoot Charcot neuroarthropathy using previously published cost data. METHODS: A Markov model was used to compare Charcot reconstruction and its alternatives in three progressively worsening clinical scenarios: no foot ulcer, uncomplicated (or uninfected) ulcer, and infected ulcer. Our base case scenario was a 50-year-old adult with diabetes and unstable midfoot deformity. Patients were placed into health states based on their disease stage. Transitions between health states occurred annually using probabilities estimated from the evidence obtained after systematic review. The time horizon was 50 cycles. Data regarding costs were obtained from a systematic review. Costs were converted to 2019 USD using the Consumer Price Index. The primary outcomes included the long-term costs and QALYs, which were combined to form ICERs. Willingness-to-pay was set at USD 100,000/QALY. Multiple sensitivity analyses and probabilistic analyses were performed to measure model uncertainty. RESULTS: The most effective strategy for patients without foot ulcers was Charcot reconstruction, which resulted in an additional 1.63 QALYs gained and an ICER of USD 14,340 per QALY gained compared with lifetime bracing. Reconstruction was also the most effective strategy for patients with uninfected foot ulcers, resulting in an additional 1.04 QALYs gained, and an ICER of USD 26,220 per QALY gained compared with bracing. On the other hand, bracing was cost effective in all scenarios and was the only cost-effective strategy for patents with infected foot ulcers; it resulted in 6.32 QALYs gained and an ICER of USD 15,010 per QALY gained compared with transtibial amputation. As unstable midfoot Charcot neuroarthropathy progressed to deep infection, reconstruction lost its value (ICER USD 193,240 per QALY gained) compared with bracing. This was driven by the increasing costs associated with staged surgeries, combined with a higher frequency of complications and shorter patient life expectancies in the infected ulcer cohort. The findings in the no ulcer and uncomplicated ulcer cohorts were both unchanged after multiple sensitivity analyses; however, threshold effects were identified in the infected ulcer cohort during the sensitivity analysis. When the cost of surgery dropped below USD 40,000 or the frequency of postoperative complications dropped below 50%, surgical reconstruction became cost effective. CONCLUSIONS: Surgeons aiming to offer both clinically effective and cost-effective care would do well to discuss surgical reconstruction early with patients who have unstable midfoot Charcot neuroarthropathy, and they should favor lifetime bracing only after deep infection develops. Future clinical studies should focus on methods of minimizing surgical complications and/or reducing operative costs in patients with infected foot ulcers. LEVEL OF EVIDENCE: Level II, economic and decision analysis.

Cost comparison: limb salvage versus amputation in diabetic patients with charcot foot.

BACKGROUND: The negative impact on health-related quality of life in patients with Charcot foot has prompted operative correction of the acquired deformity. Comparative effectiveness financial models are being introduced to provide valuable information to assist clinical decision making. METHODS: Seventy-six patients with Charcot foot underwent operative correction with the use of circular external fixation. Thirty-eight (50%) had osteomyelitis. A control group was created from 17 diabetic patients who successfully underwent transtibial amputation and prosthetic fitting during the same period. Cost of care during the 12 months following surgery was derived from inpatient hospitalization, placement in a rehabilitation unit or skilled nursing facility, home health care including parenteral antibiotic therapy, physical therapy, and purchase of prosthetic devices or footwear. RESULTS: Fifty-three of the patients with limb salvage (69.7%) did not require inpatient rehabilitation. Their average cost of care was $56,712. Fourteen of the patients with amputation (82.4%) required inpatient rehabilitation, with an average cost of $49,251. CONCLUSIONS: Many surgeons now favor operative correction of Charcot foot deformity. This investigation provides preliminary data on the relative cost of transtibial amputation and prosthetic limb fitting compared with limb salvage. The use of comparative effectiveness models such as this simple attempt may provide valuable information in planning resource allocation for similar complex groups of patients. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer.

BACKGROUND: In 2007, we reported a summary of data comparing diabetic foot complications to cancer. The purpose of this brief report was to refresh this with the best available data as they currently exist. Since that time, more reports have emerged both on cancer mortality and mortality associated with diabetic foot ulcer (DFU), Charcot arthropathy, and diabetes-associated lower extremity amputation. METHODS: We collected data reporting 5-year mortality from studies published following 2007 and calculated a pooled mean. We evaluated data from DFU, Charcot arthropathy and lower extremity amputation. We dichotomized high and low amputation as proximal and distal to the ankle, respectively. This was compared with cancer mortality as reported by the American Cancer Society and the National Cancer Institute. RESULTS: Five year mortality for Charcot, DFU, minor and major amputations were 29.0, 30.5, 46.2 and 56.6%, respectively. This is compared to 9.0% for breast cancer and 80.0% for lung cancer. 5 year pooled mortality for all reported cancer was 31.0%. Direct costs of care for diabetes in general was $237 billion in 2017. This is compared to $80 billion for cancer in 2015. As up to one-third of the direct costs of care for diabetes may be attributed to the lower extremity, these are also readily comparable. CONCLUSION: Diabetic lower extremity complications remain enormously burdensome. Most notably, DFU and LEA appear to be more than just a marker of poor health. They are independent risk factors associated with premature death. While advances continue to improve outcomes of care for people with DFU and amputation, efforts should be directed at primary prevention as well as those for patients in diabetic foot ulcer remission to maximize ulcer-free, hospital-free and activity-rich days.

The benefits of prophylactic treatment with APCC in patients with haemophilia and high-titre inhibitors: a retrospective case series.

Prophylactic infusion of factor concentrates is a safe, effective intervention for preventing arthropathy in patients with haemophilia; on-demand treatment is insufficient to prevent the orthopaedic complications and subsequent haemophilic arthropathy that stem from recurrent joint haemorrhages. The usefulness of prophylaxis in haemophilia patients without inhibitors suggests that patients with haemophilia and inhibitors could derive similar benefits. In patients with haemophilia and high-titre (>5 BU mL(-1)) inhibitors, bleeding episodes are treated with bypassing agents such as activated prothrombin complex concentrates (APCCs) and recombinant activated factor VII (rFVIIa, NovoSeven; Novo Nordisk A/S, Bagsvaerd, Denmark). It is possible to administer bypassing therapy regularly to prevent haemorrhages, with the goal of limiting arthropathy and serious life- and limb-threatening bleeding. The data evaluating the efficacy and safety of this approach in patients with inhibitors are limited, consisting of results from one prospective trial and retrospective case reports. This report describes our experience with the prophylactic use of the APCC Factor Eight Inhibitor Bypassing Activity, Anti-Inhibitor Coagulant Complex, Vapor Heated (FEIBA; Baxter AG, Vienna, Austria). Data from patients at one treatment centre were retrospectively evaluated. Case records of six patients with haemophilia A or B and high-titre inhibitors were identified. When APCC was administered regularly, most patients exhibited a reduction in the numbers of haemorrhages, an improvement in orthopaedic status, and an improvement in quality of life. Prophylaxis with APCC can reduce haemorrhages and halt further joint deterioration in patients with haemophilia and inhibitors.

Gender differences in morbidity and health care utilization among adult obstructive sleep apnea patients.

STUDY OBJECTIVE: To explore gender differences in morbidity and total health care utilization 5 years prior to diagnosis of obstructive sleep apnea (OSA). DESIGN: Case-control study; patients were recruited between January 2001 and April 2003. SETTING: Two university-affiliated sleep laboratories. PATIENTS: 289 women (22-81 years) with OSA were matched with 289 men with OSA for age, body mass index (BMI), and apnea-hypopnea index (AHI). All OSA patients were matched 1:1 with healthy controls by age, geographic area, and primary physician. MEASUREMENTS AND RESULTS: Women with OSA compared to men with OSA have lower perceived health status and Functional Outcomes of Sleep Questionnaire score (54.5% vs. 28.4%, P <0.05 and 67.5+/-21.4 vs. 76+/-20.1, P <0.05, respectively). Compared to men with OSA, women with OSA have higher risk of hypothyroidism (OR 4.7; 95% CI, 2.3-10) and arthropathy (OR 1.6, 95% CI, 1.1-2.2) and lower risk for CVD (OR 0.7; 95% CI, 0.5-0.91). Compared to controls, both women and men with OSA had 1.8 times higher 5-year total costs (P <0.0001). Compared to men with OSA, expenditures for women with OSA are 1.3 times higher (P <0.0001). The multiple logistic regression (adjusting for BMI, AHI) revealed that age (OR 1.04; 95% CI, 1.01-1.07), antipsychotic and anxiolytic drugs (OR 2.3; 95% CI, 1.2-4.4), and asthma (OR 2.4; 95% CI, 1.1-5.6) are independent determinants for "most costly" OSA women. CONCLUSION: Compared to men with similar OSA severity, women are heavier users of health care resources. Low FOSQ score and poor perceived health status in addition to overuse of psychoactive drugs are associated with high health care utilization among women with OSA.

Benchmark analysis of diabetic patients with neuropathic (Charcot) foot deformity.

During a 10-year period, 237 patients (129 women, 108 men) with a diagnosis of neuropathic (Charcot) arthropathy of the foot and ankle were treated in a tertiary care university hospital medical center. During this period, 115 of the patients (48.5%) were treated nonoperatively as outpatients with local skin and nail care, accommodative shoe wear, and custom foot orthoses. A total of 120 (50.6%) underwent 143 operations. Surgery included 21 major limb amputations, 29 ankle fusions, 26 hindfoot fusions, 23 exostectomies, and 23 debridements for osteomyelitis. It is widely accepted that patients with diabetes are at risk for developing foot ulcers, which can lead to lower extremity amputation. Within the population of diabetic patients, it is widely accepted that patients with neuropathic (Charcot) arthropathy of the foot and ankle have one of the highest likelihoods of having to undergo lower extremity amputation. The current emphasis in care of the foot of a diabetic patient involves a multidisciplinary team approach combining patient education, skin and nail care, and accommodative shoe wear. As data from prophylactic programs become available, resource allocation and cost of care can be compared with this benchmark baseline. This benchmark analysis can be used by those who are responsible for allocating resources and projecting healthcare costs for this "high utilization"/high risk patient population.