This Podium Presentation summarized the initial findings of a study that applied an interactive budget impact model (BIM) to assist surgeons and hospitals with cost/benefit analyses of: 1) incremental costs associated with iliac crest bone graft harvest and local bone graft harvest; 2) additional costs associated with graft site enhancers; and 3) utilization of an orthobiologic bone graft substitute (Β-TCP with rhPDGF-BB) as a replacement of autograft. The objective of the study was to facilitate informed decision-making through the application of comparative clinical and economic value assessments of competing interventions in foot and ankle fusion.

1. An Analysis of Cost of
Autologous Bone Graft
Nicholas A. Abidi, MD
Angeline M. Carlson, BS, RPh, PhD
Erik M. Harris, MHA

2. 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

3. 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.

4. Bone Formation Process
Reproduced courtesy of Jeffrey O Hollinger, 2006 © BioMimetic Therapeutics, Inc.
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]

5. Introduction
• Current “gold-standard” utilizes autogenous bone
graft harvest for foot and ankle procedures
– Iliac crest bone graft (ICBG)
– Proximal tibia
– Distal tibia Local bone graft (LBG)
– Calcaneous
• No multicenter studies currently assess the
incremental costs and budgetary impact of ICBG or
LBG harvest in foot and ankle procedures

6. 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.

7. 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.

8. 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

9. Ten US Surgeon Survey
Resource Inputs

10. 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®

11. Incremental Costs of Bone
Graft Harvest
Calculating the Cost Impact of Complications

12. Graft Harvest Site Pain
Actual Patient Experience
Data Source = Prospective 434-Patient North American Non-Inferiority Pivotal Trial Comparing Autograft to an Orthobiologic Substitute

13. Budget Impact Comparison
Autograft Harvest vs. Orthobiologic Graft Substitute

14. Incremental
Costs of
Bone Graft
Substitute
Using
cadaveric
allograft,
synthetics, and
PRP/BMA

15. Budgetary Impact Analysis Matrix
Autograft and Graft Substitute Products in F/A Fusion
High
Auto-
PDGF
Graft
with
High Clinical Value matrix
High
(ICBG Clinical Value
or LBG)
(e.g. osteoconductive scaffold, living cells
Low Cost High Cost BMPs
osteoinductive growth factors)
(not
Bone Healing Triad
labeled
for F/A
fusion)
PRP or
PRP BMA
Stem
with
Low Clinical Value BMA
Low Clinical
Allo-
Value
Cells
graft
Low Cost
TCP Allo- High Cost
Graft
DBM
Hospital Costs
Low (i.e. added costs to the hospital associated with OR time, length of stay, High
complications, and acquisition costs for supplemental material)

16. 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.

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