For many manufacturers, the period between FDA submission and the PDUFA date feels deceptively quiet. Clinical work is largely complete, pricing assumptions have already been modeled, and commercial teams are waiting for the green light. But in reality, this pre-launch window is one of the most consequential phases of a brand’s lifecycle—and one of the riskiest.
As discussed in our recent on-demand webinar, Reducing Risk: Five Steps for a Fearless Launch, the decisions made (or deferred) during this pivotal period often determine whether a product establishes early momentum or spends years trying to recover lost ground. Here are five major risks that can derail your product launch, along with mitigation strategies:
Risk #1: Getting the Uptake Curve Wrong
One of the most common pre-launch missteps is overestimating peak uptake. When early adoption lags behind expectations, the consequences extend beyond missed revenue targets. Payers and PBMs pay close attention to early utilization. Slow uptake erodes a brand’s negotiating leverage, as it signals to many payers that a therapy may not offer meaningful clinical or economic benefits. In the meantime, competitors are all too ready to step in and capture market share that may never be fully recoverable.
The Fix: Practice Evidence-Based Forecasting
The solution starts with realism. Evidence-based forecasting, grounded in launch analogs and real-world data, is essential to give your team a realistic roadmap. To better understand what happened with similar drug launches, your team should carefully select your brand’s ideal historic analogs. By triangulating payer policies, claims and ERM data, and analog performance, your team can see exactly what elements of a manufacturer’s PIE presentations payers responded to—and which fell flat.
Risk #2: Misjudging Your Value Proposition
Internal confidence in a product is natural and necessary, but it can also be misleading. Even highly differentiated therapies must compete against the existing standard of care, including off-label options that physicians are already comfortable prescribing. A novel mechanism of action or new route of administration does not automatically translate into payer-perceived value.
The Fix: Align Value Props to Payer and Provider Reality
To avoid this trap, manufacturers need a clear, payer-validated understanding of how their product fits into the current treatment landscape. That means looking beyond clinical trial data to real-world evidence: claims, EMR notes, prescribing patterns, and patient journeys. It also means pressure-testing assumptions about how payers will respond to differentiation before those assumptions are embedded in launch messaging.
Reviewing simulated payer decision-making sessions, such as mock P&T reviews, can be especially valuable. Seeing how payers discuss a product when the manufacturer is not in the room often reveals objections and concerns that would otherwise surface too late, after policies are written.
It’s also important to figure out which differentiators are most important to payers, providers and patients. Are payers most interested in improving the overall cost of care, or in having more treatment options? How might providers be persuaded to prescribe your brand over others? Targeted market research can reveal the right catalyst to use to transform provider behavior.
Risk #3: Contracting Too Much—or Too Little
Contracting decisions have an outsized impact on gross-to-net. Under-contracting can leave market share on the table, while over-contracting can permanently compress margins without delivering meaningful access gains. The challenge is that pricing alone does not determine coverage outcomes. Some payers may require rebates simply to place a product on formulary, while others may reserve preferred positioning for brands that align closely with their cost-of-care priorities.
The Fix: Base Your Contracting Decisions on ROI Expectations
Understanding these dynamics requires careful payer segmentation and a clear view of where contracting will deliver the highest ROI. Given the reality of leaner account management teams, payer prioritization is critical. Your team should focus early efforts on the payers that are most likely to impose restrictive policies on your brand. It is far easier to secure favorable access at launch than it is to reverse restrictive decisions.
It’s important to understand how payers are currently managing access within the space that you’re launching into, which is where MMIT’s payer policy and restriction data comes in handy. Your team will also need to account for channel dynamics. PBM‑driven retail markets often require manufacturers to “pay‑to‑play,” and the rebate expectations can be significant. Some manufacturers decide to price their brands a bit higher to create room for competitive rebates.
Essentially, the point of payer segmentation is to determine the value of contracting for each segment. How much do you need to pay for access? With a higher rebate, will payers grant your product preferred status? What’s the geographic distribution of payer and PBM lives? Do you know which payers have most of your patient population? The answers will inform your strategy and allow you to discern which payers to engage first.
Risk #4: Being Unprepared for the Unexpected
Even the best-planned launches encounter surprises. Your brand’s label may be narrower than anticipated, or the FDA may have added new diagnostic requirements or mandated that your brand follow a Risk Evaluation and Mitigation Strategies (REMS) program. Various external forces can also reshape the access landscape overnight, from regulatory changes to broader market disruptions.
The Fix: Practice Contingency Planning and Be Ready to Pivot
While no team can predict every outcome, manufacturers can prepare by strengthening their ability to adapt. Having predefined mitigation strategies, supported by rapid market research and real-time feedback loops, will allow your team to better adjust course without losing momentum. For example, conducting rapid payer research after an unexpected label change might help your team determine how to best reassure prescribing physicians about your brand’s clinical efficacy.
Market‑specific research helps to validate your team’s assumptions and gauge payer reactions to new regulations, competitor launches, or shifts in provider behavior. It’s also important that your team walk through the manufacturing and distribution process and carefully anticipate any supply constraints. Ironically, underestimating demand can be just as damaging as overestimating it. Recent examples in vaccines and metabolic disease have shown how shortages can disrupt prescribing behavior, erode provider confidence, and create openings for competitors.
Effective launch planning requires close alignment between commercial, manufacturing, and distribution teams, with contingency plans in place for both upside and downside scenarios. When shortages do occur, transparent communication and clear mitigation strategies can help preserve trust with providers and payers alike.
Risk #5: Scrambling to Execute Your Launch Plan
Launch chaos is common but avoidable. Many teams underestimate the time and coordination required to activate vendors, train account directors, and equip their sales reps with the tools needed for effective pull‑through. Without the right teams and processes in place, manufacturers run the risk of never creating any momentum.
The Fix: Engage Payers, Providers and Vendors Early and Often
Don’t wait to engage your vendors. Make sure that your sales reps are ready to go and armed with all the promotional tools they need, from a brand website to persuasive leave-behind materials. Delaying the implementation of digital pull‑through tools can also cause teams to miss early opportunities. For example, one manufacturer waited six months after launch to deploy our FormTrak in Veeva solution—only to receive several major contracts three days after launch, with no way for reps to communicate the wins. Make sure you have an activation strategy in place.
Similarly, don’t wait to engage payers. Your team should have an accurate, stress-tested PIE deck ready and available, and you should be prepared to provide the clinical and cost efficacy data payers will want. Your messaging and pricing should also be aligned with payers’ expectations. If your PIE presentation doesn’t address the real issues—or if you wait several months to engage your highest-priority payers—your brand will not get the coverage your team desires.
And finally, make sure to engage providers early and often. By the time a product is approved, prescribers should already understand where it fits, which patients will benefit most, and why it represents a meaningful advance over the current options. Early disease state education is much more important than many pharma companies realize, especially if your therapy is a disruptor. In rare disease especially, early physician engagement is often the catalyst that drives payer action, not the other way around. Eager physicians can generate demand for first-to-market drugs, causing payers to write policies and place therapies on formulary.
Don’t Forget: You Only Launch Once!
Regardless of the therapeutic area or type of therapy, launching a new brand is always a disruption to the status quo. To combat market inertia, your team will need to ensure that payers and providers understand your brand’s differentiation and are ready to act.
Launch success requires constant measurement every step of the way. While you cannot eliminate risk entirely, your team can build flexible risk mitigation plans that allow you to pivot quickly when the unexpected happens. If your strategy isn’t maximizing your brand’s potential, don’t be afraid to deploy a new strategy. By grounding your decisions in real-world data and staying agile, your team will be able to redefine the standard of care before your competitors have a chance to catch up.
For an in-depth discussion of these issues, watch our on-demand webinar, Reducing Risk: Five Steps for a Fearless Launch. To discover how our products can help you achieve your launch goals, learn more about MMIT’s Analytics, Strategic Launch Report and Evaluate forecast, P&T Perspectives and Rapid Response.
