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Copyright © 2017 QuintilesIMS. All rights reserved. Launch Excellence 20 September 2017 Conference „Market Access“
Copyright © 2017 QuintilesIMS. All rights reserved.
Launch Excellence
20 September 2017
Conference „Market Access“
1QuintiilesIMS Confidential
Introductory questions
• Proč jsou launche tak důležité?
• Nejčastější chyby a problémy při zavádění nového produktu na trh v
praxi
• Jak by měl být úspěšný launch projektově strukturován a řízen?
• Které oblasti jsou nejdůležitější z pohledu marketingu a brandingu?
• Představení zdařilé kampaně - její průběh a spolupráce jednotlivých
oddělení
2QuintiilesIMS Confidential
A typical patent lasts ~20 years; the average marketing
time of an original product is only 12 years
PharmaCo value chain
20 years
12 years
Time
GBP
DiscoveryClinical research &
developmentRegulatory
Sales & Marketing
Launch Mid life Late life
Patent
expiry
R&D: USD 1 billion
1 in 10.000 molecules successful
3
The six month window is a precursor of successful uptake
requiring early preparation to get the launch right at Day 1
QuintiilesIMS Confidential
• Only a minority of launches make significant improvements in their market share trajectory up to five years post launch
• Early launch behaviours have implications for launches for a very long period of time in mature markets
• Whilst it is possible to improve, most do not – hence, it is extremely important to plan to get launch right the first time
6 Month Opportunity Window15%
65%
The six-month window
Less than 20%
of launches
make significant
improvements
MarketShare
Source IMS Health; n = 3,563 launches
4QuintiilesIMS Confidential
The magnitude of new products is very high (77%) and
still gaining importance
Contribution of new products (NMEs & Line extensions)
Source: QI sell-in database [MAT/07/2017], Rx + OTC reg.
Share of sales in 2017: New vs Old products
77%
23% OLD productMarketed 5 years ago or earlier
NEW productMarketed in last 4 years
5
Early country engagement is the goal, but this is often
challenged by competing priorities
QuintiilesIMS Confidential
-30 -24 -20 -18 -12 -6 months
“I can’t pay a sales team salary for 12 months pre-launch –what will they be doing, anyway?”
“I can’t bear the risk that approval and reimbursement will be delayed and I will have to sustain heavy levels of investment for another six months”
“Real market shaping can’t start until we are in the market”
“Why build insight so early when it might all have changed by the time we launch?”
“We don’t know what the label is- how can we build a strategic plan?”
Alignment of Sales, Commercial and Medical may not be always easy
6QuintiilesIMS Confidential
A growing number of companies fail or underperform in
the following areas
Source: IMS Health Consulting interviews, IMS Launch Excellence framework
KOL management
Aligned and prepared organisation Powerful & pertinent value proposition Effective stakeholder engagement
1. Orga-
nisational
alignment
2. Capable &
motivated
teams
3. Robust
supply chain
management
4. Brand
lifecycle
potential
5. Market
Understanding
6. Clinical
evidence base
7. Value
proposition &
supporting
messages
Franchise
alignment
Launch planning &
management
Launch team
resources
Sizing &
structuring of field
resources
Medical Training
Performance
management
Supply chain
management
Manufacturing
Product
specification
Packaging
Lifecycle planning
Product
formulation
Patent
management
Market
understanding
Competitive
Intelligence
Patient flow mapping &
segmentation
Stakeholder mapping
Stakeholder segmentation and targeting
Clinical
development
strategy
Phase IIIb
programme
Phase IV
programme
Target profile &
positioning
Branding
Market
preparation
messages
Prescriber value
proposition
Payer value
proposition
8. Regulatory
approval and
market access
Trade name
search &
registration
Geographic
sequencing
Market
authorisation
Risk management
& pharmaco-
vigilance
P&MA
strategy
Payer evidence
generation
Core value dossier
9. Advocacy,
adoption &
uptake
Customer engagement
planning
Promotional spend
& mix
Campaign development
Digital marketing
Sampling
10.
Understanding
of medical &
clinical paradigm
Medical education
Disease awareness
programmes
Congresses &
symposia
Publications
Professional
organisation
relations
Public Relations
P&MA stakeholder engagement
Public Affairs
Roles &
responsibilities
Patient
relations
Provider/
Caregiver
Relations
MSL Activity
Planning
Forecasting
Internal launch
communication
Budgeting
Common Worst Practices/ Failure Items
Practices/ Processes at risk
P&MA stakeholder engagement
Lifecycle planning
Packaging Practices/ Processes with low risk
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Launch excellence means being outstanding in three
areas
QuintiilesIMS Confidential
Effectiveand efficientstakeholderengagement
• How do we effectively engage with all the relevant stakeholders?
• How do we coordinate engagement with a broad range of stakeholders at all levels of the organization?
• How do we achieve organisational alignment?
• How do we manage the consequences of misalignment?
• When should in-country pre-launch preparation start, with what levels of resourcing?
Alignedand preparedorganisation
• What clinical and pharmacoeconomic evidence for success?
• How to get hands-on clinical experience for the right prescribers in a competitive environment?
• What does this imply in terms of preparation, investment, and timing?
• How can companies build the right product profile?
Powerful andpertinent value
proposition
RWEOutcome-based
agreements
8QuintiilesIMS Confidential
The three areas translate into a proven Planning,
Tracking And Diagnostics Matrix
Foundational Success Factors
Launch Diagnostics
LaunchPlanning
Launch Tracking
EnsuringLaunch
Excellence
• What are the activities,
timelines and milestones
from now until launch?
• What are all the functional
interdependencies?
• Who is responsible for the
different activities?
• Are all key launch activities being planned?
• Is the planning and execution truly world class?
• Do we have the needed resources?
• Will activities will be executed in a timely manner?
• What are the gaps and key risks, and how do we
overcome them?
• What are key performance
indicators to define and track
success, across functions and
geographies?
• What is the best process for
timely follow-up on key issues?
• What is the best tool to enable
tracking of launch progress?
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Push-back from payers’ side does not seem to be very likely
QuintiilesIMS Confidential
We identified 6 main stakeholder-related risks, which
may threaten Product X's commercial success
Identified risks prioritization
Source: IMS Health
A. Physician-related risks
A1: Risk 1
A2: Risk 2
A3: Risk 3
A4: Risk 4
B. Payer / revision doctor-related risks
B1: Risk 5
B2: Risk 6
C. Hospital management-related risks
No major risks identifiedLow HighImpact
Low
High
Lik
eli
ho
od
A1A2
A3
A4
B1
B2
Risks to be mitigated
Key risks identified Prioritization matrix1)
Note: 1) Risk significance and likelihood is assessed via following scale: 1 – 4, where 1 is low and 4 is high
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We suggest beginning with slow market penetration and
ongoing collection of real clinical effects on physician side
High-level launch management plan
Source: QI
0 1
2
3
PMA Launch
End of testing
period
Full sales
uptake
Slow uptake / real clinical
effects collection
Switching majority of patients
to Product X
Technical preparation of launch
Physicians engagement
• Balanced education of physicians
• Support of physicians with tools to compare drug economy and track real world clinical effects
Patient association engagement
• Establishing regular contact with association
• Informing patients about available treatment options via association
Commercial strategy
• Physician targeting
• Training of salesforce
• Development of marketing support (leaflets / tools)
Key Company actions
Current launch status
Revenues
14QuintiilesIMS Confidential
Each of the stakeholders focuses on different aspect of
the value proposition
Value proposition targeting
Product X value proposition
Stakeholders chosen for interviews & analysis
Key characteristics
Complex view
Patient first
No negative publicity
Revisiondoctors
Stick to the rules
Legend: Focus on value proposition element: Very low Low Middle High Very high
Clinical1
Patient experience/ preference
2
Economic3
PhysiciansPayers Hospitalmgmt.
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Map how competitive brands are perceived by your
target physicians > try to differentiate
Brand key messages perception benchmarking
Lowers testosterone to below castrate levels <20ng/dl (9.6)
Lowers testosterone to below castrate levels <50ng/dl (9.5)
Good safety profile (9.3)
Trust and experience with the product (8.9)
Easy to administer (8.6)
Minimal breakthrough rate of testosterone less than 1% (8.5)
Flexibility of dosing options (8.0)
Relationship and support from sales representative (7.6)
Company support and investment in Urology (7.4)
Least relevant
Most relevant
Least positive evaluation Most positive evaluationEvaluation (1-10)
1 2 3 4 5 6 7 8 9 10
PERCEPTUAL MAPPING
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Typically a patient is both in out- and in-patient care
switching between multiple phycians specializations
Patient lifeline
Source: IMS analysis
Life before disease Life with disease
Length of life
Qu
ality
of
life
Lifestyle
Precondi-tions
Other illnesses evolution
HF onset
Low
Hig
h
Diagnosis & classifica-
tion
Treatment & its adjustments/ monitoring
1st hospitalization 2nd
hospitalization
4thhospitalization
5th (fatal)hospitalization
BasicEnhanced (more&
stronger drugs)Changed treatment
Symptoms
3rdhospitalization
Simplified illustation
Outpatient
InpatientCare
17QuintiilesIMS Confidential
We defined six main stages on a patient path for further
analysis
Patient path overview
Source: IMS analysis, PMR
C. Patient path
Key e
lem
en
ts a
na
lyze
dD
ec
isio
ns
ma
de
II. Capture III. Diagnostics IV. Treatment V. Monitoring VI. HospitalizationI. Symptoms
• Typical patient description
• Often/ less often/ rare symptoms
• First diagnosis (self or other physician specs)
• Patients classification techniques used
• Diagnostic techniques used
• Structure of patients by classification techniques
• Referrals to other physician specs
• Most often used classes of drugs
• Most often used drugs combinations
• Examination techniques used
• Hospitalization lead-times
• Average # of total hospitalizations per patient
• Total # of hospitalizations
• Classes vulnerable to hospitalizations
• Share of patients having hospitalization
• Visit or not visit physician
• Physician visit choice
• Diagnostic tools & techniques choice
• Collaboration with other physicians
• Patient classification
• Treatment choice
• Treat patient self or send for care to other physican
• Regular check frequencies
• Examination tools & techniques choice
• Change in treatment
• Where to send a patient from hospital
Stages
18QuintiilesIMS Confidential
Goal is to enlarge the last stage of patient flow pipeline –
conservative estimate is a pool of 8k patients
Potential based on patient flow
Source: Epi data, Focus group, PMR, expert interviews
Pa
tie
nt
po
pu
lati
on
200k 40%: 80k 49%: 40k 40%: 16k 90% :14k 56%: 8k
Opportunity window 1
Opportunity window 2
Opportunity window 3
Total HF universe
DiagnosedReduced
ejection fractionQualified
(Co-)treated by cardiologist
Willing
19QuintiilesIMS Confidential
Most important for targeting will be actively prescribing
KOLs and „A“ segment line specialists
Physician targeting design
Source: IMS analysis
Major relevant specializations
Group 1
Group 2
Group 3
Hospital
Ambulance
KOLs
„Line“ physicians
„Academics“
Active prescribers
„Quazi“ group 1
Others
A
B
C
Note: Subjects to F2F targeting (detailing) Subjects to general HF education program
Targeting priorityGeneral structure of the major relevant physician specializations
20QuintiilesIMS Confidential
Almost 50% of Czech physicians are above 50 years old,
which determines their attitude to receiving information
CZ physician decomposition by age
Source: UZIS, 2013
0%1%2%3%4%5%6%7%8%
-29
70+
65-69
55-59
50-54
45-49
35-39
40-44
30-34
60-64
0% 1% 2% 3% 4% 5% 6% 7% 8%
Men Women
Average age
49Average age
48
21
11
10
9
8
12
Usage frequency - pharmco
13Un
de
res
tim
ati
on
by p
harm
ac
o1)
7
6
5
4
3
1
2
QuintiilesIMS Confidential
We have identified 4 segments based on our matrix
evaluation…
Matrix of promotional channels – Physicians overall [#]
Source: PMR; QuintilesIMS
Channel 1
Channel 2
Channel 3
Channel 9
Channel 5
Channel 8
Channel 4
Channel 6
Channel 7
Channel 10
Channel 11
Channel 12
Channel 130
Enhance greatly Enhance slightly Track/monitorMaintain, but evaluate
1) Underestimated – should to be used more often in future than today
1
2
3
4
5
6
7
8
9
10
11
12
13
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Outcomes from matrix evaluation were discussed with
remaining indicators resulting in channels’ segmentation
Overall evaluation of all promotional channels
Source: PMR; QuintilesIMS
Promotional channel Value added Importance Frequency -
physicians
Frequency -
companies
Underesti-
mation
Channel 1
Channel 2
Channel 3
Channel 4
Channel 5
Channel 6
Channel 7
Channel 8
Channel 9
Channel 10
Channel 11
Channel 12
Channel 13
1
2
3
4
5
6
7
8
9
10
11
12
13
Enhance greatly Enhance slightly Track/monitorMaintain, but evaluate
QuintiilesIMS Confidential
23QuintiilesIMS Confidential
Launch excellence requires different approach in each of
the three segments – all require organizational excellence
Launch attributes
Organizational Excellence
Innovative/Original Generic Rx OTC
Key
stakeholder
• Payer & prescriber • Prescriber &
pharmacist
• Pharmacist &
Consumer
Popular source of
potential failure
• Improper preparation • Wrong targeting
• Lack of prioritization
• Unspecified value
proposition
Obvious success
trigger
• Drug efficacy • Be the first generic • Clear consumer value
proposition
Selected action
example
• Patient Access • Targeting • Promo-Mix
24QuintilesIMS Confidential
Based on our analysis we clustered the launches into
four categories
Source: IMS Thought Leadership; Average First-Year Promotion Investment by Archetype
“Science Sells”“It’s about Shaping
(market/prod)”
“Who Benefits” “Emphasize
the Difference”
Launch
Archetypes
Le
ve
l o
f d
iffe
ren
tiati
on
high
low
Level of unmet needhigh low
1. HIGH unmet need in the market with HIGH
product differentiation
2. LOW unmet need in the market with HIGH
product differentiation
3. HIGH unmet need in the
market with LOW product differentiation
4. LOW unmet need in the market with LOW
product differentiation
25QuintilesIMS Confidential
This overview is a good example that the archetype
indicates future success, but is not the only determinant
Number and Success of Launches per Category
1. “Science Sells” 2. “It’s about Shaping (market/prod)”
4. “Who Benefits” 3. “Emphasize the Difference”
Launch
Archetypes- Germany Example –
“Good” (15)
“Average” (7)
“Poor” (15)
“Good” (9)
“Average” (3)
“Poor” (10)
“Good” (20)
“Average” (4)
“Poor” (20)
“Good” (34)
“Average” (14)
“Poor” (27)
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Please contact us for more information
Our contact details
Tomáš Khorel
Senior Consultant, CZ&SK
+420 778 726 767
