Shaping the Marketplace to SupportSuccessful Oncology Product Launches:   Tactics for Educating KOLs, Physicians,         ...
Research Objective and MethodologyThis study explores best practices in educating, informing and preparing themarketplace ...
Universe of Learning: 26 Companies Engaged Research participants included 34 executives and managers from 26 leading pharm...
10 Steps To Excellence: Key Themes from Market Education Research  Brand, medical and market education leaders describe va...
Start Early With Thought Leader Education & ServicesThought leaders are the bellwethers of market direction. They help com...
Get KOLs In at Phase II to Create OwnershipIf your compound doesn’t have a novel MOA or it’s not a first-in-class, it can ...
Investigator Segmentation Systems Help Tailor OutreachSegment investigators to understand their motivations and objectives...
Early Access Programs Common in OncologyOne Top 10 pharma company said it only provides Early Access Programs (EAP) for li...
Oncology Publishing Strategies Rely on Key Congresses & Journals The Oncology segment places highest importance on publish...
One Study = Five PublicationsPublish multiple articles from one study to give marketing multiple presentation points and t...
Benchmark Start Periods: MedEd Ramps Up in Phase II & Latter Phase III Across the multi-therapeutic area benchmark class, ...
Integrate PR and Advocacy with Right Message While it makes strategic sense to marry a public relations campaign with coll...
Meet Payers Early to Educate and Win AcceptanceMeet with all the marketplace players well in advance of a product launch t...
Best Practices & Lessons Learned: KOLs & TimingBenchmark partners shared their best practices and key lessons learned rega...
About Best Practices, LLC Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet...
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Shaping the Marketplace to Support Successful Oncology Product Launches Tactics for Educating KOLs, Physicians, Patients and Payers Report Summary

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Pharmaceutical and biotech companies realize the importance of educating the marketplace to improve the likelihood of a successful launch of their new products. As payers’ influence in the marketplace has grown, so has the importance of effective payer education tactics – no more so than in the oncology therapeutic area where therapies can cost $10,000 a month or more. This Best Practices®, LLC study provides benchmarks around timing of payer-oriented market education and effective education tactics for payers.

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Shaping the Marketplace to Support Successful Oncology Product Launches Tactics for Educating KOLs, Physicians, Patients and Payers Report Summary

  1. 1. Shaping the Marketplace to SupportSuccessful Oncology Product Launches: Tactics for Educating KOLs, Physicians, Patients and Payers % Strategic Benchmarking Research, Analysis & Recommendations BEST PRACTICES, 1 ® Copyright © Best Practices®, LLC LLC
  2. 2. Research Objective and MethodologyThis study explores best practices in educating, informing and preparing themarketplace for new products – through Physician, Patient, and Payer education,publications, advocacy and communication strategies. Study Objective & Methodology Key Study Objectives This field research and benchmarking •Identify key education tactics for study probed the broad array of medical thought leaders, physicians, patients, education and marketing practices and payers conducted two to three years prior to •Assess key market-education launch that best inform and shape the practices, including thought leader marketplace. services, MedEd, scientific A quantitative survey harvested current publications, patient advocacy & education, clinical trials & payer best practices and emerging trends in education educating the marketplace to support successful product launches. In addition, •Identify key timing factors & deep-dive executive interviews were education mix conducted with selected participants to provide qualitative insights and emerging •Describe critical market entry pitfalls trends. and future trends BEST PRACTICES, 2 ® Copyright © Best Practices®, LLC LLC
  3. 3. Universe of Learning: 26 Companies Engaged Research participants included 34 executives and managers from 26 leading pharmaceutical, biotech and medical device companies. Participating Companies BEST PRACTICES, 3 ® Copyright © Best Practices®, LLC LLC
  4. 4. 10 Steps To Excellence: Key Themes from Market Education Research Brand, medical and market education leaders describe various best practices for educating and shaping the market for new bio-pharma products. These practices can be distilled into 10 key areas that articulate a blueprint for market education excellence. 10. Allocate 1. Develop Market Ed Mix To Integrated “I think its going to “I think its going to Reflect T.A. & Continuous boil down to being boil down to being Competitive Thought Leader 2. Manage able to actually 9. Orchestrate able to actually Med Ed Timing Landscape Strategies Clinical Trials To Win Highly identify by individual identify by individual To Reach Right Constituencies Regarded customer what Investigators & customer what At Right Times channel they want TLs channel they want 8. Use PR & New MARKET information from and 3. Data Disclosures information from and Technologies For EDUCATION Inform Medical how youre going to Leveraged Reach to Community of Your how youre going to Patients, Physicians, EXCELLENCE Progress & reach them most reach them most & Payers Commitment efficiently, and almost efficiently, and almost 7. Start Payer 4. Communicate going through aa going through Education Early; Clinical Science decision tree that Focus On Cost decision tree that Thru Journals & looks at effectiveness & Health 6. Inform 5. Use Multi- Congresses looks at effectiveness Outcomes Patients Thru Channel Med. and cost . .. ...” and cost ..” Education & Ed. To Inform -Senior Vice President, Marketing Advocacy Group Health Care -Senior Vice President, Marketing Collaborations Providers BEST PRACTICES, 4 ® Copyright © Best Practices®, LLC LLC
  5. 5. Start Early With Thought Leader Education & ServicesThought leaders are the bellwethers of market direction. They help companies understand wheretherapeutic guidelines and practices are headed; they influence how practicing physicians respond tonew therapies. Not surprisingly, the largest response groups signaled Phase II as the kickoff to mostthought leader services. Some companies with robust pipelines and deep-standing commitment to theirtherapeutic areas start thought leader services as early as pre-clinical research phases. Q6. Developing Thought Leaders: Please check when you should start each activity for educating thought leaders. Total Benchmark Class Engaging Thought Providing Communicating Developing Leaders & Medical Critical Integrated Conducting Key Science Information and Thought Leader Advisory Boards Investigators Liaison Sharing Research Strategies in Clinical Services Insights Trial Protocol Development Pre-Clinical 6% 18% 3% 18% 12% Phase I 15% 12% 12% 24% 9% Phase II 41% 26% 6% 47% 29% Phase III-3 Years 21% 24% 15% 6% 26% Phase III-2 Years 15% 6% 21% 3% 12% Phase III-1 Year 3% 12% 32% 0% 6% NDA thru Launch Year 0% 3% 12% 3% 6%(n=34) BEST PRACTICES, 5 ® Copyright © Best Practices®, LLC LLC
  6. 6. Get KOLs In at Phase II to Create OwnershipIf your compound doesn’t have a novel MOA or it’s not a first-in-class, it can be difficult to bring KOLs intoyour development program. One approach is to get the KOL involved in the planning of the developmentprogram so that they develop a feeling of ownership for the program. “You have to let them think theyre designing “You have to let them think theyre designing the development program. So you involve the development program. So you involve them from Phase IIIIonward and they help you them from Phase onward and they help you write the protocols, and by the time theyve write the protocols, and by the time theyve gone through that, its their baby just as much as gone through that, its their baby just as much as ititis yours” ––Global Head of Clinical and Medical is yours” Global Head of Clinical and Medical Services Services “We’d let doctors have raw substance samples so that they could get their Ph.D. students“We’d let doctors have raw substance samples so that they could get their Ph.D. studentsplaying with ititand some of the pre-clinical publications would come out from their own labs. playing with and some of the pre-clinical publications would come out from their own labs.We control that quite tightly, but other companies I Iworked with used to use that as aaway of We control that quite tightly, but other companies worked with used to use that as way of engaging key opinion leaders and generating extra useful data. It really got the guysengaging key opinion leaders and generating extra useful data. It really got the guysinvolved. They could play with ititin their own hands and do what they want with ititand design involved. They could play with in their own hands and do what they want with and designsome of their own studies. That really gave them aafeeling of ownership. ” ” some of their own studies. That really gave them feeling of ownership.––Global Head of Clinical and Medical Services Global Head of Clinical and Medical Services BEST PRACTICES, 6 ® Copyright © Best Practices®, LLC LLC
  7. 7. Investigator Segmentation Systems Help Tailor OutreachSegment investigators to understand their motivations and objectives and tofine-tune your recruitment and relationship plan to reflect investigatormotivation profile.Physician Motivation Segments “It’s not clear that each investigator Drug is just one segment. There is a Develop- predominant motivation and a ers second and third motivation. Science Business Motivated Minded Money is not usually the primary Healers driver. They don’t want to go bankrupt. When you ask them, they Thought Career tell you money is third or fourth Leaders Climbers level of importance.” Publishers -- Senior Director, Clinical Operations, Pharmaceutical Company BEST PRACTICES, 7 ® Copyright © Best Practices®, LLC LLC
  8. 8. Early Access Programs Common in OncologyOne Top 10 pharma company said it only provides Early Access Programs (EAP) for life-threatening conditions, which leads to EAPs mostly in oncology. Benefits of EAPs Benefits of EAPs “I think in all specialty areas the level of experimentation is high, but in oncology Provide potentially life-saving Provide potentially life-saving its taken to a much higher level. They therapies to patients not participating in therapies to patients not participating in will put every patient into some kind of pivotal trials pivotal trials study, because drugs tend to come to Provide physicians with direct positive Provide physicians with direct positive market very quickly with the new drugs, experience of their patients who benefit which means that all the details are not experience of their patients who benefit worked out. It will have been tested in from therapy from therapy one population, but maybe the doctor Provide physicians with additional Provide physicians with additional thinks it could be of benefit in another experience with different patients who experience with different patients who population or a slightly different way of differ from overall trial group differ from overall trial group use or whatever. Theres a huge amount of patients in the oncology area that are Provide insights that may reveal Provide insights that may reveal in some kind of clinical trial or another.” additional marketplace potential for additional marketplace potential for – Global Head of Clinical and Medical therapy therapy Services BEST PRACTICES, 8 ® Copyright © Best Practices®, LLC LLC
  9. 9. Oncology Publishing Strategies Rely on Key Congresses & Journals The Oncology segment places highest importance on publishing clinical research in primary journals, appearing at critical congresses and to a lesser degree on some online scientific publications. Similar to the multi-therapeutic area benchmark class, secondary journals and events are important. Q15. Please rate the importance of publishing your clinical results in various channels: Total Benchmark Class Oncology Segment Highly Important Important Highly Important Important Major Congresses or Events (Intl/Natl) 83% 13% Primary Journal 80% 20% Major Congresses or Events Primary Journal 83% 17% 70% 30% (Int’l/Nat’l) Online Scientific Publications 17% 47% Online Scientific Publications 20% 30% Secondary Journals 10% 72% Alternative Media 10% 30% Alternative Media 4% 25% Internet Self-publication 10%10% Minor Congresses or Events (Regional 79% Minor Congresses or Events (Regional 4% 0% 89% /Local) /Local) Internet Self-publication 3% 17% Secondary Journals 0% 90% (n=31) (n=11) BEST PRACTICES, 9 ® Copyright © Best Practices®, LLC LLC
  10. 10. One Study = Five PublicationsPublish multiple articles from one study to give marketing multiple presentation points and to informhealthcare professionals across a broad spectrum. Field research reveals publishing productivityimprovements exist across therapeutic areas – including Diabetes and Oncology. Erbitux Explores Multiple Factors in Its Clinical Trials – Resulting in Many Publishing Opportunities. “So I have always used as a rule of Link to studies thumb that an expectation that I have is I want five publications from each study at a minimum, and thats primary, secondary, different data sets, subpopulations. For the [a diabetes blockbuster] program we were able to do seven for each study. They typically look at the secondary data and things as, ‘Oh, thats not interesting, its not exciting.’ But its the bread and butter because thats whats going to keep feeding the promotional machine.” – Senior VP Commercial With Diabetes Franchise BEST PRACTICES, 10 ® Copyright © Best Practices®, LLC LLC
  11. 11. Benchmark Start Periods: MedEd Ramps Up in Phase II & Latter Phase III Across the multi-therapeutic area benchmark class, critical market educating activities usually start between Phase II and early Phase III. Some companies start notably earlier than others. The “start periods” most frequently noted are circled in red for each market education activity. Q8. Educating Physicians: Please check when you should start each activity for educating physicians. Pre- Phase Phase NDA thru Phase III- Total Benchmark Class Clinica Phase I Phase II III-3 III-2 Launch 1 Year l Years Years Year Presentations at Medical Congresses 3% 12% 41% 21% 9% 15% 0% Employing Integrated Publishing Strategies 6% 18% 24% 32% 12% 9% 0% Communicating & Disseminating Clinical Trial Results 0% 15% 33% 21% 15% 12% 3% Conducting Clinical Trials 9% 29% 32% 18% 0% 9% 3% Conducting Investigator Initiated Trials 0% 6% 13% 19% 6% 23% 32% Utilizing New Technologies/Social Media for Physicians 0% 0% 6% 18% 12% 42% 21% Education Using Pre-Launch Public Relations Campaigns to 0% 3% 21% 6% 30% 21% 18% Communicate Clinical Trials Info Utilizing Speaker Programs & Training 0% 3% 6% 12% 6% 29% 44% Developing Internet-Based Education Strategies 0% 0% 12% 9% 15% 39% 24% Sponsoring CME Grants to Educate Physicians 0% 0% 6% 18% 18% 32% 26% Conducting Quality/Economics Studies Meeting 0% 9% 9% 36% 21% 12% 12% Announcing Trade/Brand Name 0% 6% 6% 12% 12% 21% 42% Announcing Generic Name 3% 27% 27% 15% 15% 6% 6% (n=34) BEST PRACTICES, 11 ® Copyright © Best Practices®, LLC LLC
  12. 12. Integrate PR and Advocacy with Right Message While it makes strategic sense to marry a public relations campaign with collaborative work you’re doing with an advocacy group, it needs to be done carefully. Steer clear of branded messages and focus on a therapeutic area and disease state information. “You have to focus on the level of “You have to focus on the level of“Typically its integrated from aaPR “Typically its integrated from PR unmet need, and then building off of perspective and an advocacy unmet need, and then building off ofperspective and an advocacy the unmet need then you talk about perspective, so youre going to work the unmet need then you talk aboutperspective, so youre going to work emerging areas or targets or with the right type of patient emerging areas or targets orwith the right type of patient programs that are addressing that and advocacy groups and your public programs that are addressing that andadvocacy groups and your public relations campaign to build the right its done in aabalanced but strategic its done in balanced but strategicrelations campaign to build the right type of messages and disseminate manner.” ––Senior Vice President, manner.” Senior Vice President,type of messages and disseminate Commercial Commercialthem.” ––Senior Vice President, them.” Senior Vice President, CommercialCommercial y Tac a teg tics Str BEST PRACTICES, 12 ® Copyright © Best Practices®, LLC LLC
  13. 13. Meet Payers Early to Educate and Win AcceptanceMeet with all the marketplace players well in advance of a product launch to educate andto map out the landscape you’ll have to traverse in order to get to the most appropriatetier in the managed markets. www.ehcca.com/presentations/medicarecongress3/precon_2c.ppt “Youve got to get out in “Youve got to get out in the marketplace and let the marketplace and let your retail pharmacies your retail pharmacies know, your health plans know, your health plans know that this is coming. know that this is coming. You dont want to surprise You dont want to surprise them, and you want to them, and you want to work with them to make work with them to make sure its included in either sure its included in either tier one or tier two on tier one or tier two on their formulary. And ififititis their formulary. And is a tier three, its a tier three a tier three, its a tier three at a reasonable co-pay.” at a reasonable co-pay.” – Executive Director, – Executive Director, Commercial Commercial BEST PRACTICES, 13 ® Copyright © Best Practices®, LLC LLC
  14. 14. Best Practices & Lessons Learned: KOLs & TimingBenchmark partners shared their best practices and key lessons learned regardingmarket education for successful new product launches. Beginning education early andinvolving Key Opinion Leaders (KOLs) are top practice areas. Use KOLS Wisely & Often “KOL development, support and integration are key.” “Have the KOLs own the content.” “Use KOLs where possible.” “KOL management and thought leader engagement needs to be early – to partner through the highs and lows of development.” Begin Early . . . “Obtain early input from all parties, including payers and patients, not just investigators and prescribers.” “You can NEVER start too early.” “Engage payers early.” “Educate early; at least one year prior to launch.” . . . However “Have a detailed plan and be cautious spending too much money too soon.” BEST PRACTICES, 14 ® Copyright © Best Practices®, LLC LLC
  15. 15. 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, 15 ® Copyright © Best Practices®, LLC LLC

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