In the past, marketers would wait until a brand was 18-24 months away from launch before planning their strategy in earnest. Today, they need to be more proactive with their prelaunch marketing efforts and get started before a drug even gets to Phase III trials.
Traditionally, the period between completion of Phase II trials and submission of a New Drug Application (NDA) has been a relatively quiet time for the marketing team of a new brand. In today’s market, however, teams jeopardize the success of their brands if they wait until NDAs are submitted to begin planning. In order to build a successful launch now, a team needs to do at least four things before the NDA for its brand goes to the FDA.
1. Assess The Payer Market
Physicians remain the primary target market for pharmaceutical campaigns. However, health plans and pharmacy benefit managers (PBMs) are exerting increasing control over physicians’ prescribing decisions and patients’ purchases. Marketers need to know more about the payer market for their products than ever before. Key questions to answer include:
- How do payers manage your category now, and how is their management likely to change by the time your product launches?
- Which brands are preferred and which are not?
- What are payers’ management goals for your category?
- How important is the category to payers?
- What defines value for them in the category?
- What advantages and disadvantages do payers perceive your new brand to have?
With the answers to these questions, the marketer can provide early guidance to the clinical team on the types of claims the product will need to make in order to be competitive at launch and develop a preliminary forecast for management.
2. Identify and Test All Value Propositions
Many brand teams still focus most of their early marketing planning efforts on defining their value propositions for physicians and patients while delaying this work for the payer market until just prior to or even after launch. That is a costly mistake. The large (and growing) impact on brand success of formulary access and prescription management practices like prior authorization means that understanding how to create value for payers is critical. Often, the product attributes that represent the most value to payers can only be demonstrated through clinical trials. Conducting these studies in Phase IV compromises a launch because the marketing team can’t differentiate the brand for payers. As a “me too” product that payers see as merely competitive, the new brand will end up fighting pricing battles for access to preferred tiers on payers’ formularies. By determining the elements of the optimal value proposition for payers, physicians and patients concurrently—and early—marketers can provide firm guidance to the clinical team on claims and outcomes that will differentiate the new brand at launch so that these can be included in Phase III trial design.
3. Determine Patients’ Sensitivity to Cost
Plans are shifting more and more responsibility for drug costs to patients. As a result, copay amounts play an increasingly important role in patients’ decisions to accept their physicians’ recommended treatments. Brand teams should determine how different labeling indications affect patients’ willingness to pay. Are they willing to pay higher copays if a new product offers fewer side effects, better efficacy or a new mechanism of action? Patients’ willingness to accept higher copays has an important effect on revenues and profit forecasts. If a brand can succeed with a non-preferred copay amount, then the brand team will have less need to contract with payers at launch and therefore the brand will have lower rebate costs and higher profits. Knowing patients’ sensitivity to copay amounts early can also help marketers provide additional input into Phase III trial designs.
4. Build Alternative Strategies and Associated Tactical Plans
What would you do if you had built a strategy and tactical plan for a new product based on a single claim, such as faster action or superior efficacy, but then the FDA specifically excluded your key claim from the final label? Would you be ready to launch? How long would it take you to build a new strategy and campaign based on the final label? These questions show the value of scenario planning in marketing.
Scenario planning is more important now than it ever was in the past. In today’s pharma market, the stakes are higher for new products and each launch is critical to a company’s success. The industry is producing far fewer blockbusters and more niche products. New categories fill with second and third entrants more quickly. Margins are falling. Major brands are losing exclusivity and the R&D pipeline can’t keep up with the lost revenue. Prior to finalizing launch, marketers need to collaborate with their regulatory colleagues to develop labeling scenarios that represent best, likely, and worst-case outcomes. Scenarios can significantly improve launch readiness later on and help the entire development team make better decisions. Here are some good applications of labeling scenarios:
Clinical development: Some clinical claims are easier to develop than others. Testing a drug’s efficacy using an emerging definition of response, for example, is relatively easy and inexpensive compared to conducting a head-to-head trial against a branded competitor. Using scenarios, the marketer can forecast the revenue available with and without the best mix of claims (e.g., the worst case). With this information, management can assess the potential ROI of specific development plans.
Message development: The messages that convey a brand’s value proposition with the best label will differ from those needed under a likely or worst-case scenario. Identifying which messages the brand needs under each scenario not only drives tactical development but can also highlight additional claims the brand will need to succeed under different labeling outcomes.
Securing approval of the final label is usually the responsibility of Regulatory Affairs. However, this group has limited accountability for the commercial success of the brand. Given the importance of labeling, firms need to ensure accountability for securing the best label possible, not just an approved label. Some companies accomplish this with a process that requires approval of proposed labels by commercial leaders. Other firms may use incentive compensation for this purpose. Applying these four lessons to your prelaunch marketing efforts can put you on the right path to a successful product introduction. To download a complimentary checklist of prelaunch activities, please visit www.healthstrategies.com/prelaunchchecklist.