Success Factors and Failure Points in Oncology Product Launches Report Summary

Success Factors and Failure Points in
Oncology Product Launches

%

Strategic Benchmarking Research, Analysis & Recommendations

BEST PRACTICES,
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Copyright © Best Practices®, LLC LLC

Table of Contents
Background
Summary of Business Issue, Key Insights, Findings and
Lessons Learned p. 4-17
Universe of Learning: Research Participants, Launch
Experience, Oncology & Other Therapeutic Area
Demographics p. 18-24
Main Deck
Winning on Differentiated Product Positioning p. 25-32
Winning a Physician’s Initial Trial of a
New Product p. 33-35
Articulating Benefits that Shape Positive
Market Perception p. 36-40
New Product Pricing Strategy p. 41-51
Thought Leader Engagement p. 52-59
Early Physician Education p. 60-70
Payer Education p. 71-75
Patient Advocacy and Education p. 76-80

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Table of Contents
Main Deck (cont.)
Preparing Market Constituents p. 81-85
Access Insights & Success Factors p. 86-93
Winning Hospital Formulary Access p. 94-96
Resource Allocation for Key Stakeholders in the Current &
Future Marketplaces p. 97-99
Investment Requirements, Resource Allocation
& Timing p. 100-110
Internal Launch Readiness p. 111-124
New Technologies for Informing Patients
& Physicians p. 125-130
Pitfalls & Stumbling Blocks p. 131-150
Demonstrating Efficacy p. 151-159
Rating Different Safety Dimensions p. 160-169
Lessons Learned, Best Practices & Future
Changes p. 170-172
About Best Practices, LLC p. 173

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Summary of Key Insights,
Operational Pitfalls &
Lessons Learned

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Framework for Presenting Insights, Practices & Pitfalls
The performance benchmark and field research have harvested scores of insights and
observations. They have been organized into the following summary framework for
discussion and planning purposes.

8. Avoid Pitfalls & 1. Differentiate Your Product
Stumbling Blocks

7. Utilize New 2. Clearly Define Target
Technologies To Inform Insights, Patient Population
Best Practices,
6. Demonstrate Pitfalls 3. Invest in Launch &
Value Across
Support
Multiple Fronts

5. Educate Key 4. Engage
Stakeholders: Physicians,
Patients & Payers Thought Leaders

BEST PRACTICES,
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1. Differentiate Your Product In A Crowded Market
Differentiation is a key factor in a new product’s launch success. While efficacy and
safety are usually considered the best ways to differentiate a new product, new
therapies in Oncology also can use secondary benefits to gain traction at launch.

Differentiating Your Product - -Secondary Benefits Can Be Win Themes:
Differentiating Your Product Secondary Benefits Can Be Win Themes:
Differentiated positioning begins on factors established in clinical trials ––such as
Differentiated positioning begins on factors established in clinical trials such as
efficacy, safety and target patient population. Secondary positioning factors have less
efficacy, safety and target patient population. Secondary positioning factors have less
overall impact ––but can be useful in aacrowded market ––and are often more directly
overall impact but can be useful in crowded market and are often more directly
influenced through Marketing. Using secondary benefits can be an effective strategy
influenced through Marketing. Using secondary benefits can be an effective strategy
for positioning aaproduct in aahighly competitive market.
for positioning product in highly competitive market.
As one executive observed during interviews: “You like to go to market with an efficacy
As one executive observed during interviews: “You like to go to market with an efficacy
message, that’s what you want. IfIfyou can’t do efficacy, fall back to safety. IfIfyou can’t
message, that’s what you want. you can’t do efficacy, fall back to safety. you can’t
do safety, you fall back to convenience. IfIfyou can’t do convenience, you fall back to
do safety, you fall back to convenience. you can’t do convenience, you fall back to
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
of life, ease of use, cost effectiveness, patient compliance, or even aacelebrity
of life, ease of use, cost effectiveness, patient compliance, or even celebrity
spokesperson are examples. Use of secondary factors varies considerably across
spokesperson are examples. Use of secondary factors varies considerably across
TAs.
TAs.
For Oncology products, several factors were cited as being effective for
For Oncology products, several factors were cited as being effective for
differentiation including: efficacy, target population, health outcomes,
differentiation including: efficacy, target population, health outcomes,
unmet needs and dosage. It is important to contrast these differences
unmet needs and dosage. It is important to contrast these differences
against other current therapies.
against other current therapies.
BEST PRACTICES,
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Universe of Learning:
Research Participants,
Launch Experience,
Oncology & Other Therapeutic
Areas Demographics

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Universe of Learning: 38 Companies Engaged

Research participants included 44 executives and managers from 38 leading
pharmaceutical, biotech and medical device companies.

Participating Companies

TGC MedTech

Laboratorios Dermatologicos Darier

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Oncology Segment: 7 Participants Engaged

Oncology research in survey participants included seven executives and
managers at six different companies.

Benchmark Partners Oncology Products Participant Titles

• SVP CCO
• Senior Consultant
• Director
• Global Sr. Marketing Mgr
• Project Manager
• Disease Area Head -
Immunology
• Associate Director -
Managed Care Marketing

BEST PRACTICES,
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Winning On Differentiated
Product Positioning:

Differentiated product positioning is
critical to market entry success. Rating
the effectiveness of different positioning
strategies and tactics for winning in the
marketplace.

BEST PRACTICES,
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Efficacy, Unmet Need Offer Best Positioning Tools
For respondents as a whole, efficacy and unmet need remain the most attractive
positioning tools for differentiating. But participants indicated that an effective use of a
tight target patient population/sub-population presents an opportunity where efficacy
and unmet need may not be differentiating options for a new product’s launch.

Q5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to
market entry success. Rate the effectiveness of different positioning strategies and tactics for
winning in the marketplace.

Not Highly Somewhat Somewhat Highly Total
n= Total Benchmark Class Used Ineffective Ineffective Effective Effective Effective
43 Efficacy Profile 2% 0% 2% 35% 60% 95%
44 Unmet medical need 2% 2% 2% 14% 80% 93%
Clearly Defined Patient Population
43
/ Sub-population
5% 2% 5% 51% 37% 88%

44 Differences from current therapies 2% 5% 7% 32% 55% 86%
44 Safety Profile 5% 0% 14% 52% 30% 82%
44 Health Outcomes 7% 2% 16% 48% 27% 75%
44 Tolerability 2% 2% 23% 45% 27% 73%
44 Ease-of -use/ patient compliance 11% 9% 9% 48% 23% 70%
44 Dosing 11% 7% 14% 43% 25% 68%
44 Cost Effectiveness 14% 2% 18% 36% 30% 66%

BEST PRACTICES,
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Positioning Planning Needed for Launch Success
Positioning a new product correctly in the competitive landscape is frequently
cited as a critical success factor. Work starts a year before launch and it take can
take a year after launch to set. Don’t underestimate its importance. “If you don’t
establish positioning, they will do it themselves and it might not be an area you
want it to be,” said a brand leader.

“Generally speaking for all brands, a critical
success factor is solidifying positioning. So
pre-launch, usually a year or year and a half
prior to approval, try to develop how you
want the drug to be positioned within the
minds of your customers. Then you use that
to campaign and message – so your critical
success factor is to get that positioning
accomplished as soon as possible after
launch. Sometimes it can be pretty quick and
sometimes it can take years.”
– Senior Brand Manager

Source: http://www.mmm-online.com/10-steps-to-product-positioning/article/24881/

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Unmet Medical Need Most Effective in Oncology Product Positioning
Most oncology heads agree that filling an unmet medical need is most advantageous to
product positioning to ensure market entry success. Efficacy profile and differences
from other current therapies were also seen as effective strategies.

Q5. Winning On Differentiated Product Positioning: Differentiated product positioning is critical to
market entry success. Rate the effectiveness of different positioning strategies and tactics for
winning in the marketplace.

Highly Somewhat Somewhat Highly Total
n= Oncology Not Used
Ineffective Ineffective Effective Effective Effective

7 Differences from current therapies 0% 0% 0% 57% 43% 100%
6 Efficacy Profile 0% 0% 0% 50% 50% 100%
Clearly Defined Patient Population
7
/ Sub-population
0% 0% 14% 43% 43% 86%

7 Health Outcomes 0% 14% 0% 43% 43% 86%
7 Unmet medical need 0% 14% 0% 14% 72% 86%
7 Dosing 0% 0% 14% 72% 14% 86%
7 Cost Effectiveness 0% 0% 29% 29% 42% 71%
7 Safety Profile 0% 0% 29% 29% 42% 71%
7 Better Delivery mechanism 0% 0% 29% 71% 0% 71%

BEST PRACTICES,
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Early Physician Education:
Rating the effectiveness of early physician
education and engagement activities that
prove most helpful to market entry and
success in a competitive marketplace.

BEST PRACTICES,
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Educate Docs via KOL Development and Ad Boards
Developing relationships with KOLs and conducting ad boards are the two most effective
early education methods for physicians, launch leaders agreed. Despite the industry’s
move away from speaker programs, participants indicated they still felt in-person
programs provided valuable education opportunities.
Q24. Physician Education: Rate the effectiveness of early physician education and engagement
activities that prove most helpful to market entry and success in a competitive marketplace.
n= Total Benchmark Class Used Ineffective Ineffective Effective Effective Effective
33 KOL Development 0% 0% 0% 21% 79% 100%
34 Advisory Boards 3% 0% 0% 29% 68% 97%
Communicating & Disseminating Clinical
34
Trial Results
0% 0% 12% 21% 68% 88%

34 Speaker Programs - in person 0% 3% 9% 44% 44% 88%
Clinical Papers - engaging thought leaders
33
as authors
0% 0% 12% 45% 42% 88%
Medical Journals Publishing - publishing
34
company research in peer reviewed journals
0% 0% 15% 35% 50% 85%
Phase IIIB/IV Studies engaging specialists /
34
KOLs
6% 0% 9% 41% 44% 85%
Health Outcomes/Quality/Economics studies
34
engaging specialists / KOLs
6% 0% 12% 47% 35% 82%
Meetings, Congresses & Symposia
34
Presentations
0% 3% 18% 35% 44% 79%

BEST PRACTICES,
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KOL Development Key for Oncology Physician Education
Although KOL development was identified as the most effective early physician education
strategy, half of Oncology respondents also consider speaker programs, health studies,
medical publishing, sharing trial results, and phase IIIB/IV studies to be “highly effective.”

Q24. Physician Education: Rate the effectiveness of early physician education and engagement
activities that prove most helpful to market entry and success in a competitive marketplace.

n= Oncology Used Ineffective Ineffective Effective Effective Effective

6 KOL Development 0% 0% 0% 33% 67% 100%
6 Speaker Programs - in person 0% 0% 0% 50% 50% 100%
Health Outcomes/Quality/Economics
6 studies engaging specialists / KOLs 0% 0% 0% 50% 50% 100%
Accredited CME grants through third
6 parties 0% 0% 17% 66% 17% 83%
6 Advisory Boards 17% 0% 0% 50% 33% 83%
Medical Journals Publishing –
6 company research 0% 0% 17% 33% 50% 83%
Communicating & Disseminating
6 Clinical Trial Results 0% 0% 17% 33% 50% 83%
Meetings, Congresses & Symposia
6 Presentations 0% 0% 17% 50% 33% 83%
Phase IIIB/IV Studies engaging
6 specialists / KOLs 0% 0% 17% 33% 50% 83%

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Payer Education:
Rating the effectiveness of early payer
education and engagement activities that
prove most critical to market entry and
success.

BEST PRACTICES,
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Ad Boards and Reimbursement Effective Payer Education
Tools for Oncology
Similar to the Benchmark Class, Oncology participants considered advisory boards and
reimbursement prospects to be highly effective payer education tools critical to market
entry and success.
Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities
that prove most critical to market entry and success.

n= Oncology Used Ineffective Ineffective Effective Effective Effective

Advisory Boards: Payer advisory boards to
5
understand payer perspectives
0% 0% 0% 20% 80% 100%

Reimbursement Prospects: Gain insight on
5 reimbursement prospects in context of 0% 0% 0% 20% 80% 100%
competitive landscape

Discount Expectations: Understand discount
5
& margin requirements for managed care
0% 0% 0% 40% 60% 100%

Unmet Needs: Understand Managed Markets'
5
view of unmet medical needs
0% 0% 0% 80% 20% 100%

Health Outcomes: Get reaction to health
5
outcomes/ health economics data
0% 0% 0% 80% 20% 100%

Price Parameters: Get guidance on
5
acceptable price parameters for target label
0% 0% 0% 40% 60% 100%

Peer Meetings with Managed Markets:
4
Team approach to critical acct meetings
0% 0% 0% 50% 50% 100%

BEST PRACTICES,
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Pitfalls &
Stumbling Blocks:

Estimating current and future risk
levels for various product pitfalls
that can derail a new product
coming into a crowded market.

BEST PRACTICES,
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Under-spending for Launches a Common Pitfall
The high price tag that comes with a new product launch is a tempting target for
executives looking to cut costs. Not spending enough to support a launch can end up
costing an organization in the long run.

“The biggest pitfall is that
companies think that they can get
away with under-spending on their
launches because they have such a
great drug that people are just going
to go ahead and buy it without
putting in the time, the effort and the
investment to make it a success.”
– Vice President, Medical

Source: http://pharmexec.findpharma.com/pharmexec/Marketing/Launch-on-a-
Budget/ArticleStandard/Article/detail/378000

BEST PRACTICES,
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Safety and Lifecycle Planning Key Positioning Pitfalls
The biggest product shaping hurdles come from the potential high risk pitfalls of not
addressing safety signals, lifecycle planning missteps, and competitive positioning errors. All
three were rated as high risk by more than 50% of the benchmark class. Failures to address
these issues will severely impact product differentiation and market performance.

Q42. Launch Risk & Market Change: Please estimate the risk level of each product shaping pitfall
that can derail a new product coming into a crowded market. First assess each pitfall in terms of
its current importance / risk level observed during the past two years. Then estimate the risk-level /
priority change you anticipate for the next two to three years for this risk or failure point.
Competitive
Indication / Lifecycle
Unclear Target Patient Sub- Positioning Errors:
Total Benchmark Safety & Side Effects Planning Pitfalls: Lifecycle
Population: Unclear target Aggressive competitors
Pitfalls: Failure to address planning missteps lead new
patient population makes blunt new product's
Class safety signals, side effect
market entry difficult against
product to enter market w/
market entry or damage
concerns, clinical trial size, wrong indication, suboptimal
entrenched competitors - its perceived efficacy,
trial duration, and other FDA dose or delivery-delaying
confusing physicians when to safety or differentiation -
(n=26) or physician concerns. market uptake & tarnishing
use new drug. and new product never
image.
recovers.
Past 24 Months To Present
Red Alert- High Risk 88% 44% 60% 54%
Yellow Alert- Medium Risk 12% 44% 36% 46%
Green Alert- Low Risk 0% 12% 4% 0%
Next 24-36 Months- Anticipated Changes
Decreasing Risk or Priority 23% 18% 18% 14%
No Risk Change 36% 45% 55% 36%
Increasing Risk or Priority 41% 36% 27% 50%

BEST PRACTICES,
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Safety & Side Effects, Lifecycle Planning High Risk Pitfalls for
Oncology
Along with the Benchmark Class, the Oncology segment chose Safety & Side Effects
and Indication/Lifecycle Planning Pitfalls as their highest risk when putting a new
product on the market.
Q42. Launch Risk & Market Change: Please estimate the risk level of each product shaping pitfall
that can derail a new product coming into a crowded market. First assess each pitfall in terms of
its current importance / risk level observed during the past two years. Then estimate the risk-level /
priority change you anticipate for the next two to three years for this risk or failure point.

Safety & Side Effects Indication / Lifecycle
Unclear Target Patient Competitive Positioning
Pitfalls: Failure to Planning Pitfalls: Lifecycle
Sub-Population: Unclear Errors: Aggressive
address safety planning missteps lead
target patient population competitors blunt new
signals, side effect new product to enter
makes market entry product's market entry
Oncology concerns, clinical
difficult against
market with wrong
or damage its perceived
trial size, trial indication, suboptimal
entrenched competitors - efficacy, safety or
duration, and other dose or delivery --
confusing physicians differentiation - and new
FDA or physician delaying market uptake
when to use new drug. product never recovers.
(n=4) concerns. and tarnishing image.

Past 24 Months To Present
Red Alert- High Risk 75% 50% 75% 25%
Yellow Alert- Medium Risk 25% 25% 25% 75%
Green Alert- Low Risk 0% 25% 0% 0%
Next 24-36 Months- Anticipated Changes
Decreasing Risk or Priority 25% 25% 25% 25%
No Risk Change 25% 50% 50% 0%
Increasing Risk or Priority 50% 25% 25% 75%

BEST PRACTICES,
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About Best Practices, LLC
Best Practices, LLC is a research and consulting firm that conducts work based on the
simple yet profound principle that organizations can chart a course to superior
economic performance by studying the best business practices, operating tactics and
winning strategies of world-class companies.

Best Practices, LLC
6350 Quadrangle Drive, Suite 200,
Chapel Hill, NC 27517
www.best-in-class.com
Telephone: 919-403-0251

BEST PRACTICES,
23 ®

Success Factors and Failure Points in Oncology Product Launches Report Summary

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Success Factors and Failure Points in Oncology Product Launches Report Summary