Unlocking Launch Success for Precision Oncology Products: Market Access Strategies You Need to Know

Precision oncology involves the customization of cancer treatment based on the individual characteristics of each patient’s disease, particularly genetic and molecular profiling, often now achieved using NGS (next-gen sequencing) of tumor tissue or even circulating tumor cells or genomic material (cDNA) in the blood. Over the past decade, advancements in sequencing technologies and targeted therapies have carved out growing market share for specific patient populations. Despite these advancements, the path to market adoption fraught with challenges, particularly in securing robust market access.

Precision Oncology presents unique challenges in for market access leaders and data presentation / value proposition. For example, clinical trials for these agents often include basket trials or adaptive designs, which are sometimes harder for payers to interpret. The use of surrogate endpoints also might draw questions from payers; even when they are highly relevant and appropriate from an FDA standpoint, not all payers may look at ORR or PFS the same way.

What do you need to consider when driving a market access strategy for a precision oncology product?

1. Work with the right biomarker/diagnostic partners

?? Prior to launch, making sure you have the right partners in place for biomarker-driven therapies is a keystone in overall access. When prescriptions and payer acceptance hinge on getting the right diagnostic up front, make sure you're working hand-in-hand with the right lab partners(s) across the board. A good lab partner can make sure that your product appears in the biomarker-driven recommendations sent back to patients and ordering physicians, which can convert them into prescribers. They may also have longitudinal data that can be used to further bolster your clinical and economic value proposition over time.

2. Drive a clear story in both clinical and economic differentiation

Successful market access strategies capitalize upon clinical value as well as clinical differentiation and economic differentiation — in other words, what makes your product stand out in a crowded and competitive field? Drive a clear story to answer this question, not only to prescribers and patients, but also to payers. Targeted therapies are exactly that: targeting a more specific patient population in a way that drives value and efficiency for that subgroup while avoiding using treatments on that population that might be more toxic or less efficacious. How do you get started with your value proposition story?

?? Robust Data: Beyond clinical safety and efficacy endpoints that are useful for marketing approval, consider differentiators in tolerability, treatment burden, administrative burden, or total cost of care. These differentiating data points go beyond clinical trial data and often require additional Real World Evidence (RWE) or third-party data sources.

?? Patient Reported Outcomes and Quality of Life: RWE/RWD can also characterize your product's impact on meaningful outcomes such as quality of life (QoL). Patient Reported Outcomes (PROs) can strengthen the evidence base and support broader payer acceptance; these may have been part of your clinical trial, or you might engage with PRO collection on a registry or real-world evidence basis, engaging patients with your brand post-launch.

3. Build an economic story and provide rationale for pricing

Payers need convincing economic evidence to accept today's pricing. Just because you have developed a high-value therapy doesn't mean a payer will make it easy for patients to access it. What types of analyses do you need to consider for your payer communications?

?? Budget Impact Models: Develop a strong Budget Impact Model (BIM) that can illustrate how your targeted therapy impacts a payer population. In precision oncology, you'll be looking at a smaller, more specific population stratified by a biomarker/diagnostic result, which should translate into a more acceptable budget impact to payers. Emphasize comparisons of your BIM vs. that of current Standard of Care (SOC) when favorable.

?? Health Economics and Outcomes Research (HEOR): Leverage HEOR to support the therapy’s value proposition with comprehensive data. This includes gathering data on comparative effectiveness, patient-reported outcomes, and long-term survival benefits.

?? Disease Burden Analyses: Conduct and present analyses to show the costs to the payer associated with disease burden, such as hospitalizations or other therapies that are less effective. If your therapy is replacing/displacing other expensive options, some with less efficacy or greater toxicity, or helps avoid hospitalizations, emphasize this as a component of your pricing justification discussions.

4. Jump into payer engagement and communication

Have your market access field teams been teed up for success around communication?

?? Early Engagement: Engage with payers early in the development process to understand their concerns and requirements. Long before launch, your payer teams should be talking in an unbranded fashion about the disease area/tumor type, the unmet need, the relatively small size of a targeted patient population, and the high costs of patients receiving inefficacious therapies or high-toxicity therapies that aren't biomarker driven.

?? Tailored Messaging: Develop clear, concise, and compelling messages to communicate value on both clinical and economic points. Keep in mind that many payer Medical Directors have little to no oncology expertise, and may have not been in clinical practice for many years. Oversimplify, concentrate on what's important to payers (budget and price on a 12-month schedule), and understand that payers care more about the current fiscal year than a long-term impact. Physicians working at a payer may care much less about clinical impact than physicians in clinical practice do.

?? Educational & Insight Gathering Initiatives: Design educational initiatives and insight gathering / market research projects with payers to create an information flow in both directions — hearing directly from them as well as sharing information with them. Help communicate the therapy’s benefits and the science behind it, and learn from them about their challenges in managing this disease area. Tactics to consider include payer advisory boards, unbranded and branded communications, HEOR scientific publications, and educational webinars.

?? Leverage Clinical Guidelines, Pathways, and Compendia: Both academic and commercial guidelines/pathways organizations can influence payer coverage decisions. Ensure that you're building out your strategy for inclusion in NCCN Guidelines/Compendia at least four to five months prior to launch; it's much more than just submitting a letter. Work with experts (such as the Sigla Sciences team!) to ensure that your content, timing, and approach around NCCN and other guidelines/pathways/compendia is accelerating your access and adoption. These information materials are the source information that flow to payer policies, electronic health record (EHR) algorithms, clinical decision-assist tools, and institution-level pathways and formularies.

5. Launch wrap-around patient assistance programs

Key strategies that wrap-around your patient population to support their access at launch include:

??? Patient Support Programs: Financial assistance, education, and support for patients is critical at launch. These programs can help mitigate out-of-pocket costs for eligible patients. Beyond that, patients and their treating physicians can get help with navigating benefits and payer issues and finding support from relevant non-profit organizations.

?? Patient Navigation: Services that help patients navigate the healthcare system and access therapy are essential, not a "nice to have". Patient navigators can assist with insurance approvals, appointment scheduling, and logistical support.

Takeaways

Precision medicine holds immense potential, but its success hinges on strategic market access initiatives. Using these tips as a checklist can help you plan for a successful market access launch in the precision oncology space.

?? Join the Conversation! What strategies have you found effective in navigating market access for precision medicine? Share your thoughts and experiences in the comments below! ?????