Attached files
file | filename |
---|---|
8-K - BIOMIMETIC THERAPEUTICS, INC. | v190026_8k.htm |
EX-99.3 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-3.htm |
EX-99.1 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-1.htm |
Economic Evaluation of Direct
Costs Associated with Harvesting
Autogenous Bone Graft in Foot
and Ankle Fusion Surgery
Nicholas A. Abidi, M.D.
Kathryn P. Anastassopoulos, M.S.
Stacey J. Ackerman, MSE, PhD
Disclosures
My Disclosures
Editorial Board Foot and Ankle Techniques
Reviewer: FAI, JBJS, JofTrauma, JAAOS
Consultant: Acumed, Arthrex, Biomet, Biomimetic
Anastassopoulos and Ackerman - Covance Market Access, Inc.
Consultant: BioMimetic Therapeutics
Introduction
Foot and ankle arthrodesis are commonly performed
in the US
110,000 procedures per year in US
Bone graft is frequently used as an adjunct
Iliac Crest
Proximal Tibia
Distal Tibia
Calcaneus
Introduction
The cost of bone grafting has been studied well in the
Spine Literature
Polly et al, Orthopaedics October, 2003
Cost comparison of BMP-2 vs. ICBG
St. John et al, American Journal of Orthopaedics January
2003
Physical and Monetary Costs Associated with Bone Graft
Harvesting (ICBG)
Introduction
No multicenter studies currently which assess direct costs of
ICBG and Local Bone Graft (LBG) in foot and ankle
arthrodesis procedures
We will address ICBG/LBG peri-operative costs in the
hospital, outpatient surgery center, post-operative pain and
complication management
This study is designed to assist surgeons, hospitals and payers
when developing cost/benefit analyses regarding utilization of
orthobiologic bone graft substitute materials which
may
eliminate the need for ICBG/LBG in foot and ankle surgery
Materials and Methods
Ten AOFAS/AAOS
Surgeons across the country-
academic and private
practice mixture
Average of 14 years
experience in foot and ankle
arthrodeses and bone
grafting
Survey instrument mailed
out, analyzed by Covance
Market Access statisticians
Materials and Methods
ICBG and LBG frequency of utilization
Additional time-operative, anesthesia, recovery room,
admission to the floor-due to graft
Additional instrumentation sets utilized for grafting
Additional bone grafting materials used to extend
autograft and backfill autograft donor site
Materials and Methods
Profile of their practices
Number of ankle and hindfoot arthrodeses per year
Patient demographics
Payer types
Etiology and clinical success rates following foot and
ankle arthrodeses
Hospital data-charge data for all costs associated
with grafting were anonymously collected for each
institution-
costs were based upon regional Medicare
conversion factor (FY 2006)
Materials and Methods
Assumptions
General anesthesia utilized in all patients when accounting for
additional time charges
Material used for graft site backfill-allograft chips
Material used for extender-DBM
50 % (ICBG) of patients require 21 additional days of pain meds
due to graft site @ $3.76 per pill
Complication analysis
None reported by authors
Reviewed national literature-incidence moderate to severe-
resulting in re-hospitalization/surgical intervention
1% on average=$5000 per episode
Results
Number of Autograft Procedures
Performed Per Year (For Foot/Ankle Fusion)
Mean (SD)
Proximal Tibia
32.5 (30.3)
Calcaneus
19.1 (22.0)
Distal Tibia
13.6 (21.5)
Iliac Crest
5.0 (7.8)
Other
1.2 (3.8)
Number of Foot/Ankle Fusion Procedures
Performed Per Year
Mean (SD)
Ankle
21.6 (11.1)
Hindfoot
32.9 (13.4)
Midfoot
23.0 (14.9)
Other
26.9 (45.8)
Results
Characteristic
Mean (SD)
Patient average age, years
50.7 (9.2)
Patient gender, percent male
58.3 (12.0)
Patient insurance type, percent of patients
Commercial insurance
66.0 (15.0)
Medicare
22.9 (10.1)
Indemnity
4.0 (9.3)
Medicaid
1.9 (3.2)
Self-pay
1.3 (3.1)
Uninsured
0.2 (0.6)
Other
3.7 (7.6)
Results
Characteristic
Mean (SD)
Diagnosis, percent of patients
Post-traumatic injury/deformity
57.0 (21.4)
Primary arthritis
29.1 (17.6)
Rheumatoid arthritis
9.8 (6.8)
Other
4.1 (5.6)
Estimated clinical success rate , percent of patients
Ankle arthrodesis
92.8 (7.4)
Hindfoot arthrodesis
90.6 (6.3)
Midfoot arthrodesis
90.2 (7.5)
Results
Mean (SD)
Medical Resource
Iliac
Crest
(N=7)
Local Donor
Site
(N=10)
Operating room time (minutes)
37.9 (17.0)
22.1 (21.6)
Recovery room time (minutes)
25.0 (12.3)
3.5 (9.4)
Room & board time, inpatient (days)
0.8 (0.6)
0.0 (0.0)
Room & board time, outpatient (hours)
0.4 (0.7)
% of patients requiring backfill of donor site
7.9 (10.8)
38.5 (43.1)
% of patients requiring autograft extender
8.9 (11.6)
17.7 (18.1)
Results-Hospital Average Cost/Patient
Iliac Crest
Local Graft
Cost Driver
Inpatient
(N=7)
Mean (SD)
Inpatient
(N=9)
Mean (SD)
Outpatient
(N=10)
Mean (SD)
Operating Room
$1,077 (564)
$524 (361)
$411 (299)
Recovery Room
$122 (76)
$9 (18)
$8 (17)
Room & Board
$522 (489)
$0 (0)
N/A
Anesthesia
$121 (101)
$72 (61)
$68 (59)
Backfill
$15 (21)
$84 (85)
$76 (85)
Extender
$48 (63)
$108 (99)
$97 (99)
Complication
Management
$50 (-)
$50 (-)
$50 (-)
Total
$1,955
$847
$710
Total Direct Medical Costs
Iliac Crest
Local Graft
Medical Resource
Inpatient
Inpatient
Operating Room
$1,077
$524
Recovery Room
$122
$9
Room & Board
$522
$0
Anesthesia
$121
$72
Backfill
$15
$84
Extender
$48
$108
Complications
$50
$50
Pain Management
$237
$59
Physician Services
$231
$211
Total
$2,423
$1,117
Discussion
Prior Studies
Scranton et al Foot Ankle Aug. 2002
Luber et al Foot Ankle Nov. 1998
Charges not costs used to calculate data
Single center studies
Cost Driver
Abidi
(2009)
Polly (2001)
Key Differences
Operating Room
$1,077
$540
Increased unit costs
Room & Board
$522
$231
Increased unit costs
Recovery Room
$122
$45
Increased unit costs
Anesthesia
$121
$60
Increased unit costs
Bone Graft
Harvester
N/A
$146
Assumed to be included in OR charge
Autograft
Extender
$48
$327
Polly assumed 3X higher frequency of
use and more expensive unit costs
Backfill
$15
$20
-
Supplies
N/A
$105
Assumed to be included in OR charge
Blood Loss
N/A
$4
Assumed to be included in OR charge
Complication
Mgmt
$50
$167
Polly assumed a higher complication
rate (3% vs. 1%)
Total
$1,955
$1,645
Clinical Significance
Must weigh many factors when deciding between
ABG vs. orthobiological device
Augment/enhance vs. substitute
Time, cost and morbidity associated with ABG
Efficacy and cost of Orthobiological devices
Currently need to consider Hospital Acquired
Conditions (HAC) penalties to surgeon via un-
expected readmission-Quality reporting and lack of
payment to all for readmission
Conclusions
ABG is associated with significant additional tangible
costs to foot and ankle arthrodesis surgery
Very little of these costs are attributable to the surgeon
Total Direct Increased Cost
ICBG-$2423 LBG-$1117
It is very difficult to quantify to human costs attributable
to bone grafting such as prolonged pain, loss of function
and need for additional procedures
Must also consider elimination of Hospital Acquired
Conditions (HAC)