Download - Diabetes Product Launches Success & Failure Points

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Success Factors and Failure Points in Metabolic Product Launches

Strategic Benchmarking Research, Analysis & Recommendations

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Table of ContentsTable of ContentsBackground

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 ContentsTable 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 & PitfallsThe 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

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 Product8. 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

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 MarketDifferentiation 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 ProductsBenchmark 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-population5% 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 Effective

Highly Effective

Total Effective

9 Unmet medical need 0% 0% 0% 11% 89% 100%9 Clearly Defined Patient Population

/ Sub-population0% 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 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

http://pharmexec.findpharma.com/pharmexec/�article/articleDetail.jsp?id=197784

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 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%



25% 0% 75%


0% 40% 60%


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%


15% 36% 48%


13% 50% 38%


13% 53% 34%



4 KOLs 0% 0% 100%


0% 25% 75%

3 Payers 33% 0% 67%



25% 50% 25%


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%


18% 18% 65%


6% 31% 63%

30 Payers 7% 33% 60%


15% 42% 42%




0% 0% 100%

3 Payers 0% 33% 67%


0% 40% 60%


4 KOLs 0% 75% 25%


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

http://www.atkearney.com/index.php/Publications/pharmaceutical-markets-the-new-price-of-admission-eaxii-2.html

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Robert [email protected]

Telephone: 919-767-9257

About Best Practices, LLCBest 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.

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