Launching Oncology Therapies:
New Realities to Consider
Sujay Kango
Chief Commercial Officer
Infinity Pharmaceuticals, Cambridge, MA
Healthcare has improved survival:
More people living with cancer or cancer free
Increasing Number of Survivors in U.S.1
3
Million
in 1971
9.8
Million
in 2001
13.7
Million
living with cancer
in 2012
1. Source: American Cancer Society
2
Are Today’s Treatments Enough?
• 1.6 Million New
Cases and 600,000
Deaths in 20141
• Every 10 minutes
someone in the
U.S. dies from a
blood cancer2
• Many cancers are
still incurable e.g.
iNHL, CLL2
1. American Cancer Society; 2. Leukemia & Lymphoma Society, Facts and Statistics 2015.
3
Over 800 Medicines in Development for Cancer1:
Majority Are Targeted Therapies
Medicines in Development for Cancers
Phase 1
Phase 2
Phase 3
Application
Submitted
23
Bladder
58
Brain
82
Breast
35
Colorectal
21
Head & Neck
84
Hematological Malignancies
30
Kidneys
106
Leukemia
35
Liver
123
Lung
92
Lymphoma
38
Multiple Myeloma
51
Ovarian
49
50
Pancreatic
Prostate
Sarcoma
17
53
Skin
227
Solid Tumors
Stomach
29
56
Other
Unspecified
1. Source: 2014 Cancer Report PhRMA.org
27
4
Over 70% of cancer pipeline may realize vision of
“personalized medicine”
Personalized Medicine is Transforming Cancer Care
73%
of cancer medicines in the
pipeline have the potential to be
personalized medicines
1. Source: 2014 Cancer Report PhRMA.org
5
Global Oncology Spend Reaches $100 Billion with a
modest growth of 6% over a 5 year period
Global Oncology Drug Spending 2010-14
US
EUS
Japan
Pharmerging
Rest of World
Spending US $B
100
2010-14 CAGR
Global 6.5%
90
5.9%
80
15.5%
70
4.2%
60
5.8%
50
40
5.3%
30
20
10
0
2010
2011
Source: IMS Health MDAS. Dec 2014
2012
2013
2014
6
In Developed Markets Growth is driven by new
products and increased volume
Oncology Spending Growth Dynamics in Developed Markets 2010-14
Protected Brands - Price
Non Original Brands
Protected Brands - Volume
Generics
OTC
LOE
New Brands
Absolute Growth Const US $M
10,000
8,000
6,000
4,515
3,808
7,389
1,166
1,350
4,000
2,000
0
-2,000
2010
2011
2012
Source: IMS MIDAS, Dec 2014; IMS Institute for Healthcare Informatics
2013
2014
7
Targeted Therapies had ~double growth
(14.6% vs 6.5%) during the same period
Targeted Therapies Growth 2010-14
Developed
Pharmerging
Rest of World
60
14.4%
50
Spending US $B
2010-14 CAGR
Global 14.6%
19.0%
14.4%
40
30
20
10
0
2010
2011
Source: IMS Health MDAS. Dec 2014
2012
2013
2014
8
Key Takeaways
• Despite significant progress, treatment advances vary across
cancer types1
– 5 year survival rate of lung cancer increased by 54% since 1975
• However, only 17.4% lung cancer patients survive at 5 years
– 5 year survival for AML is 25%
– 5 year survival for Myeloma is 46%
– 5 year survival for NHL is 70%
• Significant clinical benefit in select patient segments driven by
– Targeted medicines, immuno-oncology, combinations, biomarkers
– Many molecules are in development for multiple indications including
less common malignancies
• Oncology therapies are a $100 Billion global market
– Constitutes 1% of total healthcare spend
1. 2014 Cancer Report & SEER Fact Sheets 2. Global Oncology Trends Report by IMS
9
Key Implications To Consider
• Intensified competition—new MOAs, fast followers and or next
generation in class molecules
– 45 NMEs launched 2010-2014; 10 in 2014 alone2
– Short lead time to maintain novel or in-class exclusivity
– Considerations on launch strategies and share
• Opportunities exist in oncology but successful product launches
will require:
– Navigating the complex development landscape
– Changing market dynamics and
– Evolving stakeholder environment
10
Key Commercial Stakeholders:
Decision Making Influence Is Evolving
NEED
Holistic account
management and
specialized
knowledge
•
•
•
•
NPs, PAs
Pharmacist
Reimbursement Mgrs
Oncology Nurses
NEED
Outcome &
evidence based
partnerships
NEED
Informed decision
making & personal
choice
11
Community Hematologist/Oncology Practice Trends:
Evolving Dynamics Create New Opportunities
• Gaining therapeutic knowledge continues to be of key importance
– Integrated support to improve outcomes, patient experience and
practice efficiency is welcomed
• Consolidation/Integration are rapidly changing the physician
practice
– Access to industry is declining
– Practice level clinical pathways are becoming common
– 45% of practices currently use pathways for major solid tumors1
• Dispensing of specialty medicines
– 33% or 1200/4200 International Oncology Network (ION) community
oncology practices result in 35,000 scripts per month2
1HIRC
2ION
Market Research Report, 2014.
Solutions AmeriSource Bergen Company Data Presentation, 2015.
12
Payor Oversight Is Increasing
13
Common Payer Approach: Implement Pathways
Payer prioritization of tumor types for pathway implementation
Q1: For which tumor types has your plan already developed pathways?
Q2: What are your plan’s next priorities for development of clinical pathways in oncology?
100
80
10%
33%
38%
60
40
19%
38%
29%
86%
62%
29%
62%
20
48%
43%
29%
19%
0
Breast
Lung
Currently on Pathway
Colorectal
Multiple
Myeloma
Prostate
Metastatic
Melanoma
Non
Hodgkins
Lymphoma
High Priority for Pathway Development
14
Timeline of Targeted Opposition on Drug Pricing
15
CMS Pilot: Part B Payment Model Rule Proposal
(released March 8, 2016 comments by May 9, 2016)
• Two phases of the proposal to be tested over next 5 years
– Phase I restructure ASP+6% payment model to ASP+2.5% plus a flat
fee of $16.80 which would increase at CPI annually
– Phase II is much broader and will test 5 value-based strategies
•
•
•
•
•
discounting and eliminating cost-sharing,
clinical decision support tool use,
indications-based pricing,
reference pricing, and
manufacturer risk-sharing agreements
16
Key Global Market Access Trends
Theme
Trend
Implications
The economic
crisis
Payers are concerned about the number of
branded novel agents & combination
therapies entering oncology
Reducing payer uncertainty
Innovative payment models and
Therapeutic guidelines could impact
combination therapy – even in less
restrictive markets (e.g. US)
More refined
assessments of
added clinical
benefit
Payers are increasing requirements on
comparator choices: H2H studies vs. SOC
“mandated” or strongly preferred
Use of RWE in absence of appropriate
comparators
Comparator selection during design of pivotal
studies needs to take into account market
access implications
Leverage indirect treatment comparisons
Evidence to justify comparator arm is key
Increasing
prevalence of
structured HTA
Payers in markets with sophisticated HTAs
will only accept premium pricing for
treatments that address clear unmet needs
Showing significant OS and PFS
improvements will be key.
Consider alternatives for access to
entire/broad population (e.g. select 1st line
patients)
Payers are becoming more sophisticated in
referencing prices from a variety of countries
Price bands &
Local/Reginal Strategies
Increasing
prevalence of
international
price
referencing
17
Key Implication Of Payer/Access Trends: Pressure to
Demonstrate Value and Transparent Pricing
Value
Estimation
• Create value
proposition
• Develop
initial price
assumptions
Purchase
Decision
Analysis
• Anticipate how
payers and other
key stakeholders
will interpret and
respond to the
value proposition
• Develop and test
initial price and
access
assumptions
Global
Product
Optimization
• Identify and
quantify price
realization
tactics
• Provide global
pricing policy
recommendation
18
Patients Are Becoming More Informed
19
65% of American adults are on social media
Of these…
71%
28%
Sources: Huffington Post, Pew Research Center
28%
26%
23%
75% of American adults seek health info online
Most common sources
•
•
•
•
•
•
•
•
WebMD (56%)
Wikipedia (31%)
Health magazine websites (29%)
Facebook (17%)
YouTube (15%)
Blog (13%)
Patient communities (12%)
Twitter (6%)
Sources: IMS Institute for Healthcare Informatics, Mashable
Discussion Topics by Patient Journey Stage
(Prostate Cancer Example1)
Diagnosis
and PreTreatment
Treatment
•
•
•
•
Tumor Markers
Skepticism
Chemo prevention
Biopsy
•
•
•
•
Treatment Options
HCP visit
Alternative Treatments
Side Effects
•
•
Living with •
Cancer •
33%
26%
16%
13%
9%
3%
Remission
Relapse
6%
3%
67%
20%
6%
6%
Financial
43%
Active surveillance 25%
Emotional concerns 14%
Informational needs 6%
Global Oncology Trends Report 2015: IMS
Radiology exam
Physical exam
22
Patient Trends and Implications
• Patient community is active and is seeking information
• Brand discussions do occur across platforms
• Patients are more empowered and beginning to shifting the
balance on decision making
– Knowledge
– Increase out of pocket payments
– Co-insurance models
• Implications:
– Key to understand patient needs, concerns and appropriate
engagement
23
Industry dynamics, a limited window for success, and launch uptake
correlation with long-term success increase the pressure to “get it right”
Impact of Year 1 on
Future Performance
73% Meet/Beat
Year 2
64% Meet/Beat
Year3
35%
Beat
Year 1
Impact of Year 1 on
Future Performance
65%
Miss
Year 1
15% Meet/Beat
Year 2
35% Meet/Beat
Year3
Though great launches often involve great products, superior launch
strategy, planning and execution always matter
Source: Evaluate Pharma World Preview. The Smart Cube. Deloitte Analysis. Revenue data obtained from DataMonitor;
forecast data obtained from analyst reports.
Note: Assessment is based on global revenue for ~50 drugs launched in 2007, 2008 and 2009 for top pharma companies
24
Critical to Develop Launch Strategy to Meet Today’s
Market Challenges and Opportunities
“Where to Play”
What sets of customers
should you invest in?
Market
Definition
Stakeholder
Prioritization
& Behavioral
Objectives
“How to Win”
What should you do for
each set of customers?
Business
Opportunity
Desired
Customer
Experience
Value
Proposition
Segmentation
Positioning &
Messaging
Commercial
Model
25
CML Case Study:
Growth Driven by Approval of New Therapies
CML Sales (U.S.)
3,000
Jan 2013
Iclusig Launch
Gleevec
Sprycel
Annual Sales ($ M)
2,500
Sep 2012
Bosulif Launch
(Ph+ CML)
Total Market
2,000
May 2001
Gleevec
Launch
1,500
June 2006
Sprycel
Launch
1,000
Oct 2007
Tasigna
Launch
500
0
2005
Source: EvaluatePharma.
2006
2007
2008
2009
2010
2011
2012
2013
2014
26
Multiple Myeloma Case Study
Improved survival in multiple myeloma
and the impact of novel therapies
Shaji K.Kumar, S. Vincent Rajkumar, Angela Dispenzieri, Martha Q. Lacy,
Suzanne R. Hayman, Francis K. Buadi, Steven R. Zeldenrust, David Dingli,
Stephen J.Russell, John A. Lust, Philip R. Greipp, Robert A. Kyle, and Morie A. Gertz
“Those diagnosed in the last decade
had a 50% improvement in overall
survival (44.8 vs. 29.9 months)…we
demonstrate improved outcome of
patients with myeloma in recent years,
both in the relapsed setting as well as
at diagnosis.”
27
Summary
• Opportunities exist in oncology therapy to meet unmet medical
needs BUT vary across malignancies
• Shape development plan early to ensure the program data will
meet or exceed high bar
• Stakeholder dynamics have evolved
• Revise the launch play book
– Opportunity to apply lessons from EU & other HTA markets as US
market beginning to seek value-based arrangements
– Prioritize timing, investment mix and stakeholder plans
• Short exclusive time prior to competitive entrants gain market authorizations
• Traditional model of go-to-market and or HCP engagement may not be predictive
28
BACK UPS>>>>
29
Developing customer models guide us in identifying required
launch capabilities and matching the right resources
The Go-to-Market Model will be executed in a structured process of designing the customer engagement
model, defining the capabilities and resources required, and finally determining metrics
30
NAMD Letter to Congress – October 28, 2014
“Congress can exert downward
pricing on Sovaldi and similarlypriced specialty drugs targeting
large patient populations. While
we recognize that direct price
controls would be a politically
volatile topic which could be
expected to encounter
substantial pushback, a strong
case can be made for the unique
circumstances of hepatitis C in
particular.”
31
Prices are reflective of multiple factors including clinical
value; these drivers are magnified in the biotech space
32
While a wide global price corridor is not unusual, issues like
international reference pricing are integral to global optimization
Value
Estimation
Purchase Decision
Analysis
Sources: Database from Client, Redbook, FDA, The Medical Letter (http://secure.medicalletter.org/w1394d), NCI secondary research
PNH - Paroxysmal Nocturnal Hemoglobinuria HAE - Hereditary Angioedema SBS – Short Bowel Syndrome CF – Cystic Fibrosis
* Hemophilia prices are challenging to analyze based on wide variations in dosing and compliance with prophylactic treatments
Global Product
Optimization
33
While a wide global price corridor is not unusual, issues like
international reference pricing are integral to global optimization
Value
Estimation
Purchase Decision
Analysis
Source: IMS MIDAS, IMS Lifecycle, Price RX, l’Assurance Maladie, Lauer-Taxe, Gazzetta Ufficiale, BotPlusNet, MIMS and
Vertex research. Prices used in the calculation are for a course of therapy or annual, if chronic. Prices are current for EU
(assume relatively unchanged over time). For US: *Launch price or oldest Price RX value. † US WAC at launch, less than price
in some EU countries, but has risen 50% since launch (note also likely heavy net discounting in EU). FX rates also a factor
Global Product
Optimization
34