What Not to Do During an Oncology Launch: Pitfalls That Impact Access

Janet Serluco | SVP, Access Experience Team Oncology Lead
Madeline Waldron, PharmD, BCOP | Vice President, Oncology Clinical Solutions

Launching a new oncology therapy is a high-stakes endeavor. The global oncology drug market is projected to reach over $400 billion by 2028, resulting in fierce competition and increased financial scrutiny, making it more critical than ever to optimize access.

A breakthrough cancer drug can transform patient outcomes, but without a strategic access plan, even great therapies may stumble to optimize access. In oncology, traditional market access playbooks aren’t enough. Success demands navigating complex clinical evidence, payer pressures, and provider ecosystem dynamics.

Below, we highlight key pitfalls to avoid – in both provider and payer engagement – that can derail an oncology therapeutic’s launch access and uptake.

What Not to Do: Provider Engagement  

1. Assume One Site’s Lessons Apply to All  

In oncology, if you’ve seen one practice, you’ve seen one practice. Every cancer center – whether a large academic hospital or a community clinic – has distinct processes and challenges. A strategy or insight that succeeds at one site might flop elsewhere. The field also evolves quickly, so assumptions from 2025 can be outdated by 2026.

Don’t use a one-size-fits-all approach. Profile each practice and meet them where they are – identify their unique needs in workflow, staffing, reimbursement, etc. – and adapt your support accordingly.

2. Assume Pathway Positioning Guarantees Uptake  

Earning a spot on an oncology clinical pathway is valuable, but it doesn’t ensure physicians will use your drug. Pathway utilization remains relatively low; fewer than half of oncology practices strictly track or enforce pathway adherence, and there is wide variation in site-specific interpretation of parent pathways.

Moreover, utilization management has become more nuanced, blending insurer rules, electronic health record (EHR) decision support, and pathway suggestions in daily practice. Don’t treat pathway inclusion as synonymous with access. You still need to engage providers continuously about where your therapy fits in practice, assist with clinical decision support integration, and reinforce the value of your drug for appropriate patients and foster clinical champions.

3.  Have a Weak EHR Integration Strategy  

Oncologists and their care teams live in the EHR. If your treatment isn’t well-integrated into their electronic workflow, it may be “out of sight, out of mind.” Don’t stop at a basic EHR template that just regurgitates the prescribing information. Instead, develop robust order sets and decision support tools that match and enhance practice operations.  

4. Overlook Clinical Pharmacists  

In many oncology practices, clinical pharmacists are the experts behind the scenes driving access. They develop treatment pathways, manage formularies, optimize & enforce EHR processes, and educate the medical team. Yet manufacturers sometimes focus only on physicians or department heads and overlook these key influencers.

Don’t ignore the clinical pharmacist. Engage them early with tailored resources: provide them with detailed information about dosing, safety, and operational aspects of your drug. Listen to their feedback, too. These pharmacists often identify practical barriers to access and can champion your therapy if they’re convinced of its value.

 5. Underestimate Operational Barriers and Competing Priorities  

Gaining formulary approval is just one step; implementing a new therapy in a hospital or clinic is another challenge entirely. Operational barriers – like building the regimen into the EHR, training nurses and pharmacists, updating infusion protocols, and obtaining buy-in from various committees, distribution and reimbursement delays – can significantly impact uptake.

Practices also juggle many priorities, from other drug launches to system upgrades. Don’t assume a signed contract means immediate usage. Identify and help address these operational needs in advance. By understanding a site’s practical realities, you not only speed up adoption but also build trust and partnership.

What Not to Do: Payer Engagement  

1. Assume Approval Means Easy Coverage

FDA approval, or even an NCCN Category of Evidence rating of 2A or greater, doesn’t guarantee the coverage it once did. Don’t assume coverage equals open access. Nearly 70% of all new drug scripts face rejection, as payers impose prior authorizations or other utilization management tools to limit access. Plan for these hurdles from the start, especially when FDA label, NCCN designation, and trial design are incongruent.

2. Delay or Limit Payer Outreach

Engaging payers only at launch (or just sending a dossier) is a missed opportunity. Payers appreciate information from manufacturers as they plan formulary decisions that often occur within the first weeks/months of approval. Don’t wait: start payer discussions early (pre-approval if possible 12 months in advance) to shape those coverage decisions. Continue dialogue post-launch to address any policy language discrepancies to label, proposed restrictions, or questions in real time.

3. Use a One-Size-Fits-All Value Story

Every payer has different priorities, yet many manufacturers use generic messaging. It’s no surprise that only 1 in 4 payers find pharma’s information tailored to their needs. Don’t use a boilerplate pitch. Customize your value proposition story to address the unique concerns of each type of payer (e.g., clinical, financial, operational). For instance, highlight hospital cost offsets to plans focused on total cost of care, or survival and safety data to those emphasizing outcomes. Relevant content drives engagement.

4. Skimp on Evidence That Matters

High clinical efficacy from pivotal trials alone may not secure favorable coverage – payers want to see robust evidence of real-world value. Don’t rely solely on internal “data on file.” While payers and P&T committees are generally skeptical of unpublished manufacturer economic models, a solid model with customizable inputs may help some plans better evaluate your drug in their member population.

Develop a strong “launch and beyond” real-world evidence generation plan: early market access and HEOR collaboration to design studies that meet the outcomes needs of access decision makers can drive initial and sustained access and publish or present in peer-reviewed venues.

Show how your drug performs in practice (e.g., reduces hospitalizations/ER visits, total cost of care reductions or offsets) to build credibility and address payer concerns.

5. Ignore Utilization Management Trends

Assuming oncology products are exempt from cost controls is dangerous. Don’t ignore the rise of utilization management as payers are increasingly using tools like new to market blocks, step therapy, pathway outsourcing and tighter prior authorization criteria in oncology, which can delay patient access.

Stay ahead of these trends: anticipate likely restrictions and prepare support for providers (e.g., templates for appeals, quick-turnaround hub services) to navigate them. Also consider innovative contracts (like outcomes-based agreements) to give payers confidence and potentially ease coverage barriers.

Get Support for a Successful Oncology Launch

Launching an oncology product is complex, but you don’t have to do it alone. Precision AQ’s Access Experience Team, EHR integration experts, and OncoGenius® clinical experts are ready to partner with you to develop and execute a launch plan that navigates these challenges. By learning from these “what not to do” examples, you can proactively do what it takes to optimize access so that your innovation reaches the patients who need it, without undue delay.