Success Factors & Failure Points in Cardiovascular Product Launches

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Success Factors and Failure Points in Cardiovascular 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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Business Issue & Corporate Challenge

Background:

Many organizations in the biopharmaceutical sector have promising therapies in development across multiple therapeutic areas, although high-growth areas such as diabetes, cardiology and oncology have drawn considerable attention from the biopharma industry.

However, recent industry product launches have produced noteworthy failures and successes. Consequently, this field research was undertaken to illuminate both success and failure factors informing recent market entry blockbusters and disappointments.

Use Insights To Inform & Use Insights To Inform & Inspire MarketInspire Market--Entry Entry

Success for New Success for New Cardiovascular Products Cardiovascular Products

Field Research & Insight Development:

Engaged 44 external executives at 38 companies to participate in an extensive online survey to collect quantitative data around product launches.

Collected data from executives who reflected on some 30 products, including cardiovascular, diabetes, and other therapeutic areas.

Conducted deep-dive interviews with 6 external companies

INFORMINFORM

Study Objective:

This project probed failure points and success factors in recent biopharmaceutical product launches, including those in the cardiovascular therapeutic area. The insights and lessons learned can inform market entry planning.

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Best Engagement Strategies Vary By Therapeutic Area: Thought leader engagement is a critical success factor across all therapeutic areas. However, key relationship tactics score quite differently across Cardiology, Diabetes and the multi-therapeutic area class.

Consulting and Ad Boards score much higher in Diabetes than in Cardiology – and both rate MSL (Medical Science Liaison) services as more valuable than in other therapeutic areas. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs and your company’s tenure in the therapeutic area.

Medical Affairs Sub-Groups Are Key To Winning KOLS: Identifying the right key opinion leaders to support a scientific platform is critical for successful launches. Just as important is having the right number of KOLs involved. MSL and scientific publications are also highly important engagement tools in Cardiology and other therapeutic areas. All require the active support and coordinated engagement of Medical Affairs.

Relationship Strategies Can Help Win Key Hospitals: Winning influential hospitals requires strong relationship strategies to identify key decision makers and advocates. A strategic approach calls for identifying decision makers, developing advocates and executing a customized strategic plan for each hospital. This will require coordination between marketing, key account managers and the field-based sales team.

Best Engagement Strategies Vary By Therapeutic Area: Thought leader engagement is a critical success factor across all therapeutic areas. However, key relationship tactics score quite differently across Cardiology, Diabetes and the multi-therapeutic area class.

Consulting and Ad Boards score much higher in Diabetes than in Cardiology – and both rate MSL (Medical Science Liaison) services as more valuable than in other therapeutic areas. It’s imperative that product launch teams craft engagement strategies reflecting therapeutic area needs and your company’s tenure in the therapeutic area.

Medical Affairs Sub-Groups Are Key To Winning KOLS: Identifying the right key opinion leaders to support a scientific platform is critical for successful launches. Just as important is having the right number of KOLs involved. MSL and scientific publications are also highly important engagement tools in Cardiology and other therapeutic areas. All require the active support and coordinated engagement of Medical Affairs.

Relationship Strategies Can Help Win Key Hospitals: Winning influential hospitals requires strong relationship strategies to identify key decision makers and advocates. A strategic approach calls for identifying decision makers, developing advocates and executing a customized strategic plan for each hospital. This will require coordination between marketing, key account managers and the field-based sales team.

4. Engage Thought Leaders For SuccessThought leader engagement remains key to a successful launch across all therapeutic areas. However, relationship strategies need to be tailored to a therapeutic area to be most effective. Medical Affairs plays a pivotal role in creating effective KOL strategies.

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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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Participant TitlesCardiology ProductsBenchmark Partners

Cardiology research participants included seven executives and managers at six different companies, including four industry leaders.

• Product Physician

• Business Intelligence Manager

• Marketing Manager

• Marketing Director

• Medical Director

• Partner

• Global Brand Leader - VP

TGC MedTech

Cardiology Segment: 7 Participants Engaged

Clivarine

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Unmeet Need, Efficacy Lead Cardiology 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 = Cardiology Not Used

Highly Ineffective

Somewhat Ineffective

Somewhat Effective

Highly Effective

Total Effective

7 Unmet medical need 0% 0% 0% 29% 71% 100%7 Efficacy Profile 0% 0% 0% 29% 71% 100%7 Safety Profile 0% 0% 0% 43% 57% 100%7 Ease-of -use/ patient compliance 0% 0% 0% 57% 43% 100%7 Differences from current therapies 0% 0% 0% 57% 43% 100%7 Tolerability 0% 0% 14% 43% 43% 86%7 Better Patient Compliance 0% 0% 14% 43% 43% 86%7 Cost Effectiveness 0% 14% 0% 43% 43% 86%6 Clearly Defined Patient Population

/ Sub-population17% 0% 0% 67% 17% 83%

In the Cardiology segment, launch leaders felt there were many positioning tools available that could be effective to differentiate from competitors. Whereas the Total Benchmark Class did not give any of the positioning tools a total effectiveness rating of 100%, the Cardiology segment gave five positioning strategies that designation (which combines Somewhat Effective and Highly Effective).

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Value Approach to Pricing Strategy Favored by All

Q8. New Product Pricing Strategy: When developing your new product pricing strategy, what approach do you favor?

Head to Head Comparisons,

25%

Risk-based Pricing, 2.5%

Value-based, 72.5%

Head to Head Comparisons,

14.3%

Risk-based Pricing, 14.3%

Value-based, 71.4%

(n=40)

Total Benchmark Class Cardiology

(n=7)

Launch leaders in the Total Benchmark Class & Cardiology segment clearly approach pricing strategy with a focus on value. Interviewed executives noted that payers are sophisticated enough to know the difference between price and value – value has to show quality of life improvement for patients and reduced health care spending for payers (i.e. fewer hospitalizations, strokes, heart attacks).

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Product Differences Can Leverage Superior Prices

Q9. Pricing & Differentiation: Please assess which product differentiation factors best permit superior pricing against competitors.

n = Total Benchmark Class Not Used

Not Important

Less Important

Somewhat Important

Highly Important

Total Important

41 Superior Efficacy 5% 0% 0% 22% 73% 95%41 Differences from current standard therapy 0% 0% 10% 27% 63% 90%41 Superior Health outcomes 5% 0% 7% 22% 66% 88%40 Addressing Unmet Medical Need 5% 0% 8% 13% 75% 88%41 Targets New Patient Sub-population 5% 2% 7% 44% 41% 85%41 Superior Safety 5% 0% 20% 39% 37% 76%41 Reduced side effects / no side effects 5% 2% 37% 32% 24% 56%41 Ease of use/ patient compliance 10% 10% 32% 37% 12% 49%40 Superior Duration 20% 0% 33% 38% 10% 48%40 Dosing Improvements 18% 5% 35% 33% 10% 43%41 New Method of Action 10% 20% 41% 20% 10% 29%

While efficacy remain king in pricing, launch leaders clearly value the use of any differences a new product has from existing therapies as a way to justify superior pricing in the marketplace. Note the high importance that respondents placed on a product meeting an unmet need, indicating the value of identifying any sub-populations that are particularly impacted by a new product.

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Health Outcomes Vital for Pricing in Cardiology

Q9. Pricing & Differentiation: Please assess which product differentiation factors best permit superior pricing against competitors.


Not Important

Less Important

Somewhat Important

Highly Important

Total Important

7 Superior Efficacy 0% 0% 0% 14% 86% 100%7 Superior Health outcomes 0% 0% 14% 14% 71% 86%7 Addressing Unmet Medical Need 0% 0% 14% 29% 57% 86%7 Targets New Patient Sub-population 0% 0% 14% 43% 43% 86%7 Superior Safety 0% 0% 14% 43% 43% 86%7 Differences from current standard therapy 0% 0% 29% 29% 43% 71%7 Reduced side effects / no side effects 0% 0% 29% 29% 43% 71%7 Ease of use/ patient compliance 0% 14% 14% 57% 14% 71%7 Superior Duration 0% 0% 29% 57% 14% 71%7 Dosing Improvements 0% 14% 14% 57% 14% 71%7 New Method of Action 0% 29% 29% 29% 14% 43%

Superior efficacy is the trump card for pricing in Cardiology; it received the highest ratings as a differentiator that helps win superior pricing against competitors. Various other factors also receive high impact scores to help with pricing differentiation. Health outcomes, showing unmet need, new sub-populations, superior safety, positive differences and reduced side effects – all receive high importance ratings for pricing.

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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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Protocol Design Top TL Strategy in Cardiology

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.


Highly Ineffective


Somewhat Effective

Highly Effective

Total Effective

6 Protocol Design: Engage key thought leaders to help design Phase III and Phase IV clinical trial protocols

0% 0% 0% 17% 83% 100%

6 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% 33% 67% 100%

6 Medical Science Liaisons: Using MSLs to educate thought leaders about benefits of new drug compared with competitors.

0% 0% 0% 33% 67% 100%

6 Clinical trial involvement: Working with thought leaders to gain their involvement in investigators in clinical trials.

0% 0% 0% 67% 33% 100%

6 Scientific Publications: Engage in writing scientific publications

0% 0% 17% 33% 50% 83%

Eighty-three percent of participants in Cardiology suggest engaging thought leaders in protocol design for Phase III and IV clinical trials is “Highly Effective” for creating an informed marketplace at launch. In addition to protocol design, harnessing information from advisory boards, using MSLs to educate thought leaders, and involving thought leaders in clinical trials also are effective engagement strategies in the Cardiology area.

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Medical Conferences and Sci Pubs Distribution Sometimes Effective TL Strategies in Cardiology

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.


Highly Ineffective


Somewhat Effective

Highly Effective

Total Effective

6 Medical Conferences: Attend medical conferences to talk to thought leaders

0% 17% 0% 67% 17% 83%

6 Distribute scientific publications to thought leaders

0% 0% 17% 83% 0% 83%

6 Professional Association: Engage specialists and other key opinion leaders through professional associations

17% 0% 17% 33% 33% 67%

6 Consulting: Hiring thought leaders to provide insights into the best educational approaches to convince physicians to try a new therapy.

0% 0% 33% 50% 17% 67%

6 Thought Leader Views of Market: Share and discuss market research findings with thought leaders regarding the market and clinical guidelines

0% 0% 33% 50% 17% 67%

Unlike the Total Benchmark Class, 83% of participants in the Cardiology segment find that attending medical conferences and distributing scientific publications can be effective ways to engage thought leaders at launch. Hiring thought leaders to provide insights into the best physician education approaches and sharing research findings with thought leaders are not as effective strategies in Cardiology when compared to TBC.

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Grow Market: TBC, Cardiology Value Patient Groups

n = TBC No Low High

33 Specialists 0% 30% 70%

34 KOLs 6% 29% 65%

34 Primary Care Physicians

18% 18% 65%

35 Patients / Patient Advocacy Groups

6% 31% 63%

30 Payers 7% 33% 60%

33 Policymakers / Government

15% 42% 42%

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 = Cardiology No Low High

6 Specialists 0% 0% 100%

6 KOLs 0% 17% 83%

6 Primary Care Physicians

0% 17% 83%

6 Patients / Patient Advocacy Groups

0% 17% 83%

5 Payers 0% 20% 80%

6 Policymakers / Government

0% 33% 67%

Grow Market

Going from 38% to 63% of TBC participants, patient and advocacy group education becomes increasingly important when moving from winning share to growing the market. For participants in Cardiology, continuing to educate and win support from policymakers/ government grows more important at this stage.

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Future Market: TBC, Cardiology See Few Changes in AllocationsOverall, market education resource allocations change very little when looking forward in the next 36 months. Educating thought leaders and physicians still receives half of the education resources for market entry. Cardiology area participants recommend spending 20% of market education resources on patient advocacy group education in the future.

Q21. Future Market Entry next 36 months: Looking forward in the next 36 months, what allocation changes do you recommend to reach the same key stakeholder groups for successful market

entry in the same therapeutic area.

Other, 2%

Thought Leader & Physician Education,

48%Government / Public Payers

Education, 15%

Private Payer Education,

15%

Patient Advocacy & Education,

20%

Other, 3%Patient Advocacy &

Education, 15%

Private Payer Education, 17%

Government / Public Payers

Education, 18%

Thought Leader & Physician Education, 48%

(n=35)

Total Benchmark Class Cardiology

(n=6)

Increase of 5 percentage points

from current allocation.

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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.

Cardiology

(n=6)

Safety & Side Effects Pitfalls: Failure to address safety signals, side effect

concerns, clinical trial size, trial duration, and other FDA

or physician concerns.

Unclear Target Patient Sub-Population: Unclear target patient population

makes market entry difficult against entrenched

competitors - confusing physicians when to use new

drug.

Indication / Lifecycle Planning Pitfalls: Lifecycle planning missteps lead new product to enter market with

wrong indication, suboptimal dose or delivery -- delaying market uptake

and tarnishing image.

Competitive Positioning Errors:

Aggressive competitors blunt new product's

market entry or damage its perceived efficacy,

safety or differentiation - and new product never

recovers.

Past 24 Months To Present

Red Alert- High Risk 100% 50% 83% 67%

Yellow Alert- Medium Risk 0% 50% 17% 33%

Green Alert- Low Risk 0% 0% 0% 0%

Next 24-36 Months- Anticipated Changes

Decreasing Risk or Priority 25% 0% 25% 0%

No Risk Change 50% 50% 25% 50%

Increasing Risk or Priority 25% 50% 50% 50%

Safety Top Concern in Cardiology Product ShapingFailure to address safety signals, lifecycle planning, and competitive positioning errors can be critical mistakes when trying to launch a successful Cardiology product. If there are safety concerns from clinical trials, a creative competitive positioning strategy needs to be developed before coming to market.

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High-Risk Products Require Targeted Sales

“The most skittish docs around - as related to bleeding - are not the interventional cardiologists. They don't care because they could manage it. It is not primary care (docs) because they never see it (bleeding). It's ‘clin cards.’ It's those docs that are responsible for making that initial prescription for platelet inhibitors outside of a hospital setting. These cardiologists are scared to death of bleeding complications. They don't manage them every day in the hospital. They don't want that on their conscience or their record. And so, to the extent that you've got a black box product that forces you to start your conversation with the risk of severe bleeding, it is going to undermine any expectations you might have had of driving new patient business outside of the hospital setting.”

– Former Effient Launch Team Manager

• 850 reps were calling on primary care physicians and clinical cardiologists

• The absence of studies and scientific papers to help them see how to use prasugrel was an early problem that diminished its launch potential.

Ironically, the high-potential of Effient, an anti-platelet therapy, worked against it at launch. More than 85% of the sales force was calling immediately on physicians that were not well targeted to be among the first users of Effient (prasugrel) – especially outside of the hospital environment.

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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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Success Factors & Failure Points in Cardiovascular Product Launches

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