Success Factors and Failure Points in Metabolic Product Launches Report Summary

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Copyright © Best Practices, LLC
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Success Factors and Failure Points in
Metabolic Product Launches
Strategic Benchmarking Research, Analysis & Recommendations

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Table of Contents
Background
 Summary of Business Issue, Key Insights, Findings and Lessons Learned p.4-18
 Universe of Learning: Research Participants, Launch Experience, Cardiology,
Metabolics & Other Therapeutic Area Demographics p.19-26
Main Deck
 Winning on Differentiated Product Positioning p.27-36
 Winning a Physician’s Initial Trial of a New Product p.37-39
 Articulating Benefits that Shape Positive Market Perception p.40-44
 New Product Pricing Strategy p.45-56
 Thought Leader Engagement p. 57-65
 Early Physician Education p.66-76
 Payer Education p. 77-81
 Patient Advocacy and Education p.82-86
 Preparing Market Constituents p.87-91
 Access Insights & Success Factors p.92-100
 Winning Hospital Formulary Access p.101-103
 Resource Allocation for Key Stakeholders in the Current & Future Marketplaces
p. 104-106
 Investment Requirements, Resource Allocation & Timing p.107-117

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Table of Contents
 Internal Launch Readiness p.118-131
 New Technologies for Informing Patients & Physicians p.132-137
 Pitfalls & Stumbling Blocks p.138-159
 Demonstrating Efficacy p.160-168
 Rating Different Safety Dimensions p.169-178
 Lessons Learned, Best Practices & Future Changes p.179-181
 About Best Practices, LLC p.182

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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.
Insights,
Best Practices,
Pitfalls 3. Invest in Launch &
Support
4. Engage
Thought Leaders
5. Educate Key
Stakeholders: (Physicians,
Patients, & Payers)
6. Demonstrate
Value Across
Multiple Fronts
2. Clearly Define Target
Patient Population
7. Utilize New
Technologies To Inform
1. Differentiate Your Product
8. Avoid Pitfalls &
Stumbling Blocks

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 Differentiating Your Product - Secondary Benefits Can Be Win Themes:
Differentiated positioning begins on factors established in clinical trials – such as
efficacy, unmet needs, safety and target patient population. Secondary positioning
factors have less overall impact – but can be useful in a crowded market – and are
often more directly influenced through Marketing. Using secondary benefits can be an
effective strategy for positioning a product in a highly competitive market.
 As one executive observed during interviews: “You like to go to market with an efficacy
message, that’s what you want.. If you can’t do efficacy, fall back to safety. If you can’t
do safety, you fall back to convenience. If you can’t do convenience, you fall back to
pricing.” Secondary or even tertiary positioning factors have been win themes. Quality
of life, ease of use, cost effectiveness, patient compliance, or even a celebrity
spokesperson are examples. Use of secondary factors varies considerably across TAs.
In Diabetes, preventive benefits, unmet need, weight control, health outcome are
rated as most effective
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 considered the best ways to differentiate a new product, new therapies in
Diabetes also can use secondary benefits to gain traction at launch.

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Universe of Learning: 38 Companies Engaged
Participating Companies
Research participants included 44 executives and managers from 38 leading
pharmaceutical, biotech and medical device companies.
Laboratorios Dermatologicos Darier
TGC MedTech

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Diabetes research participants included nine executives and managers at seven industry
leading companies.
Participant Titles
• Business Manager
• Marketing Manager
• Marketing Manager
• Senior Training Manager
• Senior Brand Manager
• Marketing Director
• Global Marketing Director
• Director, Strategic Planning
• Former Senior Vice President
Diabetes Segment: 9 Participants Engaged
Levothyroxine
Taspoglutide
Diabetes Products
Benchmark Partners

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Efficacy, Unmet Need Offer Best Positioning Tools
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.
n = Total Benchmark Class Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
43 Efficacy Profile 2% 0% 2% 35% 60% 95%
44 Unmet medical need 2% 2% 2% 14% 80% 93%
43 Clearly Defined Patient Population
/ 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%
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.

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The fact that the BMS/AZ Diabetes product Onglyza had a safety and efficacy profile very
similar to market leader Januvia created problems across a number of critical fronts:
Payers, KOLs, Prescribers and Patients. The result - a disappointing launch.
Lack of Differentiation Creates Domino Effect
“I think they didn’t have a great
differentiation strategy. Their
efficacy was undifferentiated. If
you’re the same efficacy-wise, you
have to have some other good
compelling reason, or interesting
reason or a promotional reason to
consider it. I never got the sense of
what that really was.”
– Januvia Marketing Leader
“There isn’t anything good to say because there’s no mention of why is this
better or why this is different.” – Januvia Marketing Leader
Pitfalls Created by Onglyza’s
Lack of Differentiation
Insurers reluctant to add to
formulary at same tier as like-
priced Januvia.
No good reason for prescribers to
shift from tried-and-true Januvia.
KOLs unlikely to advocate change
in prescribing habits.

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Unmet Need, Clear Patient Group Best Diabetes Positioners
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.
n = Diabetes Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
9 Unmet medical need 0% 0% 0% 11% 89% 100%
9 Clearly Defined Patient Population
/ Sub-population
0% 0% 0% 44% 56% 100%
9 Efficacy Profile 0% 0% 11% 22% 67% 89%
9 Differences from current therapies 11% 0% 0% 22% 67% 89%
9 Dosing 0% 11% 0% 44% 44% 89%
9 Health Outcomes 0% 0% 11% 56% 33% 89%
9 Tolerability 0% 0% 11% 67% 22% 89%
9 Safety Profile 11% 0% 11% 78% 0% 78%
9 Patient Quality of Life 0% 0% 22% 33% 44% 78%
For the Diabetes segment, meeting an unmet need and having a clearly defined patient
population were seen as the best positioning tools for differentiation. Interestingly, they
were followed by five positioning tools that were seen as almost equally effective,
indicating they are important strategies in the Diabetes area.

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Ad Boards & Trial Involvement Effective TL Strategies
Q22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagement
strategies for creating an informed and receptive marketplace at launch for your new product.
n = Total Benchmark Class Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
34 Advisory boards: Using TLs from
therapeutic areas to understand what
aspects of the drug to focus on for
interactions with the physician
community
0% 0% 0% 24% 76% 100%
34 Clinical trial involvement: Working with
thought leaders to gain their involvement
in investigators in clinical trials.
0% 0% 0% 44% 56% 100%
34 Protocol Design: Engage key thought
leaders to help design Phase III and
Phase IV clinical trial protocols
0% 0% 3% 35% 62% 97%
34 Scientific Publications: Engage in writing
scientific publications
0% 0% 3% 44% 53% 97%
33 Medical Science Liaisons: Using MSLs to
educate thought leaders about benefits
of new drug compared with competitors.
3% 0% 6% 39% 52% 91%
To engage thought leaders, overall participants rate advisory boards and clinical trial
involvement as effective strategies for creating an informed, receptive marketplace at
launch. Asking key thought leaders to help design Phase III and IV clinical trial protocols
and to contribute to scientific publications are also effective engagement strategies.

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KOLs Should Span Across Various Levels of Influence
“Well, I’d say you have to have enough on sort
of every different level. You’ve got maybe the
top 50 or 100 national thought leaders and
those are obviously the same within a
therapeutic category. The second level is one
that is probably where there is a significant
amount of real influence like regional academic
medical centers. It’s in the regional KOLs
within certain hospital or academic systems
that may not have the publication power, but
get them involved and in on publications and
second author - stuff like that.”
– Marketing Manager, Top 10 Pharma
The size of the KOL group needed to create market acceptance should be spread across
different levels of the KOL landscape – national, regional, academic and local. Look for
the influencers in your particular therapeutic area who may fall under the industry’s radar
or who may be shadow thought leaders in a related therapeutic area.
Source: http://pharmexec.findpharma.com/pharmexec/
article/articleDetail.jsp?id=197784

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MSLs and Ad Boards Highly Effective for Diabetes
Q22. Thought Leader Engagement: Rate the effectiveness of various thought leader engagement
strategies for creating an informed and receptive marketplace at launch for your new product.
n = Diabetes Not
Used
Highly
Ineffective
Somewhat
Ineffective
Somewhat
Effective
Highly
Effective
Total
Effective
4 Advisory boards: Using TLs from
therapeutic areas to understand what
drug aspects to focus on for interactions
with the physician community.
0% 0% 0% 0% 100% 100%
3 Medical Science Liaisons: Using MSLs to
educate thought leaders about benefits
of new drug compared with competitors.
0% 0% 0% 0% 100% 100%
4 Clinical trial involvement: Working with
thought leaders to gain their involvement
in investigators in clinical trials.
0% 0% 0% 25% 75% 100%
4 Consulting: Hiring thought leaders to
provide insights into the best
educational approaches to convince
physicians to try a new therapy.
0% 0% 0% 50% 50% 100%
4 Protocol Design: Engage key thought
leaders to help design Phase III and
Phase IV clinical trial protocols
0% 0% 0% 50% 50% 100%
Diabetes area participants agree that harnessing insights from advisory boards and
using MSLs to educate thought leaders about new drug benefits are “Highly Effective”
strategies to engage thought leaders at launch. Other effective strategies in Diabetes
include: trial involvement, consulting, protocol design, and scientific publication writing.

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Enter Market: Diabetes Area Focuses on Payers
n = TBC No Low High
36 KOLs 0% 3% 97%
34 Payers 0% 18% 82%
33 Specialists 3% 15% 82%
35 Policymakers /
Government
6% 31% 63%
33 Patients / Patient
Advocacy Groups
12% 36% 52%
31 Primary Care
Physicians
26% 68% 6%
Q19. Preparing Market Constituents: Rate the importance of educating and winning support from
each market constituency in order to (1) Enter market, (2) Win Share, and (3) Grow Market.
n = Diabetes No Low High
5 KOLs 0% 0% 100%
4 Payers 0% 0% 100%
Advocacy Groups
25% 0% 75%
5 Policymakers /
Government
0% 40% 60%
3 Primary Care
Physicians
0% 100% 0%
Enter Market
Although KOLs are important to have supporting the new product, Diabetes area
participants also focus early education efforts on payers, specialists and patients/ patient
advocacy groups. At this stage, educating primary care physicians receives the lowest
importance ranking.

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Win Share: Diabetes See KOL Support as Still Necessary
n = TBC No Low High
33 KOLs 0% 24% 76%
31 Payers 10% 35% 55%
33 Primary Care
Physicians
15% 36% 48%
Advocacy Groups
13% 50% 38%
32 Policymakers /
Government
13% 53% 34%
4 KOLs 0% 0% 100%
4 Primary Care
Physicians
0% 25% 75%
3 Payers 33% 0% 67%
4 Policymakers /
Government
25% 50% 25%
Advocacy Groups
0% 100% 0%
Win Share
As with market entry, Diabetes area participants still rate KOLs as the most important
market constituent to educate and win support from while trying to gain share. However,
75% say primary care physicians are also of high importance to win share, unlike their
low importance rating when entering the market.

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Grow Market: Support from PCPs Important for Diabetes
n = TBC No Low High
34 KOLs 6% 29% 65%
34 Primary Care
Physicians
18% 18% 65%
Advocacy Groups
6% 31% 63%
30 Payers 7% 33% 60%
33 Policymakers /
Government
15% 42% 42%
5 Primary Care
Physicians
0% 0% 100%
3 Payers 0% 33% 67%
Advocacy Groups
0% 40% 60%
4 KOLs 0% 75% 25%
4 Policymakers /
Government
25% 50% 25%
Grow Market
To grow the market, all participants in the Diabetes area place the highest importance on
educating and gaining support from primary care physicians. Support from specialists
and KOLs, the top two placeholders in the benchmark class, fall below PCPs, payers and
patients/ patient advocacy groups for Diabetes participants.

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Managed Care Coverage Altering Launch Approach
“The most critical success factor is
managed care. Everybody launches
a brand differently – if you want to
launch the moment it’s approved,
then the challenge with that is
you’re introducing a drug to
doctors that is not going to get
covered, no matter what your price
point is. Some do prolong their
launch until they actually have
some coverage – so they’ll get the
approval, get coverage and then
launch but not everybody wants to
do that because they want to get it
out there.” – Senior Brand Manager
Winning payer coverage is challenging many organizations and changing their launch
approach. While some therapeutic areas, like Diabetes, usually get immediate coverage –
albeit at a Tier 3 level until a review is complete – other TAs will not get coverage until a
review. Some still believe in launching as soon as an approval hits, while others prefer an
approach of approval, coverage, launch. There are pros and cons to both approaches.
Source: http://www.atkearney.com/index.php/Publications/pharmaceutical-markets-the-new-price-of-admission-eaxii-2.html

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Link for Report: Metabolic Product Launches Success Factors

Success Factors and Failure Points in Metabolic Product Launches Report Summary

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