Now more than ever, oncology innovators need to ground early commercial decision making in a deep understanding of how the science of their product directly solves a need that patients with cancer will have at time of launch. The hypersegmentation and rapid evolution of most oncology landscapes, driven by scientific advancements, global regulatory changes, and an increasing focus on value-based medicine, make this a challenging prospect. This article will explore how pharmaceutical companies can navigate the complexities of today’s oncology landscapes and achieve success by adopting a broader perspective in their commercial strategy.
Oncology markets present unique commercialization challenges
In all business opportunities, the path to successful commercialization means building a bridge between your innovation and an unmet need in a way that will generate revenue. But commercializing an oncology product in 2024 means identifying and linking to an authentic shortfall in the lived experience of a patient with cancer, not just a perceived gap in the market. Until recently, commercialization of an oncology product was similar to any other pharmaceutical launch. Today, developers need a deep understanding of target markets, the patients, and other stakeholders in those markets, and the science underlying the innovation. Oncology market segmentation has moved beyond sites of origin to numerous molecular sub-segments with unique patient experiences and needs, in many cases taking on attributes of development in rare disease. This trend is good for patients because it means more personalized care, but for developers, it means it’s more challenging than ever to identify the point of entry with the highest probability of success.
Commercialization challenges in oncology are driven by:
• Hypersegmented diseases with defined characteristics
• Variability between different cancer types
• The oncology healthcare environment
• Challenges in the patient journey
• The needs of healthcare providers
(HCPs), Integrated Delivery Networks (IDNs), and payers
Drug developers seeking to define the value of their innovation must invest in gaining a broader perspective, starting earlier in the program’s life cycle than they would have 5 years ago. Identifying the right patient segment and fully understanding their (and the providers’) experiences, including access challenges, is an essential first step that can then be used to align the commercial strategy—and soon after the clinical program/TP—to real unmet needs, thereby maximizing the chances of return on investment. Expert external partners are a critical and cost-effective path to success, because the need for specialized insight may pre-date the point at which a company stands up internal expertise on a product team.
- Understanding the patients and the providers
Shared decision making and patient advocacy are encouraged in oncology, meaning the patient’s perspective can be a more influential factor in determining access to treatment compared to other therapy areas. Even though only a fraction of patients with cancer or their caregivers are directly involved with advocacy groups, the effort these groups put into representing patients and communities is vital to care and becomes a crucial market-shaping component. Mapping out advocacy groups and planning deep, long-term partnerships with them helps keep a program in line with the needs of patients as they evolve. As cancer therapies become more specialized, advocacy becomes an even more critical way for developers to acquire and maintain a nuanced understanding of specific patient needs, which may differ from those of the broader patient population for a particular tumor type. The ongoing two-way involvement also helps patients understand the significance of their own voice, even if the absolute number of cases like theirs is relatively small.
The serious, often life-threatening prognosis of cancer gives oncology prescribers more decision-making power than those in other therapy areas. HCPs across the world have varying levels of control over the treatments available to their patients. In the US, however, oncology prescribers have more decision-making power, plus they have started to own more of the patient journey and influence treatment distribution strategies. This means they are thinking more about the holistic process of managing patients, accessing medications directly, fitting new treatments into their practice flow and processes, and planning out what services they need in place to support the new treatments. Understanding how HCPs weigh these factors to make treatment and practice management decisions will lead to a product commercialization strategy that will naturally lead to prescriptions, but it is also vital to designing effective program packaging, ensuring the right patient services are in place, and ensuring optimal access.
- Striking the balance between the patient journey and the provider experience
Ultimately, patients are focused on meeting their specific needs and HCPs are focused on patient care, but their perspectives can sometimes be at odds with each other. It is certainly possible to build tailored strategies that align with the requirements of both groups, but it can be challenging to strike a balance, as illustrated in the examples below. In these situations, if developers were to prioritize the perspective of HCPs, patients and advocacy groups may feel frustrated and not heard.
- Survivorship goals
Through multiple lines of better therapy, some previously terminal cancers can now be managed as chronic diseases. HCPs may focus on the huge win of improved survival, while patients may focus on other new unmet needs: quality-of-life or financial impacts from long-term maintenance therapies, threats to fertility, risks of secondary cancers, etc.
- “Serious” side effects?
Some non-life-threatening side effects of anticancer drugs, such as fatigue and hair loss, are downplayed by HCPs but are top-of-mind for patient advocacy groups because of the quality-of-life and emotional impact they can have.
Practical barriers to personalized medicine
In concept, companion diagnostic tests should be a clear win with patients, HCPs, and regulators, because they identify the right drug for the right patient and prevent unnecessary exposure. However, practical gaps in diagnostic test implementation or access can be real barriers to uptake of the drug, despite a compelling value proposition. For example, national healthcare or private insurance coverage may provide access to a drug but not reimburse its companion diagnostic. In other cases, the time required to get test results may delay care beyond what patients are willing to wait for. In these cases, HCPs and patients may have differences of opinion on the value of personalized care, risking that part of the market may be lost to “all-comer” treatments and uptake will be sub-par.
The power of real-world evidence
Ultimately, the goal is not only to get the drug to the regulatory endpoint and into the market but also to ensure patients can access and benefit from it in all target markets, which requires supporting real-world evidence. Regulators are also starting to recognize the importance of a well-rounded submission package that includes real-world evidence. If developers have invested in understanding the needs of patients at the outset, they will be better equipped to identify practical endpoints and datasets to feed into commercial strategies. This approach enables developers to generate more effective real-world data by aligning resources and activities with the unique needs of patients and providers. Furthermore, because an emphasis on prospective real-world evidence is still not a universal practice, early investment in this kind of data also helps developers build stronger rapport with key stakeholders beyond HCPs.
By actively listening to patients and HCPs and making seminal program decisions based on their perspectives—rather than course-correcting post-launch—developers can set successful commercial strategies and make sure they stay aligned with evolving needs.
Oncology commercialization: Time for a broader perspective
Understanding the needs of the full spectrum of external stakeholders and then aligning them with commercial strategy can be overwhelming for oncology drug developers. Moreover, commercial decisions need to be made before developers have built out or allocated resources to certain functions, such as medical affairs or market access. How is it possible, then, to approach commercialization from a broad perspective when the scope is so extensive and most companies will not yet have built out the needed expertise on their staff? External strategic commercialization partners can help companies bridge gaps in expertise at the early stages of a program. The right experts have the necessary broad experience to shoulder some of the work, drive connectivity between functions, and serve as an objective sounding board to ensure everyone is working together toward a tighter, stronger commercial focus. This approach requires an up-front investment that is ultimately cost-effective, because in the longer term, it improves a company’s chances of commercial success in a rapidly evolving market.
