Post on 28-Mar-2018
Launching Oncology Therapies:
New Realities to Consider
Sujay KangoChief Commercial Officer
Infinity Pharmaceuticals, Cambridge, MA
Healthcare has improved survival:
More people living with cancer or cancer free
2
Increasing Number of Survivors in U.S.1
3
Million
in 1971
9.8
Million
in 2001
13.7Million
living with cancer
in 2012
1. Source: American Cancer Society
3
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
1. American Cancer Society; 2. Leukemia & Lymphoma Society, Facts and Statistics 2015.
• Many cancers are
still incurable e.g.
iNHL, CLL2
Over 800 Medicines in Development for Cancer1:
Majority Are Targeted Therapies
4
Bladder
Brain
Breast
Colorectal
Head & Neck
Hematological Malignancies
Kidneys
Leukemia
Liver
Lung
Lymphoma
Multiple Myeloma
Ovarian
Pancreatic
Prostate
Sarcoma
Skin
Solid Tumors
Stomach
Other
Unspecified
Medicines in Development for CancersPhase 1
Phase 2
Phase 3
Application
Submitted
1. Source: 2014 Cancer Report PhRMA.org
23
58
82
35
21
84
30
106
35
123
92
38
51
49
50
17
53
227
29
56
27
Over 70% of cancer pipeline may realize vision of
“personalized medicine”
5
73%
of cancer medicines in the
pipeline have the potential to be
personalized medicines
Personalized Medicine is Transforming Cancer Care
1. Source: 2014 Cancer Report PhRMA.org
Global Oncology Spend Reaches $100 Billion with a
modest growth of 6% over a 5 year period
6
2010-14 CAGR
Global 6.5%
2010 2011 2012 2013 2014
100
90
80
70
60
50
40
30
20
10
0
Spen
din
g U
S $
B
5.9%
15.5%
4.2%
5.8%
5.3%
US EUS Japan Pharmerging Rest of World
Source: IMS Health MDAS. Dec 2014
Global Oncology Drug Spending 2010-14
In Developed Markets Growth is driven by new
products and increased volume
7
2010 2011 2012 2013 2014
Abso
lute
Gro
wth
Const
US
$M
Protected Brands - Price
Non Original Brands
Protected Brands - Volume
Generics
LOE
Source: IMS MIDAS, Dec 2014; IMS Institute for Healthcare Informatics
Oncology Spending Growth Dynamics in Developed Markets 2010-14
OTC New Brands
10,000
8,000
6,000
4,000
2,000
0
-2,000
3,808
1,1661,350
4,5157,389
Targeted Therapies had ~double growth
(14.6% vs 6.5%) during the same period
8
2010 2011 2012 2013 2014
0
60
50
40
30
20
10
Spen
din
g U
S $
B
Developed Pharmerging Rest of World
Source: IMS Health MDAS. Dec 2014
Targeted Therapies Growth 2010-14
2010-14 CAGR
Global 14.6%
14.4%
19.0%
14.4%
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
91. 2014 Cancer Report & SEER Fact Sheets 2. Global Oncology Trends Report by IMS
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
11
NEED
Informed decision
making & personal
choice
NEED
Outcome &
evidence based
partnerships
NEED
Holistic account
management and
specialized
knowledge
• NPs, PAs
• Pharmacist
• Reimbursement Mgrs
• Oncology Nurses
Community Hematologist/Oncology Practice Trends:
Evolving Dynamics Create New Opportunities
12
• 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 Market Research Report, 2014.2ION Solutions AmeriSource Bergen Company Data Presentation, 2015.
Payor Oversight Is Increasing
13
14
Common Payer Approach: Implement Pathways
Payer prioritization of tumor types for pathway implementationQ1: 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?
0
20
40
60
80
100
Breast Lung Colorectal MultipleMyeloma
Prostate MetastaticMelanoma
NonHodgkins
Lymphoma
10%
86%
33%
62%
38%
62%
19%
48%
38%
43%
29%
29%
29%
19%
Currently on Pathway High Priority for Pathway Development
15
Timeline of Targeted Opposition on Drug Pricing
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
17
Reducing payer uncertainty
Innovative payment models and
Therapeutic guidelines could impact
combination therapy – even in less
restrictive markets (e.g. US)
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
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
Payers are concerned about the number of
branded novel agents & combination
therapies entering oncology
The economic
crisis
More refined
assessments of
added clinical
benefit
Increasing
prevalence of
structured HTA
Increasing
prevalence of
international
price
referencing
Theme ImplicationsTrend
Key Implication Of Payer/Access Trends: Pressure to
Demonstrate Value and Transparent Pricing
18
Value
Estimation
Purchase
Decision
Analysis
Global
Product
Optimization
• Create value
proposition
• Develop
initial price
assumptions
• Anticipate how
payers and other
key stakeholders
will interpret and
respond to the
value proposition
• Develop and test
initial price and
access
assumptions
• Identify and
quantify price
realization
tactics
• Provide global
pricing policy
recommendation
Patients Are Becoming More Informed
19
65% of American adults are on social media
28%71% 28% 26% 23%
Of these…
Sources: Huffington Post, Pew Research Center
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 Pre-
Treatment
• Tumor Markers 33%
• Skepticism 26%
• Chemo prevention 16%
• Biopsy 13%
Treatment
• Treatment Options 67%
• HCP visit 20%
• Alternative Treatments 6%
• Side Effects 6%
Living with Cancer
• Financial 43%
• Active surveillance 25%
• Emotional concerns 14%
• Informational needs 6%
22Global Oncology Trends Report 2015: IMS
Radiology exam 9%
Physical exam 3%
Remission 6%
Relapse 3%
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”
24
Impact of Year 1 on
Future Performance
73% Meet/Beat
Year 2
64% Meet/Beat
Year3
Impact of Year 1 on
Future Performance
15% Meet/Beat
Year 2
35% Meet/Beat
Year3
35%
Beat
Year 1 65%
Miss
Year 1
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
Critical to Develop Launch Strategy to Meet Today’s
Market Challenges and Opportunities
25
“Where to Play” “How to Win”
What sets of customers
should you invest in?
What should you do for
each set of customers?
Market
Definition
Business
Opportunity
Stakeholder
Prioritization
& Behavioral
Objectives
Segmentation
Desired
Customer
Experience
Value
Proposition
Positioning &
Messaging
Commercial
Model
CML Case Study:
Growth Driven by Approval of New Therapies
26
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
0
500
1,000
1,500
2,000
2,500
3,000 CML Sales (U.S.)Gleevec
Sprycel
Total Market
An
nu
al S
ale
s (
$ M
)
Source: EvaluatePharma.
June 2006
Sprycel
Launch
May 2001
Gleevec
Launch Oct 2007
Tasigna
Launch
Sep 2012
Bosulif Launch
(Ph+ CML)
Jan 2013
Iclusig Launch
Multiple Myeloma Case Study
27
“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.”
Improved survival in multiple myeloma
and the impact of novel therapiesShaji 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
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
30
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
NAMD Letter to Congress – October 28, 2014
31
“Congress can exert downward
pricing on Sovaldi and similarly-
priced 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.”
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
33
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
Value
Estimation
Purchase Decision
Analysis
Global Product
Optimization
While a wide global price corridor is not unusual, issues like
international reference pricing are integral to global optimization
34
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
Value
Estimation
Purchase Decision
Analysis
Global Product
Optimization