Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.

STUDY DESIGN: Economic modeling of data from a multicenter, prospective registry. OBJECTIVE: The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA: ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis. METHODS: Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05). RESULTS: BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ±â€Š$6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ±â€Š$17,000) than for patients without pseudarthrosis ($61,000 ±â€Š$25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients. CONCLUSION: BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research. LEVEL OF EVIDENCE: 2.

Application of Hydroxycholesterols for Alveolar Cleft Osteoplasty in a Rodent Model.

BACKGROUND: Bone morphogenetic proteins (BMPs) have played a central role in the regenerative therapies for bone reconstruction, including alveolar cleft and craniofacial surgery. However, the high cost and significant adverse effect of BMPs limit their broad application. Hydroxycholesterols, naturally occurring products of cholesterol oxidation, are a promising alternative to BMPs. The authors studied the osteogenic capability of hydroxycholesterols on human mesenchymal stem cells and the impact of hydroxycholesterols on a rodent alveolar cleft model. METHODS: Human mesenchymal stem cells were treated with control medium or osteogenic medium with or without hydroxycholesterols. Evaluation of cellular osteogenic activity was performed. A critical-size alveolar cleft was created and one of the following treatment options was assigned randomly to each defect: collagen sponge incorporated with hydroxycholesterols, BMP-2, or no treatment. Bone regeneration was assessed by means of radiologic and histologic analyses and local inflammation in the cleft evaluated. Moreover, the role of the hedgehog signaling pathway in hydroxycholesterol-mediated osteogenesis was examined. RESULTS: All cellular osteogenic activities were significantly increased on human mesenchymal stem cells treated with hydroxycholesterols relative to others. The alveolar cleft treated with collagen sponge with hydroxycholesterols and BMP-2 demonstrated robust bone regeneration. The hydroxycholesterol group revealed histologically complete bridging of the alveolar defect with architecturally mature new bone. The inflammatory responses were less in the hydroxycholesterol group compared with the BMP-2 group. Induction of hydroxycholesterol-mediated in vitro osteogenesis and in vivo bone regeneration were attenuated by hedgehog signaling inhibitor, implicating involvement of the hedgehog signaling pathway. CONCLUSION: Hydroxycholesterols may represent a viable alternative to BMP-2 in bone tissue engineering for alveolar cleft.

Cost-Effectiveness Analysis of Demineralized Bone Matrix and rhBMP-2 versus Autologous Iliac Crest Bone Grafting in Alveolar Cleft Patients.

BACKGROUND: The standard of care for patients with alveolar cleft deformities is autologous bone grafting using iliac crest bone graft (ICBG). The combination of demineralized bone matrix with recombinant human bone morphogenetic protein-2 (DBX/rhBMP-2), as a substitute for ICGB, has been shown to have similar bony incorporation within the maxilla without donor-site morbidity. It has been argued that one of the drawbacks of using DBX/rhBMP-2 is the higher cost. The aim of this study was to compare the cost, operative time, and hospital length of stay associated with these two treatment modalities. METHODS: A chart review was conducted for 71 patients who underwent secondary alveolar cleft reconstruction. Forty patients received ICBG and 31 patients underwent reconstruction using DBX/rhBMP-2. Operative costs, operative time, and hospital length of stay were compared between the two groups. RESULTS: The average total operative cost was $6892 in the ICBG surgery population versus $4836 in the DBX/rhBMP-2 population (p < 0.01). Statistically significant decreases in anesthesia, pharmacy, and operating room costs were found in patients who underwent the DBX/rhBMP-2 surgery. Operative time decreased from an average of 97.3 minutes to 67.0 minutes (p < 0.01), and length of inpatient stay decreased from an average of 29.8 hours to 9.3 hours (p < 0.01). CONCLUSION: In the treatment of alveolar cleft deformities, operative material costs were greater in the DBX/rhBMP-2 group but-secondary to decreased hospital, anesthesia, pharmacy, and operating room costs-DBX/rhBMP-2 was more cost-effective than ICBG.

Counting the Cost of Failed Spinal Fusion for Relief of Low Back Pain: Does Primary Fusion With Bone Morphogenetic Protein Make Economic Sense From a Primary Payer Perspective?

STUDY DESIGN: A retrospective cohort study. OBJECTIVES: To investigate the unknown direct costs of failed instrumented lumbar fusion using iliac crest bone graft (ICBG) and subsequent reoperation utilizing recombinant human bone morphogenetic protein-2 (rhBMP-2) from a primary payer perspective. SUMMARY OF BACKGROUND DATA: Recent evidence has demonstrated increased rates of instrumented lumbar fusion and utilization of rhBMP-2 to treat a range of conditions causing lower back pain. For health care providers with finite financial resources, there is an increasing demand to evaluate economic costs of available treatment modalities. The high cost of rhBMP-2 has often been cited as a leading reason for delaying its universal acceptance as a preferred substitute to ICBG. It has been hypothesized that rhBMP-2 may demonstrate cost-effectiveness if pseudarthrosis and reoperation rates are decreased, thus avoiding subsequent expenditure. METHODS: This was a retrospective cohort study of patients who underwent instrumented lumbar fusions utilizing rhBMP-2. Hospital finance records were used to calculate direct total expenditure incurred by the primary payer for the procedure using rhBMP-2. For patients who received rhBMP-2 in a secondary lumbar fusion, additional total expenditure related to the patients' failed primary instrumented fusion with ICBG was also sought. RESULTS: The mean total costs associated with failed instrumented lumbar fusion using ICBG and reoperation using rhBMP-2 totaled £47,734 per patient. The total direct costs of a policy of primary instrumented lumbar fusion with rhBMP-2 were less at £26,923 per patient; however, this was not significant. CONCLUSIONS: To date, this is the first study to report the costs of failed primary instrumented lumbar fusions using ICBG and subsequent secondary fusions using rhBMP-2 from a primary payer perspective. On the basis of this evidence, a policy of using rhBMP-2 in all patients undergoing a primary instrumented lumbar fusion cannot be recommended.

Biological substitutes/extenders for spinal arthrodesis: which agents are cost-effective?

STUDY DESIGN: Systematic review. OBJECTIVE: To evaluate the cost-effectiveness of lumbar or cervical spinal arthrodesis using biological substitutes and extenders compared with iliac crest autograft for the treatment of degenerative spinal conditions. SUMMARY OF BACKGROUND DATA: The cost-effectiveness of using bone graft substitutes and extenders for spinal fusion compared with using iliac crest autograft is not yet well established. METHODS: A systematic search of PubMed/MEDLINE, the Cochrane Collaboration Library, EMBASE, the CRD (Centre for Reviews and Dissemination) database, and Tuft's CEA registry for literature published through December 2013 was performed to identify full formal economic analyses comparing the use of biological grafts with iliac crest bone graft in spinal fusion for thoracolumbar or cervical degenerative, deformity, and traumatic spinal conditions. Economic outcomes such as cost per improved outcome or cost per quality-adjusted life year were reported in the context of the model type, analytic perspective clinical comparisons, and sensitivity analyses employed. RESULTS: The search strategy yielded 88 citations, and 6 full economic analyses ultimately met our inclusion criteria. For the comparison of recombinant human bone morphogenetic protein-2 to iliac crest bone graft in the lumbar spine, data from 4 cost-effectiveness studies and 1 cost-utility study provided discordant conclusions that varied with type of data used, cost-measurement methods, and study design. In the cervical spine, one study suggested that from a societal perspective, anterior cervical discectomy and fusion (ACDF) with allograft is similarly cost-effective as ACDF with autograft. CONCLUSION: The results suggest that compared with use of iliac crest bone graft in lumbar spinal fusion, use of recombinant human bone morphogenetic protein is not cost-effective from a payer perspective with higher upfront costs, but it may be cost-effective from a societal perspective due to a decrease in lost productivity. The data in this study also suggest that from a societal perspective, ACDF with allograft is similarly cost-effective to ACDF with autograft. LEVEL OF EVIDENCE: 3.

Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis.

BACKGROUND: Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures. METHODS: Three hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2. RESULTS: OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2. CONCLUSIONS: Results of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.

Clinical sequelae after rhBMP-2 use in a minimally invasive transforaminal lumbar interbody fusion.

BACKGROUND CONTEXT: Recent reports of postoperative radiculitis, bone osteolysis, and symptomatic ectopic bone formation after recombinant human bone morphogenetic protein-2 (rhBMP-2) use in transforaminal lumbar interbody fusions (TLIFs) are a cause for concern. PURPOSE: To determine the clinical and radiographic complications associated with BMP utilization in a minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) environment. STUDY DESIGN/SETTING: Retrospective clinical case series at a single institution. PATIENT SAMPLE: Five hundred seventy-three consecutive patients undergoing an MIS-TLIF. OUTCOME MEASURES: Reoperation rates and total costs associated with complications of rhBMP-2 use and pseudarthrosis. METHODS: A retrospective review of 610 consecutive patients undergoing an MIS-TLIF (2007-2010) by a single surgeon at our institution was performed (mean age 48.7 years, range 26-82 years). All patients underwent an MIS laminectomy with bilateral facetectomy, single TLIF cage, unilateral pedicle screw fixation, and 12 mg (large kit) or 4.2 mg (small kit) of rhBMP-2. The BMP-2 collagen-soaked sponge was placed anteriorly in the disc space, followed by local bone graft, and then the cage was filled only with local bone and no BMP-2. Patients were evaluated at 6 months and 1 year with computed tomography (CT) scan. Those demonstrating neuroforaminal bone growth, osteolysis/cage migration, or pseudarthrosis were reviewed, and cost data including direct cost/procedure for both index and revision surgeries were collected. RESULTS: Of the 573 patients, 10 (1.7%) underwent 15 additional procedures based on recalcitrant radiculopathy and CT evidence of neuroforaminal bone growth, vertebral body osteolysis, and/or cage migration. Thirty-nine patients (6.8%) underwent reoperation for clinically symptomatic pseudarthrosis. Bone overgrowth was associated with nerve impingement and radiculopathy in all 10 patients (small kit, n=9; large kit, n=1). Osteolysis and cage migration occurred in 2 (20%) of these same 10 patients. Average total costs were calculated per procedure ($19,224), and the costs for reoperation equaled $14,785 per encounter for neuroforaminal bone growth and $20,267 for pseudarthrosis. CONCLUSIONS: Symptomatic ectopic bone formation, vertebral osteolysis, and pseudarthrosis are recognized complications with the use of rhBMP-2 in MIS-TLIFs. Potential causes include improper dosage and a closed space that prevents the egress of the postoperative BMP-2 fluid collection. Management of these complications has a substantial cost for the patient and the surgeon and needs to be considered with the off-label use of rhBMP-2.

Bone morphogenetic protein (BMP) for fracture healing in adults.

BACKGROUND: Delay in fracture healing is a complex clinical and economic issue for patients and health services. OBJECTIVES: To assess the incremental effectiveness and costs of bone morphogenetic protein (BMP) on fracture healing in acute fractures and nonunions compared with standards of care. SEARCH STRATEGY: We searched The Cochrane Library (2008, Issue 4), MEDLINE, and other major health and health economics databases (to October 2008). SELECTION CRITERIA: Randomised controlled trials (RCTs) and full or partial economic evaluations of BMP for fracture healing in skeletally mature adults. DATA COLLECTION AND ANALYSIS: All clinical and economic data were extracted by one author and checked by another. MAIN RESULTS: Eleven RCTs, all at high risk of bias, and four economic evaluations were included. Apart from one study, the times to fracture healing were comparable between the BMP and control groups. There was some evidence for increased healing rates, without requiring a secondary procedure, of BMP compared with usual care control in acute, mainly open, tibial fractures (risk ratio (RR) 1.19, 95% CI 0.99 to 1.43). The pooled RR for achieving union for nonunited fractures was 1.02 (95% CI 0.90 to 1.15). One study found no difference in union for patients who had corrective osteotomy for radial malunions. Data from three RCTs indicated that fewer secondary procedures were required for acute fracture patients treated with BMP versus controls (RR 0.65, 95% CI 0.50 to 0.83). Adverse events experienced were infection, hardware failure, pain, donor site morbidity, heterotopic bone formation and immunogenic reactions. The evidence on costs for BMP-2 for acute open tibia fractures is from one large RCT. This indicates that the direct medical costs associated with BMP would generally be higher than treatment with standard care, but this cost difference may decrease as fracture severity increases. Limited evidence suggests that the direct medical costs associated with BMP could be offset by faster healing and reduced time off work for patients with the most severe open tibia fractures. AUTHORS' CONCLUSIONS: This review highlights a paucity of data on the use of BMP in fracture healing as well as considerable industry involvement in currently available evidence. There is limited evidence to suggest that BMP may be more effective than controls for acute tibial fracture healing, however, the use of BMP for treating nonunion remains unclear. The limited available economic evidence indicates that BMP treatment for acute open tibial fractures may be more favourable economically when used in patients with the most severe fractures.

A health economic analysis of the use of rhBMP-2 in Gustilo-Anderson grade III open tibial fractures for the UK, Germany, and France.

The purpose of this study was to determine the cost savings from a societal perspective for recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III A and B open tibial fractures treated with a locked intramedullary nail and soft-tissue management in the UK, Germany, and France. Health care system costs (direct health care costs) and costs for productivity losses (indirect health care costs) were calculated using the raw data from the Bone Morphogenetic Protein Evaluation Group in Surgery for Tibial Trauma "BESTT study". Return-to-work time for estimation of productivity losses was assumed to correspond with the time of fracture healing. For calculation of secondary interventions costs and productivity losses the respective 2007/2008 national tariffs for surgical procedures and average national wages for the UK, Germany, and France were used. For a 1 year perspective, overall treatment costs per patient after the initial surgery of the control vs. the rhBMP-2 group were 44,757 euros vs. 36,847 euros for the UK, 50,197 euros vs. 40,927 euros for Germany and 48,766 euros vs. 39,474 euros for France in favour of rhBMP-2 with overall savings overall savings per case of rhBMP-2 treatment of 7911 euros for the UK, 9270 euros for Germany, and 9291 euros for France which was mainly due to reduced productivity losses by significant faster fracture healing in the rhBMP-2 group (p=0.01). These savings largely offset the upfront price of rhBMP-2 of 2266 euros (1790 pounds) in the UK, euros 2970 in Germany, and 2950 euros in France. Total net savings can be estimated to be 9.6 million euros for the UK, 14.5 million euros for Germany, and 11.4 million euros for France. The results depend on the methodology used particularly for calculation of productivity losses and return-to-work time which was assumed to correspond with fracture healing time. In summary, despite the apparent high direct cost of rhBMP-2 in grade III A and B open tibial fractures, at a national level there are net cost savings from a societal perspective for all three countries.

RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age.

STUDY DESIGN: Prospective randomized controlled trial of rhBMP-2/ACS (Infuse bone graft) versus iliac crest bone graft (ICBG) for lumbar spine fusion in patients over 60 years of age. OBJECTIVE: To report on clinical, radiographic, and economic outcomes, at 2-year follow-up, in patients treated by posterolateral lumbar fusion with rhBMP-2/ACS versus ICBG. SUMMARY OF BACKGROUND DATA: RhBMP-2/ACS is widely used "off-label" for posterolateral spinal fusion. Despite encouraging initial reports, outstanding issues include the need for evidence regarding safety and efficacy in an older population; and an assessment of cost-effectiveness. METHODS: Patients over 60 years old were randomized to rhBMP-2/ACS (n = 50) or ICBG (n = 52). Oswestry Disability Index, Short Form-36, and numerical rating scales for back and leg pain were determined preoperatively and at 6, 12, and 24 months postoperatively. Fusion was evaluated by fine-cut computed tomography scan 2 years postoperatively by 3 reviewers. All in-patient and subsequent out-patient event costs were recorded by a dedicated hospital coder. RESULTS: Two-year postoperative improvement in Oswestry Disability Index averaged 15.8 in the rhBMP-2/ACS group and 13.0 in the ICBG group. Mean improvement in Short Form-36 physical component score was 6.6 in the rhBMP-2/ACS group and 7.5 in the ICBG group. There were 20 complications in the ICBG group and 8 complications in the rhBMP-2/ACS group (P = 0.014). Sixteen ICBG and 10 rhBMP-2/ACS patients required additional treatment for persistent back or leg symptoms. Two rhBMP-2/ACS patients had revision procedures, 1 for nonunion. Eight patients in the ICBG group had revision procedures, 5 for nonunion. Mean fusion grade on computed tomography scan was significantly (P = 0.030) better in the rhBMP-2/ACS (4.3) compared with the ICBG group (3.8). Mean cost of the initial admission was $36,530 in the rhBMP-2/ACS group and $34,235 in the iliac crest bone graft (ICBG) group. Total cost of care over 2 years was $42,574 for the ICBG group and $40,131 for the rhBMP-2/ACS group. CONCLUSION: RhBMP-2/ACS is a viable ICBG replacement in older patients in terms of safety, clinical efficacy, and cost-effectiveness.

Health economics: a cost analysis of treatment of persistent fracture non-unions using bone morphogenetic protein-7.

OBJECTIVE: To compare the cost implications of treatment of persistent fracture non-unions before and after application of recombinant human bone morphogenetic protein-7 (BMP-7). METHOD: Of 25 fracture non-unions, 9 were treated using BMP-7 alone and 16 using BMP-7 and bone grafting. These patients were prospectively followed up, and the costs incurred were analysed. RESULTS: The mean number of procedures per fracture performed before application of BMP-7 was 4.16, versus 1.2 thereafter. Mean hospital stay and cost of treatment per fracture before receiving BMP-7 were 26.84 days and pound 13,844.68, versus 7.8 days and pound 7338.4 thereafter. The overall cost of treatment of persistent fracture non-unions with BMP-7 was 47.0% less than that of the numerous previous unsuccessful treatments (p=0.001). CONCLUSIONS: Treating fracture non-unions is costly, but this could be reduced by early BMP-7 administration when a complex or persistent fracture non-union is present or anticipated.

[Health-economic considerations for the use of BMP-2 for spinal surgery in Germany]. / Gesundheitsökonomische Uberlegungen für den Einsatz des Knochenwachstumsfaktors BMP-2 in der Wirbelsäulenchirurgie für das deutsche Gesundheitssystem.

INTRODUCTION: BMP-2 can replace autogenous bone grafting in lumbar one-level anterior lumbar interbody fusions (ALIF). The current G-DRG system does not reimburse the upfront price of 2,970 euro per BMP-2 application for hospitals in Germany. The purpose of the current study was to create a health economic model to evaluate the financial savings for health care providers (hospitals) and health care payers (health care insurance) that can be achieved by the use of BMP-2 in spine surgery. METHODS: A previously published pooled data analysis was used in which BMP-2 showed significant improvements in the treatment after ALIF surgery compared to autogenous bone grafting, including earlier return to work time and reduced revision rates. These medical findings were transformed into economic data based on the regulations of the German health system of 2005. RESULTS: The significantly shorter return to work time under BMP-2 treatment generates important financial savings for health care insurances offsetting the upfront prize of 2,970 euro for BMP-2. Savings for hospitals are mainly related to shorter surgery time due to the absence of the bone grafting procedure and faster discharge of the patient. CONCLUSIONS: The combination of improved medical outcome by BMP-2 treatment for the patient and net savings for the entire health care system in Germany represents a "dominant" strategy from a health economic perspective. This implicates that BMP-2 in ALIF procedures is to be recommended from a health economic point of view for the German health care system.

Economic considerations for the use of recombinant human bone morphogenetic protein-2 in open tibial fractures in Europe: the German model.

The addition of recombinant human bone morphogenetic protein (rhBMP-2) to the standard of care, consisting of soft tissue management and intramedullary nailing, in the BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) study led to a significantly better outcome for the patient. Reductions in fracture healing time, secondary interventions for delayed fracture healing and infection rates were observed with 1.50 mg/mL rhBMP-2 compared with the standard of care alone. In Germany the approximate cost of applying one dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) to an open tibial fracture is euro2970. The current German-Diagnosis-Related Group reimbursement system provides one flat rate per hospital stay or treatment case, and does not take into account the costs of rhBMP-2 application. Therefore there is no reimbursement for the price of rhBMP-2 for hospitals by health insurance companies. However, the above mentioned improvements in medical outcome could lead to important savings for health care systems, particularly for health insurance companies. A sound economic model to assess the cost-effectiveness and budget impact of rhBMP-2 is required. Using medical data from the BESTT study the differences in fracture healing time, in reduction of secondary interventions for fracture healing and infection treatment can be transferred into economic savings. It is anticipated that the overall savings that can be achieved by rhBMP-2 treatment in open tibia fractures, offset the upfront price of rhBMP-2 and lead to net savings for health insurance companies.

[Cost-benefit analysis of the use of rhBMP-2 in open tibial fractures: savings from a health insurer's perspective]. / Kosten-Nutzen-Betrachtung des Einsatzes von rhBMP-2 bei offenen Tibiafrakturen: Nettoeinsparungen aus Krankenkassensicht erzielbar.

BACKGROUND AND PURPOSE: The purpose of the current study was to evaluate savings from the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in open tibia fractures by faster fracture healing and reduction of secondary treatment costs from a health insurance perspective for Germany and to compare them to the upfront price of 2900 EUR of rhBMP-2. METHODS: Raw data from a previously published study (BESTT study) were used to conduct an economic calculation for secondary treatment costs for each patient from the standard care group and the 1.5 mg/ml rhBMP-2 group based on G-DRG 2005 prices from a health insurer's perspective for an observation period of 1 year for Germany. RESULTS: The use of rhBMP-2 leads to savings of 5697 EUR and 3183 EUR per patient for Gustilo-Anderson grade IIIB and all grade IIIA and B injuries, respectively. These savings offset the upfront price of 2900 EUR of rhBMP-2 and, therefore, net savings of 2797 EUR and 283 EUR for grade IIIB and all grade IIIA and B injuries can be achieved, respectively. These savings are mainly due to reduced sickness payments because of faster fracture healing in the rhBMP-2 group. CONCLUSIONS: The current study shows that the use of rhBMP-2 in Gustilo-Anderson grade IIIA and B open fractures leads--besides the better medical outcome for patients as shown previously in the BESTT study--to net savings from a health insurer's perspective.