2. 2
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
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3. 3
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
AGENDA
Introduction
Sean Harper, M.D.—Executive Vice President, Research
and Development
Repatha® Phase 3
CV Outcomes Study
Marc Sabatine, M.D., M.P.H.—Chairman of the TIMI Study Group,
Brigham and Women’s Hospital, Harvard Medical School
Repatha® Value
Joshua Ofman, M.D.—Senior Vice President, Global Value, Access
and Policy
Conclusion Sean Harper, M.D.
Q&A
Sean Harper, M.D.
Joshua Ofman, M.D.
Marc Sabatine, M.D., M.P.H.
Tony Hooper—Executive Vice President, Global Commercial Operations
Scott Wasserman, M.D.—Vice President, Research and Development
Terje R. Pedersen, M.D., Ph.D.—Oslo University Hospital, Ullevål
CV = cardiovascular
7. An Academic Research Organization of
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FOURIER
Further cardiovascular OUtcomes
Research with PCSK9 Inhibition in
subjects with Elevated Risk
MS Sabatine, RP Giugliano, AC Keech, N Honarpour,
SM Wasserman, PS Sever, and TR Pedersen,
for the FOURIER Steering Committee & Investigators
American College of Cardiology – 66th Annual Scientific Session
Late-Breaking Clinical Trial
March 17, 2017
8. An Academic Research Organization of
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Sever P & Mackay J. Br J Cardiol 2014;21:91-3
Giugliano RP, et al. Lancet 2012;380:2007-17
Sabatine MS, et al. NEJM 2015;372:1500-9
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
– Chaperones LDL-R to destruction circulating LDL-C
– Loss-of-fxn genetic variants LDL-R LDL-C & risk of MI
Evolocumab
– Fully human anti-
PCSK9 mAb
– ~60% LDL-C
– Safe & well-tolerated in
Ph 2 & 3 studies
– Exploratory data
suggested CV events
Background
evolocumab
9. An Academic Research Organization of
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Objectives
In patients with established cardiovascular disease
on statin therapy:
• Test whether the addition of evolocumab reduces the
incidence of major cardiovascular events
• Examine the long-term safety & tolerability of
evolocumab
• Investigate the efficacy and safety of achieving
unprecedented low levels of LDL-C
10. An Academic Research Organization of
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Trial Organization
Executive Committee
Marc S. Sabatine (Co-Chair) Terje R. Pedersen (Co-Chair)
Robert P. Giugliano Anthony C. Keech Peter S. Sever
TIMI Study Group
Stephen D. Wiviott (CEC Chair) Cheryl Lowe Leah Zahn
Marc P. Bonaca (Safety Chair) Polly Fish (Director of Ops) Tim Abrahamsen
Sabina Murphy (Director of Stats) Kelly Im (Assoc Dir Stats) Julia Kuder
Estella Kanevsky
Sponsor: Amgen
Scott M. Wasserman Narimon Honarpour Rob Scott
Armando Lira Pineda Kelly Hanlon Beat Knusel
Ransi Somaratne Christopher Kurtz Thomas Liu
Huei Wang
Independent Data Monitoring Committee
Charles H. Hennekens (Chair) Felicita Andreotti Colin Baigent
W. Virgil Brown Barry R. Davis
John W. Newcomer
Sarah K. Wood
Lipid Monitoring Committee
John LaRosa (Chair) Benjamin Ansell Anders Olsson
11. An Academic Research Organization of
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Trial Design
Evolocumab SC
140 mg Q2W or 420 mg QM
Placebo SC
Q2W or QM
LDL-C ≥70 mg/dL or
non-HDL-C ≥100 mg/dL
Follow-up Q 12 weeks
Screening, Lipid Stabilization, and Placebo Run-in
High or moderate intensity statin therapy (± ezetimibe)
27,564 high-risk, stable patients with established CV disease
(prior MI, prior stroke, or symptomatic PAD)
RANDOMIZED
DOUBLE BLIND
Sabatine MS et al. Am Heart J 2016;173:94-101
12. An Academic Research Organization of
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Endpoints
• Efficacy
– Primary: CV death, MI, stroke, hosp. for UA, or coronary revasc
– Key secondary: CV death, MI or stroke
• Safety
– AEs/SAEs
– Events of interest incl. muscle-related, new-onset diabetes,
neurocognitive
– Development of anti-evolocumab Ab (binding and neutralizing)
• TIMI Clinical Events Committee (CEC)
– Adjudicated all efficacy endpoints & new-onset diabetes
– Members unaware of treatment assignment & lipid levels
Sabatine MS et al. Am Heart J 2016;173:94-101
13. An Academic Research Organization of
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Argentina Estonia Japan Singapore
Alberto J. Lorenzatti Margus Viigimaa Atsushi Hirayama Leslie Tay
Australia Finland Latvia Slovakia
John Amerena Matti J. Tikkanen Andrejs Erglis Slavomíra Filipová
Austria France Lithuania South Africa
Kurt Huber François Schiele Jolita Badariene Lesley Burgess
Belgium Germany Malaysia South Korea
André Scheen Ioanna Gouni-Berthold Wan A. Wan Ahmad Donghoon Choi
Brazil Greece Mexico Spain
José F.K. Saraiva Loukianos Rallidis G. Gonzalez-Galvez José López-Miranda
Bulgaria Hong Kong Netherlands Sweden
Borislav G. Georgiev Chung-Wah Siu J. Wouter Jukema Lennart Nilsson
Canada Hungary Norway Switzerland
Lawrence A. Leiter Kalman Toth Terje R. Pedersen François Mach
Chile Iceland Philippines Taiwan
Jorge L. Cobos Gudmundur Thorgeirsson Gregorio G. Rogelio Min-Ji Charng
China India Poland Turkey
Lixin Jiang P. Deedwania & V. Chopra Zbigniew A. Gaciong S. Lale Tokgozoglu
Colombia Ireland Portugal Ukraine
Jose L.A. Mendoza Brendan McAdam Jorge Ferreira Oleg Kraydashenko
Czech Republic Israel Romania United Kingdom
Richard Ceska Basil S. Lewis Gheorghe A. Dan Peter S. Sever
Denmark Italy Russia United States
Henrik K. Jensen Gaetano M. De Ferrari Marat V. Ezhov Robert P. Giugliano
Steering Committee
14. An Academic Research Organization of
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27,564 patients randomized at 1242 sites
in 49 countries between 2/2013 – 6/2015
Global Enrollment
15. An Academic Research Organization of
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Randomized 27,564 patients
Evolocumab
(N=13,784)
Placebo
(N=13,780)
Premature perm.
drug discontinuation
5.6%/yr 5.8%/yr
Withdrew consent 0.29%/yr 0.35%/yr
Lost to follow-up 5 patients 13 patients
Follow-up median 26 months (IQR 22-30)
Ascertainment for primary endpoint was complete for
99.5% of potential patient-years of follow up
Follow-up
2907 patients experienced primary
endpoint
1829 experienced key secondary endpoint
16. An Academic Research Organization of
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Baseline Characteristics
Characteristic Value
Age, years, mean (SD) 63 (9)
Male sex (%) 75
Type of cardiovascular disease (%)
Myocardial infarction 81
Stroke (non-hemorrhagic) 19
Symptomatic PAD 13
Cardiovascular risk factor (%)
Hypertension 80
Diabetes mellitus 37
Current cigarette use 28
Pooled data; no differences between treatment arms
Median time from most
recent event ~3 yrs
17. An Academic Research Organization of
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Baseline CV Meds
Characteristic Value
ASA and/or P2Y12 Inhibitor (%) 92
Beta-blocker (%) 76
ACE inhibitor or ARB and/or
aldosterone antagonist (%)
78
18. An Academic Research Organization of
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Lipid Lowering Therapy
& Lipid Levels at Baseline
Characteristic Value
Statin use (%)*
High-intensity 69
Moderate-intensity 30
Ezetimibe use (%) 5
Median lipid measures (IQR) – mg/dL
LDL-C 92 (80-109)
Total cholesterol 168 (151-189)
HDL-C 44 (37-53)
Triglycerides 133 (100-182)
Pooled data; no differences between treatment arms
*Per protocol, patients were to be on atorva ≥20 mg/d or equivalent.
1% were on low intensity or intensity data were missing.
Statin intensity defined per ACC/AHA 2013 Cholesterol Guidelines.
19. An Academic Research Organization of
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0
10
20
30
40
50
60
70
80
90
100
0 12 24 36 48 60 72 84 96 108120132144156168
LDLCholesterol(mg/dl)
Weeks
LDL Cholesterol
Evolocumab
(median 30 mg/dl, IQR 19-46 mg/dl)
Placebo
59% mean reduction (95%CI 58-60), P<0.00001
Absolute reduction: 56 mg/dl (95%CI 55-57)
20. An Academic Research Organization of
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0
10
20
30
40
50
60
70
80
90
100
0 12 24 36 48 60 72 84 96 108 120
LDLCholesterol(mg/dl)
Weeks
LDL Cholesterol
Cohort of 11,077 patients who
• had all measurements through 120 weeks
• did not discontinue study drug
• did not D concomitant background lipid-lowering Rx
Evolocumab
Placebo
Similar data out to 4 years
in OSLER-1
(JAMA Cardiology online)
21. An Academic Research Organization of
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0%
2%
4%
6%
8%
10%
12%
14%
16%
Primary Endpoint
Evolocumab
Placebo
Months from Randomization
CVDeath,MI,Stroke,
HospforUA,orCorRevasc
0 6 12 18 24 30 36
Hazard ratio 0.85
(95% CI, 0.79-0.92)
P<0.0001 12.6%
14.6%
22. An Academic Research Organization of
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0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
Key Secondary Endpoint
Months from Randomization
CVDeath,MI,orStroke
0 6 12 18 24 30 36
Hazard ratio 0.80
(95% CI, 0.73-0.88)
P<0.00001
Evolocumab
Placebo
7.9%
9.9%
23. An Academic Research Organization of
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Types of CV Outcomes
Endpoint
Evolocumab
(N=13,784)
Placebo
(N=13,780) HR (95% CI)
3-yr Kaplan-Meier rate
CV death, MI, or stroke 7.9 9.9 0.80 (0.73-0.88)
Cardiovascular death 2.5 2.4 1.05 (0.88-1.25)
Death due to acute MI 0.26 0.32 0.84 (0.49-1.42)
Death due to stroke 0.29 0.30 0.94 (0.58-1.54)
Other CV death 1.9 1.8 1.10 (0.90-1.35)
MI 4.4 6.3 0.73 (0.65-0.82)
Stroke 2.2 2.6 0.79 (0.66-0.95)
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More Intensive LDL-C Lowering
& CV Death
# of CV Deaths
Trial Year More
Intensive
Rx Arm
Less
Intensive
Rx Arm
HR (95% CI)
PROVE-IT TIMI 22 2004 27 36 0.74 (0.45-1.22)
A2Z 2004 86 111 0.76 (0.57-1.01)
TNT 2005 101 127 0.80 (0.61-1.03)
IDEAL 2005 223 218 1.03 (0.85-1.24)
SEARCH 2010 565 572 0.99 (0.88-1.11)
IMPROVE-IT 2015 538 537 1.00 (0.89-1.13)
Summary 1540 1601 0.96 (0.90-1.03)
More intensive
therapy better
Less intensive
therapy better
0.2 0.5 1 2 5
NEJM 2004;350:1495-504
JAMA 2004;292:1307-16
NEJM 2005;352:1425-35
JAMA 2005;294:2437-45
Lancet 2010;376:1658-69
NEJM 2015;372:2387-97
No clear benefit on CV mortality
25. An Academic Research Organization of
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Types of CV Outcomes
Endpoint
Evolocumab
(N=13,784)
Placebo
(N=13,780) HR (95% CI)
3-yr Kaplan-Meier rate
CVD, MI, stroke, UA, or revasc 12.6 14.6 0.85 (0.79-0.92)
CV death, MI, or stroke 7.9 9.9 0.80 (0.73-0.88)
Cardiovascular death 2.5 2.4 1.05 (0.88-1.25)
MI 4.4 6.3 0.73 (0.65-0.82)
Stroke 2.2 2.6 0.79 (0.66-0.95)
Hosp for unstable angina 2.2 2.3 0.99 (0.82-1.18)
Coronary revasc 7.0 9.2 0.78 (0.71-0.86)
Urgent 3.7 5.4 0.73 (0.64-0.83)
Elective 3.9 4.6 0.83 (0.73-0.95)
Death from any cause 4.8 4.3 1.04 (0.91-1.19)
26. An Academic Research Organization of
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Key Subgroups
Subgroup Patients
Overall 27564
Type of disease
MI alone 19113
Stroke alone 3366
PAD alone 1505
Polyvascular disease 3563
Baseline LDL-C
Q1 (<80 mg/dl) 6961
Q2 (80-<92 mg/dl) 6886
Q3 (92-109 mg/dl) 6887
Q4 (>109 mg/dl) 6829
Baseline statin intensity
High 19103
Not high 8461
Ezetimibe
Yes 1440
No 26124
Initial Dosing Regimen
Every 2 weeks 24774
Monthly 2790
1° Endpoint HR (95% CI) Key 2° Endpoint HR (95% CI)
1.0
EvoMab better Pbo better
0.4 2.5 1.0
EvoMab better Pbo better
0.4 2.5
All Pinteractions NS
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Lower LDL-C Is Better
P<0.0001
Patients divided by quartile of baseline LDL-C and by treatment arm
Q4
Q3
Q2
Q1
Q4
Q3
Q2
Q1
Placebo
Evolocumab
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LDL-C & D in Plaque Volume
JAMA 2016;316:2373-84
29. An Academic Research Organization of
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0%
2%
4%
6%
8%
0%
2%
4%
6%
8%
Landmark Analysis
Evolocumab
Placebo
Months from Randomization
CVDeath,MI,Stroke
0 3 9 12 24 30 366 12 18
16% RRR
HR 0.84 (95%CI 0.74-0.96)
P=0.008
25% RRR
HR 0.75 (95%CI 0.66-0.85)
P<0.00001
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0%
2%
4%
6%
8%
0%
2%
4%
6%
8%
Fatal or Nonfatal MI or Stroke
Evolocumab
Placebo
Months from Randomization
FatalorNonfatalMIorStroke
0 3 9 12 24 30 366 12 18
19% RRR
HR 0.81 (95%CI 0.70-0.93)
P=0.003
33% RRR
HR 0.67 (95%CI 0.59-0.77)
P<0.00001
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Comparison to Cholesterol
Treatment Trialists Collaboration
Major Coronary Events
Stroke
Coronary revascularization
Major Vascular Events
0.78 (0.70-0.86)
0.77 (0.66-0.91)
0.75 (0.67-0.84)
0.77 (0.73-0.82)
Lipid-lowering therapy better Lipid-lowering therapy worse
Hazard Ratio (95% CI) per 1 mmol/L reduction in LDL-C
2.01.0
CTTC Meta-analysis Year 2
CTTC data from Lancet 2010;376:1670-81
0.5
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Comparison to Cholesterol
Treatment Trialists Collaboration
Major Coronary Events
Stroke
Coronary revascularization
Urgent
Elective
Major Vascular Events
0.78 (0.70-0.86)
0.80 (0.71-0.90)
0.77 (0.66-0.91)
0.77 (0.63-0.94)
0.75 (0.67-0.84)
0.73 (0.62-0.86)
0.84 (0.73-0.98)
0.77 (0.73-0.82)
0.83 (0.76-0.90)
Lipid-lowering therapy better Lipid-lowering therapy worse
Hazard Ratio (95% CI) per 1 mmol/L reduction in LDL-C
2.01.0
CTTC Meta-analysis Year 2
FOURIER Year 2
CTTC data from Lancet 2010;376:1670-81
0.5
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Safety
Evolocumab
(N=13,769)
Placebo
(N=13,756)
Adverse events (%)
Any 77.4 77.4
Serious 24.8 24.7
Allergic reaction 3.1 2.9
Injection-site reaction 2.1 1.6
Treatment-related and led to d/c of study drug 1.6 1.5
Muscle-related 5.0 4.8
Cataract 1.7 1.8
Diabetes (new-onset) 8.1 7.7
Neurocognitive 1.6 1.5
Laboratory results (%)
Binding Ab 0.3 n/a
Neutralizing Ab none n/a
New-onset diabetes assessed in patients without diabetes at baseline; adjudicated by CEC
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Summary for Evolocumab
• LDL-C by 59%
– Consistent throughout duration of trial
– Median achieved LDL-C of 30 mg/dl (IQR 19-46 mg/dl)
• CV outcomes in patients already on statin therapy
– 15% broad primary endpoint; 20% CV death, MI, or stroke
– Consistent benefit, incl. in those on high-intensity statin, low LDL-C
– 25% reduction in CV death, MI, or stroke after 1st year
– Long-term benefits consistent w/ statins per mmol/L LDL-C
• Safe and well-tolerated
– Similar rates of AEs, incl DM & neurocog events w/ EvoMab & pbo
– Rates of EvoMab discontinuation low and no greater than pbo
– No neutralizing antibodies developed
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Conclusions
In patients with known cardiovascular disease:
1. PCSK9 inhibition with evolocumab
significantly & safely major cardiovascular
events when added to statin therapy
2. Benefit was achieved with lowering LDL
cholesterol well below current targets
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Further Details
Article available at www.nejm.org
Slides available at www.TIMI.org
38. 38
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
IN CV DISEASE, ECONOMIC VALUE IS DRIVEN BY BASELINE
EVENT RATE AND TREATMENT EFFECTIVENESS
Efficacy
Baseline
Event
Rates
Direct
Medical
Costs
Drug
Costs
Quality
of Life
Treatment
Duration
Length
of Life
Indirect
Medical
Costs
39. 39
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
EVENT RATES BASED ON REAL-WORLD DATA ARE HIGHER
THAN EVENT RATES REPORTED IN CLINICAL TRIALS
4.5 5.2
9.8
12.3
0
2
4
6
8
10
12
14
EventRateper100
Patient-Years
Real-World
Data3
• CV events include MI, UA, IS, coronary revascularization (coronary artery bypass graft or percutaneous coronary intervention), or CV-related death
• Real-world event rates are based on an analysis of patients in the UK CPRD database between 2004 and 2011. Patients were included in the
analysis based on eligibility criteria for the Repatha® Outcomes Study—FOURIER3
CTTC1
Meta-Analysis
Repatha® Outcomes Trial2
First Event
All Events
First Event
All Events
MI = myocardial infarction; UA = unstable angina; IS = ischemic stroke; CPRD = Clinical Practice Research Datalink; 1. CTTC, et. al. Lancet 2010 376: 1670-1681; 2. Sabatine MS, et al . NEJM.
[published online ahead of print March 17, 2017]; 3.Toth PP, et al. J Med Econ. 2017. In Press
40. 40
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Analyses using event
rates from trials
Analyses using real-
world event rates
BaselineEventRate(%)
1. Kazi DS, et al. JAMA. 2016;316(7):743-753. 2. Arrieta A, et al. PLoS One. 2017;12(1):e0169761. 3. Jena AB, et al. Am J Manag Care. 2016;22(6):e199-e207. 4. Gandra SR, et al. Clin Cardiol.
2016;39(6):313-320. 5. Toth PP, et al. J Med Econ. 2017. In Press. 6. Data on file, Amgen; [PHE Analysis; 2017]
Less Value More Value
USE OF REAL-WORLD EVENT RATE DATA TRANSLATES
INTO PCSK9 INHIBITOR REAL-WORLD ECONOMIC VALUE1-6
16
14
12
10
8
6
4
2
–
41. 41
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Value-Based Price Range†
LDL > 70 = $7,700–$11,200
LDL > 100 = $10,400–$15,000
Economic analyses using
real-world event rates show
value-based price ranges
from $11,900–$17,000*
THE ECONOMIC VALUE OF REPATHA®
REPATHA® OUTCOMES TRIAL
• 20% RRR on hard MACE composite endpoint
• 25% RRR on hard MACE composite endpoint at > year 1
• 33% RRR on fatal and nonfatal MI or CVA at > 1 year
• Economic models typically include mortality benefit seen in CTTC
• Multiple alternative approaches employed using a 2-year time lag
RRR = relative risk reduction; MACE = major adverse cardiovascular event; CVA = cerebrovascular accident; CTTC = Cholesterol Treatment Trialists Collaboration; *Jena AB,
et al. Am J Manag Care. 2016;22(6):e199-e207. Gandra SR, et al. Clin Cardiol. 2016;39(6):313-320. Toth PP, et al. J Med Econ. 2017. In Press; †Willingness to pay of $150K/QALY
PRIOR PUBLICATIONS
42. 42
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
PRICES IN THE MARKET TODAY ARE WITHIN
THE VALUE-BASED PRICE RANGE
Current
Net Prices
$15,000
per year
Value-Based Price Range
LDL > 100
LDL > 70
$10,400
per year
$11,200
per year
$7,700
per year
43. 43
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Current utilization management is preventing appropriate patients from
getting the right treatment, the lack of outcomes data has been a barrier
and this key objection can be taken off the table
The Repatha® Outcomes data provide added conviction that the
discounted prices in the U.S. market today are value based
Innovative contracts/financial risk-sharing agreements aimed at allowing
payers to fulfill their access obligations while providing budget
predictability as utilization increases
Amgen will offer contracting options to payers willing to remove access
barriers, including one option that offers a refund of the cost of Repatha®
for all of their eligible patients who have a heart attack or stroke
AMGEN IS COMMITTED TO HELPING PATIENTS GET ACCESS
TO REPATHA®
Compelling
Outcomes Data
Added Conviction
Innovative Risk-
Sharing Contracts
Outcomes-Based
Contracts
44. 44
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
VALUE-BASED
PRICING
Per-Member-
Per-Year
Threshold
Volume
Discounts
Outcome
Based
Refund
OR
LDL Contract
OR
Performance and
Outcomes Based
Contracts
CV Events
Contract
OR
Contracts Based
on Cost
Predictability
TO ADDRESS ACCESS RESTRICTIONS, AMGEN IS OFFERING INNOVATIVE RISK-SHARING
PERFORMANCE CONTRACTS TO ENGAGE PAYERS IN IMPROVING HEALTH OUTCOMES
These are innovative contract options that will be discussed with payers
45. 45
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
NUMBER NEEDED TO TREAT (NNT) DOES NOT DETERMINE
A MEDICINE’S VALUE
NNT is Not Recommended by Health Authorities*—
Is Rarely Used in Health Economics
NNT Counts Events, Not the Impact of Events
Well-Known Limitations in Health Economics
“QALYs are health economic measures
incorporating both benefits and harms of
each treatment outcome. In contrast, NNT
or NNH simply summarizes the proportion
of patients impacted positively or
negatively by the treatment”
“QALYs provide significantly more
information regarding the impact of
different outcomes that may result from
therapeutic alternatives rather than the few
outcomes addressed by NNT or NNH”
QALY = quality-adjusted life year; NNH = number needed to harm
*Sanders et al, JAMA. 2016; 316(10): 1093-1103
NNT Does Not Capture Important Elements of Value—
Quality of Life or Additional Years of Life
Garg et al, Annals of Pharmacotherapy. 2013;47(3):380-387
46. 46
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
PHYSICIAN ASSOCIATIONS AND PATIENT ORGANIZATIONS ARE
INCREASING THEIR ACTIVITIES ON ISSUES OF PATIENT ACCESS
American Medical Association 21 principles to reform prior-authorization requirements
American College of
Cardiology survey
Barriers to New Medications for Cardiovascular Disease
National Lipid Association survey Challenges in Prescribing PCSK9 Inhibitors
American Society for Preventive
Cardiology Town Hall meeting
Unraveling a Therapeutic Conundrum: A Town Hall on Barriers
to Access PCSK9
American Association of Clinical
Endocrinologists
New lipid guidelines published online January 30 with PCSK9s
second-line therapy after statins
FH Foundation
Implementing “Find FH” to improve diagnosis rates; gathering data
on treatment patterns; collaborating with Express Scripts to improve
pharmacy coverage for patients with FH
FH = familial hypercholesterolemia
48. 48
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
Primary Results of EBBINGHAUS, a Cognitive Study of Patients Enrolled
in the FOURIER Trial
Giugliano et. al. Abstract 404-16
Late-Breaking Clinical Trials, Saturday, March 18, 9–9:10 a.m. ET
Characteristics of Patients Approved and Denied Access
to PCSK9i Therapy by Payers
Baum et al. Abstract 1258-435
Innovations in Advocacy and Patient Centered Care, Saturday, March 18, 3:45–4:30 p.m. ET
Early Challenges for PCSK9 Inhibitor Prescriptions and Patients:
Rejections and Rates Unfilled
Navar et al. Abstract 415-08
Featured Clinical Research III, Sunday, March 19, 2–2:10 p.m. ET
Cardiac Myosin Activator, Omecamtiv Mecarbil, Improves Left Ventricular Myocardial
Deformation in Chronic Heart Failure (COSMIC-HF)
Biering-Sørensen et al. Abstract 1248-244
Heart Failure and Cardiomyopathies: What Next When All Else Is Failing?, Saturday, March 18, 3:45–4:30 p.m. ET
AMGEN CARDIOVASCULAR: ACC 2017 HIGHLIGHTS
49. 49
Provided March 17, 2017, as part of an oral presentation and is qualified by
such, contains forward-looking statements, actual results may vary
materially; Amgen disclaims any duty to update.
• One of the largest CV outcomes trials, including not only those with prior heart attack, but also
prior stroke and symptomatic peripheral artery disease
• Patients were on optimized statin therapy and other CV therapies
• 20% RRR in “hard” MACE composite endpoint of MI, stroke or CV death despite relatively
short (2.2 year) duration of therapy and best current care background therapy—25% RRR
beyond year 1
– Fatal and nonfatal MI or stroke: RRR = 33% beyond year 1
• Effect on CV outcomes extends to LDL-C levels as low as 20 mg/dL, consistent with the effect
seen on atherosclerotic plaque in GLAGOV, with no new safety issues identified
• We look forward to working with payers to improve the health of these high-risk patients,
and have several innovative financial risk sharing programs
• We estimate at least 100,000 heart attacks and strokes could have been avoided last year in
the U.S. alone if all of the appropriate on-label high-risk patients were treated with Repatha®
SUMMARY