Current Edition

The Oncology Crux – Asking the Smart Oncology Questions Before Shaping an Asset’s Journey to Market   

With over 2,000 oncology clinical trials currently ongoing, the speed at which the market is evolving makes it increasingly difficult for pharmaceutical companies to differentiate their assets and maximise their value proposition, and thus their commercial potential. Asking the right questions at the outset of an asset’s journey to market is essential to make informed decisions and develop a successful commercialisation strategy and product launch.

In this article, Jason Gilbody, Principal, Strategic Consulting at Envision Pharma Group and co-lead of Envision Oncology Solutions explores the unique challenges in the oncology market and the key factors that pharmaceutical companies should consider for a successful product launch.

What Makes Oncology Product Launches Different?
Launching an oncology drug differs significantly from launching drugs in other therapeutic areas due to the unique characteristics of cancer as a disease, the variability amongst cancers, the healthcare environment around treating cancers, and the specific needs and challenges faced by patients, healthcare providers, and payers in the oncology space. These differences shape the strategy, execution, and follow- up activities associated with oncology drug launches. Pharmaceutical companies can better prepare for oncology product launches early in development by asking questions, such as:

  • Where does the product fit in complex oncology treatment landscapes?
  • How does the regulatory approval path impact an oncology product’s launch strategy?
  • How can patient support and engagement be used to support a successful oncology product launch?
  • What special considerations are necessary when determining sales force size and structure when launching an oncology drug?
  • What special considerations exist around pricing and reimbursement for oncology products?

Addressing these questions early in a product’s commercialisation journey allows developers to gain a deeper and more accurate perspective of the patients they serve and the markets they live in. The insights gained enable drug developers to make informed decisions, providing a solid foundation for an oncology product launch.

Where Does the Product Fit in Complex Oncology Treatment Landscapes?
The oncology treatment landscapes are characterised by rapid scientific advancements, evolving standards of care, and crowded development pipelines. New therapies are constantly being brought to market, leading to changes in the treatment guidelines. This makes it difficult for products to stand out and can be confusing for healthcare providers (HCPs) trying to understand where a drug fits into the current treatment landscape. Developers can address these challenges by continually evaluating the positioning of their products using competitive intelligence.

A deep understanding of the current and future market landscape, including competitor pipelines, product launches, and drug data forms the basis of successful launches. Given the competitiveness of oncology markets, having a well-informed, comprehensive, and highly agile launch strategy is a significant advantage. By understanding where the drug fits in the patient journey, educational materials and messaging can be targeted to the appropriate patient population.

The increased targeting of specific molecular pathways or biomarkers is a clear trend in oncology drug development. In 2023, all 14 new molecular entities approved for an oncology indication targeted a molecular pathway or biomarker. Although this increase in precision medicine is promising for cancer patients, it also contributes to the challenging oncology landscape. For example, drugs targeting a specific molecular pathway or biomarker will likely require concurrent development and approval of a companion diagnostic (CDx) to identify that specific target.

Managing the approval and launch of the CDx adds a layer of complexity and coordination when bringing an oncology drug to market. When a drug requires a CDx, it is imperative to educate HCPs on patient selection, testing, and treatment protocols that typically exist when dealing with precision medicines. A plan for educating the market on your drug’s CDx is critical to a successful launch. Even if a CDx is not necessary for your product, understanding how biomarker assays and genetic tests will be relied upon by HCPs to prescribe your product is critical when educating the market, and for the successful adoption of your product.