Launching a new therapy is one of the most consequential moments in a pharmaceutical brand’s lifecycle. As we’ve said before, you only launch once! The difference between brands that achieve their uptake goals and those that fall short often comes down to one factor: how quickly can a team identify problems and adapt their strategy accordingly?
Many manufacturers enter a brand’s launch year with carefully developed forecasts, access assumptions, and adoption targets. Yet even the best plans can—and should—change in the face of real-world market dynamics. Competitors might enter the market earlier than expected, or payer policies might become more restrictive, or unexpected access barriers might arise.
In our recent on-demand webinar, First Year After Launch: Achieving Your Uptake Goals, we shared tips on how your market access team can rapidly diagnose and reverse setbacks in that first pivotal year. Here are the five steps we recommend:
Step 1: Track Performance Weekly, Not Monthly
Many pharma companies rely on monthly reporting cycles once a product reaches the market, but in our experience, that cadence is insufficient. During launch year, manufacturers should monitor uptake, utilization, prescribing trends, payer coverage, and patient access on a weekly basis. If a launch plan is simply a collection of assumptions — how quickly will payers cover our brand; how will prescribers respond; how will our competitors react — the key is recognizing deviations from that plan early enough to take corrective action.
Small issues can quickly become major obstacles if they’re not identified early. For example, if prescription volume is lower than expected, your team needs to determine whether the problem stems from awareness, access, affordability, distribution, or competitive pressure. Or if your brand’s coverage is less favorable than expected, perhaps your value story is to blame: how are payers perceiving your differentiators? What do payers think about your efficacy data, or your contracting strategy?
We like to say that our Message Monitor tool acts as a report card for your value story, because it gives you fly-on-the-wall insights into what payers are thinking about and remembering after your account directors walk out of the room. Receiving that feedback within 48 hours of a meeting is invaluable, because it allows your team to change that narrative almost immediately, depending on the reactions you’ve heard.
Essentially, your team should treat the first year after launch as an ongoing diagnostic exercise. Every metric should help answer a simple question: What’s preventing the next patient from starting therapy?
Step 2: Monitor Coverage Decisions Relentlessly
Payer coverage decisions during the first six to twelve months after launch often determine whether a brand reaches its uptake goals. According to our PAR Analytics data, more than 50% of new drugs are currently blocked at launch, and nearly 60% of payers across the U.S. impose new-to-market blocks prior to P&T review. These restrictions can remain in place for months after launch.
Ideally, your market access team should already have completed a payer segmentation exercise to assess the likelihood and timing of access decisions across the payer landscape. This kind of research will let you know which payers are likely to initially block access, when P&T reviews are expected, and which organizations are most likely to provide early coverage.
Prioritizing payer accounts in this manner will allow your team to focus its resources on the payers who require immediate engagement. Even with a good payer segmentation and prioritization plan in place, it’s important to continuously monitor policy changes, as payers can make decisions faster than expected—and restrictive policies can appear with no warning. One of the best reports that MMIT offers is our Policy and Restriction Insights report, which provides weekly update tracking through Analytics.
In addition, MMIT’s Searchlight alerting tool is helpful for diagnosing policy problems before they become a trend. Searchlight uses automated monitoring, real-time alerts and AI-powered summaries to help your team spot meaningful changes in time to make a difference. For example, if a payer publishes a restrictive policy that does not become effective for three months, your account managers may be able to convince the payer to write the policy to label instead, because the restrictive policy is not actually in effect yet.
Step 3: Reduce Access Friction for Prescribers
A drug’s clinical efficacy data may earn a physician’s attention, but ease of access often determines whether they end up prescribing the new brand. Many manufacturers assume physicians will prescribe a product if they believe it offers meaningful clinical benefits. In reality, providers must also feel confident that they can successfully navigate the reimbursement process.
Even in therapeutic areas with high disease severity and high unmet need—such as oncology, cardiology, and rare disease—physicians still require access-related information before they feel comfortable prescribing. In fact, recent MMIT research reveals that 73% of oncologists and other specialists believe coverage details should be a standard part of sales conversations.
The easier manufacturers make it for providers to answer patient-level access questions like the following, the more likely physicians are to prescribe:
- Is the therapy covered? Are there step edits?
- Will prior authorization be required? What documentation is needed?
- How burdensome is the approval process? How quickly can patients start therapy?
This is particularly important in specialty and high-cost TAs, where utilization management is common. Even when PA requirements exist, providers are often willing to prescribe if they understand the process, can anticipate the administrative burden required, and believe it is manageable.
Manufacturers should ensure that sales teams, field reimbursement managers, account teams, and patient support organizations are aligned around access education. With so many patients impacted by new-to-market blocks, access in the early months is likely to depend largely on physicians’ willingness to walk through the medical exception process—which can require lots of back-and-forth communication, as prescribers typically don’t know what a medical director needs to see for approval.
Your sales reps will need to help HCPs understand what the medical exception process looks like at the individual payer level. What notes and documentation are required? Roughly 80% to 90% of medical exceptions are approved, but the success rate depends on prescribers’ knowledge of the process. Improving utilization by any means necessary is also crucial for improving payer coverage. If there is no demand for your brand—if no prescriptions are coming through—payers are likely to claim there is no need for a policy to be created in the first place.
In addition to providing dynamic coverage data for a prescriber’s patient population, MMIT’s promotional tool, FormTrak, also embeds PA and medical exception forms into the platform—so reps can walk HCPs through the prescribing process at the point of engagement.
Step 4: Don’t Ignore the Patient’s Role in Uptake
Launch teams often focus on payer and physician behavior while overlooking a critical stakeholder: the patient. Of course, patients can encounter barriers at every stage of the treatment journey. Some may be unaware that a new treatment exists, while others may hesitate to discuss embarrassing symptoms with their physician. Many patients end up abandoning treatment because of affordability concerns or confusion about coverage requirements.
Understanding patient behavior requires more than anecdotal feedback. Manufacturers should use real-world claims and utilization data to identify where patients are dropping out of the treatment journey. Questions worth investigating include:
- Are patients requesting the therapy from their physicians?
- Are prescriptions being abandoned at the pharmacy?
- Are affordability concerns driving treatment delays?
- Are patients successfully completing prior authorization requirements?
These insights can help your team identify where educational campaigns, patient support services, affordability programs, or disease awareness efforts may be needed. In some therapeutic categories, changing patient behavior may be just as important as influencing physician behavior.
Step 5: Connect Access Data to Real-World Utilization
Perhaps the most important lesson from launch year is that access data alone doesn’t tell the whole story. Your brand’s coverage may appear favorable on paper, yet utilization remains disappointing. Likewise, strong physician interest may fail to translate into prescriptions because of operational barriers occurring elsewhere in the treatment journey.
Manufacturers need a connected view of payer coverage, claims activity, prescribing behavior, pharmacy fulfillment, rejection rates, and patient abandonment data to uncover previously unnoticed barriers. For example, a manufacturer may discover that:
- Physicians are prescribing, but pharmacies aren’t dispensing
- Coverage exists, but claims are being rejected
- Patients are overusing your copay assistance program, despite having available insurance coverage
- Certain specialty pharmacies are creating unexpected access friction
Instead of guessing where problems exist, your launch team can use these insights to target specific payers, providers, pharmacies, or regions that are limiting uptake. Our custom Access Impact Dashboard provides a holistic view of brand performance, payer coverage, territory details, the patient journey, and other metrics via integrated real-world data.
To summarize, the first year after launch should be viewed as a continuous cycle of measurement, diagnosis, and optimization. The manufacturers that succeed are not necessarily those with the perfect launch strategy. Instead, they are the ones that identify challenges fastest and respond most effectively.
For details on how MMIT can help your team maximize uptake and utilization, learn more about our Strategic Launch Report for analog analysis and payer segmentation; our Analytics and Searchlight products for payer policy alerts and analysis; RWD Insights for real-world patient journey information; Message Monitor for payer and IDN perception research; and FormTrak for seamless HCP promotion.
