Download File - Jason M Bloom

Intrepid Health Solutions
Ematuzumab Launch
November 15, 2013
TEAM 1
David Waintraub
Jason Bloom
Manasa Parakala
Michael Kwatkoski
Executive Summary
WHO?
HER2/neu Breast Cancer Patients
WHAT?
Ematuzumab-Disruptive Monoclonal Antibody
WHERE?
Launch in the United States
WHEN?
FDA Approval by 2015
Risk Sharing Pricing Model
High Overall Survival
High Complete Response
Rate
No Cardiac Risk
WHY?
2
What is HER2/neu?
•
•
•
•
•
Biomarker: promotes cancer cell growth
Causes aggressive cancer
38,400 diagnosed each year
Standard of Care: Genetech’s Herceptin
New Paradigm: Perjeta enhances Herceptin’s effectiveness
3
Breast Cancer Continuum
Before Surgery
After Surgery
NeoAdjuvant
Adjuvant
Stage I
II
Before/After Surgery
Metastatic
III
1st Line
2nd
3rd
4th
HER2/neu : 38,400 patients/year
4
Perjeta Landscape
Before Surgery
After Surgery
NeoAdjuvant
Adjuvant
Before/After Surgery
Metastatic
Stage I
II
III
1st Line
2nd
P
P
P
P
P
P
E
E
E
E
E
E
3rd
4th
5
Metastatic 1st Line: Ema vs. Perjeta
Comparative Effectiveness Research
Results
Ema Projected
Perjeta Actual
Placebo
Complete
Response
8.4%
5.5%
4.2%
Overall Survival
>50 months
~50 months
37.6 months
Safety
No Cardiac Risk
Cardiac Risk
Cardiac Risk
PFS
5.5 months
6.1 months
-
Administration
60 min
60 min, 30-60min
-
6
Breast Cancer Continuum
Before Surgery
After Surgery
NeoAdjuvant
Adjuvant
Stage I
II
Before/After Surgery
Metastatic
III
1st Line
2nd
3rd
4th
HER2/neu : 38,400 patients/year
7
Neoadjuvant: Ema vs. Perjeta
Comparative Effectiveness Research
Results
Ema Projected
Perjeta Actual
Placebo
pCR
>39.3%
39.3%
21.5%
Secondary
Endpoint
No Cardiac Risk
Cardiac Risk
Cardiac Risk
8
Breast Cancer Continuum
Before Surgery
After Surgery
NeoAdjuvant
Adjuvant
Stage I
II
Before/After Surgery
Metastatic
III
1st Line
2nd
3rd
4th
HER2/neu : 38,400 patients/year
9
Pricing Argument
Ematuzumab: $6500/month Perjeta: $5900/month
• Comparative Effectiveness Research
• Risk sharing model
• Lower overall health care costs
10
Comparative Effectiveness Research
• Stronger Complete Response
• Stronger Overall Survival
• No Cardiac Risk
11
Risk Sharing Model
Ema Projected
Perjeta Actual
Price per
patient
$6500/month
$5900/month
Rebate
20% based
on ORR
$1300
$0
Adjusted
price after
rebate
$5200
$5900
Savings
$700
$0
12
Lower Overall Healthcare Costs
• Value Based Purchasing
• Shifting story from price of drug to overall cost of care
• High Complete Response
• No Cardiac Risk
• Accountable Care Organizations
• Pay for total continuum of patient
• Look at drug’s efficacy
• Overall cost
13
Better Drug, Better Plan
• Have better results for less costs
• Head to head studies
• Risk sharing model
• Uniform message to medical community
• Payors, physicians, and patients
14
Pre-Launch Plan
• Timeline of Phase III Data
• San Antonio Breast Cancer Symposium: December 2013
• Metastatic 1st Line Phase III Data
• American Society of Clinical Oncology: June 2014
• Neo-Adjuvant Phase III Data
15
Ema SWOT Analysis
STRENGTHS
•
•
•
•
Higher Complete Response
Higher Overall Survival
No Cardiac Risk
Innovative Pricing Model
OPPORTUNITIES
• Adjuvant
nd
• 2 line metastatic
• Potential to expand in oncology
WEAKNESSES
•
•
•
•
•
nd
2 to Market
Genentech franchise
st
1 time in oncology
Progression Free Survival
Longer drug administration
THREATS
• Phase III results weaker than
projected
• New product launches in the
breast cancer space
16
Questions?
17