Cost effectiveness analysis for commonly used human cell and tissue products in the management of diabetic foot ulcers.

Background and Aims: This study considers the cost-effectiveness of commonly used cellular, acellular, and matrix­like products (CAMPs) of human origin also known as human cell and tissue products (HCT/Ps) in the management of diabetic foot ulcers. Methods: We developed a 1-year economic model assessing six CAMPs [cryopreserved placental membrane with viable cells (vCPM), bioengineered bilayered living cellular construct (BLCC), human fibroblast dermal substitute (hFDS), dehydrated human amnion chorion membrane (dHACM), hypothermically stored amniotic membrane (HSAM) and human amnion membrane allograft (HAMA) which had randomized controlled trial evidence compared with standard of care (SoC). CAMPs were compared indirectly and ranked in order of cost-effectiveness using SoC as the baseline, from a CMS/Medicare's perspective. Results: The mean cost, healed wounds (hw) and QALYs per patient for vCPM is $10,907 (0.914 hw, 0.783 QALYs), for HAMA $11,470 (0.903 hw, 0.780 QALYs), for dHACM $15,862 (0.828 hw, 0.764 QALYs), for BLCC $18,430 (0.816 hw, 0.763 QALYs), for hFDS $19,498 (0.775 hw, 0.757 QALYs), for SoC $19,862 (0.601 hw, 0.732 QALYs) and $24, 214 (0.829, 0.763 QALYs) for HSAM respectively. Over 1 year, vCPM results in cheaper costs overall and better clinical outcomes compared to other CAMPs. Following probabilistic sensitivity analysis, vCPM has a 60%, HAMA 40% probability of being cost-effective then dHACM, hFDS, BLCC, and lastly HSAM using a $100,000/healed wound or QALY threshold. Conclusions: All CAMPs were shown to be cost-effective when compared to SoC in managing DFUs. However, vCPM appears to be the most cost-effective CAMP over the modelled 52 weeks followed by HAMA, dHACM, hFDS, BLCC, and HSAM. We urge caution in interpreting the results because we currently lack head-to-head evidence comparing all these CAMPs and therefore suggest that this analysis be updated when more direct evidence of CAMPs becomes available.

An All-Suture-Based Technique for Meniscal Repair Is Cost-Effective in Comparison to Partial Meniscectomy for Horizontal Cleavage Tears.

Purpose: To determine the cost-effectiveness of meniscal repair (MR) using an all-suture-based technique when compared to partial meniscectomy (PM) for horizontal cleavage tears (HCTs) from a payor's perspective in the United States. Methods: A state-transition model and cost-utility analysis were developed from a US payor's perspective to project treatment costs and quality-adjusted life-years (QALYs) in a cohort of 35-year-old patients without osteoarthritis at baseline and presenting with either a lateral or medial HCT. Two outpatient costing perspectives were used, namely ambulatory surgical centers (ASCs) and hospitals. The state-transition model had 7 health states with transition probabilities, costs, and utilities obtained from the existing literature. Cost-effectiveness was assessed using a willingness-to-pay threshold of $100,000/QALY, and sensitivity analysis considered the effects of parameter uncertainty on model results. MR failure rates were focused on an all-suture-based technique; however, in a separate scenario, this study considered effectiveness data from various MR techniques and devices. Results: MR dominated PM over a lifetime horizon, increasing QALYs by 0.43 per patient and decreasing the cost by $12,227 per patient within a hospital setting (and by $12,570 within an ASC). MR with an all-suture-based technique continued to be the dominant treatment when age at primary treatment was varied between 30 and 60 years. Sensitivity analysis showed that MR was not cost-effective in year 1, was cost-effective from year 2, and was cost-saving from year 6 onward from both ASC and hospital perspectives. Probabilistic sensitivity analysis found that MR was cost-effective over a lifetime horizon in 99% of 10,000 iterations on base-case analysis. Conclusions: Using a lifetime horizon, this study found that from a payor's perspective, MR is a cost-saving intervention when compared with PM in patients with an HCT. Level of Evidence: Level III, economic analysis.

Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy.

INTRODUCTION: Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant REGENETEN showed long-term improvements in clinical scores. The aim of the study was to assess the cost-effectiveness of REGENETEN combined with SOC (SOC + REGENETEN) compared to SOC alone from both National Healthcare Service (NHS) and societal perspectives in Italy. METHODS: A decision analytic model was developed to estimate the number of tears healed and costs for the two considered treatment strategies over 1 year. Clinical data were retrieved from the literature, and the clinical pathways for the management of patients with RCTs were retrieved from four key opinion leaders in Italy. RESULTS: Over a 1-year time horizon, healed lesions were 90.70% and 72.90% for surgical repair of RCTs with and without REGENETEN, respectively. Considering the NHS perspective, mean costs per patient were €7828 and €4650 for the two strategies, respectively, leading to an incremental cost-effectiveness ratio (ICER) of €17,857 per healed tear. From the societal perspective, the mean costs per patient were €12,659 for SOC and €11,784 for REGENETEN, thus showing savings of €4918 per healed tear when the bioinductive implant is used. The sensitivity analyses confirmed the robustness of the model results. CONCLUSION: In the context of paucity of cost-effectiveness studies, our findings provide additional evidence for clinicians and payers regarding the value of a new treatment option that supports a tailored approach for the management of patients with RCTs.

The rotator cuff refers to a group of four muscles, with tendons connected to the upper arm bone, which act together to allow lifting and rotating the shoulder. A tear of the rotator cuff can affect either a single tendon or multiple tendons. Typical first-line treatment includes conservative therapies, which aim to alleviate pain and reduce functional impairment, but are often ineffective. Persisting disease is usually managed through conventional surgical repair. Recently, REGENETEN, a collagen-based bioinductive implant derived from purified bovine Achilles tendon, positioned over the site of the damaged rotator cuff, achieved successful rotator cuff tendon repair with an increase in healed tears of 17.80% at 1 year compared to conventional surgery. Considering the National Healthcare Service perspective in Italy, the cost needed to achieve one additional healed tear using REGENETEN compared to conventional surgery is €17,857. From the societal perspective, which includes patients' productivity losses from hospital admission to return to work, the use of REGENETEN may be cost-saving compared to conventional surgery. The findings of our study provide evidence for clinicians and payers to support the value of a new treatment option for patients with rotator cuff lesions.

Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears.

Purpose: This study was conducted to investigate whether the use of resorbable bioinductive collagen implant (RBI) in addition to conventional rotator cuff repair (conventional RCR) is cost-effective when compared to conventional RCR alone, in the treatment of full-thickness rotator cuff tears (FT RCT). Methods: We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with FT RCT. The probabilities for healing or failure to heal (retear) were estimated from the published literature. Implant and healthcare costs were estimated from a payor's perspective in 2021 U.S. prices. An additional analysis included indirect cost estimations (e.g., productivity losses). Sensitivity analyses explored the effect of tear size, as well as the impact of risk factors. Results: The base case analysis demonstrated that resorbable bioinductive collagen implant + conventional rotator cuff repair results in incremental costs of $232,468 and an additional 18 healed RCTs per 100 treated patients over 1 year. The estimated incremental cost-effectiveness ratio (ICER) is $13,061/healed RCT compared to conventional RCR alone. When return to work was included in the model, RBI + conventional RCR was found to be cost saving. Cost-effectiveness improved with tear size with the largest benefit seen in massive tears compared to large tears, as well as patients at higher risk of retearing. Conclusions: This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving. Level of Evidence: Level IV, economic analysis.

Single-use negative pressure wound therapy reduces costs in closed surgical incisions: UK and US economic evaluation.

OBJECTIVE: Single-use negative pressure wound therapy (sNPWT) following closed surgical incisions has a demonstrable effect in reducing surgical site complications (SSC). However, there is little health economic evidence to support its widespread use. We sought to evaluate the cost-effectiveness of sNPWT compared with standard care in reducing SSCs following closed surgical incisions. METHOD: A decision analytic model was developed to explore the total costs and health outcomes associated with the use of the interventions in patients following vascular, colorectal, cardiothoracic, orthopaedic, C-section and breast surgery from the UK National Health Service (NHS) and US payer perspective over a 12-week time horizon. We modelled complications avoided (surgical site infection (SSI) and dehiscence) using data from a recently published meta-analysis. Cost data were sourced from published literature, NHS reference costs and Centers for Medicare and Medicaid Services. We conducted subgroup analysis of patients with diabetes, an American Society of Anesthesiologists (ASA) score ≥3 and body mass index (BMI) ≥30kg/m2. A sensitivity analysis was also conducted. RESULTS: sNPWT resulted in better clinical outcomes and overall savings of £105 per patient from the UK perspective and $637 per patient from the US perspective. There were more savings when higher-risk patients with diabetes, or a BMI ≥30kg/m2 or an ASA≥3 were considered. We conducted both one-way and probabilistic sensitivity analysis, and the results suggested that this conclusion is robust. CONCLUSION: Our findings suggest that the use of sNPWT following closed surgical incisions saves cost when compared with standard care because of reduced incidence of SSC. Patients at higher risk should be targeted first as they benefit more from sNPWT. This analysis is underpinned by strong and robust clinical evidence from both randomised and observational studies.

Early Economic Evaluation Demonstrates That Noncomputerized Tomography Robotic-Assisted Surgery Is Cost-Effective in Patients Undergoing Unicompartmental Knee Arthroplasty at High-Volume Orthopaedic Centres.

BACKGROUND: For over fifty years, unicompartmental knee arthroplasty (UKA) has been used to treat single-compartment osteoarthritis of the knee and is considered a safe alternative to total knee arthroplasty (TKA). The development and use of robotic-assisted surgery (r-UKA) have made the execution of the procedure more precise, and various studies have reported improved radiographic outcomes and implant survival rates; however, its cost-effectiveness is unknown. This study aimed at assessing the cost-effectiveness of noncomputerized tomography (non-CT) r-UKA compared to the traditional unicompartmental knee arthroplasty (t-UKA) method in patients with unicompartmental knee osteoarthritis from the UK payer's perspective. METHODS: We developed a 5-year four-state Markov model to evaluate the expected costs and outcomes of the two strategies in patients aged 65 years. Failure rates for t-UKA were taken from the British National Joint Registry while data for non-CT r-UKA were obtained from a 2-year observational study. Cost was obtained from the NHS reference cost valued at 2018/19 GBP£, and a discount rate of 3.5% was applied to both costs and benefits. RESULTS: For a high-volume orthopaedic centre that performs 100 UKA operations per year, non-CT r-UKA was more costly than t-UKA but offered better clinical outcomes, and the estimated cost per QALY was £2,831. The results were more favourable in younger patients aged less than 55 and sensitive to case volumes and follow-up period. CONCLUSION: Non-CT r-UKA is cost-effective compared with t-UKA over a 5-year period. Results are dependent on case volumes and follow-up period and favour younger age groups.

Cost-effectiveness analysis of single use negative pressure wound therapy dressings (sNPWT) compared to standard of care in reducing surgical site complications (SSC) in patients undergoing coronary artery bypass grafting surgery.

BACKGROUND: There is a growing interest in using negative pressure wound therapy in closed surgical incision to prevent wound complications which continue to persist following surgery despite advances in infection measures. OBJECTIVES: To estimate the cost-effectiveness of single use negative pressure wound therapy (sNPWT) compared to standard of care in patients following coronary artery bypass grafting surgery (CABG) procedure to reduce surgical site complications (SSC) defined as dehiscence and sternotomy infections. METHOD: A decision analytic model was developed from the Germany Statutory Health Insurance payer's perspective over a 12-week time horizon. Baseline data on SSC, revision operations, length of stay, and readmissions were obtained from a prospective observational study of 2621 CABG patients in Germany. Effectiveness data for sNPWT was taken from a randomised open label trial conducted in Poland which randomised 80 patients to treatment with either sNPWT or standard care. Cost data (in Euros) were taken from the relevant diagnostic related groups and published literature. RESULTS: The clinical study reported an increase in wounds that healed without complications 37/40 (92.5%) in the sNPWT compared to 30/40 (75%) patients in the SC group p = 0.03. The model estimated sNPWT resulted in 0.989 complications avoided compared to 0.952 and the estimated quality adjusted life years were 0.8904 and 0.8593 per patient compared to standard care. The estimated mean cost per patient was €19,986 for sNPWT compared to €20,572 for SC resulting in cost-saving of €586. The findings were robust to a range of sensitivity analyses. CONCLUSION: The sNPWT can be considered a cost saving intervention that reduces surgical site complications following CABG surgery compared to standard care. We however recommend that additional economic studies should be conducted as new evidence on the use of sNPWT in CABG patients becomes available to validate the results of this economic analysis.

Comparing the costs and outcomes of an integrated twin compression screw (ITCS) nail with standard of care using a single lag screw or a single helical blade cephalomedullary nail in patients with intertrochanteric hip fractures.

BACKGROUND: Surgical treatment is the optimal strategy for managing intertrochanteric fractures as it allows for early rehabilitation and functional recovery. The purpose of the study was to assess the cost-effectiveness of commonly used cephalomedullary nails for the treatment of unstable intertrochanteric hip fractures. METHODS: A decision analytic model was developed from a US payer's perspective using clinical data from a pairwise meta-analysis of randomised controlled trials (RCTs) and comparative observational studies comparing the integrated twin compression screw (ITCS) nail versus two single-screw or blade cephalomedullary nails [single lag screw (SLS) nail and single helical blade (SHB) nail]. The model considered a cohort of 1000 patients with a mean age of 76, as reported in the clinical studies over a 1-year time period. Cost data was obtained from the Center for Medicare and Medicaid Services website and published literature and adjusted for inflation. One-way and probabilistic sensitivity analyses were conducted to assess the effect of uncertainty in model parameters on model conclusions. RESULTS: The model estimated 0.546 quality-adjusted life years (QALYs) and 0.78 complications avoided by using the ITCS nail and 0.455 QALYs and 0.67 complications avoided for the standard of care, using SLS or SHB nails. The cost per patient was $34,336 for patients treated with an ITCS nail and $37,036 for patients treated with the standard of care respectively, resulting in a cost saving of $2700 in favour of the ITCS nail. More savings were observed when the ITCS nail was compared to the SHB ($3280 per patient) and SLS ($1652 per patient). The findings were robust to a range of both one-way and the probabilistic sensitivity analyses. CONCLUSION: In conclusion, the ITCS nail can be considered a cost saving intervention in patients undergoing intertrochanteric fracture fixation with an intramedullary device. Clinicians and policy makers should be encouraged to adopt healthcare technologies such as ITCS that will help them to provide quality healthcare despite falling budgets.

Cost-effectiveness analysis of single-use negative pressure wound therapy dressings (sNPWT) to reduce surgical site complications (SSC) in routine primary hip and knee replacements.

We sought to evaluate the cost-effectiveness of single-use negative pressure wound therapy in patients undergoing primary hip and knee replacements using effectiveness data from a recently completed non-blinded randomized controlled trial. A decision analytic model was developed from UK National Health Service perspective using data from a single-centre trial. 220 patients were randomized to treatment with either single-use negative pressure wound therapy or standard care i.e., film dressings of clinician choice and followed for 6 weeks. Outcomes included dressing changes, length of stay, surgical site complications, cost and quality adjusted life years. The randomized controlled trial reported a reduction in dressing changes (p = 0.002), SSC (p = 0.06) and LOS (p = 0.07) in favor of single-use negative pressure wound therapy compared with standard care. The model estimated 0.116 and 0.115 QALY gained, 0.98 and 0.92 complications avoided for single-use negative pressure wound therapy and standard care, respectively. The cost/patient was £5,602 ($7,954) and £6,713 ($9,559) for single-use negative pressure wound therapy and standard care respectively resulting in cost-saving of £1,132 ($1,607) in favor of single-use negative pressure wound therapy. Greater savings were observed in subgroups of higher risk patients with BMI ≥ 35 and ASA ≥ 3 i.e., £7,955 ($11,296) and £7,248 ($10,293), respectively. The findings were robust to a range of sensitivity analyses. In conclusion, single-use negative pressure wound therapy can be considered a cost saving intervention to reduce surgical site complications following primary hip and knee replacements compared with standard care. Providers should consider targeting therapy to those patients at elevated risk of surgical site complications to maximize efficiency.

A systematic review and meta-analysis of clinical outcomes associated with nanocrystalline silver use compared to alternative silver delivery systems in the management of superficial and deep partial thickness burns.

OBJECTIVE: The purpose of this systematic review and meta-analysis was to assess the clinical effectiveness of nanocrystalline silver compared to alternative silver delivery systems (silver sulphadiazine [SSD] and silver nitrate) in adults and children with superficial and deep partial thickness burns. METHODS: PubMed, EMBASE, Cochrane and other databases were searched to identify relevant randomised controlled trials and observational studies. RESULTS: Eight studies that assessed both nanocrystalline silver and SSD and one study that compared nanocrystalline silver vs. silver nitrate were identified. Nanocrystalline silver compared to SSD/silver nitrate was associated with a statistically significant reduction in infections (odds ratio [OR] 0.21, 95% CI 0.07-0.62, p=0.005), length of stay in hospital (mean difference -4.74 (95% CI -5.79 to -3.69, p=0.00001) and surgical procedures (OR 0.40, 95% CI 0.28-0.56, p=0.00001). Three studies that reported on pain had lower pain scores with nanocrystalline silver use than with SSD/silver nitrate; a high level of heterogeneity precluded pooling estimates. CONCLUSION: This comprehensive systematic review and meta-analysis of the available evidence suggest that the use of nanocrystalline silver dressings results in shorter length of stay in hospital, less pain, fewer surgical procedures and reduced infection rates compared to silver sulphadiazine/silver nitrate.

An Overview of Clinical and Health Economic Evidence Regarding Porcine Small Intestine Submucosa Extracellular Matrix in the Management of Chronic Wounds and Burns.

Small intestine submucosa (SIS) has been extensively evaluated in preclinical models and developed into commercially produced medical technologies intended for use in several different indications. The SIS extracellular matrix cellular and/or tissue-based product is a commercially available, porcine-derived SIS dressing. The purpose of this review was to consider the role of the SIS dressing in the management of chronic wounds and burns. Using a variety of search terms from the literature to describe the SIS dressing, the following databases were searched: PubMed, York Centre for Reviews and Dissemination database, National Health Service Economic Evaluation database, Health Technology Assessment database, and the Cochrane Library. The search identified 78 studies of which 21 met the inclusion/exclusion criteria. Of those, 14 involved chronic wounds, 3 described the management of burn wounds, and 4 were economic evaluations. The wide variety of comparative treatments and outcomes studied precluded the use of meta-analysis techniques. Study results show SIS dressings may improve outcomes in chronic wounds and cost less than several alternative biological wound treatments. Studies to examine their efficacy in burn wound management are warranted.

Estimating the Clinical Outcomes and Cost Differences Between Standard Care With and Without Cadexomer Iodine in the Management of Chronic Venous Leg Ulcers Using a Markov Model.

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world and present a significant financial and resource burden to health care systems. Cadexomer iodine (CI) is an antimicrobial dressing indicated for use in chronic exuding wounds. The aim of this study was to estimate the cost utility of using CI + standard care (SC) - ie, high compression multicomponent bandaging including debridement - compared with SC alone in the management of chronic (>6 months' duration) VLUs from a payer's perspective. A Markov model was constructed to evaluate the cost and clinical benefits (healing and decreased infection rates) of the 2 treatment modalities over a 1-year period using data from 4 randomized, controlled clinical studies (RCTs) included in a recent Cochrane review and cost data from a recently published economic evaluation of VLUs. Costs were calculated using 2014 United States dollars; wound outcomes in- cluded complete healing in 212 patients reported in the Cochrane meta-analysis and quality-adjusted life years (QALYs), with utility values obtained from 200 patients with VLUs calculated using standard gamble. Treatment with CI over 1 year was $7,259 compared to $7,901 for SC. This resulted in a cost savings of $643/patient in favor of CI compared with SC. More patients treated with CI (61%) had their wounds healed compared to 54% treated with SC. Furthermore, patients treated with CI+SC experienced 6 additional ulcer-free weeks compared to persons treated with SC alone (ie, 25 ulcer- free weeks compared to 19 ulcer-free weeks, respectively). Overall, CI resulted in 0.03 more QALYs (ie, 0.86 QALYs compared to 0.83 for SC). The use of CI in addition to SC compared to SC alone over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs The results of this study suggest CI is cost effective com- pared to SC alone in the management of patients with chronic VLUs. Prospective, controlled clinical studies are needed to elucidate the effect and cost effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.