An Analysis of Cost of Autologous Bone Graft

Nicholas A. Abidi, MD

Angeline M. Carlson, BS, RPh, PhD Erik M. Harris, MHA

Disclosures • Nicholas Abidi, MD6,8, presenting author

– Editorial Board Foot and Ankle Techniques

– Reviewer: FAI, JBJS, J of Trauma, JAAOS

– Chair, Health Policy Committee, AOFAS

– AOFAS Delegate to AMA

– Board of Directors, California Orthopaedic Association

– No consulting fees, honoraria or any other form of direct or indirect payment or compensation was received for this presentation

• Angeline Carlson, BS, RPh, PhD3B

– Chief Manager, Director of Research and Principle Founding Member, Data Intelligence Consultants, LLC

– Consultant: BioMimetic Therapeutics

• Provided assistance with pharmacoeconomic and cost data analysis, literature review, and writing support to the presenter

• Erik Harris, MHA3A

– Director of Reimbursement, BioMimetic Therapeutics

• Provided access to the budgetary impact cost calculator modeling tool used in this presentation, assistance with literature review, and writing support to the presenter

3A = Paid employee for a company or supplier 6 = Other material support from a company or supplier 3B = Paid consultant for a company or supplier 8 = Medical/Orthopaedic publications editorial/governing board

Introduction • Autogenous bone graft is currently the gold standard for

augmenting bone repair and fusion procedures of the foot and ankle

• The incidence of complications and postoperative morbidity following bone graft harvest are high and can result in increased surgical time and hospital stays

• Bone healing/regeneration requires 3 essential cellular qualities: – Osteoconduction = a bony surface/matrix/scaffold that permits new bone

growth on the surface and/or into its structure.

– Osteoinduction = recruiting and stimulating stem cells and progenitor cells necessary to achieve the critical mass of cells necessary to form a repair blastema.

– Osteogenesis = the process whereby new bone is formed by osteoblastic stem cell activity and differentiation of progenitor cells into osteoblasts along an osteoblastic pathway.

Bone Formation Process

Source: DiGiovanni CW, Lin S, Pinzur M. Recombinant human PDGF-BB in foot and ankle fusion. Expert Review of Medical Devices; Vol. 9; No. 2, 111-122 [2012]

Reproduced courtesy of Jeffrey O Hollinger, 2006 © BioMimetic Therapeutics, Inc.

Introduction

• Current “gold-standard” utilizes autogenous bone graft harvest for foot and ankle procedures – Iliac crest bone graft (ICBG)

– Proximal tibia

– Distal tibia

– Calcaneous

• No multicenter studies currently assess the incremental costs and budgetary impact of ICBG or LBG harvest in foot and ankle procedures

Local bone graft (LBG)

Balancing Patient Outcomes and Costs

“We have gone from believing that financial considerations should

have no bearing on doctors' clinical judgment to thinking that they

should be central to it.”

Stone, DA. The Doctor as Businessman: The Changing Politics of a Cultural Icon. Journal of Health Politics, Policy and Law 22(2-Apr, 1997): 533-556.

Study Purpose and Goal

• This study applies an interactive budget impact model (BIM) to assist surgeons and hospitals with cost/benefit analyses of: – Incremental costs associated with ICBG and LBG

– Additional costs associated with graft site enhancers

– Utilization of an orthobiologic bone graft substitute

• Facilitating informed decision-making through the application of comparative clinical and economic value assessments of competing interventions.

Materials and Methods • Development of the interactive budgetary impact

model* included: – Critical review of literature related to bone graft harvest in

foot and ankle procedures

– Survey of 10 US-based AOFAS/AAOS surgeons in academic and private practice

– Results from a 434-patient, multi-center, prospective RCT

– Review by six end-users representing 15 Canadian hospitals to incorporate the Canadian hospital perspective; the country for which the budgetary impact model* was developed

• The Canadian health care system represents a generalized hospital budgetary model due to the relative absence of a privatized health insurance system.

*The Canadian hospital-based budget impact model used in this study was developed in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) principles for budgetary impact analysis

Ten US Surgeon Survey Resource Inputs

Incremental Costs of

Bone Graft Harvest

Time, Instruments, and Ancillary Surgical Costs

Ioban™ is a trademark of 3M™

Gelfoam® is a registered trademark of Pharmacia & Upjohn Company LLC

Acumed Bone Graft Harvesting System is a trademark of Acumed®

Incremental Costs of Bone Graft Harvest

Calculating the Cost Impact of Complications

Graft Harvest Site Pain Actual Patient Experience

Data Source = Prospective 434-Patient North American Non-Inferiority Pivotal Trial Comparing Autograft to an Orthobiologic Substitute

Autograft Harvest vs. Orthobiologic Graft Substitute Budget Impact Comparison

Incremental Costs of

Bone Graft Substitute

Using cadaveric allograft,

synthetics, and PRP/BMA

Bone

Hea

ling T

riad

(e

.g.

ost

eoco

nduct

ive s

caff

old

, livin

g c

ells

ost

eoin

duct

ive g

row

th f

act

ors

)

Low Hospital Costs

(i.e. added costs to the hospital associated with OR time, length of stay, complications, and acquisition costs for supplemental material)

High

High

Budgetary Impact Analysis Matrix Autograft and Graft Substitute Products in F/A Fusion

Allo-Graft

BMPs (not

labeled for F/A fusion)

High Clinical Value

Low Cost

High Clinical Value

High Cost

Low Clinical Value

Low Cost

Low Clinical Value

High Cost

Stem Cells

Auto- Graft (ICBG

or LBG)

PDGF with

matrix

PRP

BMA

TCP

DBM

PRP or BMA with Allo-graft

Conclusions •Must weigh many factors when deciding between autograft bone harvest vs.

orthobiological bone graft substitute vs. allograft/synthetic bone graft substitute

•Both ICBG and LBG carry notable incremental costs related to OR time, length of stay, complications, and short- and long-term patient experience with graft harvest site issues

Autograft is not free

Base incremental costs associated with ICBG and LBG harvest from the budget impact model begin at $1,601 CAD and $755 CAD baseline, and can likely be higher depending on actual surgeon practices and hospital costs

Supplemental material, which should be considered in all fusion cases, adds to the overall cost, yet not all supplemental materials provide the fullest complement of the bone healing triad elements.

•Orthobiologic bone graft substitute can carry a higher up-front acquisition cost, but it can overcome the cost disadvantages of supplemental bone graft materials and complications of autograft bone harvest, to yield overall per-case and annualized cost savings when all incremental costs are equally compared.

DiGiovanni CW, Lin S, Pinzur M. Recombinant human PDGF-BB in foot and ankle fusion. Expert Review of Medical Devices; Vol. 9; No. 2, 111-122 [2012].

DiGiovanni CW, Petricek JM. The evolution of rhPDGF-BB in musculoskeletal repair and its role in foot and ankle fusion surgery. Foot Ankle Clin N Am 15, 621-40 [2010].

Hollinger JO, Hart CE, Hirsch SN, Lynch S, Friedlaender GE. Recombinant human platelet-derived growth factor: biology and clinical applications. J Bone Joint Surg Am 90 (Suppl 1), 48-54 [2008a].

DeOrio JK, Farber DC. Morbidity associated with anterior iliac crest bone grafting in foot and ankle surgery. Foot Ankle Int 26,147-151 [2005].

Geideman W, Early JS, Brodsky J. Clinical results of harvesting autogenous cancellous graft from the ipsilateral proximal tibia for use in foot and ankle surgery. Foot Ankle Int 25,451-455 [2004].

Raikin SM, Brislin K. Local bone graft harvested from the distal tibia or calcaneus for surgery of the foot and ankle. Foot Ankle Int 26, 449-453 [2005].

Chou LB, Mann RA, Coughlin MJ, McPeake WT, Mizel MS. Stress fracture as a complication of autogenous bone graft harvest from the distal tibia. Foot Ankle Int 28,199-201[2007].

Kim DH, Rhim R, Li L, et al. Prospective study of iliac crest bone graft harvest site pain and morbidity. The Spine Journal 9 (11), 886-92.

Schwartz CE, Martha JF, Kowalski P, et al. Prospective evaluation of chronic pain associated with posterior autologous iliac crest bone graft harvest and its effect on postoperative outcome. Health Qual Life Outcomes 7, 49-56 [2009].

Frohberg U, Mazock JB. A review of morbidity associated with bone harvest from the proximal tibial metaphysis. Mund Kiefer Gesichts Chir 9, 63-65 [2005].

Polly DW, Ackerman SJ, Shaffrey CI, et al. A cost analysis of bone morphogenetic protein versus autogenous iliac crest bone graft in single-level anterior lumbar fusion. Orthopedics 26 (10), 1027-37 [2003].

St. John TA, Vaccaro AR, Sah AP, et al. Physical and monetary costs associated with autogenous bone graft harvesting. Am J Orthop 32, 18-23 [2003].

Lohmann H, Grass G, Rangger C, Mathiak G. Economic impact of cancellous bone grafting in trauma surgery. Arch Ortho Trauma Surg 127, 345- 348 [2007].

Dahabreh Z, Calori GM, Kanakaris NK, Nikolaou VS, Giannoudis PV. A cost analysis of treatment of tibial fracture nonunion by bone grafting or bone morphogenetic protein-7. Int Orthopaedics 33, 1407-1414 [2009].

Laurencin C, Khan Y, El-Amin SF. Bone graft substitutes. Ex Rev Med Devices 3 (1), 49-57 [2006].

DeLong WG, Einhorn TA, Koval K, et al. Bone grafts and bone graft substitutes in orthopaedic trauma surgergy: a critical analysis. J Bone Joint Surg Am 89-A (3), 649-58 [2007].

Liporace FA, Bibbo C, Azad V, Koerner, Lin SS. Bioadjuvants for complex ankle and hindfoot reconstruction. Foot Ankle Clin N Am 12, 75-106 [2007].

References

Caplan AI, Correa D. PDGF in bone formation and regeneration: new insights into a novel mechanism involving MSCs. J Orthop Res online DOI 10.1002/jor.21462 [2011].

Shapiro F. Bone development and its relation to fracture repair. The role of mesenchymal osteoblasts and surface osteoblasts. Eur Cells Materials 15, 53-76 [2008].

Nevins M, Giannobile WV, McGuire MK, et al. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol 76: 2205-2215 [2005].

Graham S, Leonidou A, Lester M, Heliotis M, Mantalaris A, Tsiridis E. Investigating the role of PDGF as a potential drug therapy in bone formation and fracture healing. Expert Opin Investig Drugs 18 (11), 1633-54 [2009].

Daniels T, DiGiovanni C, Lau JT, Wing K, Younger A. Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. Foot Ankle Int 31, 473-9 [2010].

DiGiovanni CW, Baumhauer J, Lin SS, et al. Prospective, randomized, multi-center feasibility trial of rhPDGF-BB versus autologous bone graft in a foot and ankle fusion model. Foot Ankle Int Online DOI 10.3113/FAL.2011.0344 [2011].

Griffin XL, Smith CM, Costa ML. The clinical use of platelet-rich plasma in the promotion of bone healing: a systematic review. Injury, Int. J. Care Injured 40, 158-162 [2009].

Jacobs JJ, Andersson GBJ, Bell JE, et al. United States Bone and Joint Decade: The Burden of Musculoskeletal Diseases in the United States. Rosemont,IL: American Academy of Orthopaedic Surgeons. [2008] Available on line at: http://www.boneandjointburden.org.

Arrington ED, Smith WJ, Chambers HG, Bucknell AL, Davino NA. Complications of iliac crest bone graft harvesting. Clin Orthop. 1996;300-309.

Banwart JC, Asher MA, Hassanein RS. Iliac crest bone graft harvest donor site morbidity: a statistical evaluation. Spine. 1995;20:1055-1060.

BioMimetic Therapeutics, Inc; Canada/U.S. Multicenter Randomized Control Study BMTI-2006-01; A 434-Patient, Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions; pivotal clinical trial data on file at BioMimetic Therapeutics, Inc.

Goulet JA, Senunas LE, DeSilva GL, Greenfield ML. Autogenous iliac crest bone graft: complications and functional assessment. Clin Orthop. 1997;76-81.

O’Keeffe RM, Riemer BL, Butterfield SL. Harvesting of Autogenous Cancellous Bone Graft from the Proximal Tibial Metaphysis: A Review of 230 Cases. J Orthop Trauma. 1991; 5(4):469-474.

Schnee CL, Freese A, Weil RJ, Marcotte PJ. Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion. Spine. 1997;22:2222-2227.

Schulhofer DS, Oloff LM. Iliac Crest Donor Site Morbidity in Foot and Ankle Surgery. J Foot and Ankle Surgery. 1997;36(2):155-158.

Urban JA. Cost analysis of surgical site infections. Surg Infect (Larchmt). 2006;7 Suppl 1:S19-22. Review.

Stone, DA. The Doctor as Businessman: The Changing Politics of a Cultural Icon. Journal of Health Politics, Policy and Law 22(2-Apr, 1997): 533-556.

Mauskopf JA, Sullivan SD, Lieven A, Caro J, Mullins CD, Nuijten M, Orlewska E, Watkins J, Trueman P. Principles of Good Practice for Budget Impact Analysis: Report of the ISPOR Task Force on Good Research Practices — Budget Impact Analysis. Value in Health; Vol. 10; No. 5, 336-347 [2007]

References