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PM360 January 2010
THINK TANK
LAUNCH STRATEGIES FOR BLASTING OFF IN 2010
How did the biggest pharmaceuticals achieve blockbuster status? PM360 asked industry experts from across the spectrum to share their top strategies for launching new products.
Top Five Launches since 2005
Chantix (Smoking Cessation)
Pfizer
Launched June 2006
First-Year Retail Sales: $66,079,567
Lyrica (Pain)
Pfizer
Launched August 2005
First-Year Retail Sales: $56,370,868
Atripla (HIV)
BMS/Gilead
Launched July 2006
First-Year Retail Sales:
$50,810,140
Ambien CR (Sleep Aid)
Sanofi-Aventis
Launched September 2005
First-Year Retail Sales: $48,520,979
Januvia (Diabetes)
Merck
Launched October 2006
First-Year Retail Sales: $47,702,042
Source: SDI
John Ross
Chief Operating Officer
SDI
jross@sdihealth.com
Launching a new drug? Well, the new pharmaceutical commercial model provides some clear challenges and opportunities.
One critical factor for a successful launch will be how well marketers move beyond old approaches that best served the small-molecule commercial model and use nontraditional metrics to guide their strategies. With fewer potential blockbusters, launch strategies will need to become more specific. The most common mistake marketers make is relying on traditional Rx-based metrics that lack the multidimensional view needed to present effective information to physicians, payers, and patients.
Defining a Product’s Fit
Understanding where a new product fits into a market and why it’s superior to alternatives for certain patients is critical and can’t be done effectively with traditional data alone. TRx and NRx information is not enough to create a differential advantage. Here’s why.
TRx and NRx…
- do not offer insight into a physician’s patient population. These data can’t illustrate breakdowns by age, gender, ethnicity, co-morbidities, and education level.
- cannot distinguish truly new patients and switches from continuing business.
- can’t determine shared patients, referrals, or group practice dynamics.
- do not offer insight about where care is administered. Hospital and facility affiliations are not tracked; significant launches such as IVs and injectables, for which retail prescriptions are not issued, also cannot be tracked.
The best approach for marketers is to create an enhanced patient profile—which can include such information as diagnosis, prescription history, adherence behavior, and consumer characteristics—to pinpoint candidates who are a good fit for the new therapy. Using this enhanced profile to guide promotion ensures that only patients who are solid candidates for the brand are targeted, which is crucial in this environment of increasingly stringent regulations and tightened spending.
Lori Kewin
Director of Account Service
Topin & Associates
lkewin@topin.com
A product launch is such a complex, multifaceted endeavor that companies and agencies can get distracted from some of the more “routine” aspects of campaign development.
Take the creative brief, for example. The brief is a foundational document (some might say the most important document an agency produces) that sets the direction for a product launch campaign. Yet, too often, after months spent in strategic planning, position research, message testing, advisory boards, and more, the brief becomes a form that’s filled out and approved as the team rushes toward campaign development.
Yet it’s the document an agency lives by—and therefore the document creative ideas live or die by. So to not make the brief the best it can be in terms of insights and guidance, or to not get the right people to embrace it and sign off on it can often lead to creative that doesn’t meet everyone’s expectations.
And because product launches are usually filled with unknowns, the brief that you start with isn’t necessarily the brief that’s right. We’ve seen companies learn more and refine their product vision as they near launch, yet never go back and revisit the creative brief to make sure these additional insights are not only captured and understood by the agency, but used to inform and inspire the creative development.
There are lots of opportunities for mistakes, lots of things beyond anyone’s control, during a product launch. That’s why it’s that much more important to stick to those proven, tested, “routine” parts of the agency-client process when companies are in the crazed launch mode.
A successful launch readiness platform employs many perspectives and a robust evaluation of multiple stakeholders—not the least of which are the specialists, primary care physicians (PCPs), advocacy groups, and payers. With the latest introduction of Nucynta (a novel dual mechanism of action analgesic for the relief of moderate to severe acute pain in adults older than 18 years of age), many of the disciplined launch readiness processes were followed to allow understanding of the existing competitive landscape, market definition, and pain policies by state where regional marketing approaches are needed. Payer demands for pharmaco-economic and specific outcome data always must be part of your initial package. The launch was preceded by a multi-disciplinary unbranded education campaign that provided us not only the roadway to bridge over the education gaps but also insight into the habitual prescribing practices within this pain space. All this market exchange allowed us to tailor our product introduction with the necessary specialty-specific clinical data and value discussions to the payers.
The New Reality
With the current movement for healthcare reform, many efforts were invested in generating outcome data and relevant pharmaco-economic findings (some still in the works through a pragmatic design) that can apply the rationale for Nucynta in a landscape of a highly generic competitive landscape.
The critical factors for a successful launch included clinical data primed with outcome measures and comparative structure that allows a differentiated value proposition beyond the traditional stakeholders and provides a “spinal cord” to all your campaign components. This was followed by a significant segmentation to realize where the opportunity was for more rapid adoption and define a buying process both in the retail and in the hospital to map all the points of critical customer interface. Lastly, the training and consultative skills of all those who touch stakeholders had to be optimized with flexible resources to accommodate geographical differences. Accountability and certification were integrated at all levels of the organizations and continue to be tracked weekly.
Avoid Common Mistakes
Don’t assume you know the customers, and don’t extrapolate your findings from one customer group to another. Be sure to adjust and stay amiable.
Think Big, Act Small
Mass-market, blockbuster drugs are no longer the sole catalyst for company growth. Aside from targeting smaller company acquisition to enhance pipelines, big pharma is learning it must think big, act small, and embrace speed. This necessitates streamlining sales forces to strengthen connections and expand their role, becoming knowledge facilitators with access to disease-state expertise. Leveraging Closed-Loop Marketing also enables on-demand discussion, where interactive messaging is refined quickly to build better customer connections.
Emphasis on Comparative Effectiveness
Comparative effectiveness research (CER) marks an opportunity for product differentiation in the highly competitive marketplace. CER will draw out product differentiators, propelling them ahead of category competitors. Medical marketing will be the key driver for this messaging, and dedicated managed-care sales reps—skilled in interpreting analytics around patient-centric outcomes, compliance, and disease-state management—will be critical in creating unique selling positions for clients.
Harnessing the Powers of Web 3.0
Passive audiences will give way to the activist patient. Companies must embrace innovation and explain how clinical efforts improve the human condition. A digital presence alone will not suffice—communications must be grounded in strong data to amplify relevance and resonate with patient and clinical communities. Cutting-edge technology may bring an audience to the message, but only dynamic content will strengthen their loyalty over time.
Answering the future’s challenges, successful product launches, relaunches, or brand extensions must be grounded in patient-centric messaging coupled with strong relationships. Campaigns will soon move beyond product profiles to expressions of health and wellness. Products are a dime a dozen—but brands that drive health and wellness are precious.
Rob Likoff
CEO
Group DCA
rob.likoff@groupdca.com
An Uncertain Future
There is no question that the environment we expect to see in 2010 will challenge our industry to be more innovative than ever. However, the uncertainty of this environment plays an even bigger role than the strict guidelines imposed within it. Marketers need to know what the playing field is and then we can be innovative. Without guidance, we tend to become overly cautious. A good example of this is the recent confusion about the use of social media. There are always new approaches and new technologies to leverage to replace older and restricted approaches. The key is knowing how to use them.
Critical Factors
There are always some critical success factors in terms of communicating with physicians for a successful launch. While it is hard to create a “one size fits all” list, some very important steps include: Targeting the right people, segmenting and then delivering the right message, leveraging communication channel preferences, delivering best-in-class programs, collecting insights, and most importantly, understanding your customers. With new technologies, we can better profile and listen to what our customers want. And that is a step that can help determine a successful product launch.
Mistakes Made
Don’t fall in love with your own story—and don’t forget that habits are hard to change even if you have “great data.” One of my favorite quotes is: “Everyone wants to have a relationship with their customers. The problem is that your customers don’t want to have a relationship with you.” This challenge can be met by making sure that you serve up the right message to the right doctors, the way they want to receive it with best-in-class execution—and then ask and listen to what they want next.
The Same Principles Apply
With relaunches and brand extensions, if you have been listening to your marketplace then you already have a lot of information about “what worked and why,” so you may already know what your customers want. With a new product launch, you don’t necessarily have this information.
Anshal Purohit
VP, Strategy & New Business
Purohit Navigation
purohit@purohitnavigation.com
The impact that healthcare reform, reimbursement, and increased regulatory scrutiny will have on product launches is multifaceted. Many factors, already being felt, necessitate the adoption of a strategic approach to marketing and managing a brand that ensures choices are grounded in results and provide a higher return on the marketing investment.
The circumstances reveal broad complexities for patients, healthcare professionals, and pharmaceutical companies alike. Layered, these issues may make the forecast appear dreary. But whether launching a brand, relaunching a brand, or continuing to market an existing product, there is hope for those who are sensitive to key brand issues and use the shifting terrain as an opportunity to position a brand powerfully and competitively.
There are critical factors for a successful launch:
- Partnering with a full-service integrated agency
- Leveraging market research
- Knowing the customer and the competition
- Monitoring positioning and key messages regularly
- Diversifying marketing efforts
- Choosing measurable tactics (think nontraditional)
One of the most important steps is to collaborate closely with a full-service integrated marketing agency that can lend strategic insight to the decision-making process. It may literally pay to talk to marketing companies that offer integrated services. Partners who provide integrated services often represent a benefit to a tightening budget. With little downtime, cross-functional teams can be in the loop and up to speed, ready to execute a new strategic or tactical initiative. This partner becomes the ultimate “brand consultant” in forming strategy, developing breakthrough creative, and expanding media platforms. Additionally, a resource that is often underused is market research.
It can help reveal patient mindsets, unearth hidden issues, and identify subjects respondents are reluctant to address openly. Customer insights gained can produce breakthrough ideas that will be helpful moving forward. Ultimately, a carefully thought-out approach considers the needs of the customer, the actions of the competitors, the special challenges of the pharmaceutical landscape, and the importance of sound tactics that have a clear goal and are measurable.
Common Mistakes
One area I would describe as open for improvement in new product launches is the amount of time spent in pre-market conditioning. There is no shortcut that I’ve seen. You have to take the time to do the homework. So, for example, if you are launching a new molecule with a novel MOA and want to differentiate versus current therapies, it takes time to work with the Opinion Leaders to develop a shared understanding of the mechanism, to work collaboratively to develop new class and brand specific nomenclature, to seed that new nomenclature and new class branding in your publication strategy and your medical education, and to tell that story appropriately and consistently in pre-launch.
Importance of Payers
As the environment here in the U.S. evolves with the growing importance of payers, an anticipated larger role for the federal government, and the continued scrutiny of the pharma industry from not only the federal regulatory agencies but also in the court of public opinion, all of this will, undoubtedly, impact new product planning. Meaningful differentiation will be key. A demonstrated, significant clinical benefit. A transparent pricing model. All of which should be encouraging to those in our business—we have the tools to share with today’s stakeholders (clinicians, patients, payers, involved loved ones) our brand story across many mediums as we launch a brand. And the most successful launches will be addressing all of these stakeholders in the brave new world.
Relaunches
In fact, relaunches are among the hardest thing to do in our business. We live in a branded world. The brand owns a position in the physician’s mind that is grounded in both the left-brained scientific story that we’ve told about the brand thus far as well as in the right-brained imagery and context that the physician “feels” about the brand. Changing those perceptions is just as hard—often harder—than launching a new brand. It takes the same disciplined, relaunch plan to recondition the market to look at and think about the brand differently, and that takes a commitment to not only new data, but often new brand identity elements as well.
David Chapman
Managing Partner
CommonHealth
dchapman@commonhealth.com
There’s no question a product launch in 2010 needs a different approach than the “sheer-throw-weight” reach and frequency model traditionally employed by pharma.
Let’s look at the key factors:
- First and foremost, third-party payers and other audiences potentially more influential than prescribers (such as government, advocacy groups, and employers) are key.
- It’s a world of diminished sales forces with fewer print publications and a huge spectrum shift to digital and online video.
- Peer-to-peer communications are increasingly under scrutiny, hamstringing the free discourse that once took place under the auspices of CME, redefining the role of primary investigators and other KOLs, and challenging the timely publication of data.
- Proven brand identity and awareness-building reminders have been banned if not deemed medically relevant.
Thankfully, there is a key concept we can apply to help ensure rapid uptake and brand “bonding” at the earliest possible juncture: It’s targeting. Not in the old sense of covering top-decile physicians. I mean targeting stakeholders who need to be informed rapidly and convincingly—via a medium they find trustworthy and convenient. This requires knowing who you need to reach, and how and when to get them the launch story. It means knowing which physicians are superfluous, even if their previous prescribing behavior looks tempting. Targeting can lead to different decisions about who becomes a regional KOL, a speaker, or a visited physician when reevaluated through more robust demographic and psychographic behavior. Targeting is also key when selecting who to reach in nonpersonal promotion. If we understand how, when, and where they want information, we can create advocates by building strong virtual relationships with both the company and the brand. Amazon has done so with millions of people who buy books and other unseen items without ever meeting an actual Amazon employee. How? Amazon targets those who will respond to their e-business model. And they constantly morph their interface with their business e-model based on customers’ behavior.
The key to success in all future launches is exquisite targeting that dictates live personal contact opportunities and widely varied digital customer relationship initiatives.
Gil Bashe
EVP, Health Practice Director
Makovsky + Company
gbashe@makovsky.com
Convergence of the “watch-your-wallet” and “show-me” gatekeepers point the way to the essential 2010 product launch strategy—demonstrate clinical value before, during, and after launch. Emphasizing scientific innovation and ongoing clinical trial effort must be center stage in the new marketing communications environment.In a world of “What am I paying for?” science returns to the forefront as the cornerstone for successful brand positioning and extensions. Communication tools evolve (for instance, digital); however, in a spendthrift healthcare reform environment, marketers need to ramp up their efforts around amplifying innovation.
The House bill includes a Wal-Mart-esque proposal for generics’ "First-Free Fill," eliminating co-pay costs the first time a patient switches from brand to generic. Who doesn’t like free? Marketers need to focus on physicians making prescribing decisions by communicating a strong clinical rationale for the brand. Physicians and PBM medical directors will advocate for brands showing clear clinical differences and addressing their patient needs.
The ’90s gave consumers greater voice in health product decision making and DTC became the mascot of mega-brands. Today government agencies and pharmacy benefit managers hold product selection sway. The combination of code-bundling averaging reimbursement between brands and generics—already comprising 70% of medicines dispensed—cemented change in the branded marketing landscape. Not showing scientific difference is to fall into the trap set by legislatively mandated comparative effectiveness measures.
Communications is about creating dialogue. Healthcare audiences are speaking with one another. Physicians will take prescribing cues from traditional and new decision makers—third-party guidelines, reimbursement agency recommendations, public comment (for example, analysts, investigators, and media) and company promotion. To neglect audiences influencing the national healthcare wallet is tantamount to opening a door to bad press, poor formulary position, and unenthusiastic health professionals and possible thumbs-down on the brand.
Neil Matheson
CEO
Huntsworth Health
neil.matheson@hhna.com
The new buzzword in the U.K. is “Market Access.” Pharmaceutical companies have market-access departments staffed with market-access professionals, and because of this, specialist market-access agencies have emerged. The key driver of this new initiative in the U.K. is reimbursement and the significant hurdles that a new drug must navigate to gain access to a government-based payer market.
However, I view “market access” as a much broader concept. I believe “market access” encompasses everything you must do to successfully launch a new product. It is imperative that the brand strategy is not just focused on reimbursement and acceptance by payers but on each and every factor that will facilitate effective market access. In order to gain access to the market, a new product must address a number of complex and often overlapping issues which change considerably based on the definition of the market. For example, a primary-care product will be different than a specialty product, an oral medication will be different than an infused medication, a product with a relatively benign side effect profile will be different than one with more risks associated with it, and a product that is consumer-driven (for example, erectile dysfunction medication) will be different than a professional-driven product (an oncology agent, for example).
The market is now much more complex than it has been in the past. Consumers, patients, and caregivers play a significant role in their own healthcare decision-making; physicians, physician assistants, and nurse practitioners can all make prescribing decisions; and payers manage access through disease management guidelines, patient management protocols, and drug formularies. Pharmaceutical marketers have traditionally only had to worry about effectively communicating to the physician when launching a new product. Now they must address all audiences and understand the market dynamics associated with communicating to those audiences. It is suddenly a lot more complex.
The key to success is to identify the three to four factors that will impact success at launch and focus investment on those three to four factors that will realize the greatest return. In this way, resources will be more effectively applied to major drivers of a successful launch.
Lorna Weir
Chief Marketing Strategist
Vox Medica
lweir@voxmedica.com
Product launch efforts today are more exciting than ever. No longer can we neatly segment our audiences and predict behavior on history. Now we are charged with seeing opportunities while varied constituencies of influencers are in constant motion, the tools we use to communicate change daily, and the overall rules of the game can change as we go.
With healthcare reform, increasing pressure of payers on cost containment, and the stringent regulatory environment including REMS mandates, pressures are great on all fronts. Today’s launch may conjure up an image of a boat entering choppy waters rather than the analogous thrill of a rocket careening into space.
To be successful today, it’s vital to look beyond your desired outcomes and understand the dynamics of the market. It’s easy to cite the product study data points, but to build competitive immunity one has to look across the interconnected healthcare decision-making community including patients, providers, payers, regulatory, and others.
We employ the following criteria—or checklist—as part of our proprietary process for launch, relaunch, and brand extensions:
- Identify leverage points; do not simply conduct a landscape assessment
- Mindset segmentation before targeting is key
- Positioning is not as much a message as it is aspirational and earned
- Instill appropriate use in targeted patients through a compelling value proposition
- Inventive implementation not just innovation is key to being relevant
- Engagement factor in addition to traditional ROI defines real-world success
- Offer a simple, compelling reason to consider your product—complexity rarely motivates early adoption
- Achieve a threshold level of access across key distribution channels to alleviate frustration among early adopters of your brand
- Know the language of your audience and speak in their voice whenever possible
- Think beyond the impact of sales force detailing—provide HCPs with on-demand access to essential information and support services
- Define the metrics that matter and optimize against these measures as soon as possible post-launch
A successful launch today is one that sets forth a clear vision and builds upon it in all that follows. As none of us can control the environment, the foundation of your brand has to be solid and built to endure flux. By clearly establishing your intent and acknowledging this new world in your efforts—from proactive risk communications around a REMS mandate to strategic social media usage—you can thrive in any sea change.
Stephen Wray
President & CEO
Cadient Group
stephen.wray@cadient.com
The Influence of Healthcare Reform
Healthcare reform, in our view, will empower consumers and payers more than ever before. As it relates to our clients’ market development strategies, we emphasize the need to consider the payer and formulary decision makers comparable to prescribers in terms of their influence upon brand launch success in today’s market. We also emphasize that the pre-launch phase is the time to develop precision in the brand’s clinical messaging and differentiating benefits in the context of its health economics platform.
Critical Factors
A launch checklist for success includes:
Common Mistakes
There are a number of areas where we consistently see gaps in launch planning. For example: Not thinking multi-channel or enabling customers to choose channel preference. In today’s world, share of voice will come from multiple points of engagement. Also, many launch brands continue to place insufficient emphasis upon nonphysician healthcare professional audiences, whose information and service needs are distinct from physician audiences.
Relaunches
In addition, relaunches or new indications provide marketers with an opportunity to reassess the stakeholder environment, gaining a clear understanding of customer perceptions of your brand, messages, and value proposition. Altering your approach to channel preference, stakeholder prioritization, payer partnerships, and analytics can help marketers to establish an enhanced growth trajectory from these brand lifecycle milestones.
The most common mistake that I see in the context of a launch is overplanning and underexecuting. A launch is an incredibly exciting time. Expectations are high, visibility is high, and there is a shared sense of purpose. You seek to do everything right and everything different from what anyone has ever done before.
And then, one fateful day, the FDA accepts your NDA and you realize that you have about 11 months to make it all happen. You’ve spent your time analyzing things that you now believe don’t matter. You have an in-depth, clear understanding of how to execute that new social media strategy… except for regulatory discussion that will likely kill it all. But you haven’t spoken to your sales training team or the sales management team in a month.
It’s time to get it in gear! The first step is probably done…you have a core insight that will drive the brand. You’ve figured out your core communication strategy and are probably beginning messaging research.
Now is the time to work with sales training and your sales management group to make sure that the needs of your sales force are met. Think in terms of the Goldilocks strategy: You don’t want too much in the way of materials to educate, motivate, and ingratiate the team…and you don’t want too little either. You want the amount that is just right. It’s my experience that many brand teams don’t do their homework with this important vector, and the last several months prior to launch are a mad dash to meet the needs of this important group…when planning even a few short months sooner would have made a huge difference.