Académique Documents
Professionnel Documents
Culture Documents
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1herapeuuc
8ange
ARX-01 Phase 3 Program
29
Surgery 1ype Study 1ype S|tes N Data
Abdomlnal &
CrLhopedlc Surgery
(lA309)
Cpen-label,
Acuve-comparaLor
1
o
L: anent G|oba|
Assessment of Method of a|n
Contro| over 48 hrs
26
339
1:1
nov 2012
Abdomlnal Surgery
(lA310)
uouble-bllnd, lacebo-
conLrolled
1
o
L:Sum of a|n Intens|ty
D|erence over 48 hrs
13
178
2:1
Mar 2013
CrLhopedlc Surgery
(lA311)
uouble-bllnd, lacebo-
conLrolled
1
o
L:Sum of a|n Intens|ty
D|erence over 48 hrs
34
426
3:1
May 2013
IAP309: Primary Endpoint
anent G|oba| Assessment - 48 hours (I11 opu|anon)
GA 48 demonstrates non-|nfer|or|ty and super|or|ty for Nano1ab (I11 opu|anon)
GA 48 among comp|eters demonstrates super|or|ty for Nano1ab
GA 24 and 72 hr (I11 popu|anon) a|so stansnca||y super|or |n favor of Nano1ab
30
78.S
6S.6
60
64
68
72
76
80
Sufentan|| Nano1ab
(n=177)
IV CA Morph|ne
(n=180)
o
f
a
n
e
n
t
s
|
n
e
a
c
h
G
r
o
u
p
Good]Lxce||ent kanng
22.1
3.7
12.9
-20
-10
0
10
20
30
p<0.001
p=0.007
r|mary Lndpo|nt Non-Infer|or|ty Compar|son
IAP309:
PGA-48 Completer Population
31
S0.7
39.7
42.S 41.9
6.8
17.6
0
0.7
0
10
20
30
40
S0
60
Sufentan|| Nano1ab (n=146) IV Morph|ne (n=136)
o
f
a
n
e
n
t
s
Lxce||ent Good Ia|r oor
Compar|son between two groups (p=0.03)
IAP309:
SPID-48 and TOTPAR-48 Scores
32
76.S
70.4
60
70
80
Sufentan|| Nano1ab
(n=177)
IV CA Morph|ne
(n=180)
S
I
D
o
v
e
r
4
8
h
o
u
r
s
LS Mean SID-48
98.3
90.2
80
90
100
Sufentan|| Nano1ab
(n=177)
IV CA Morph|ne
(n=180)
1
C
1
A
k
o
v
e
r
4
8
h
o
u
r
s
LS Mean 1C1Ak-48
=0.S46
=0.0S8
IAP309:
PGA-48 and SPID-48 by Surgery Type
33
81.1
83.3
69.6
66.7
66.7
63.3
S0
60
70
80
Abdom|na|
(n=79)
n|p
(n=162)
knee
(n=116)
t
s
S
c
o
r
|
n
g
G
o
o
d
]
L
x
c
e
|
|
e
n
t
GA-48
Sufentan|| Nano1ab Morph|ne IV CA
108
106
42
122
97
29
0
2S
S0
7S
100
12S
Abdom|na|
(n=79)
n|p
(n=162)
knee
(n=116)
4
8
h
o
u
r
S
I
D
SID-48
Sufentan|| Nano1ab Morph|ne IV CA
*
* p<0.0S
IAP309: Speed of Onset and
Drop-out due to Inadequate Analgesia
34
3
4
S
6
0
0
.
2
S
0
.
S
0
.
7
S
1
2
4
6
8
1
0
1
2
a
n
e
n
t
k
e
p
o
r
t
e
d
a
|
n
I
n
t
e
n
s
|
t
y
keducnon |n a|n Intens|ty
Sufentan|| Nano1ab Morph|ne IV CA
*
* *
1|me from hrst dose of study drug (hours)
0
2
4
6
8
10
4 8 12 16 20 24 28 32 36 40 44 48
k
-
M
L
s
n
m
a
t
e
d
L
v
e
n
t
k
a
t
e
(
)
1|me aher hrst study drug dos|ng (hrs)
Drop-out - Inadequate Ana|ges|a
Sufentan|| Nano1ab Morph|ne IV CA
* p<0.01
3
4
S
6
7
0 0.S 1 4 8 12
Abdom|na|
(n=37 Suf, 42 Mor)
*
IAP309: Speed of Onset in Each Population
35
1|me from hrst dose of study drug (hours)
3
4
S
6
7
0 0.S 1 4 8 12
n|p
(n=84 Suf, 78 Mor)
Sufentan|| Nano1ab
Morph|ne IV CA
*
3
4
S
6
7
0 0.S 1 4 8 12
knee
(n=S6 Suf, 60 Mor)
*
*
* p<0.0S * p<0.0S * p<0.0S
IAP309: Doses Used by Time Period
36
28.2
36.2
28.2
7.3
0
10
20
30
40
S0
<24 24-<48 48-72 >72
o
f
a
n
e
n
t
s
Sufentan|| (Doses |n 48 hours)
1S.6
22.2
21.1
41.1
0
10
20
30
40
S0
<24 24-<48 48-72 >72
o
f
p
a
n
e
n
t
s
Morph|ne (Doses |n 48 hours)
13
9
12
0
S
10
1S
20
2S
30
0-12 hr 12-24 hr 24-48 hr
M
e
d
|
a
n
D
o
s
e
s
U
s
e
d
Sufentan|| (Doses]Study er|od)
2S
17
19
0
S
10
1S
20
2S
30
0-12 hr 12-24 hr 24-48 hr
M
e
d
|
a
n
D
o
s
e
s
U
s
e
d
Morph|ne (Doses]Study er|od)
IAP309: Sufentanil Doses by Time Period/Surgery
37
17
1S
17.S
0
S
10
1S
20
0-12 hr 12-24 hr 24-48 hr
knees (Med|an S1)
11
9
12
0
S
10
1S
20
0-12 hr 12-24 hr 24-48 hr
n|ps (Med|an 31)
11 11
16
0
S
10
1S
20
0-12 hr 12-24 hr 24-48 hr
Abdom|na| (Med|an 40)
12
10
1S
0
S
10
1S
20
0-12 hr 12-24 hr 24-48 hr
Cvera|| (Med|an 39.S)
IAP309: Patient and Nurse Ease of Care
38
4.4S
4.07
3.6
3.8
4
4.2
4.4
4.6
Sufentan|| Nano1ab IV CA Morph|ne
anent Lase of Care
4.27
3.82
3.6
3.8
4
4.2
4.4
4.6
Sufentan|| Nano1ab IV CA Morph|ne
Nurse Lase of Care
4.1S
3.84
3.2
3.4
3.6
3.8
4
4.2
Sufentan|| Nano1ab IV CA Morph|ne
anent Sansfacnon
3.92
3.3S
3.2
3.4
3.6
3.8
4
4.2
Sufentan|| Nano1ab IV CA Morph|ne
Nurse Sansfacnon
<0.001
=0.017
=0.004 <0.001
IAP310 & IAP311 Primary Endpoint:
SPID-48 ITT Population
39
0
20
40
60
80
100
120
0.23 0.73 2 6 10 16 24 32 40 48
1
|
m
e
-
W
e
|
g
h
t
e
d
S
I
D
IA 310 - Abdom|na|
SufenLanll nano1ab lacebo
-20
0
20
40
60
80
100
0.23 0.73 2 6 10 16 24 32 40 48
1
|
m
e
-
W
e
|
g
h
t
e
d
S
I
D
1|me aher hrst study drug dos|ng
(hrs)
IA 311 - Crthoped|c
SufenLanll nano1ab lacebo
p=0.001
<0.001
AE Profile vs Meta Analysis of IV PCA opioid
40
Study
Sufentan|| -
310 & 311
|acebo -
310 & 311
Cashman & Do||n,
'94 &'9S (9S CI)
Abdom|na|:n|p:knee () 27:38:33
Nausea 46.9 36 26.8-37.6
Vom|nng 11.7 6.1 17.1-24.8
Consnpanon S.1 2.4
Cxygen Desaturanon 7.7 3 S.6-22
Itch|ng 6.8 0 10.7-17.S
Ur|nary ketennon 1.2 0 6.6-2S
Confus|ona| State 2.1 1.2
Sedanon]Somno|ence 2.3 0.6 4.6-6.4
IAP309: Rate of Oxygen Desaturation Events
41
19.7
12.4
9.6
30
20
16.1
0
S
10
1S
20
2S
30
3S
t
s
w
|
t
h
C
2
D
e
s
a
t
L
v
e
n
t
s
SufenLanll
Morphlne
C
2
<93 C
2
<94 C
2
<93
p=0.028
Conclusions
42
Subllngual sufenLanll provldes ldeal k prole for 8n dosed oplold
Plgh llpophlllclLy allows non-lv dellvery, rapld LranslL Lo braln
Subllngual depoL enables 90-mlnuLe re-doslng vs 40-mlnuLe for lv
no acuve meLabollLes, rapld L
1/2ke0
ellmlnaLes dose-sLacklng rlsk
SLrong SufenLanll nano1ab CA SysLem Cllnlcal role Lmerglng
LxcellenL acuLe paln conLrol, early paln conLrol superlor Lo lv morphlne
Auracuve AL prole wlLh low raLe of oxygen desaLurauon evenLs
Superlor auenL Sausfacuon and nurse Lase of Care Lo lv morphlne
uevlce ellmlnaLes programmlng errors, faclllLaLes pauenL ambulauon
Panel Q&A
ur 8lchard 8erkowlLz
ur Lugene vlscusl
ur amela almer
am Llndley, 8n
43
Formulary Adoption
Mlke A. 8oyal, Mu, !u, M8A
Chlef Cllnlcal Aalrs,
Acel8x harmaceuucals, lnc.
45
lrom lnvenLory conLrol Lo rauonal use
Lnsure LhaL safe and eecuve drugs are avallable
ldenufy preferred drugs and avold Lherapeuuc dupllcauon
CosL conLrol: aggresslve conLracung and conLrol mechanlsms
lormulary managemenL wlLh sLrlcL &1 conLrols
urug use pollcy maklng
urug use monlLorlng
Hospital Formularies and the Modern P&T Process
46
The Old Days: Formulary Review
New Request by any MD
Fill out application
Approved
Formulary Inclusion
harmacy open Lo see sales reps/MSLs
1urnaround ume: days Lo a few weeks
use o formulary slmple and frequenL
Lnd user Lralnlng could occur before
approval
Cost Focus has Shifted Power to Pharmacy in
P&T Process
47
AdvanLage Lo new producLs whlch sausfy unmeL needs or have
pharmacoeconomlc beneLs
Several physlclans may need Lo advocaLe for new addluon
rocess ls more dellberaLe
Amerlcan College of Cllnlcal harmacy
Resulting in Todays Multilayered Process
48
New Drug Requests by multiple
MD; Department Chiefs helpful
Fill out applications; write letters
Get on P&T schedule
Formal Pharmacy Review
Not Approved
To Med/Exec Cmte Review
Final
Approval
Formulary Inclusion
Decision by Med/Exec Cmte
Pharmacy Preparation of Monograph
Without Pharma input
Approved
Key Influencers of Speed of P&T Approvals
49
ChaL rooms Lo share lnfo abouL new producLs
CounLer-deLalllng
8esLrlcLed access Lo &1 members/process
Lack of publlshed acuve comparaLor and pharmacoeconomlc daLa
MandaLory walung perlods posL luA approval
erlodlc &1 schedullng wlLh llmlLed # of producLs revlewed
harmacy conLrol of presenLers aL &1 meeungs
uevlce analysls may requlre anoLher commluee lnpuL
Sufentanil NanoTab Formulary Expectations
50
lv CA cosLs and challenges already well undersLood
non-lnvaslve, pre-programmed CA SysLem auLomaucally auracuve
Acuve comparaLor daLa Lo currenL SLandard of Care wlLh comparable emcacy
expecLed by &1 Commluees ln research, buL exceedlng expecLauons are:
uemonsLrauon of superlorlLy Lo lv CA morphlne
lasLer onseL and reduced percenLage of oxygen desaLurauon evenLs
CosL as a facLor ls manageable
LxpecL comparable prlclng Lo currenL lv CA
ulerenuauon based on pauenL sausfacuon, cllnlcal beneLs, and
overall cosL reducuon expecLed Lo encourage adopuon
Cverall, expecL formulary adopuon Lo be rapld
Publication Strategy Supporting Formulary
Assessment
51
2013
creaLe awareness of lv CA llmlLauons and problems
beneLs of sufenLanll, especlally when glven subllngually
sophlsucauon and lnherenL conLrols of Lhe SysLem
posluve resulLs from Lrlals (posLer and saLelllLe presenLauons)
2014
shl Lo publlcauons ln pharmacy [ournals wlLh a focus on cosL
savlngs, pauenL sausfacuon, and poLenual reducuon ln error raLes
and ALs wlLh a swlLch from lv CA
2013
reLurn focus on posluve resulLs from Lhe SysLem
messaglng Lo end users
Medical Affairs Strategy
52
CoordlnaLe wlLh commerclal Lo opumlze reach/frequency and ldenufy
early LargeLs
locus on pharmacoeconomlc value wlLh pharmacy dlrecLors, lead wlLh 309
acuve comparaLor (lv CA) daLa ln uossler and presenLauons
use a blended Leam of harmus (for dlmculL &1s) and 8n LducaLors (for
educauon, asslsLance wlLh pull Lhrough) Lo sLarL early on
CaplLallze on lnvesugauonal slLes as cenLers of excellence" for reglonal
rlpple eecL - early posluve Lrlal experlence predlcLs &1 approval
locus phase 4 acuvlues on developlng besL pracuces" for speclc
surgerles LhaL lnclude Lhe SysLem as parL of mulumodal approaches
laclllLaLe developmenL of sLandlng orders
AsslsL pharmacy depLs ln MuL/uuL deslgns LhaL augmenL
pharmacoeconomlc daLa
Commercialization
8lchard klng
Chlef Lxecuuve Cmcer,
Acel8x harmaceuucals, lnc.
The Post-Operative Pain Market is Dynamic
1rends
o||nca|
Lconom|c
Soc|o|og|ca|
1echno|og|ca|
Macro Inuences
Length of Stay]Semng
1ypes of rocedures
a|n Management
Stakeho|ders
ke|mbursement and Cost
otenna| Dr|vers of Adopnon for Any roduct |n th|s Area
Cost-eecnveness (re|anve to current standard of care)
anent sansfacnon, |ead|ng to |nsntunona| focus on pa|n management
54
Source: 8oseua CuallLauve lnLervlews, lall 2011.
Pain Management Focus and Trends in US
55
Length of Stay
CpporLunlLy for producL LhaL helps Lo reduce lengLh of sLay ls hlgh
ush for shorLer lengLh of sLay lmplles paln belng pushed Lo home semng
rocedure M|x and Invas|veness
CpporLunlLy for producLs wlLh eecuve paln rellef for 6-23 hr posL-op sLay
Mu|nmoda| Ana|ges|a
CpporLunlLy for non-lnvaslve, pauenL-conLrolled analgesla dellvery as componenL
of oLherwlse xed doslng reglme
Lmergence of Insntunona| a|n 1eams
ln addluon Lo surgeons, supporL from anesLheslologlsLs/paln speclallsLs crlucal
auenLs emerglng as sLakeholder, as pauenL sausfacuon more lmporLanL
Cost
23-hour sLay supporL and cosL eecuveness key focl
Sources: 8oseua Mlnl-quanL Survey elded Lo 29 physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
8oseua CuallLauve lnLervlews, lall 2011.
Introducing..
56
(sufentanil sublingual
microtablet system)
For use in hospitals only.
For use only with ZALVISO
Sufentanil sublingual microtablet system
N
D
C
X
X
X
X
-
Y
Y
Y
Y
-
P
P
L
O
T
N
O
.
X
X
X
X
X
E
X
P
D
A
T
E
D
D
M
M
Y
Y
P ONLY
CONTENTS cartridge
1 40*equals 22.5 mcg sufentanil citrate
For management of moderate to severe acute pain.
! " # $ % & ' ( ) *
(sufentanil sublingual
microtablet system)
15mcg* sufentanil/microtablets
376 170 431
1 inch
BLACK
(sufentanil sublingual
microtablet system)
CONTROLLER
(sufentanil sublingual
microtablet system)
CONTROLLER
1 inch
(sufentanil sublingual
microtablet system)
CONTROLLER
(sufentanil sublingual
microtablet system)
CONTROLLER
Pouched Cartridge Label
Label on Controller Packaging
Product Logo
Regulatory Pathways
57
NDA athway
SubmlL nuA (C3 2013)
luA llles nuA (C4 2013)
uAAA ulvlslon revlew
CuL8 Leads (urug)
Cu8P ConsulLauon (uevlce)
Approval (C3 2014) for slngle label
for use of drug and devlce for
moderaLe Lo severe acuLe paln
managemenL ln hosplLal semng
no AdComm LxpecLed (PosplLal use
producL, noL Lo go home)
MAA athway
Acel8x Lo deLermlne CenLral vs
MuLual 8ecognluon aLhway
MAA submlsslon wlll be for drug
producL (C2 2014)
uevlce wlll be presenLed Lo noued
8ody Lo pursue CL mark (C2 2014)
Approval (C2 2013) for drug producL
and CL mark for devlce granLed
Acel8x can LranslaLe Cul / llu
languages Lo Lu speclc
requlremenLs
US Surgical Procedures Evolving Settings
58
Strateg|c Importance
ost-operanve Length of Stay
lnapproprlaLe
auenL 1ypes
ApproprlaLe auenL 1ypes (# rocedures wlLh ModeraLe Lo Severe
aln)
6-12 hours 23 hours 1-2 days 2+ days
1
r
e
a
t
m
e
n
t
S
e
m
n
g
lnpauenL
osL-op
Surglcal
rocedures
(31,680k)
C
o
g
n
l
u
v
e
o
r
p
h
y
s
l
c
a
l
l
m
p
a
l
r
m
e
n
L
L
h
a
L
p
r
e
v
e
n
L
s
p
a
u
e
n
L
s
f
r
o
m
u
s
l
n
g
a
p
a
u
e
n
L
-
c
o
n
L
r
o
l
l
e
d
d
e
v
l
c
e
Low
(1,679k)
Medlum/Plgh
(3,071)
Plgh
(8,047)
PosplLal
AmbulaLory
Surgery
(PCu)
(24,890k)
Low
(933k)
Medlum
(930k)
n/A n/A
ASC
(18,813k)
Low
(1,367k)
Low
(212k)
n/A n/A
Low
Cpportun|ty
Plgh
CpporLunlLy
Sources: 8oseua Mlnl-quanL Survey elded Lo 29 physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
Moderate-to-Severe Pain in US Hospital Settings
59
nosp|ta| |n-panent, moderate-to-severe acute pa|n, post-operanve
12M procedures per annum, alvlso poLenually usable ln 93 cases
nosp|ta| |n-panent, moderate-to-severe acute pa|n, not post-operanve
7.4M pauenLs per annum, alvlso poLenually usable 66-80 cases
lndlcauon llkely Lo cover Lhls pauenL populauon
lv push oplold medlcauon ls sLandard for acuLe non-posL-operauve paln, noL lv CA
hyslclans reporLed alvlso may be supplemenLary Lo lv push, raLher Lhan a replacemenL
nosp|ta| am||ated hosp|ce, moderate-to-severe acute pa|n
LsL. 300k pauenLs per annum, alvlso usable ln 40 cases
lndlcauon llkely Lo cover Lhls pauenL populauon
A8x-01 ls poLenual replacemenL for llquld morphlne, measured by nurse when dosed
Sources: 8oseua Mlnl-quanL Survey elded Lo 29 physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
8oseua CuallLauve lnLervlews, lall 2011.
8.3
9.2
8.3
7.9
0.0
1.0
2.0
3.0
4.0
3.0
6.0
7.0
8.0
9.0
10.0
Ortho OBGYN Gen Surgeon Anes
Auracnveness kanng of Akk-01
2
Crtho C8GN Gen Surgeon Anesth
8.8
8.1
7.8
7.8
8.8
7.4
0.0
1.0
2.0
3.0
4.0
3.0
6.0
7.0
8.0
9.0
10.0
Gastro OBGYN Gen Surgeon
Auracnveness kanng of Akk-01
1
Gastro Crtho C8GN Card|o Gen Surg Anesth
Physician Reaction to Acute Pain Product Profile
60
uS hyslclans
1
Lu hyslclans
2
1. 8oseua: Mlnl-quanL Survey of 29 uS physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
2: 8oseua: CuallLauve lnLervlews wlLh 33 Lu physlclans (9 anesLheusLs/22 surgeons/4 kCLs) ln Sprlng 2013
Physician Reaction to Product Profile
61
1bls ls o blq lmptovemeot becoose tbe
poueot coo qet oot of beJ polcket.
- C8/C?n
1
lts o 10 lf lm osloq lcAs ooJ woot to
swltcb. lts oo 8 becoose lts sull o ootcouc
meJlcouoo. lo oo lJeol wotlJ, lm lookloq
fot sometbloq otbet tboo o ootcouc. -
CrLhopedlc Surgeon
1
lt qlves o poueot posslblllty to move
otoooJ, be ot sbe Joesot bove to be ueJ
op to tbelt beJ.
- AnesLheusL, oland
2
lts vety outocuve. Aoytbloq tbot
woolJ qlve poueots powet to coottol
tbelt polo, ooJ less wotk fot ootses ls
blqbly outocuve. AnesLheslologlsL
1
5ofeotooll ls tbe petfect Jtoq, l ose
lt oll tbe ume. - CardloLhoraclc
Surgeon
1
1bete ote mooy oJvootoqes bete
combloeJ. oo wlll bove o qteot
compllooce bete. l tblok tbot
poueots wlll occept lt vety well, l
qoess mocb mote os tbe lv lcA.
- CrLhopedlc Surgeon, Cermany
2
1. 8oseua: Mlnl-quanL Survey of 29 uS physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
2: 8oseua: CuallLauve lnLervlews wlLh 33 Lu physlclans (9 anesLheusLs/22 surgeons/4 kCLs) ln Sprlng 2013
62
Segmentation
All physlclans lnLervlewed have sLrong lnLeresL ln alvlso
llrsL segmenLauon lLer wlll be formulary approval
MarkeL segmenLauon wlll focus on llkely sequence of adopuon
CrLhopedlc surgerles rsL (1.3M per annum
1
)
23-hour sLay surgerles also early (4M p.a
2
)
Cl and C?n surgerles, supporLed by abdomlnal daLa seL (4.3M p.a
1
)
C1 (1M p.a
1
), C8 (2M p.a
1
), fuslon/fracLure surgerles (1M p.a
1
) as
famlllarlLy wlLh alvlso grows
8urns, oLher acuLe ln-hosplLal paln (7M p.a
2
) opporLunlsucally
1. nauonal PosplLal ulscharge Survey, 2010
2. 8oseua Mlnl-quanL Survey elded Lo 29 physlclans (13 hosplLallsLs and 14 anesLheslologlsLs) ln WlnLer 2011.
Building Commercial Infrastructure
63
P2 2013: Markeung Leam esLabllshed (2 Senlor, 2 Mld-managemenL)
P1 2014: MSL Leam esLabllshed / deployed (6-8 MSLs), Sales SLrucLure
llnallzed
C3 2014: Sales ManagemenL 1eam Lmployed (6-8 8eglonal ulrecLors)
C4 2014: MSL's, Sales ManagemenL, ConLracung Leam push for lormulary
8evlew and Approval
C1 2013: Sales 8eps deployed (up Lo 63, dependenL on formulary
adopuons), roducL Sale lnluaLed, hase 3 publlcauons appearlng
Pricing and Pharmacoeconomics
64
0
30
100
130
200
230
300
330
Lo lv CA Pl lv CA alvlso
8ange C
o
s
t
p
e
r
p
a
n
e
n
t
f
o
r
2
d
a
y
s
(
5
)
urug 1ublng uevlce
harmacoeconomlc value creaLed by:
Lllmlnauon of programmlng errors
Lllmlnauon of excess doslng due pump fallure
Lllmlnauon of lv slLe lnfecuon rlsk for lv CA
Larller and easler ambulauon poLenually
acceleraLes hosplLal release
Larly onseL paln rellef resulLs ln lower oplold
doslng, less overshooL
8educed SALs (parucularly oxygen
desaLurauon) resulLs ln lower lCu vlslLs/cosLs
Lnhanced auenL Sausfacuon resulLs ln
lmproved CMS relmbursemenL, hlgher
hosplLal markeL share
Cost of Managing IV PCA - 2 days of therapy
Cost Per Patient
Staff Time and Labor
1,2,3,4
$85.82
Medical Cost of Adverse Events Caused by IV PCA Errors
5,6
$50.05
Administrative Costs due to Adverse Events Caused by IV PCA Errors
7,8
$96.85
TOTALS $230
Pharmacoeconomics
Literature identifies cost of managing IV PCA
uoes noL accounL for:
oLenual beneL of early ambulauon resulung ln hlgher bed Lurnover
lmproved auenL Sausfacuon lmpacL on relmbursemenL or pauenL volume
CosL of pump malnLenance ln 8lomedlcal Lnglneerlng
65
1. Average of nurses ume esumaLes by Lvans eL al 2007, 8onneL eL al 2009, Mordln eL al 2007 and Chonlere eL al 1998
2. LxperL oplnlon by Alex Macarlo Mu from dlscusslons wlLh PosplLal harmaclsLs
3. Medlan 8ase Salary + 8onus + 8eneLs obLalned from SalaryCenLer.com, P8 Salary Wlzard
4. A Comparlson of nurse 1asks and 1lme assoclaLed wlLh Lwo pauenL-conLrolled analgesla modallues uslng delphl panels, Lvans C, eL al aln Man nurs 2007, 8,2, 86-93
3. Melssner 8, eL al. Posp harm 2009,44:312-324.
6. Campbell Alllance MarkeL 8esearch SLudy - 2003 esumaLe of uS pauenLs LhaL use lv CA umps
7. Source.: 1oby Cordon Sc u - LxperL oplnlon lnLervlews and llLeraLure revlew - uec 2009
8. 8lomedLcon Analysls of Pankln eL al 2007 reporLs of lv CA Lrrors
Conclusion
66
SLrong alvlso Cllnlcal role Lmerglng
LxcellenL acuLe paln conLrol, early paln conLrol superlor Lo lv morphlne
Auracuve AL prole wlLh low raLe of oxygen desaLurauon evenLs
Superlor auenL Sausfacuon and nurse Lase of Care Lo lv morphlne
uevlce ellmlnaLes programmlng errors, faclllLaLes pauenL ambulauon
Worklng Lowards C3 2013 nuA Submlsslon
Commenclng Commerclal reparauon
lans ln hand Lo bulld commerclal lnfrasLrucLure
SlgnlcanL amounL of markeL undersLandlng work compleLed
uenluve posluonlng and brandlng work underway
Closing Q&A
Mlke 8oyal
8lchard klng
am almer
67