success factors and failure points in oncology product launches report summary

23
BEST PRACTICES, ® LLC 1 Copyright © Best Practices®, LLC % Success Factors and Failure Points in Oncology Product Launches Strategic Benchmarking Research, Analysis & Recommendations

Upload: marty-daniel-with-best-practices-llc

Post on 14-Dec-2014

1.883 views

Category:

Health & Medicine


1 download

DESCRIPTION

Research summary for "Success Factors and Failure Points in Oncology Product Launches." Contact me to view the full report.

TRANSCRIPT

Page 1: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC1

Copyright © Best Practices®, LLC

%

Success Factors and Failure Points in Oncology Product Launches

Strategic Benchmarking Research, Analysis & Recommendations

Page 2: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC2

Copyright © Best Practices®, LLC

Table of ContentsTable of ContentsBackground

Summary of Business Issue, Key Insights, Findings and Lessons Learned p. 4-17Universe of Learning: Research Participants, Launch Experience, Oncology & Other Therapeutic Area Demographics p. 18-24

Main DeckWinning on Differentiated Product Positioning p. 25-32Winning a Physician’s Initial Trial of a New Product p. 33-35Articulating Benefits that Shape Positive Market Perception p. 36-40New Product Pricing Strategy p. 41-51Thought Leader Engagement p. 52-59Early Physician Education p. 60-70Payer Education p. 71-75Patient Advocacy and Education p. 76-80

Page 3: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC3

Copyright © Best Practices®, LLC

Table of ContentsTable of ContentsMain Deck (cont.)

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

Page 4: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC4

Copyright © Best Practices®, LLC

Summary of Key Insights, Operational Pitfalls &

Lessons Learned

Page 5: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC5

Copyright © Best Practices®, LLC

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

Page 6: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC6

Copyright © Best Practices®, LLC

Differentiating Your Product - Secondary Benefits Can Be Win Themes:Differentiated positioning begins on factors established in clinical trials – such as efficacy, 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.

For Oncology products, several factors were cited as being effective for differentiation including: efficacy, target population, health outcomes, unmet needs and dosage. It is important to contrast these differences against other current therapies.

Differentiating Your Product - Secondary Benefits Can Be Win Themes:Differentiated positioning begins on factors established in clinical trials – such as efficacy, 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.

For Oncology products, several factors were cited as being effective for differentiation including: efficacy, target population, health outcomes, unmet needs and dosage. It is important to contrast these differences against other current therapies.

1. Differentiate Your Product In A Crowded MarketDifferentiation 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.

Page 7: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC7

Copyright © Best Practices®, LLC

Universe of Learning: Research Participants,

Launch Experience, Oncology & Other Therapeutic

Areas Demographics

Page 8: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC8

Copyright © Best Practices®, LLC

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

Page 9: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC9

Copyright © Best Practices®, LLC

Participant TitlesOncology ProductsBenchmark Partners

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

• SVP CCO

• Senior Consultant

• Director

• Global Sr. Marketing Mgr

• Project Manager

• Disease Area Head -Immunology

• Associate Director -Managed Care Marketing

Oncology Segment: 7 Participants Engaged

Page 10: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC10

Copyright © Best Practices®, LLC

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.

Page 11: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC11

Copyright © Best Practices®, LLC

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.

Page 12: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC12

Copyright © Best Practices®, LLC

Positioning Planning Needed for Launch Success

“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

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.

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

Page 13: Success Factors and Failure Points in Oncology Product Launches Report Summary

13Copyright © Best Practices®, LLC BEST PRACTICES,

®LLC

n = Oncology Not Used Highly Ineffective

Somewhat Ineffective

Somewhat Effective

Highly Effective

Total Effective

7 Differences from current therapies 0% 0% 0% 57% 43% 100%

6 Efficacy Profile 0% 0% 0% 50% 50% 100%

7 Clearly Defined Patient Population/ 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%

Unmet Medical Need Most Effective in Oncology Product Positioning

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.

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.

Page 14: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC14

Copyright © Best Practices®, LLC

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.

Page 15: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC15

Copyright © Best Practices®, LLC

Educate Docs via KOL Development and Ad Boards

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 NotUsed

HighlyIneffective

SomewhatIneffective

SomewhatEffective

HighlyEffective

TotalEffective

33 KOL Development 0% 0% 0% 21% 79% 100%34 Advisory Boards 3% 0% 0% 29% 68% 97%

34 Communicating & Disseminating Clinical Trial Results 0% 0% 12% 21% 68% 88%

34 Speaker Programs - in person 0% 3% 9% 44% 44% 88%

33 Clinical Papers - engaging thought leaders as authors 0% 0% 12% 45% 42% 88%

34 Medical Journals Publishing - publishing company research in peer reviewed journals 0% 0% 15% 35% 50% 85%

34 Phase IIIB/IV Studies engaging specialists / KOLs 6% 0% 9% 41% 44% 85%

34 Health Outcomes/Quality/Economics studies engaging specialists / KOLs 6% 0% 12% 47% 35% 82%

34 Meetings, Congresses & Symposia Presentations 0% 3% 18% 35% 44% 79%

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.

Page 16: Success Factors and Failure Points in Oncology Product Launches Report Summary

16Copyright © Best Practices®, LLC BEST PRACTICES,

®LLC

KOL Development Key for Oncology Physician Education

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.

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.”

n= OncologyNot Used

Highly Ineffective

Somewhat Ineffective

SomewhatEffective

HighlyEffective

TotalEffective

6 KOL Development 0% 0% 0% 33% 67% 100%

6 Speaker Programs - in person 0% 0% 0% 50% 50% 100%

6Health Outcomes/Quality/Economicsstudies engaging specialists / KOLs 0% 0% 0% 50% 50% 100%

6Accredited CME grants through thirdparties 0% 0% 17% 66% 17% 83%

6 Advisory Boards 17% 0% 0% 50% 33% 83%

6Medical Journals Publishing –company research 0% 0% 17% 33% 50% 83%

6Communicating & DisseminatingClinical Trial Results 0% 0% 17% 33% 50% 83%

6Meetings, Congresses & SymposiaPresentations 0% 0% 17% 50% 33% 83%

6Phase IIIB/IV Studies engagingspecialists / KOLs 0% 0% 17% 33% 50% 83%

Page 17: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC17

Copyright © Best Practices®, LLC

Payer Education: Rating the effectiveness of early payer

education and engagement activities that prove most critical to market entry and

success.

Page 18: Success Factors and Failure Points in Oncology Product Launches Report Summary

18Copyright © Best Practices®, LLC BEST PRACTICES,

®LLC

n= Oncology Not Used

Highly Ineffective

SomewhatIneffective

SomewhatEffective

HighlyEffective

TotalEffective

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

5Reimbursement Prospects: Gain insight on reimbursement prospects in context of competitive landscape

0% 0% 0% 20% 80% 100%

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

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

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

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

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

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.

Ad Boards and Reimbursement Effective Payer Education Tools for Oncology

Q25. Payer Education: Rate the effectiveness of early payer education and engagement activities that prove most critical to market entry and success.

Page 19: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC19

Copyright © Best Practices®, LLC

Pitfalls & Stumbling Blocks:

Estimating current and future risk levels for various product pitfalls

that can derail a new product coming into a crowded market.

Page 20: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC20

Copyright © Best Practices®, LLC

Under-spending for Launches a Common Pitfall

“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

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.

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

Page 21: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC21

Copyright © Best Practices®, LLC

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.

Total Benchmark Class

(n=26)

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 w/

wrong indication, suboptimal dose or delivery-delaying

market uptake & 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 PresentRed 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 ChangesDecreasing Risk or Priority 23% 18% 18% 14%

No Risk Change 36% 45% 55% 36%

Increasing Risk or Priority 41% 36% 27% 50%

Safety and Lifecycle Planning Key Positioning PitfallsThe 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.

Page 22: Success Factors and Failure Points in Oncology Product Launches Report Summary

22Copyright © Best Practices®, LLC BEST PRACTICES,

®LLC

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, Lifecycle Planning High Risk Pitfalls forOncology

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.

Oncology

(n=4)

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 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%

Page 23: Success Factors and Failure Points in Oncology Product Launches Report Summary

BEST PRACTICES,®

LLC23

Copyright © Best Practices®, LLC

Best Practices, LLC6350 Quadrangle Drive, Suite 200,

Chapel Hill, NC 27517www.best-in-class.com

Telephone: 919-403-0251

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.