Rethinking Evidence Generation for In-Licensed Assets: A Case from Follicular Lymphoma

In-licensing can be a powerful strategy for pharma companies looking to expand their portfolios quickly. But when it comes to oncology, particularly in areas like relapsed-refractory follicular lymphoma, acquired assets often come with baggage: fragmented trials, uncertain value, and evidence strategies that weren’t designed with long-term global access in mind.

One company found itself in exactly this position. The asset it had brought in showed promise, but the evidence base was fractured, the regulatory pathway was risky, and payer negotiations loomed large. Without a reset, the product risked stalling before it could achieve sustainable impact.

Where the Asset Stood

The challenges were complex, but clear:

• No unified strategy: Evidence generation efforts were scattered, failing to bridge regulatory, payer, and clinical requirements across regions.

• Inherited inefficiencies: The company was spending heavily on investigator-initiated trials (IITs) that offered little relevance to HTA or reimbursement bodies.

• Fragile clinical foundation: Approval was built on a single-arm trial, limiting the asset’s credibility against competitors with stronger comparative data.

• US-driven burdens: Post-marketing commitments demanded by the FDA were draining resources and slowing progress in other regions.

• Global blind spots: Without real-world data or economic evidence, the product’s long-term sustainability in the rest of the world was in doubt.

For an asset that needed to prove its value fast, this was an unsustainable trajectory.

How the Strategy Shifted

The company took a step back and reimagined its approach through an Integrated Evidence Generation Plan (IEGP). The process began with deep listening — interviews across alliance stakeholders helped surface frustrations, priorities, and opportunities. A targeted review of competitors’ strategies revealed what successful HTA and payer submissions had in common, providing a benchmark for success.

From there, two workshops laid the groundwork for transformation:

• Strategic Alignment: The first session focused on diagnosing the gaps. What were the biggest barriers to access? Where was the evidence weakest? What data would truly matter to regulators, HTA bodies, and payers?

• Execution & Ownership: The second session shifted into solutions. The team designed comparative effectiveness studies to strengthen the clinical story, planned RWE initiatives to demonstrate long-term safety and effectiveness, and developed payer-focused HEOR models to articulate value. Importantly, US post-marketing requirements were not treated as a burden in isolation but woven into a broader, globally relevant strategy. Clear roles and responsibilities ensured that delivery wouldn’t slip through the cracks.
  
  The Results
  
  

  The impact was immediate and practical:

  • Smarter spending: Low-value IITs were cut or repurposed, freeing resources for evidence that truly moved the needle.

  • Stronger submissions: With new comparative and real-world data, the asset was positioned to engage HTA bodies and payers with confidence.

  • Improved reimbursement potential: Tailored HEOR and economic modeling supported more favorable pricing and access outcomes.

  • Regulatory resilience: US post-marketing obligations were aligned with global needs, creating a smoother pathway across markets.

  • Future-proofing: A long-term evidence plan for ROW markets ensured the product wouldn’t stall outside of the US and EU.
    
    What This Case Shows
    
    

    This experience underscores a broader truth about in-licensed assets: inheriting a product means inheriting its evidence gaps. Unless those are proactively addressed, companies risk pouring resources into studies that add little strategic value.

    By reframing evidence generation as a unified, cross-market, and payer-conscious strategy, the client not only rescued an asset from stagnation but also built the foundation for sustainable global impact.

    For pharma leaders, the lesson is clear: don’t just inherit an asset, rebuild its evidence story for the future.