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Oncology products are a cornerstone of biopharmaceutical innovation, driving both revenue growth and scientific breakthroughs. The global oncology drug market is projected to reach $409 billion by 2028, underscoring its dominance in industry pipelines and sales.^1,2

Despite this promise, securing market access for oncology therapies is uniquely challenging. The high-stakes nature of cancer care, coupled with rapid scientific advancements and increasing payer and regulatory pressures, demands a specialized approach beyond traditional market access strategies.

Foundational market access principles such as robust clinical evidence, early engagement with healthcare ecosystem stakeholders, and compelling value propositions remain critical. However, oncology necessitates a more nuanced strategy due to its complexity, which is driven by personalized medicine, diverse treatment modalities such as immunotherapy, and evolving payment models.

Success requires deep market expertise and seamless integration of tactics spanning market access, patient services, and medical affairs to create effective, tailored strategies. Biopharma companies need a forward-looking market access strategy, or they risk being left behind and not competing to win in the growingly competitive marketplace.

The Unique Complexity of Oncology Market Access

Oncology market access is unique because it is rarely defined by payer negotiations or coverage. Rather, oncology market access requires a sophisticated, multi-dimensional strategy that integrates deep clinical expertise with a hands-on understanding of the different stakeholders in the healthcare ecosystem.

Market access leaders must navigate the interplay of clinical, operational, and financial factors across diverse customer segments, beyond the payer and pharmacy benefit manager (PBM). These include other stakeholders that influence patient access, such as integrated delivery networks (IDNs), group purchasing organizations (GPOs), oncology-oriented benefit managers, specialty pharmacies (SPs), and community oncology entities.

Multi-stakeholder perspectives are particularly critical in oncology due to the impact of medical benefit design on combined drug regimens and multi-modality treatment plans, which may include radiation and surgery. Oncology market access also involves considerations such as oncology pathways, value-based care models, site-of-care optimization, and patient support programs.

These elements facilitate access at key points in the patient journey beyond treatment selection, including patient identification, biomarker testing, adherence, and both financial and clinical toxicity management. Securing formulary placement or a positive coverage policy is just the first step in a larger picture—comprehensive market access must go further for successful adoption.

The following sections highlight how oncology complexities intersect with traditional market access principles.

Three Pillars of Product Market Access for Oncology

1. Clinical Evidence and Optimizing Outcomes: Beyond Payer Barriers

A strong clinical value story is essential in a competitive landscape. However, oncology market access requires more than payer-focused strategies. It must also consider positioning on clinical pathways, institutional protocols, and in real-world treatment settings. Without a differentiated and robust value story, a product may achieve FDA approval and NCCN guideline recommendations but fail to secure a preferred pathway position limiting access and commercial success in ways that were not anticipated.

The Impact of Oncology Pathways on Product Access
Clinical pathways, developed by payers or providers, play a pivotal role in treatment decision-making. Understanding pathway influence is as critical as securing formulary placement. For example, MMIT highlighted a case in which multiple PD-1 inhibitors were FDA-approved for late-stage urothelial cancer and covered by payer formularies.

However, an IDN’s pathway program designated only one PD-1 inhibitor option as preferred, potentially limiting the prescriber’s view and ultimately access to other appropriate PD-1 inhibitor treatments.^3,4 This underscores the need for clinical value propositions that also support positive pathway placement with payers, IDNs, and third-party pathway companies. Ensuring positive positioning with these different stakeholders is not a one-size-fits-all solution because each stakeholder has different incentives that don’t consistently align.

2. Building Trust with Healthcare Ecosystem Stakeholders

Establishing trust with HCPs is paramount. In oncology, engagement is particularly challenging due to the complexity of treatment decisions, rapid innovation, and personalized regimens. Unlike other therapeutic areas where treatment decisions may involve single agents spanning one benefit design, oncology treatments may include both medical and pharmacy benefits, span multi-specialty treatment modalities, and extend throughout the patient journey from diagnosis to survivorship.

To build trust, biopharma companies must demonstrate a deep understanding of the clinical, operational, and financial complexities that oncologists face. This includes education using an omnichannel approach, articulating value across different treatment settings, and supporting outcomes from biomarker testing through therapy integration and post-prescribing considerations such as adherence and toxicity management. Studies show oncologists manage over 200 cancer conditions with limited field engagement, emphasizing the need for efficient, meaningful messaging.^5,6

A lack of effective field tactical approaches designed to reduce educational and operational product implementation may limit prescribing for oncologists that do not have resources with staffing shortages. Effective engagement should include compliant tactical solutions such as order sets, biomarker testing resources, and seamless collaboration between commercial and medical teams to support scientific exchange on toxicity management and adherence.

This robust approach builds trust and strengthens biopharma relationships beyond the individual product while reflecting positively on the overall biopharma company that may be planning for future line extensions or new product launches in the oncology space.⁷

3. Financial Value Proposition and Payment Model Considerations

A well-defined financial value proposition is critical given oncology’s diverse payment models and practice economics. Unlike other therapeutic areas, oncology practices derive over 50% of their revenue from buy-and-bill drug reimbursement.8 In contrast, areas like primary care rely more on evaluation and management services rather than pharmaceuticals.

Misunderstandings of the non-clinical factors that drive prescribing repeatedly misinform strategy, a negative consequence that can be avoided with targeted market research. Below are some financial levers that should be considered when designing contracting strategies and other financial models. Not getting this piece effectively designed can strangle market access.

Key Financial Considerations

• Payer Arrangements: Contracting strategies must address both fee-for-service (FFS) models—where drug margins and rebates drive value—and value-based care (VBC) models, where success depends on total cost of care or outcomes. Biopharma companies must also navigate evolving drug pricing regulations, such as the Inflation Reduction Act (IRA) and the impact of regulatory change on reimbursement.^9,10
• Product Complexity and Site of Care: Some therapies, such as bispecific antibodies, require inpatient initiation but outpatient maintenance administration, introducing multi-stakeholder financial considerations. Additionally, drug costs can vary significantly based on the site of care, with hospital outpatient settings often being more expensive than private practices.¹¹ Emerging trends, including infusion suites, home administration, and physician-owned SPs, may further influence product adoption and financial viability.
• Alignment with Practice Goals: For oral therapies covered under the pharmacy benefit, the network dispensing strategy is a critical consideration, particularly for limited distribution products. Including a stakeholder in the dispensing network has significant financial and relationship implications, making it essential to align market access strategies with network design. For example, incorporating integrated medical dispensing within the network can strengthen engagement with community oncology practices, enhance care coordination, and improve medication adherence.¹² Conversely, a network centered on traditional SPs may offer greater scalability and deeper PBM integration and experience. Beyond dispensing strategies, practice alignment can be further enhanced through medical affairs collaborations, such as real-world evidence generation—an asset in the context of VBC contracts.⁹

Biopharma companies should implement flexible financial value proposition strategies that deliver value across diverse customer segments and payment models. Traditional rebate-focused contracting at the PBM or payer level may not provide sufficient value at the practice or IDN level, where additional barriers such as pathways exist. VBC or other flexible or combination financial pricing considerations can offer a more adaptable solution, particularly if improving outcomes across the patient journey, capturing real-world patient experience, or balancing financial drivers beyond drug margin is important.⁹

The Path Forward: Deep Oncology Expertise as a Necessity

Oncology market access requires a tailored approach that extends beyond traditional commercial frameworks. With rising drug costs and increasing payer controls, the future will demand bespoke managed market strategies to balance product access with affordability and outcomes. Future oncology market access strategies should incorporate:

• Integrated insights and omnichannel engagement. Example solutions include tools to support multi-disciplinary education across different learning platforms, operational tactics such as order sets to streamline adoption and key support programs like patient assistance initiatives. Ultimately, biopharma cross-functional collaboration remains key for execution. This includes aligning market access, patient services, and medical affairs, when possible, to develop customized solutions that address access barriers and improve patient outcomes.
• Deep clinical expertise spanning the patient journey from the key areas such as diagnosis, treatment selection, and beyond into survivorship and end-of-life care. It also includes incorporating different stakeholder experiences beyond payers and PBMs, and considers others such as IDNs, GPOs, and community oncology.
• Forward-looking clinical and economic value aligned with diverse payment models across both FFS and VBC arrangements not just for the healthcare environment today. Strategies need forward-looking positioning for the evolving healthcare, regulatory, and treatment landscape.

In an era of rapid innovation and shifting payment landscapes, oncology-focused market access expertise is no longer a competitive advantage—it is a necessity. Biopharma companies that embrace this specialized approach will optimize product launches and ensure transformative therapies reach the patients who need them most.

References

1. www.drugdiscoverytrends.com/top-50-pharma-companies-by-drug-discovery-patents-and-other-insights/.

2. www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-oncology-trends-2024.

3. www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.

4. www.mmitnetwork.com/thought-leadership/pathway-or-perish-the-two-pronged-hurdle-to-ensuring-access-in-oncology/.

5. www.zs.com/insights/restricted-access-pharma-reps-rethinking-sales-planning-oncology.

6. www.cancerresearchuk.org/about-cancer/what-is-cancer/how-cancer-starts/types-of-cancer.

7. www.pharmexec.com/view/driving-innovation-how-collaboration-between-medical-affairs-and-commercial-teams-is-transforming-the-industry#.

8. www.appliedpolicy.com/the-impact-of-the-inflation-reduction-act-on-physicians/?utm_source=chatgpt.com.

9. www.valuebasedcancer.com/issues/2021/december-2021-vol-12-no-6/3001-avbcc-panel-explores-value-based-contracting-in-oncology-care?utm_source=chatgpt.com.

10. https://www.cardinalhealth.com/en/services/specialty-physician-practice/resources/healthcare-policy/inflation-reduction-act.html.

11. www.ebri.org/health/publications/issue-briefs/content/cost-differences-for-oncology-medicines-based-on-site-of-treatment.

12. www.prnewswire.com/news-releases/prime-therapeutics-finds-1-1-million-waste-reduction-opportunity-with-medically-integrated-dispensing-compared-to-central-specialty-pharmacy-301559458.html.