What drives launch excellence Decoding the DNA in launching brands

1
What drives launch excellence?Decoding the DNA
in launching brands

• Raymond Hill, GM, Consulting, IMS Health
• May 7, 2007
• PBIRG 2007 AGM, Savannah, GA

2
Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

3
The largest quantitative assessment of launches
ever conducted
All launches

• Started with every product with quantifiable
  office based physician promotion from launch
• Used the richness of IMS data to go as broadly
  as possible
• Identified launches meeting multiple quantitative
  criteria of excellence
• Interviewed individuals involved in outstanding
  launches
• Combined anecdotal evidence with analysis to
  identify keys to success

4,225 promoted launches, 2,470 products 71
therapy areas 8 countries, 8 years
61 outperforming products for one or more
countries
35 outperforming products for two or more
countries
Launch Excellence
includes most specialist products
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What defines an excellent launch?
Quantification metric 2 countries, 2 years into
launch
Description
Market dominance
Promotional effectiveness
Maximizing opportunity
5
Excellent launches out-perform on all three
measuresOut-performers in two or more countries
Proportion that are outperforming products
45
52
11
NCEs
Market dominance
Promotional effectiveness
1
Combination Products
35
4
Reformulations
Outperforming Products (1.4 of universe)
4
Specialist Led
1
Primary Led
31
Blockbuster products (as at 2006)
57
Maximizing opportunity
6
A company does not have to be large to have
outstanding launches
Only 18 companies with out-performing launches
Source IMS Launch Excellence database, IMS RD
Focus, Pfizer and Leo Pharma have been excluded
from the graphic as outliers, but included in the
averages
7
Many companies launching significant brands lack
a track record of excellent launches
Novartis 5
Schering-Plough/ Organon
GSK 1
Wyeth 2
Lilly 1, Bristol-Myers Squibb 2
Pfizer
Astra- Zeneca 1 Abbott 1
Sanofi Aventis
Merck Co 1
Eisai 1 Roche
Shire, Amgen 1
BayerSchering 1
Johnson Johnson
Daiichi Sankyo 1, UCB, Novo Nordisk 1
Boehringer Ingelheim
Nycomed, Takeda
Procter Gamble

• No company has ever had more than one excellent
  launch in a single year in the same country

Source IMS Launch Excellence database, IMS RD
Focus, analyst reports on company pipeline
potential Number of potential blockbusters. NB.
Oncology and other exclusively hospital launches
excluded from x axis, but included on y
8
Pharma companies need to focus on four key areas
to improve launch effectiveness
Source IMS interviews with industry executives
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Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

10
A narrow launch opportunity window in most major
countries
Percentages of launches with significant changes
in launch trajectory

• 3 out of 4 launches will not improve the launch
  path theyre on in the initial 6 months by the
  end of the 2 year period
• In the US, Germany, Spain, Japan, 90 of launch
  trajectories are set in the first six months

Italy
Canada
UK
France
Spain
Japan
Germany
US
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Most new to brand share growth is over by an
average of 13 weeks in the US
21 products experienced a new to brand share
increase after inflection with an average
increase of 27.5 (median is 29)
Dynamic measure is New to Brand Share (defined as
share of new patients plus patients switched to
launch brand)
1 brand remains flat
Uptake inflection occurs on average at week 13.4
(median is 13)
19 products experienced a new to brand share
decrease after inflection with an average
decrease of 34.4 (median is 34)
Dataset IMS analysis of 41 launch brands in the
US market, 2004-2006
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Future launch standards Optimizing for the
launch window
Right pre-launch preparation, the right leading
indicators, right contingency planning
Engage the right decision makers
Link lead indicators to performance diagnostic
and contingency planning
Learn locally, respond globally

• Pre-launch activities generating the optimum
  level and type of awareness, priming decision
  makers to action immediately post-launch
• Prescribers intent to prescribe, identifying
  patients who are immediate candidates for launch
• Payors agreement to provide access and funding

• Establish lead indicators tracking performance in
  dynamic market with timely (weekly) benchmarks
  for share and mix (new versus switch)
• Develop pull-the-trigger contingency plans to
  effect immediate corrective action

• Apply learnings from the critical six month
  launch period directly to the launch
  consolidation plan for building the launch from 6
  months-2 years
• Assess performance in early launch countries
  closely to feed into adjustments for
  later-launch country plans

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Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

14
Almost half of all outperforming launches are
market expandersbut not all innovators
Outperforming launches
Out-performing market expanders by French
Transparency (ASMR) rating
46 market expanders
Equivalent non-outperforming launches
9 market expanders
ASMR Ratings
Rated Highly innovative
Rated Less innovative
Market expansion is a broad definition built on
overall increase in market value growth measure
of whether patient volume, patient value, or
both, was increased
Source IMS Launch Excellence database ASMR
rating of 4-6 or unrated (not all products have
been ASMR rated)
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Market expanders engage decision makers at all
levels on the patient treatment path
Engagement
DECISION MAKERS

• Disease definition
• Government priorities
• Public attitudes
• Medical community attitudes

Fosamax An excellent launch, engaged all levels
POLICYMAKERS

• Convinced payers and policymakers of the value of
  intervention
• Clinicians were educated to recognise and
  prescribe for osteoporosis
• Patients awareness raised of osteoporosis and
  potential treatments

• Healthcare system culture
• Payor priorities
• Cost of disease

PAYORS

• Disease profile/public awareness
• Patient ownership of disease

PATIENTS

• Traditional promotional levers

Non-excellent launches more likely to engage only
at the prescriber level will be insufficient as
their power reduces
PRESCRIBERS
Source IMS interviews
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Future launch standards Engage all decision
makers and expand markets
Invest early and effectively to engage and expand
your market
Align investments to the drivers and the launch
decision makers behind them
Align clinical and commercial understanding of
growth drivers
Segment the patient opportunity

• From Phase III, a detailed understanding of
  growth segments and drivers that is
• country specific
• based on understanding of market and competitive
  environment relevant to launch
• Agreed with clinical and commercial, so both
  align behind it

• Invest earliest and heaviest in addressing the
  decision makers which will have greatest power at
  launch
• Align clinical incentives so that addressing
  payer needs successfully is explicit in trial
  strategy

• Segment and characterise the target patient
  groups throughout product development in a
  directly commercially relevant way
• By launch, understanding of the target patient
  groups must be
• Clear on the patient segments to focus effort
• Detailed on the approach to access these segments
  in terms of decision maker investments

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Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

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Detail impact is dependent on prescriber power
this differs widely between countries
How much does detailing drive launch?

• There is a 6-fold variation between the countries
  in year one, and a 4-fold variation in year two
• The UK is a significant outlier, with detail only
  9.5 of launch in year 1, and 15.5 year 2
• Total office based rep numbers are very high in
  US, Japan and UK relative to their impact

CONTRIBUTION OF DETAIL
Source IMS Launch Excellence database P-value in
all countries and years is 0.005 or less (99.5
likely result is not chance)
19
The future in detail driven markets depends on
the impact of health economics
Inverse relationship of health economic
requirements to detail impact

• Future healthcare system changes must be
  evaluated for how they will change decision maker
  power
• UK and Canada are markers for the direction in
  which other markets will evolve
• HTA assessment introduced in Germany from 2005,
  and has impacted detailing effectiveness

As payer power increases over prescriber power,
detail contribution to launch success will reduce
70
60
50
40
2nd YEAR DETAILING IMPACT
30
20
10
0
US
Japan
Italy
Spain
Germany
France
Canada
UK
Health economic evaluation requirements,
predominant environment for launches in Launch
Excellence database
None
Optional
Mandatory
Source IMS Launch Excellence database
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Future launch standards Adapt locally to new
models
Customized adaptation to real launch uptake
decision makers by country and therapeutic area

• Integrate global marketing view with local
  requirements and resource allocation

Look at new sales and marketing models by therapy
area
Change the payer conversation to a value based
discussion

• Implement evidence based assessments to
  understand relative decision power of different
  launch decision makers at local level
• Make these specific to the launch, to the time
  period of the launch, to subnational region and
  decision maker type as necessary

• Implement novel physician-patient-payer
  engagement models, e.g., physician-as-partner
  model for mature diseases

• Leverage learnings from Phase III trial designs
  which address the payer as customer
• Engage payer pre-Phase III at a strategic level
  lay groundwork for engaging on a budgetary level
  in the year prior to launch

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Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

22
Launch excellence, even for top performers,
varies greatly across countries

• The difference between highest and lowest market
  share attainment after two years on each country
  market is significant even for excellent launches

70
average difference between highest and lowest
market share after 2 years on each market26
60
50
40
VARIANCE BETWEEN HIGHEST AND LOWEST MARKET SHARE
AFTER 2 YEARS IN EACH COUNTRY MARKET
30
20
10
0
Source IMS Launch Excellence database, IMS
analysis
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Building a consistent framework for alignment on
launch potential and resource is a key challenge
CEO/SHAREHOLDERS

• Motivated to set stretch launch targets
• View launch resource allocation as clinical
  development/global market preparation
• Launch perspective based on product and global
  market factors

Challenge Find the framework to align global
with local

• Product potential assessment common assumptions,
  base data, approach
• Resource allocation priorities reconcile product
  and portfolio focused plans
• Strategies and tactics global and local
  investments for market expansion

Global Brand Team

• Motivated to set conservative launch targets
• View launch resource allocation within portfolio
• Launch perspective based on customer and local
  market factors

LOCAL AFFILIATES/LOCAL BRAND TEAM
Source IMS interviews
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Future launch standards Align organization,
cross chasms
Alignment of purpose between international to
local
Build alignment into the planning process
Create enterprise-wide launch focus
Benchmark and track performance timely and
consistently

• Conduct integrated and evidence-based analysis of
  investment alternatives before launch, globally
  and locally
• Ensure that data, assumptions, research and
  analytics are used and understood consistently
  across functions and between countries right
  from the start

• Align the most company senior management at the
  head of the launch effort
• Incentivise sales force on the real drivers of
  launch success identify and eliminate
  performance metrics which dilute focus

• Use metrics to assess correct implementation of
  launch strategy at all levels
• Correct use of messaging and positioning
• Sales force alignment and correct resource use
• Outcomes of activities with all decision makers

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Agenda

• What is launch excellence
• Keys to success
• Optimize and adjust within launch window
• Engage all decision makers and expand markets
• 3. Adapt locally to new models
• 4. Align organization, cross chasms
• Summary

26
Summary the future for launch is complex and
risky
More decision maker complexity
Earlier (and riskier) investment decisions
Excellence in pre-launch planning
and implementation
The one P (prescribers) has become 4 Ps (add
policy makers, payors, and patients) Different
power by country, by therapy area Different
approaches and investment requirements
Clinical trials that focus on the payor as
customer a new paradigm of clinical trial
design Market making investments with difficult
to assess returns, risks, and payback periods
Significantly increased pre-launch non clinical
investments At local as well as international
level Pre-launch planning at an unprecedented
fine level of detail